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Item 1. Business

2023-03-30 compared with 2022-03-24 · 763 added, 750 removed, 246 unchanged (86% of the section changed)

Business Overview

We are a biomedical company focused on transforming women’s healthcare by developing novel solutions and next-generation advancements providing significant clinical impact to address severely

underserved areas.

Our mission is to provide women worldwide with superior minimally-invasive, non-surgical product technologies, accessible in the office, improving patient care and overall health economics.

We are a woman-founded and led

company with an expansive, internally created intellectual property portfolio with over 150 patents globally, in-house chemistry, manufacturing, and controls (CMC) and device manufacturing capabilities and proven ability to develop and

commercialize products.

Our suite of products and product candidates address what we believe are multi-billion dollar global market segments in which there has been little advancement for many years, helping women avoid pharmaceutical solutions,

implants and surgery that can be expensive and expose women to harm.

We are a biomedical company focused on transforming women’s healthcare by developing novel solutions and next-generation advancements providing significant clinical impact to address severely underserved areas.

mission is to provide women with superior minimally-invasive, non-surgical product technologies, accessible in the office, improving patient care and overall health economics.

We are a woman-founded and led company with an expansive, internally

created intellectual property portfolio with over 150 patents globally, in-house chemistry, manufacturing, and controls (CMC) and device manufacturing capabilities and proven ability to develop and commercialize products.

Our suite of products

and product candidates addresses what we believe are multi-billion dollar global market segments in which there has been little advancement for many years, helping women avoid pharmaceutical solutions, implants and surgery that can be expensive

and expose women to harm.

With an initial focus in the area of reproductive health, our two lead product candidates offer solutions for two ends of the spectrum:

FemBloc for permanent birth control and

FemaSeed as an artificial insemination infertility treatment.

FemBloc for permanent birth control and FemaSeed as an artificial insemination

infertility treatment.

FemBloc – Our Permanent Birth Control Solution .

Our permanent birth control solution in development includes our proprietary FemBloc system, which

features dual intrauterine directional delivery targeting both fallopian tubes simultaneously with a degradable biopolymer followed by an ultrasound confirmation test to confirm procedure success.

If approved, we expect FemBloc to be the first

and only non-surgical permanent birth control option, using a minimally invasive delivery system that locally instills a degradable biopolymer, which is designed to cause the fallopian tubes to close using the patient’s own scar tissue, resulting

in permanent birth control for the patient without a permanent implant.

We believe the FemBloc solution will be the safest and most natural approach for permanent birth control.

FemBloc has the potential to offer significant advantages over the

only existing option, surgical tubal ligation, or “having her tubes tied.” FemBloc is a procedure that can be completed in a physician’s office, with no anesthesia, no incisions or cannulation, no specialty skill set or capital equipment and

minimal pain and recovery time, and no residual implant remaining in the patient’s body after the scar tissue develops, which we believe will likely be at half the cost.

We believe there are also significant advantages over other temporary or

reversible methods that women may be using in lieu of the surgical tubal ligation option, as FemBloc does not use hormones or leave a long-term implant behind.

Our permanent birth control solution combines FemBloc with an ultrasound in-office

diagnostic test, which uses saline and air contrast to permit the same physician to evaluate the fallopian tubes in-office to confirm the success of FemBloc approximately three months after the FemBloc procedure, rather than requiring the patient

to visit another provider for a radiology-based exam, exposing the patient unnecessarily to radiation and the use of x-ray dye.

We have studied FemBloc in two clinical trials (a pilot safety study and a pivotal trial) pursuant to an FDA approved investigational device exemption (IDE) evaluating safety in a total of 183

Subjects are being followed for five years for safety, and for the initial 49 subject pilot study, three years of follow-up have been completed.

There have been no serious safety events reported to date in any of the subjects and over

90% of the events reported that were classified as related to the device, procedure or both, were on the day of the procedure or within seven days after the procedure.

The reported events were anticipated and the majority (80%) of these events

were bleeding or spotting and/or pain or cramps and over 75% were classified by the physician as mild.

Physicians observed that their subjects found the procedure to be highly tolerable, with subject self-reported pain scores similar to placement

Almost every case (96%) was assessed by the physician to be extremely simple or very simple to perform and 99% found it easier than tubal ligation surgery.

At the ultrasound confirmation test conducted three months following the FemBloc

procedure, there was no evidence of remaining biopolymer detected in subjects, which may indicate that the biopolymer completely degraded and likely exited the subject with possible menstruation.

Subjects found the FemBloc procedure and

confirmation test to be highly tolerable, with pain or discomfort scores similar to placement of other intrauterine devices, such as IUDs.

The mean score for FemBloc procedure was 4.3 and for the confirmation test was 3.0, on visual analog scale

(VAS) from 0-10 where 10 is the highest measure of pain/ discomfort.

During the conduct of these two clinical studies, unintended pregnancies occurred in subjects who were told to rely on FemBloc (six pregnancies for the pilot study and three pregnancies for the

pivotal trial).

Our permanent birth control solution in development includes our proprietary FemBloc system, which features dual intrauterine

directional delivery targeting both fallopian tubes simultaneously with a degradable biopolymer followed by an ultrasound confirmation test to confirm procedure success.

If approved, we expect FemBloc to be the first and only non-surgical

permanent birth control option, using a minimally invasive delivery system that locally instills a degradable biopolymer, which is designed to cause the fallopian tubes to close using the patient’s own scar tissue, resulting in permanent birth

control for the patient without a permanent implant.

FemBloc has the potential to offer significant advantages over the only existing option, surgical tubal ligation, or “having her tubes tied.” FemBloc is a procedure that can be completed in a

physician’s office, with no anesthesia, no incisions or cannulation, no specialty skill set or capital equipment and minimal pain and recovery time, and no residual implant remaining in the patient’s body after the scar tissue develops, which we

believe will likely be at half the cost.

We believe there are also significant advantages over other temporary or reversible methods that women may be using in lieu of the surgical tubal ligation option, as FemBloc does not use hormones or leave

a long-term implant behind.

Our permanent birth control solution combines FemBloc with an ultrasound in-office diagnostic test, which uses saline and air contrast to permit the same physician to evaluate the fallopian tubes in-office to confirm

the success of FemBloc approximately three months after the FemBloc procedure, rather than requiring the patient to visit another provider for a radiology-based exam, exposing the patient unnecessarily to radiation and the use of x-ray dye.

We have studied FemBloc in three clinical trials (a pilot safety study, a pivotal trial, and a validation study) pursuant to an FDA approved investigational device exemption (IDE) for each study with evaluation of

safety in a total of 228 subjects.

Subjects are being followed for five years for safety, and for the initial 49 subject pilot study, four years of follow-up have been completed.

There have been no serious safety events reported to date in any of

the subjects and over 90% of the events reported that were classified as related to the device, procedure or both, were on the day of the procedure or within seven days after the procedure.

The reported events were anticipated and the majority of

these events were bleeding or spotting and/or pain or cramps and over 75% were classified by the physician as mild.

Physicians observed that their subjects found the procedure to be highly tolerable, with subject self-reported pain scores similar

to placement of IUDs.

Almost every case (96%) was assessed by the physician to be extremely satisfied or very satisfied with the procedure and 96% found it easier than tubal ligation surgery.

At the ultrasound confirmation test conducted three

months following the FemBloc procedure, there was no evidence of remaining biopolymer detected in subjects, which may indicate that the biopolymer completely degraded and likely exited the subject with possible menstruation.

Subjects found the

FemBloc procedure and confirmation test to be highly tolerable, with pain or discomfort scores similar to placement of other intrauterine devices, such as IUDs.

The mean score for FemBloc procedure was 4.6 and for the confirmation test was 3.3,

on visual analog scale (VAS) from 0-10 where 10 is the highest measure of pain/ discomfort.

During the conduct of the first two clinical studies, unintended pregnancies occurred in subjects who were told to rely on FemBloc (six pregnancies for the pilot study and three pregnancies for the pivotal trial).

These pregnancies were due to misinterpretation of the ultrasound test using the FemChec device, as reviewed and confirmed by an independent clinical events committee.

FDA viewed these unintended pregnancies as a safety concern

and, as a result, in February 2019 we paused the pivotal clinical trial for FemBloc (although subjects are still followed for safety through 5 years).

Subsequently, the agency recommended conducting a small clinical study in a new cohort of

subjects to evaluate the adequacy of certain proposed mitigations and validate the ultrasound confirmation test.

We began this small study in June 2020 pursuant to an IDE approval, where up to 50 subjects at 5 U.S.

sites will receive two

confirmation tests (ultrasound and traditional radiology).

Subjects are informed to rely on FemBloc only if both tests confirm procedure success.

We plan to use the study data to support which of the two confirmation tests (ultrasound or

radiology) should be studied in a new pivotal trial to support a potential future application for PMA for FemBloc.

Results of the small study along with the trial design for the pivotal clinical trial is planned for submission to the FDA in the

first quarter of 2023.

FDA viewed these unintended pregnancies as a safety concern and, as a result,

in February 2019 we paused the pivotal clinical trial for FemBloc (although subjects are still followed for safety through 5 years).

Subsequently, the agency recommended conducting a small clinical study in a new cohort of subjects to evaluate

the adequacy of certain proposed mitigations and validate the ultrasound confirmation test.

The study enrollment concluded in September 2022, in which 45 subjects at five U.S.

sites received two confirmation tests (ultrasound and traditional

Subjects were informed to rely on FemBloc only if both tests confirm procedure success.

There were no pregnancies in subjects told to rely on FemBloc.

We plan to use the study data to support which of the two confirmation tests

(ultrasound or radiology) should be studied in a new pivotal trial to support a potential future application for PMA for FemBloc.

Results of the small study along with the trial design for the pivotal clinical trial is planned for submission to

the FDA in the first quarter of 2023.

FemaSeed – Our Artificial Insemination Solution .

Our artificial insemination solution in development includes our proprietary FemaSeed product candidate

for artificial insemination, which features single intrauterine directional delivery with sperm, offering significant advantages over existing artificial insemination solutions, including being the first and only approach that allows selective

delivery of sperm locally and directly to the fallopian tube where conception occurs.

Our artificial insemination solution combines FemaSeed with a diagnostic companion product, our FDA-cleared and marketed FemVue device, which, creates saline

and air contrast to safely assess the fallopian tubes for patency prior to treatment with FemaSeed.

Fallopian tube patency is necessary for successful fertilization, and we believe FemVue offers significant advantages over other existing

procedures, including being the first product for ultrasound evaluation of a woman’s fallopian tubes as part of a diagnostic infertility assessment.

The safety profile of FemaSeed to date is supported by data from our FemBloc clinical trials and

a post-market study of an identical single intrauterine directional delivery device design, for which we received FDA clearance for another indication.

In April 2021 we received an IDE approval from FDA that allowed us to initiate a pivotal trial

for the FemaSeed device.

The first subject was enrolled in July 2021, and we anticipate an analysis of interim data the fourth quarter of 2022.

Completion of enrollment is expected in the first half of 2023 followed by a planned submission of

the results from the trial to FDA in support of a future de novo classification request for FemaSeed.

Our FemVue product, a companion diagnostic to FemaSeed, currently has marketing clearances or

authorization in the United States, Europe, Canada, and Japan.

Our artificial insemination solution in development includes our proprietary FemaSeed product candidate for artificial

insemination, which features single intrauterine directional delivery with sperm, offering significant advantages over existing artificial insemination solutions, including being the only approach that allows selective delivery of sperm locally

and directly to the fallopian tube where conception occurs.

Our artificial insemination solution combines FemaSeed with a diagnostic companion product, our FDA-cleared and marketed FemVue device, which, creates saline and air contrast to safely

assess the fallopian tubes for patency prior to treatment with FemaSeed.

FemVue can be used with our FDA-cleared and marketed FemCath device, which allows for selective evaluation of the fallopian tube.

Fallopian tube patency is necessary for

successful fertilization, and we believe FemVue offers significant advantages over other existing procedures, including being able to provide ultrasound evaluation of a woman’s fallopian tubes as part of a diagnostic infertility assessment.

safety profile of FemaSeed to date is supported by data from our FemBloc clinical trials and a post-market study of an identical single intrauterine directional delivery device design, for which we received FDA clearance for another indication.

In April 2021 we received an IDE approval from FDA that allowed us to initiate a pivotal trial for the FemaSeed device.

The first subject was enrolled in July 2021.

In October 2022, we announced an updated study design for the pivotal trial,

which now focuses on couples experiencing male factor infertility.

This update reflects a revised strategy to address this underserved population experiencing infertility with a goal of facilitating accelerated enrollment.

Completion of

enrollment is expected in the second quarter of 2023 followed by a planned submission of the results from the trial to FDA in support of a future de novo classification request for FemaSeed.

Our FemVue product, a companion diagnostic to FemaSeed,

currently has marketing clearances or authorization in the United States, Canada, and Japan.

Our FemCath product, currently has marketing clearance in the United States.

Extenuating circumstances at clinical trial sites may result in a slowdown in enrollment due to consolidation activities and the aftermath of the

overturn of Roe v Wade.

It has been reported that there have been over 25 transactions since the start of 2021 in the infertility market, which is rapidly evolving into large commercial entities.

This rapidly changing market dynamics may be

disruptive to the practice and affect the conduct of clinical studies as integration occurs.

The American Society of Reproductive Medicine (ASRM) issued a statement March 17, 2023 on the abortion policy proposals affecting reproductive

ASRM stated, “At the crux of the issue many of the proposals to ban or otherwise limit access to abortion care fail to protect the use of assisted reproductive technologies, including IVF, and so-called “personhood” measures

(defining life as beginning at conception or fertilization) are multiplying across the nation, causing alarm bells to sound for medical practitioners and infertility patients alike.

Such proposals could, intentionally or not, limit and even ban

the use of IVF and routine, safe, and medically proven procedures, such as the removal of an embryo that fails to implant in a uterus, or the disposal of unused embryos.” This uncertainty may affect subject enrollment in clinical studies being

conducted at facilities providing infertility services.

Additional Women’s Health Solutions .

We have also developed a novel technology platform for tissue sampling intended to be marketed alongside our other

women-specific medical products in the physician’s office setting.

Our FDA-cleared FemCerv product is a biopsy device for endocervical curettage that can be used to sample cervical cells and tissue circumferentially with sample containment within

the device to minimize contamination.

We have also developed a novel technology platform for tissue sampling intended to be marketed alongside our other women-specific medical

products in the physician’s office setting.

Our FDA-cleared FemCerv product is a biopsy device for endocervical curettage that can be used to sample cervical cells and tissue circumferentially with sample containment within the device to minimize

contamination.

We sponsored a post-market study of FemCerv where subjects found the procedure to be relatively pain-free and the sample obtained was complete for analysis, which we believe may aid in reliable diagnosis.

FemEMB product candidate in development is designed to obtain a comprehensive and uncontaminated sample of the endometrial cells and tissue in an office procedure.

We believe there is a market opportunity for use of FemEMB in continuous

monitoring by multiple sampling procedures that may be employed by physicians during and after treatments for cancers, abnormal bleeding, or other uterine treatments, such as prior to an endometrial ablation.

In addition, we plan to explore

expanded indications for the single or dual intrauterine directional delivery to instill therapeutic drugs for the treatment of ailments of the fallopian tubes, for which we have issued patents.

Our FemCerv product was

introduced to the United States market in December 2022.

Our FemEMB product candidate in development is designed to obtain a comprehensive and uncontaminated sample of the endometrial cells and tissue in an office procedure.

We believe there is

a market opportunity for use of FemEMB in continuous monitoring by multiple sampling procedures that may be employed by physicians during and after treatments for cancers, abnormal bleeding, or other uterine treatments, such as prior to an

endometrial ablation.

In addition, we plan to explore expanded indications for the single or dual intrauterine directional delivery to instill therapeutic drugs for the treatment of ailments of the fallopian tubes, for which we have issued

The following table summarizes our current products and product candidate pipeline:

We are a woman-founded, woman-led biomedical company, with a team of experienced biotechnology and medical device developers.

Our founder and chief executive officer, Kathy Lee-Sepsick has over

25 years of entrepreneur and executive experience in the medical device field with over 100 patents globally.

Dov Elefant, our chief financial officer, has over 25 years of experience leading public and private biotech companies throughout

various stages.

Our founder and chief executive officer, Kathy Lee-Sepsick has over 25 years of

entrepreneur and executive experience in the medical device field with over 100 patents globally.

Dov Elefant, our chief financial officer, has over 25 years of experience leading public and private biotech companies throughout various stages.

Edward Evantash, MD, our chief medical officer, has over 20 years of successful leadership in medical affairs and clinical strategy development and practiced as an obstetrician-gynecologist.

Daniel Currie, our Senior Vice

President, Operations has over 30 years of operational experience in the medical device industry, including assignments at early stage and large, established companies.

Our experienced leadership team with concentrated development expertise has

an unwavering commitment to advancing women’s health.

We have raised over $100 million since inception from both institutional and strategic investors, including Medtronic and executives from leading life science companies and our initial public

offering, or IPO, in June 2021.

Daniel Currie, our Senior Vice President,

Operations has over 30 years of operational experience in the medical device industry, including assignments at early stage and large, established companies.

Christine Thomas, our Senior Vice President, Regulatory & Clinical Affairs has over

20 years of successful leadership including global strategy development, operations, and executive responsibility for established medical device companies.

Our experienced leadership team with concentrated development expertise has an unwavering

commitment to advancing women’s health.

We have raised over $100 million since inception from both institutional and strategic investors, including Medtronic and executives from leading life science companies and our initial public offering, or

IPO, in June 2021.

Our Intellectual Property and Production Capabilities

We have designed and developed the proprietary methods utilized in our women’s health solutions so that they are protected by patents, know-how, and trade secrets.

Each product and product

candidate in our portfolio is covered by both design and utility patents in the U.S.

Each product and product candidate in our

portfolio is covered by both design and utility patents in the U.S.

and significant ex-U.S.

1 unchanged sentence

patents and 122 issued foreign patents, 13 pending U.S.

patent applications

and 23 pending foreign patent applications.

patent applications and 17 pending

foreign patent applications.

These issued patents, and any patents granted from such applications, are expected to expire between 2023 and 2046, without taking potential patent term extensions or adjustments into account.

All of our products are manufactured or assembled at our facility, and manufacturing activities are conducted to ensure compliance with the FDA and good manufacturing practices with significant

CMC and device manufacturing infrastructure in compliance with QSR.

All of our products are manufactured or assembled at our facility, and manufacturing activities are conducted to ensure compliance with the FDA and good manufacturing practices with significant CMC and device

manufacturing infrastructure in compliance with QSR.

We have passed numerous manufacturing audits, including those by the FDA and international notified bodies.

Our goal is to become a global leader in women’s health providing safe and effective solutions that have the potential to disrupt and grow the market segments for which they address.

achieve this goal and to contribute to our future success and growth, we are pursuing the following strategies.

To achieve this goal and to

contribute to our future success and growth, we are pursuing the following strategies.

Address unmet clinical needs in multiple large markets for women.

Our initial focus is on critical areas of unmet need in reproductive health, which

is a growing challenge for women that is not optimally addressed with existing therapies.

Two ends of the spectrum (permanent birth control and infertility with artificial insemination) represent large, growing total addressable market

opportunities.

Patients who wish to control their risk of pregnancy are often utilizing temporary or reversible options or are choosing the only permanent option that bears surgical risk and expense.

We believe our FemBloc system has the

potential to offer the first non-surgical, non-implant option performed exclusively in the office without the use of anesthesia, which would potentially allow a doctor to perform multiple procedures in the same room.

Our initial focus is on critical areas of unmet need in reproductive health, which is a growing challenge

for women that is not optimally addressed with existing therapies.

Two ends of the spectrum (permanent birth control and infertility with artificial insemination) represent large, growing total addressable market opportunities.

Patients who wish

to control their risk of pregnancy are often utilizing temporary or reversible options or are choosing the only permanent option that bears surgical risk and expense.

We believe our FemBloc system has the potential to offer the first

non-surgical, non-implant option performed exclusively in the office without the use of anesthesia, which would potentially allow a doctor to perform multiple procedures in the same room.

We estimate that the U.S.

market for the FemBloc system may be over $20 billion with an immediate addressable market of over $2 billion annually.

market for the FemBloc system

may be over $20 billion with an immediate addressable market of over $2 billion annually.

We consider those electing surgery for permanent birth control annually to be our immediately addressable market.

are struggling to become pregnant are often referred to highly specialized physicians for treatment with age-old technology.

We believe our FemaSeed product has the potential to offer the first local delivery of sperm directly to the fallopian

tubes where conception occurs.

Patients who are struggling to become

pregnant are often referred to highly specialized physicians for treatment with age-old technology.

We believe our FemaSeed product has the potential to offer the first local delivery of sperm directly to the fallopian tubes where conception

We estimate the U.S.

market for FemaSeed and FemVue, a companion diagnostic product, may be over $2 billion with the immediate addressable market of over $800 million.

Execute on our clinical program to achieve FDA approval to advance our FemBloc system for use together with our companion diagnostic device for ultrasound

confirmation as the preferred option for permanent birth control for women.

We have studied FemBloc in two clinical trials pursuant to an FDA-approved IDE evaluating safety in 183 subjects and these subjects are continuing to be followed

We plan to complete the on-going small IDE study (stage II validation study), which began in June 2020, and submit the results of this study to support IDE approval for a pivotal trial that we expect to serve as the clinical support

for a future PMA approval for FemBloc.

Enrollment in this stage II validation study is expected to be completed in third quarter of 2022.

Execute on our clinical program to achieve FDA approval to advance our FemBloc system for use together with our companion diagnostic device for ultrasound confirmation as the

preferred option for permanent birth control for women.

We have studied FemBloc in three clinical trials pursuant to an FDA-approved IDE evaluating safety in 228 subjects and these subjects are continuing to be followed for safety.

plan to submit results from a small IDE study (stage II validation study), which concluded enrollment in September 2022 to support IDE approval for a pivotal trial that we expect to serve as the clinical support for a future PMA approval for

IDE submission to the FDA for the pivotal trial to support PMA approval is expected in first quarter of 2023.

Execute on our clinical program to achieve FDA grant of a de novo classification request to advance our FemaSeed product for use together with our companion

diagnostic, FemVue saline-air device, as the preferred option for artificial insemination.

The safety profile of FemaSeed is supported by data from our FemBloc clinical trials and a post-market study of an identical single intrauterine

directional delivery device design, which received FDA clearance for another indication.

In April 2021 we received an IDE approval from FDA that allowed us to initiate the pivotal trial for the FemaSeed device, with the first patient treated in

We plan on an interim data analysis in fourth quarter of 2022 and enrollment in this pivotal trial is expected to be completed in second quarter of 2023.

Execute on our clinical program to achieve FDA grant of a de novo classification request to advance our FemaSeed product for use together with our companion diagnostic, FemVue

saline-air device, as the preferred option for artificial insemination.

The safety profile of FemaSeed is supported by data from our FemBloc clinical trials and a post-market study of an identical single intrauterine directional

delivery device design, which received FDA clearance for another indication.

In April 2021 we received an IDE approval from FDA that allowed us to initiate the pivotal trial for the FemaSeed device, with the first patient treated in July 2021.

October 2022, we announced an updated study design for the pivotal trial, which will now focus on couples experiencing male factor infertility.

This update reflects a revised strategy to address this underserved population experiencing

infertility with a goal of facilitating accelerated enrollment.

Enrollment in this pivotal trial is expected to be completed in second quarter of 2023.

Continuously innovate to introduce additional product offerings for women .

We intend to continue to invest in research and development activities

focused on additional women-specific medical products and improvements and enhancements to our FemBloc system and FemaSeed product.

In addition, we have initiated manufacturing of our FDA-cleared sterile, single-use endocervical tissue sampling

product, FemCerv.

We intend to continue to invest in research and development activities focused on additional

women-specific medical products and improvements and enhancements to our FemBloc system and FemaSeed product.

In addition, we have initiated manufacturing of our FDA-cleared sterile, single-use endocervical tissue sampling product, FemCerv, which

was introduced to the U.S.

market the end of 2022.

We are continuing to develop FemEMB, a product candidate in development for endometrial sampling in support of uterine cancer detection testing.

We have designed and developed proprietary methods utilized in our women’s health

solutions and have protected these internally conceived advancements by patents, know-how, and trade secrets.

Our team has demonstrated the ability to achieve marketing authorizations and clearances in the U.S., Europe, Canada, and Japan and to

manufacture in accordance with FDA and other international governing bodies.

Availability of the additional product offerings will expand our suite of solutions for reproductive health and women’s health in general over time with the goal of

addressing aspects of care that have had negligible advancement over decades to create improved patient care and improved physician treatment options.

We have designed and developed proprietary

methods utilized in our women’s health solutions and have protected these internally conceived advancements by patents, know-how, and trade secrets.

Our team has demonstrated the ability to achieve marketing authorizations and clearances in the

U.S., Europe, Canada, and Japan and to manufacture in accordance with FDA and other international governing bodies.

Availability of the additional product offerings will expand our suite of solutions for reproductive health and women’s health in

general over time with the goal of addressing aspects of care that have had negligible advancement over decades to create improved patient care and improved physician treatment options.

Penetrate the addressable markets by promoting patient and practice awareness .

It is estimated in the U.S.

alone, approximately 800,000 women elect

surgical tubal ligation (Frattarelli et al, 2007) and 500,000 men elect vasectomy (Ostrowski, et al, 2018) annually for permanent birth control.

There are another 12 million women who utilize a non-permanent birth control option, many of whom we

believe may prefer a permanent option if it were nonsurgical.

We believe the major factor that influences this light penetration of the market is the limitations of the existing technology despite the likely familiarity of tubal ligation as an

In addition, with respect to the problem of infertility, it is currently estimated that in the United States alone, over nine million women are infertile and only a little over half proceed with some form of intervention, and only a very

small proportion undergo more advanced technologies.

We believe the major factor that influences this light penetration of the market is the cost and burden of the existing technologies despite the familiarity of intrauterine insemination as a

first-line option.

alone, approximately 800,000 women elect surgical tubal ligation

(Frattarelli et al, 2007) and 500,000 men elect vasectomy (Ostrowski, et al, 2018) annually for permanent birth control.

There are another 12 million women who utilize a non-permanent birth control option, many of whom we believe may prefer a

permanent option if it were nonsurgical.

We believe the major factor that influences this light penetration of the market is the limitations of the existing technology despite the likely familiarity of tubal ligation as an option.

with respect to the problem of infertility, it is currently estimated that in the United States alone, over 10 million women are infertile and approximately 40-50% is attributed to male factor (Kumar et al, 2015).

Only a little over half proceed

with some form of intervention and only a very small proportion undergo more advanced technologies.

We believe the major factor that influences this light penetration of the market is the cost and burden of the existing technologies despite the

familiarity of intrauterine insemination (IUI) and in-vitro fertilization (IVF) as options.

We intend to increase physician awareness through engagement and continued publication of scientific data in peer reviewed journals.

Further, we intend to engage women who are candidates for permanent birth control or who

suffer from infertility through direct patient outreach.

Further, we intend to

engage women who are candidates for permanent birth control or who suffer from infertility through direct patient outreach.

Build a commercialization infrastructure with a specialized direct sales and marketing team .

From the outset, we spent significant time understanding

the unmet needs of patients and physicians through patient and physician surveys and early engagement of physicians and key opinion leaders to properly position our solutions.

We plan to establish a commercial infrastructure prior to a potential

FDA de novo classification of our FemaSeed product.

From the outset, we spent significant time understanding the unmet needs of

patients and physicians through patient and physician surveys and early engagement of physicians and key opinion leaders to properly position our solutions.

We plan to establish a commercial infrastructure prior to a potential FDA de novo

classification of our FemaSeed product.

Our already commercially available FemVue device will be marketed along with the FemaSeed product to the same target physician, the reproductive endocrinologist.

We intend to focus the

significant majority of our sales and marketing efforts in the United States since we believe that initially nearly 90% of the potential annual global FemaSeed/FemVue sales would be generated in this market.

Our priority is to target existing

FemVue customers followed by reproductive endocrinologists in high volume areas.

Our plan is to hire a specialty sales force for our infertility products and increase the sales force as necessary for the FemBloc system, where the target physician

is the gynecologist.

In addition, we plan to continue to expand our in-house manufacturing capabilities as we scale to meet the demand and introduce new products while evaluating potential suppliers to assess the viability of outsourcing portions

of our manufacturing and assembly processes to ensure significant growth, profitability and operating leverage.

We intend to focus the significant majority

of our sales and marketing efforts in the United States since we believe that initially nearly 90% of the potential annual global FemaSeed/FemVue sales would be generated in this market.

Our priority is to target existing FemVue customers

followed by reproductive endocrinologists in high volume areas.

Our plan is to hire a specialty sales force for our infertility products and increase the sales force as necessary for the FemBloc system, where the target physician is the

gynecologist.

Our already commercially available FemCerv device will be marketed along with the FemBloc product to the same target physician, the gynecologist.

In addition, we plan to continue to expand our in-house manufacturing capabilities as

we scale to meet the demand and introduce new products while evaluating potential suppliers to assess the viability of outsourcing portions of our manufacturing and assembly processes to ensure significant growth, profitability and operating

Expand gynecologists’ practice capabilities by diversifying products and services to include artificial insemination with FemaSeed.

There are a limited

number of gynecologists performing infertility services and treatment today, but we believe this has the potential to grow over time, in particular with the introduction of FemaSeed.

FemaSeed is designed to be an in-office infertility procedure

that can be done by a gynecologist using his or her existing skillset, expanding the number of gynecologists that can offer effective fertility services to their patients without needing to refer them to an infertility specialist.

We plan to use

our gynecologic sales force for FemBloc, if approved, to introduce those physicians to FemaSeed and broaden our sales force reach for our infertility treatment beyond our initial focus on reproductive endocrinologists.

There are a limited number of

gynecologists performing infertility services and treatment today, but we believe this has the potential to grow over time, in particular with the introduction of FemaSeed.

FemaSeed is designed to be an in-office infertility procedure that can be

done by a gynecologist using his or her existing skillset, expanding the number of gynecologists that can offer effective fertility services to their patients without needing to refer them to an infertility specialist.

We plan to use our

gynecologic sales force for FemBloc, if approved, to introduce those physicians to FemaSeed and broaden our sales force reach for our infertility treatment and other companion products, such as FemVue, beyond our initial focus on reproductive

endocrinologists.

The Current Market Landscape

For permanent birth control, tubal ligation, an invasive surgical procedure requiring implants, incisions, hospitalization and general anesthesia, has been offered for decades, so risks are

It is performed either immediately after cesarean delivery or via laparoscopic procedures, which has notable disadvantages and risk of complications.

The most significant morbidity arising from tubal ligation is associated with the use of

electrical energy and inadvertent thermal damage to the bowel.

Introduction of surgical instruments into the abdominal cavity carries substantial risk of injury to intra-abdominal organs and blood vessels, with approximately 1% of all procedures

resulting in unintended further major surgery.

For permanent birth control, tubal ligation, an invasive surgical procedure requiring implants, incisions, hospitalization and general anesthesia, has been offered for decades, so risks are known.

It is performed

either immediately after cesarean delivery or via laparoscopic procedures, which has notable disadvantages and risk of complications.

The most significant morbidity arising from tubal ligation is associated with the use of electrical energy and

inadvertent thermal damage to the bowel.

Introduction of surgical instruments into the abdominal cavity carries substantial risk of injury to intra-abdominal organs and blood vessels, with approximately 1% of all procedures resulting in

unintended further major surgery.

In addition, anesthesia risk, bleeding, bowel damage, and long recovery times are inherent complication risks of tubal ligation.

Temporary and reversible contraceptive methods, such as birth control

and intrauterine devices (IUDs), are being used by women long-term as a compromise by women who are unwilling to undergo a surgical sterilization procedure because of the surgical risk, not wanting an incision, or to be exposed to risk of

Temporary and reversible contraceptive methods, such as birth control and

intrauterine devices (IUDs), are being used by women long-term as a compromise by women who are unwilling to undergo a surgical sterilization procedure because of the surgical risk, not wanting an incision, or to be exposed to risk of anesthesia.

Some may be contraindicated for surgical sterilization because of obesity or medical conditions.

Long-term use of hormonal birth control and IUDs have drawbacks as well.

Hormonal birth control is associated with health risks, such as

an increased risk of breast cancer and blood clots, and device-based birth control can result in uterine perforation and increased risks of pelvic inflammatory disease and ectopic pregnancy.

Previously available nonsurgical methods utilizing

permanent implants for closing the fallopian tubes have been removed from the market due to safety or intellectual property infringement issues, and thus the only currently available permanent birth control option is surgical tubal ligation.

Hormonal birth control is associated with health risks, such as an increased

risk of breast cancer and blood clots, and device-based birth control can result in uterine perforation and increased risks of pelvic inflammatory disease and ectopic pregnancy.

Previously available nonsurgical methods utilizing permanent

implants for closing the fallopian tubes have been removed from the market due to safety or intellectual property infringement issues, and thus the only currently available permanent birth control option is surgical tubal ligation.

For artificial insemination, traditional intrauterine insemination (IUI) is an undirected procedure delivering sperm into the uterine cavity that has been offered for decades.

IUI continues to

be offered as a first-line treatment option in spite of its low success rate due to its low cost and ease, with a short learning curve and minimal equipment requirements.

Although current IUI devices address the unfavorable environment sperm

would encounter in the vagina and cervix by placing sperm into the uterine cavity, the biology of sperm transport is complex and of the millions of sperm inseminated in the uterus, almost all fail to reach the fallopian tubes.

In contrast to the

unfavorable environment of the uterus, the fallopian tubes act as a reservoir for traveling sperm and is the location of conception.

Many women are unwilling to undergo treatment mostly due to financial reasons.

In vitro fertilization (IVF) is

extremely expensive, costing as much as $15,000 to $30,000 per IVF cycle according to Forbes Health, 2021 (with cycle effectiveness usually only around 25%), and often not covered by insurance.

IVF is also physically and emotionally demanding for

the patient, with increased risk of multiple pregnancies, ectopic pregnancy and miscarriage.

There are over nine million women in the United States known to be infertile and only 200,000 IVF cycles completed per year, indicating that IVF is not a

realistic solution available to most women.

Our FemaSeed product candidate, if approved, would establish a new category of artificial insemination:

a localized, directional delivery of sperm directly into the fallopian tube, precisely where

conception occurs.

We believe this in-office, cost-effective solution can become a first-line treatment for infertility, increasing access to infertility treatment for women and their partners.

IUI continues to be offered as a

first-line treatment option in spite of its low success rate due to its low cost and ease, with a short learning curve and minimal equipment requirements.

Although current IUI devices address the unfavorable environment sperm would encounter in

the vagina and cervix by placing sperm into the uterine cavity, the biology of sperm transport is complex and of the millions of sperm inseminated in the uterus, almost all fail to reach the fallopian tubes.

In contrast to the unfavorable

environment of the uterus, the fallopian tubes act as a reservoir for traveling sperm and is the location of conception.

Sperm count is declining at an accelerated pace globally of greater than 50% with an increasing proportion of men having

sperm counts below any given threshold for sub-fertility or infertility.

This substantial and persistent decline is now recognized as a significant public health concern.

(Levine et al, 2023).

IVF or intracytoplasmic sperm injection (ICSI) is a

highly effective first line treatment with a reported pregnancy rate of approximately 25% for male factor infertility, it is associated with significant cost and clinical risks (Ravitsky et al, 2019).

Many infertile women and couples are

unwilling to undergo treatment mostly due to financial reasons.

In vitro fertilization (IVF) is extremely expensive, costing as much as $15,000 to $30,000 per IVF cycle according to Forbes Health, 2021 (with cycle effectiveness usually only

around 25%), and often not covered by insurance.

IVF/ ICSI is also physically and emotionally demanding for the patient, with increased risk of multiple pregnancies, ectopic pregnancy and miscarriage.

There are over ten million women in the

United States known to be infertile and only 200,000 IVF cycles completed per year, indicating that IVF is not a realistic solution available to most women or couples.

Our FemaSeed product candidate, if approved, would establish a new category of

artificial insemination:

a localized, directional delivery of sperm directly into the fallopian tube, precisely where conception occurs.

We believe this in-office, cost-effective solution can become a first-line treatment for infertility,

specifically when male factor is involved, increasing access to infertility treatment for women and their partners.

The Reproductive Health Opportunity

There are an estimated 72 million reproductive aged women in the United States alone (National Center for Health Statistics, 2018).

We intend to offer comprehensive solutions for preventing

pregnancy and achieving pregnancy for women, providing cost-effective and safe solutions while avoiding surgery.

We intend to offer comprehensive solutions for preventing pregnancy and achieving

pregnancy for women, providing cost-effective and safe solutions while avoiding surgery.

During their childbearing years, most women will want to control their risk of pregnancy.

Additionally, there are many women that

wish to become pregnant that are unable to do so.

According to a Centers for Disease Control and Prevention (CDC) report, the ability to plan when to be pregnant and how many pregnancies to initiate has been called one of the ten great public

health achievements in the twentieth century.

Many women, however, who spend an average of three years seeking to become pregnant and thirty years avoiding pregnancy, are not satisfied with the current methods for preventing unwanted pregnancies

and achieving pregnancy.

Approximately 800,000 women undergo tubal ligation each year in the United States alone (Frattarelli et al, 2007), with an average cost of approximately $6,000 per procedure (Planned

Parenthood, 2019).

However, there are over an estimated 12 million women who remain on a nonpermanent birth control option long-term (National Center for Health Statistics, 2015), which we believe is due to there being only a surgical permanent

option available to women.

In addition, 500,000 men undergo a vasectomy procedure every year (Ostrowski et al, 2018).

While the 1.3 million women and their partners annually who want to permanently prevent pregnancy represent our initial

near-term market opportunity, we believe these numbers do not reflect the true demand for permanent birth control, as many do not want to submit to invasive surgical procedures such as vasectomies and tubal ligations.

The market for female

permanent birth control is large and growing, and we believe the market opportunity in the U.S.

alone could expand to exceed $20 billion with a safe and effective in-office option as women shift from temporary or reversible contraceptive

alternatives to more permanent solutions.

Additionally, there are many women that wish to become pregnant

that are unable to do so.

According to a Centers for Disease Control and Prevention (CDC) report, the ability to plan when to be pregnant and how many pregnancies to initiate has been called one of the ten great public health achievements in the

twentieth century.

Many women, however, who spend an average of three years seeking to become pregnant and thirty years avoiding pregnancy, are not satisfied with the current methods for preventing unwanted pregnancies and achieving pregnancy.

Approximately 800,000 women undergo tubal ligation each year in the United States alone (Frattarelli et al, 2007), with an average cost of approximately $6,000 per procedure (Planned Parenthood, 2019).

there are over an estimated 12 million women who remain on a nonpermanent birth control option long-term (National Center for Health Statistics, 2015), which we believe is due to there being only a surgical permanent option available to women.

addition, 500,000 men undergo a vasectomy procedure every year (Ostrowski et al, 2018).

While the 1.3 million women and their partners annually who want to permanently prevent pregnancy represent our initial near-term market opportunity, we

believe these numbers do not reflect the true demand for permanent birth control, as many do not want to submit to invasive surgical procedures such as vasectomies and tubal ligations.

The market for female permanent birth control is large and

growing, and we believe the market opportunity in the U.S.

alone could expand to exceed $20 billion with a safe and effective in-office option as women shift from temporary or reversible contraceptive alternatives to more permanent solutions.

The overall decline in birth rates in the United States and globally has resulted in aging populations that present serious challenges for the world economy and economic stability.

United States alone, it is estimated by the Centers for Disease Control and Prevention that over nine million women desire pregnancy but are unable to achieve pregnancy (National Survey of Family Growth, 2019).

Only a little over half of these

women proceed with some form of intervention, and only a very small proportion undergo more advanced assisted reproductive technologies such as IVF.

Although IUI, an artificial insemination option, is the oldest technique in reproductive medicine

and a well-accepted first-line treatment method for couples with unexplained infertility, mild male factor infertility, sexual dysfunction, and cervical factor infertility, its success rates remain relatively low.

Alternative methods to IUI have

not been advanced to meet the continuous demand for safe and effective first-line alternatives that are considerably less costly and less invasive than more advanced assisted reproductive options.

The market for IUI is large and growing, and we

believe the market in the United States alone could exceed $2 billion with a safe and effective novel first-line approach as women move to seek care for the treatment of infertility.

In the United States alone, it is

estimated by the Centers for Disease Control and Prevention that over ten million women desire pregnancy but are unable to achieve pregnancy (National Survey of Family Growth, 2019).

Only a little over half of these women proceed with some form

of intervention, and only a very small proportion undergo more advanced assisted reproductive technologies such as IVF.

Although IUI, an artificial insemination option, is the oldest technique in reproductive medicine and a well-accepted

first-line treatment method for couples with unexplained infertility, mild male factor infertility, sexual dysfunction, and cervical factor infertility, its success rates remain relatively low.

However, for couples with low total motile sperm

count, treatment with highly effective IVF/ ICSI is advised given the comparatively reduced success rates for IUI.

Alternative methods to IUI have not been advanced to meet the continuous demand for safe and effective first-line alternatives that

are considerably less costly and less invasive than more advanced assisted reproductive options.

The market for assisted reproduction is large and growing, and we believe the market in the United States alone could exceed $2 billion with a safe

and effective novel first-line approach as women move to seek care for the treatment of infertility.

Clinical Development

Overview of Clinical Programs .

We are developing a growing body of compelling clinical evidence for our intrauterine directional delivery product

We are developing a growing body of compelling clinical evidence for our intrauterine directional delivery product candidates.

Our Permanent Birth Control Solution – FemBloc and ultrasound confirmation

Preclinical Studies

We completed two animal studies to support efficacy of the occlusion, or blockage, created by the biopolymer tissue adhesive, a degradable blend of cyanide derivatives of acrylates, we use in

our FemBloc system.

We completed two animal studies to support efficacy of the occlusion, or blockage, created by the biopolymer tissue adhesive, a degradable blend of cyanide derivatives of acrylates, we use in our FemBloc system.

The first was an exploratory study of efficacy in the rabbit model, where the rabbit oviducts mimic human female fallopian tubes.

The treated animals received the biopolymer and the control received sham delivery (surgery

After breeding, the control animals became pregnant on the first breeding attempt at one month while none of the biopolymer-treated animals became pregnant after breeding attempts.

Specifically, there was a 0% fertility rate among the

biopolymer treated animals when mated at 1 month and 2.5 months or when mated at 4 months and 5.5 months.

Treatment of the oviducts of proven fertile female rabbits with the biopolymer prevented pregnancy for up to 5.5 months, the length of the

observation period.

The second animal study assessed the degree and nature of the tubal occlusion created by the biopolymer by microscope assessment of tissue sampling, or histopathology, at various time points up to 52 weeks.

It also assessed

safety by evaluation of local tissue reaction to the biopolymer and degradation and characterization of the degradation profile.

The biopolymer was observed to degrade as its presence decreased over time with no substantial surrounding tissue

loss identified and acute inflammation was observed to decrease progressively over time.

In week 1, occlusion was observed by the presence of biopolymer and over time when occlusion was observed at months 3, 6 or 12 post treatment, it was

classified as complete tissue occlusion where the tubal channel, or lumen, was absent and there was no biopolymer present.

The treated animals received the biopolymer and the control received sham delivery (surgery only).

After breeding,

the control animals became pregnant on the first breeding attempt at one month while none of the biopolymer-treated animals became pregnant after breeding attempts.

Specifically, there was a 0% fertility rate among the biopolymer treated animals

when mated at 1 month and 2.5 months or when mated at 4 months and 5.5 months.

Treatment of the oviducts of proven fertile female rabbits with the biopolymer prevented pregnancy for up to 5.5 months, the length of the observation period.

second animal study assessed the degree and nature of the tubal occlusion created by the biopolymer by microscope assessment of tissue sampling, or histopathology, at various time points up to 52 weeks.

It also assessed safety by evaluation of

local tissue reaction to the biopolymer and degradation and characterization of the degradation profile.

The biopolymer was observed to degrade as its presence decreased over time with no substantial surrounding tissue loss identified and acute

inflammation was observed to decrease progressively over time.

In week 1, occlusion was observed by the presence of biopolymer and over time when occlusion was observed at months 3, 6 or 12 post treatment, it was classified as complete tissue

occlusion where the tubal channel, or lumen, was absent and there was no biopolymer present.

Clinical Trials

Prior to the trials pursuant to the IDE discussed below, we conducted a number of clinical trials in 93 patients to evaluate various aspects of the development program.

With respect to

biopolymer effectiveness, we conducted a clinical trial on ten patients pending a planned hysterectomy procedure, which is not an indicated population for FemBloc.

Patients received the FemBloc treatment with the biopolymer through the delivery

system and returned 4 weeks post-treatment to receive a complete hysterectomy with subsequent histopathology analysis of the fallopian tubes for indications of progression towards tubal occlusion and associated tissue reactions of the biopolymer.

Although it is expected that three months is required to effect complete tubal occlusion and for the confirmation of effectiveness and reliability as permanent birth control, at 4 weeks, 30% of the fallopian tubes had either complete luminal

occlusion where the lumen was obstructed by a healing tissue response or there was narrowing of the fallopian tube by 50-90% by a similar healing tissue response.

As expected, biopolymer remained in many of the fallopian tubes and the

inflammatory response observed appeared to generally correlate with the presence of foreign material.

With respect to biopolymer effectiveness, we

conducted a clinical trial on ten patients pending a planned hysterectomy procedure, which is not an indicated population for FemBloc.

Patients received the FemBloc treatment with the biopolymer through the delivery system and returned 4 weeks

post-treatment to receive a complete hysterectomy with subsequent histopathology analysis of the fallopian tubes for indications of progression towards tubal occlusion and associated tissue reactions of the biopolymer.

Although it is expected

that three months is required to effect complete tubal occlusion and for the confirmation of effectiveness and reliability as permanent birth control, at 4 weeks, 30% of the fallopian tubes had either complete luminal occlusion where the lumen

was obstructed by a healing tissue response or there was narrowing of the fallopian tube by 50-90% by a similar healing tissue response.

As expected, biopolymer remained in many of the fallopian tubes and the inflammatory response observed

appeared to generally correlate with the presence of foreign material.

There were no serious adverse events reported.

We have studied FemBloc in two clinical studies pursuant to an FDA-approved IDE evaluating safety in 183 subjects.

We have studied FemBloc in three clinical studies pursuant to FDA-approved IDEs to evaluate safety in 228 subjects.

The first clinical study consisted of 49 subjects enrolled at five U.S.

sites and the second clinical trial consisted of 134 subjects enrolled at 14 U.S.

As part of the second clinical trial, we sponsored subjects in a control arm for surgical tubal ligation of 105 subjects for future comparison of

safety events only.

study sites, the second

clinical trial consisted of 134 subjects enrolled at 14 U.S.

study sites, and the third consisted of 45 subjects enrolled at five U.S.

As part of the second clinical trial, we sponsored subjects in a control arm for surgical tubal

ligation of 105 subjects for future comparison of safety events only.

Subjects are being followed for five years for safety, with the first subjects enrolled approaching five-year follow-up.

As shown in the figure below, other than the unintended pregnancies discussed below, the majority (94%)

of safety events reported to date occurred on the day of treatment or within seven days of the procedure and 75% of the adverse events (AE) were classified as mild.

Of the 282 adverse events reported as related to the device, procedure or both,

the most common adverse events reported in the 183 subjects were vaginal bleeding (28.0%), pelvic pain (24.8%), spotting (10.3%) and uterine cramps (8.9%).

There were no serious adverse events (SAE) reported for FemBloc.

Majority Adverse Events Occurred at Time of Procedure

As shown in the figure below, other than the unintended

pregnancies discussed below, the majority (91%) of safety events reported to date occurred on the day of treatment or within seven days of the procedure and 75% of the adverse events (AE) were classified as mild.

Of the 350 adverse events

reported as related to the device, procedure or both, the most common adverse events reported in the 228 subjects were vaginal bleeding (40.0%), pelvic pain (34.5%), uterine cramps (13.5%) and spotting (13.1%).

There were no serious adverse

events (SAE) reported for FemBloc.

Majority Adverse Events Were Mild and Occurred at Time of Procedure

Most Common Adverse Events Reported (>1%)

We have observed that the patients found the procedures in both studies to be highly tolerable, with pain scores similar to placement of other intrauterine devices, such as IUDs.

The mean pain

and discomfort score using a visual analog scale (VAS) from 0-10 was 4.3 (SD 2.8) as reported by the patient for the FemBloc treatment procedure.

In our clinical trials, we have used ultrasound confirmation with the FemChec device three months

after FemBloc treatment and have observed that no remaining biopolymer was detected in patients, which suggests that the biopolymer completely degraded and likely exited the patient with possible menstruation.

The mean pain and discomfort score

was 3.0 (SD 2.5) as reported by the patient for the ultrasound confirmation.

using a visual analog scale (VAS) from 0-10 was 4.6 (SD 2.85) as reported by the patient for the FemBloc treatment procedure.

In our clinical trials, we have used ultrasound confirmation with the FemChec device three months after FemBloc

treatment and have observed that no remaining biopolymer was detected in patients, which suggests that the biopolymer completely degraded and likely exited the patient with possible menstruation.

The mean pain and discomfort score was 3.4 (SD

2.80) as reported by the patient for the ultrasound confirmation.

There have been no serious safety events reported to date.

We recorded data on the patients for safety and additional performance measures at time of FemBloc procedure,

seven days post procedure, three months post procedure for confirmation test, three months post confirmation test, and annually through five years.

We recorded data on the patients for safety and additional performance measures at time of FemBloc procedure, seven days

post procedure, three months post procedure for confirmation test, three months post confirmation test, and annually through five years.

Enrollment ended in February 2019.

During the conduct of these two clinical studies, unintended pregnancies occurred in patients who were told to rely on FemBloc (six pregnancies for the pilot study and three pregnancies for

the pivotal trial).

During the conduct of these two clinical studies, unintended pregnancies occurred in patients who were told to rely on FemBloc (six pregnancies for the pilot study and three pregnancies for the pivotal trial).

These pregnancies were due to misinterpretation of the ultrasound confirmation test, as verified by an independent clinical events committee.

In February 2019 we paused the ongoing pivotal clinical trial for FemBloc (although

subjects are still followed for safety through 5 years).

The FDA recommended that we conduct a small IDE clinical study in a new cohort of patients to evaluate the adequacy of improvements that were made to the procedures, products and training

to mitigate the risk of unintended pregnancies, while validating the ultrasound confirmation test.

The design for the small IDE trial (stage II validation study) includes performance of two confirmation tests (ultrasound and radiology) and

subjects are informed to rely on FemBloc only if both tests confirm procedure success.

We plan to submit the results to FDA in an IDE for a pivotal trial planned to support future PMA approval of FemBloc in the first quarter of 2023.

Current and Planned Clinical Trials

As described above, a small IDE study began in June 2020 at five U.S.

sites and is ongoing.

In addition to demonstrating the adequacy of our proposed improvements that were made to the

procedures, products and training, we plan to use the study to evaluate of the two confirmation tests (confirmation and traditional radiology) to support selection of the confirmation test that will be studied in our planned pivotal clinical

trial to support the PMA.

We expect to submit the results of this trial along with the study design reflecting our assessment of the added features bolstering the administration of the confirmation test described above to the FDA in the first

quarter of 2023.

In February 2019 we paused the ongoing pivotal clinical trial for FemBloc (although subjects are still

followed for safety through 5 years).

The FDA recommended that we conduct a small IDE clinical study in a new cohort of patients to evaluate the adequacy of improvements that were made to the procedures, products and training to mitigate the risk

of unintended pregnancies, while validating the ultrasound confirmation test.

The design for the small IDE trial (stage II validation study) included performance of two confirmation tests (ultrasound and radiology) and subjects were informed to

rely on FemBloc only if both tests confirm procedure success.

There were no pregnancies in patients who were told to rely on FemBloc in this study.

In September 2022 enrollment was concluded and we plan to submit the results to FDA in an IDE

for a pivotal trial planned to support future PMA approval of FemBloc in the first quarter of 2023.

Planned Clinical Trial

We currently anticipate initiating a pivotal clinical trial after FDA approval of an IDE, which we expect to be a multicenter, unblinded prospective clinical trial.

The clinical trial will be designed to evaluate the safety and

effectiveness of our FemBloc system for permanent birth control in order to obtain PMA approval in the United States.

We anticipate building in an interim analysis of the data into the clinical trial design, subject to FDA approval.

there can be no assurance that the FDA will approve our trial design, FDA-approved third-party study designs for other permanent birth control product candidates included primary endpoint of pregnancy rate at one year after the confirmation test

and safety follow-up for two to five years post-market approval.

The clinical trial will be designed to evaluate

the safety and effectiveness of our FemBloc system for permanent birth control in order to obtain PMA approval in the United States.

We anticipate building in an interim analysis of the data into the clinical trial design, subject to FDA

Although there can be no assurance that the FDA will approve our trial design, FDA-approved third-party study designs for other permanent birth control product candidates included primary endpoint of pregnancy rate at one year after the

confirmation test and safety follow-up for two to five years post-market approval.

Our Artificial Insemination Solution.

510(k) Clearance for Different Intrauterine Directional Delivery Device

We received FDA 510(k) clearance for our FemCath FemVue (formally) Cornual Balloon Catheter, a single intrauterine directional delivery product, like FemaSeed, but for a different indication.

A post-market study in 23 subjects (45 tubes) was conducted with the product and FemVue Saline-Air device to assess selective tubal infusion with the observation of saline-air contrast.

89% had contrast observed entering the proximal portion of

the fallopian tube combined with sustained flow or exit into the peritoneal cavity.

We received FDA 510(k) clearance for our FemCath (formally FemVue) Cornual Balloon Catheter, a single intrauterine directional delivery product, like FemaSeed, but for a different indication.

A post-market study in

23 subjects (45 tubes) was conducted with the product and FemVue Saline-Air device to assess selective tubal infusion with the observation of saline-air contrast.

89% had contrast observed entering the proximal portion of the fallopian tube

combined with sustained flow or exit into the peritoneal cavity.

This is the same intended location of delivery for the FemaSeed product.

There were no serious adverse events reported.

We plan to commercialize the FemCath

product by the end of 2022.

We began commercializing the FemCath product in December

Post-Market Information

FemVue Saline - Air device, a contrast-generating product, is authorized for marketing in the United States, Europe, Canada and Japan.

There have been multiple publications and abstracts

presented with clinical evidence in support of FemVue, a diagnostic companion product to our artificial insemination solution.

It has been concluded that tubal patency assessment with FemVue is comparable to fluoroscopic hysterosalpingogram (HSG)

and it appears to be a convenient and well-tolerable method that may be performed alongside conventional ultrasound and uterine cavity assessment as part of an infertility evaluation.

Other publications have stated that FemVue is an accurate test

for diagnosing tubal occlusion and performs similarly to a fluoroscopic HSG and it could potentially replace fluoroscopic HSG.

FemVue Saline - Air device, a contrast-generating product, is authorized for marketing in the United States, Canada and Japan.

There have been multiple publications and abstracts presented with clinical evidence in

support of FemVue, a diagnostic companion product to our artificial insemination solution.

It has been concluded that tubal patency assessment with FemVue is comparable to fluoroscopic hysterosalpingogram (HSG) and it appears to be a convenient

and well-tolerable method that may be performed alongside conventional ultrasound and uterine cavity assessment as part of an infertility evaluation.

Other publications have stated that FemVue is an accurate test for diagnosing tubal occlusion

and performs similarly to a fluoroscopic HSG and it could potentially replace fluoroscopic HSG.

Current Clinical Trial

The FemaSeed pivotal trial began in July 2021, pursuant to an FDA-approved IDE received in April 2021, at multiple U.S.

sites and is ongoing.

The clinical trial is designed to evaluate the

safety and effectiveness of our FemaSeed product for localized directional intrauterine insemination in order to obtain a de novo classification in the United States.

The prospective unblinded trial will consist of up to 792 enrolled subjects

and subjects are to be followed for up to 7 weeks to evaluate for clinical pregnancy, the primary effectiveness endpoint.

In October 2022, we announced an updated study design for the pivotal trial, which

will now focus on couples experiencing male factor infertility.

This update reflects a revised strategy to address this underserved population experiencing infertility with a goal of facilitating accelerated enrollment.

The ongoing clinical trial

is designed to evaluate the safety and effectiveness of our FemaSeed product for localized directional intrauterine insemination in order to obtain a de novo classification in the United States.

The prospective unblinded trial consists of up to

214 enrolled subjects and subjects are to be followed for up to 7 weeks to evaluate for clinical pregnancy, the primary effectiveness endpoint.

If unsuccessful, subjects can receive another procedure.

There is no long-term follow-up.

The clinical trial design

includes an interim analysis of the data, which we expect in the fourth quarter of 2022.

Enrollment for the FemaSeed pivotal trial is expected to be completed in the second quarter of 2023 followed by submission of the results to FDA in support of a future de novo classification request for FemaSeed.

for the FemaSeed pivotal trial is expected to be completed in the second quarter of 2023 followed by submission of the results to FDA in support of a future de novo classification request for FemaSeed.

Our Endocervical Tissue Sampler.

Post-Market Information

FemCerv is cleared to market in the United States and Europe.

FemCerv is cleared to market in the United States.

We sponsored a post-market study for FemCerv in 112 patients undergoing further evaluation of an abnormal cervical tissue result.

It was observed that FemCerv provided samples that were reported as adequate when evaluated histologically in 94% of the patients.

Physicians reported that 95% of the patients experienced mild or no discomfort during the FemCerv procedure and 92%

of the physicians reported the FemCerv device as easy to insert.

It was observed that FemCerv

provided samples were reported as adequate when evaluated histologically in 94% of the patients.

Physicians reported that 95% of the patients experienced mild or no discomfort during the FemCerv procedure and 92% of the physicians reported the

FemCerv device as easy to insert.

There were no adverse events reported.

We plan to commercialize the FemCerv product by the end of 2022.

We began commercializing the FemCerv product in September 2022.

Manufacturing

We have developed and implemented the infrastructure required to manufacture and distribute finished medical devices, including a robust medical device quality management system which meets

the requirements of the FDA Quality System Regulation, and is certified to Medical Device Single Audit Program (MDSAP) and International Organization for Standardization (ISO) 13485:2016.

We currently manufacture or assemble all products and

product candidates and source components from contract suppliers.

We believe that we currently have sufficient capacity to meet clinical program demands, product supply and preliminary launch requirements for the FemaSeed product and believe

that, if FemaSeed is granted de novo classification, we will be able to scale up our capacity relatively quickly with limited capital investment.

We believe our manufacturing capacity is sufficient to meet global market demand for our products

for the foreseeable future until potential approval by the FDA for the FemBloc system.

While we plan to continue manufacturing our product candidates, if approved or granted marketing authorization, we will consider outsourcing arrangements for

certain sub-assemblies as needed as we scale our commercial production.

We employ a rigorous supplier assessment, qualification, and selection process targeted to suppliers that meet the requirements of the FDA and the ISO and quality standards supported by

internal policies and procedures.

We have developed and implemented the infrastructure required to manufacture and distribute finished medical devices, including a robust medical device quality management system which meets the requirements of the

FDA Quality System Regulation, and is certified to Medical Device Single Audit Program (MDSAP) and International Organization for Standardization (ISO) 13485:2016.

We currently manufacture or assemble all products and product candidates and

source components from contract suppliers.

We believe that we currently have sufficient capacity to meet clinical program demands, product supply and preliminary launch requirements for the FemaSeed product and believe that, if FemaSeed is

granted de novo classification, we will be able to scale up our capacity relatively quickly with limited capital investment.

We believe our manufacturing capacity is sufficient to meet global market demand for our products for the foreseeable

future until potential approval by the FDA for the FemBloc system.

While we plan to continue manufacturing our product candidates, if approved or granted marketing authorization, we will consider outsourcing arrangements for certain

sub-assemblies as needed as we scale our commercial production.

We employ a rigorous supplier assessment, qualification, and selection process targeted to suppliers that meet the requirements of the FDA and the ISO and quality standards supported by internal policies and

Our quality assurance process monitors and maintains supplier performance through qualification and periodic supplier reviews and audits.

We are required to maintain ISO 13485 certification for medical devices

sold in the European Economic Area (EEA) which requires, among other items, an implemented quality system that applies to component quality, supplier control, product design and manufacturing operations.

We are required to maintain ISO 13485 certification for medical devices sold in the European

Economic Area (EEA) which requires, among other items, an implemented quality system that applies to component quality, supplier control, product design and manufacturing operations.

We inspect, test, and assemble our products under strict manufacturing processes supported by internal policies and procedures with significant CMC and device manufacturing infrastructure.

perform our own final quality control testing of each product and product candidate, and we have complete control over all aspects of the manufacturing process and are compliant with QSR good manufacturing practice regulations applicable to our

We perform our own final

quality control testing of each product and product candidate, and we have complete control over all aspects of the manufacturing process and are compliant with QSR good manufacturing practice regulations applicable to our products.

Our suppliers are managed through our supplier management program that is focused on reducing supply chain risk.

Key aspects of this program include managing component inventory at the

supplier and second sourcing approaches for specific suppliers.

Key aspects of this program include managing component inventory at the supplier and second sourcing

approaches for specific suppliers.

Typically, our outside vendors produce the components to our specifications and in many instances to our designs.

Our suppliers are audited periodically by our quality department to

ensure conformity with the specifications, policies and procedures for our products.

Our suppliers are audited periodically by our quality department to ensure conformity with the

specifications, policies and procedures for our products.

In addition, we and our suppliers are subject to periodic unannounced inspections by U.S.

and international regulatory authorities to ensure compliance with

quality regulations.

We believe that, if necessary, alternative sources of supply would be available in a relatively short period of time and on commercially reasonable terms.

We also contract with a supplier who private labels HSG catheters

which are sold in our name.

and international regulatory authorities to ensure compliance with quality regulations.

that, if necessary, alternative sources of supply would be available in a relatively short period of time and on commercially reasonable terms.

We also contract with a supplier who private labels HSG catheters which are sold in our name.

We do not have long-term supply agreements and we purchase certain components for our products on a purchase order basis.

We do not currently have arrangements in place for redundant supply of

certain components of our products.

We do not currently have arrangements in place for redundant supply of certain components of

our products.

If our current third-party suppliers cannot perform as agreed, we may be required to replace those suppliers.

Although we believe that there are several potential alternative suppliers who could provide these

components, we may incur added costs and delays in identifying and qualifying any such replacement.

Although we believe that there are several potential alternative suppliers who could provide these components, we may

incur added costs and delays in identifying and qualifying any such replacement.

Finally, for our products and product candidates, we utilize third-party sterilizers to ensure these single-use products are packaged and shipped sterile for use.

If our current contract

sterilizer(s) cannot continue to perform as agreed, we may be required to identify and contract with another third-party contract sterilizer which may incur added costs and delays in identifying and qualifying any such replacement.

If our current contract sterilizer(s) cannot

continue to perform as agreed, we may be required to identify and contract with another third-party contract sterilizer which may incur added costs and delays in identifying and qualifying any such replacement.

The markets in which we compete are highly competitive and are characterized by rapid and significant technological change.

To compete successfully, we need to continue to demonstrate the

advantages of our product candidates compared to both well-established and new alternative procedures, products and technologies, and convince physicians and other healthcare decision makers of the advantages of our product and technology.

With respect to our permanent birth control solution, we expect to compete with tubal ligation, vasectomies for women’s partners, other methods of non-permanent birth control, including devices

such as IUDs, prescription drugs such as the birth control pill and injectable and implantable contraceptives and patches, and other companies developing other procedures for permanent birth control, mechanical devices and other contraceptive and

birth control methods.

There is no directly competing permanent birth control product currently on the market, or, to our knowledge, in development.

With respect to our artificial insemination solution, we expect to compete with IUI, IVF and fertility-enhancing pharmaceuticals currently in the market and those in clinical and preclinical

While there are no direct competitors in our product category of localized directional delivery for artificial insemination, there are alternatives, such as IUI and IVF.

Leading companies that produce IUI devices include Cook Medical

LLC, a subsidiary of Cook Group, Inc., Cooper Surgical, Inc., MedGyn Products, Inc.

To compete successfully, we need to continue to demonstrate the advantages of our product

candidates compared to both well-established and new alternative procedures, products and technologies, and convince physicians and other healthcare decision makers of the advantages of our product and technology.

With respect to our permanent birth control solution, we expect to compete with surgical tubal ligation, vasectomies for women’s partners, other methods of non-permanent birth control, including devices such as

IUDs, prescription drugs such as the birth control pill and injectable and implantable contraceptives and patches, and other contraceptive and birth control methods.

There is no directly competing non-surgical, non-implant permanent birth control

product currently on the market, or, to our knowledge, in development.

With respect to our artificial insemination solution, we expect to compete with IUI, IVF/ ICSI and fertility-enhancing pharmaceuticals currently in the market and those in clinical and preclinical development.

While there are no direct competitors in our product category of localized directional delivery for artificial insemination, there are alternatives, such as IUI and IVF/ ICSI.

Leading companies that produce IUI devices include Cook Medical LLC, a

subsidiary of Cook Group, Inc., Cooper Surgical, Inc., MedGyn Products, Inc.

and Rocket Medical LLC.

With respect to our tissue sampling product and product candidate, there are other procedures used in women’s health tissue sampling, such as the Pap test, HPV test and colposcopy, which are

well established and pervasive.

With respect to our tissue sampling product and product candidate, there are other procedures used in women’s health to evaluate the cervical canal, such as the Pap test, HPV test and colposcopy, which are well

established and pervasive.

Companies such as Dysis Medical and Guided Therapeutics are also developing cervical tissue sampling product candidates.

Many of our competitors have access to greater resources required to develop and market a competitive product than we do.

In addition, new competition and products may arise due to

consolidation within the industry and other companies may develop products that could compete with our product candidates, and there may be product candidates in early stages of development of which we are not aware.

In addition, new competition and products may arise due to consolidation within the industry

and other companies may develop products that could compete with our product candidates, and there may be product candidates in early stages of development of which we are not aware.

Sales & Marketing

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If the FDA grants de novo classification for FemaSeed, we expect to recruit, hire and train a direct sales force for FemaSeed.

We will seek to recruit representatives with strong sales

backgrounds and experience in infertility product sales, and with relationships with reproductive endocrinologists and gynecologists.

We intend to focus the significant majority of our sales and marketing efforts in the United States and continue

to utilize distribution partners for international markets.

While we have received regulatory clearance and marketing authorization in United States, Europe, Canada, and Japan for the FemVue device, our main commercial priority is the United

States where we expect to begin to commercialize and market our FemaSeed product and generate revenue from product sales if and when our request for de novo classification of the FemaSeed product is granted by the FDA.

Through a specialized and dedicated direct sales organization, we plan to target the approximately 1,300 reproductive endocrinologists at 450 practices who are trained and have experience

performing infertility procedures.

We will seek to recruit representatives with strong sales backgrounds and experience in

infertility product sales, and with relationships with reproductive endocrinologists and gynecologists.

We intend to focus the significant majority of our sales and marketing efforts in the United States and continue to utilize distribution

partners for international markets.

While we have received regulatory clearance and marketing authorization in United States, Europe, Canada, and Japan for the FemVue device, our main commercial priority is the United States where we expect to

begin to commercialize and market our FemaSeed product and generate revenue from product sales if and when our request for de novo classification of the FemaSeed product is granted by the FDA.

Through a specialized and dedicated direct sales organization, we plan to target the approximately 1,300 reproductive endocrinologists at 450 practices who are trained and have experience performing infertility

Specifically, we intend to initially target the approximately 50 practices that are currently customers purchasing the FemVue device.

Over 50% of the practices representing approximately 60% of the assisted

reproduction cycles performed are located in 8 states, which will be prioritized.

Over 50% of the practices representing approximately 60% of the assisted reproduction cycles

performed are located in 8 states, which will be prioritized.

We expect to begin building our sales organization prior to potential FDA authorization of the product candidate.

We plan to engage in awareness raising activities, highlighting the benefits of our FemaSeed product in jurisdictions where we are approved to market.

We also intend to promote broader

awareness of the FemaSeed product as the first localized directional intrauterine insemination option for artificial insemination among patients and physicians.

We also intend to promote broader awareness of the FemaSeed

product as the first localized directional intrauterine insemination option for artificial insemination among patients and physicians.

FemBloc – Our Permanent Birth Control Solution.

We ultimately plan to use our gynecologist-focused sales force for FemBloc, if approved, to introduce those doctors to FemaSeed and broaden our sales force reach for our infertility treatment

beyond our initial focus on reproductive endocrinologists.

We ultimately plan to use our gynecologist-focused sales force for FemBloc, if approved, to introduce those doctors to FemaSeed and broaden our sales force reach for our infertility treatment beyond our initial

focus on reproductive endocrinologists.

If approved, we expect to recruit, hire and train sales representatives for our direct sales force in the United States for FemBloc.

We will seek to recruit representatives with strong

sales backgrounds and experience in gynecology product sales, and with relationships with gynecologists.

We intend to focus the significant majority of our sales and marketing efforts in the United States and continue to utilize distribution

partners for international markets.

Through our specialized and dedicated direct sales organization, we plan to target the approximately 41,000 gynecologists who are trained and have experience performing gynecologic procedures and offering

family planning.

Over 60% of the practices representing over 60% of reproductive-aged women are located in 13 states, which will be prioritized.

Based on our clinical experience to date, we believe that physicians experienced in intrauterine procedures, such as IUD, will require minimal training to start utilizing our FemBloc system or

We will seek to recruit representatives with strong sales backgrounds and

experience in gynecology product sales, and with relationships with gynecologists.

We intend to focus the significant majority of our sales and marketing efforts in the United States and continue to utilize distribution partners for international

Over 60% of the

practices representing over 60% of reproductive-aged women are located in 13 states, which will be prioritized.

Based on our clinical experience to date, we believe that physicians experienced in intrauterine procedures, such as IUD, will require minimal training to start utilizing our FemBloc system as is the case for our

FemaSeed product.

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We plan to engage in awareness raising activities, highlighting the benefits of our FemBloc system in jurisdictions where we are approved to market.

We also intend to promote broader awareness

of the FemBloc system as the first non-surgical, non-implant option for permanent birth control among patients and physicians.

We also intend to promote broader awareness of the FemBloc system

as the first non-surgical, non-implant option for permanent birth control among patients and physicians.

Reimbursement

In the United States, we expect to derive nearly all of our revenue initially from the sale of our FemaSeed product to fertility practices, which typically bill the patient directly or for

those that have insurance coverage, various third-party payors, including private insurance companies, health maintenance organizations and other healthcare-related organizations.

For those that file with insurance, we expect that any portion of

the costs and fees associated with our FemaSeed product that are not covered by these third-party payors, such as deductibles or copayments, will be billed directly to the patient by the provider.

Third-party payors require physicians and

hospitals to identify the product and service for which they are seeking reimbursement by using Current Procedural Terminology (CPT) codes, which are created and maintained by the American Medical Association, or AMA.

As intrauterine insemination

has been widely used in patients for decades in the United States, reimbursement codes and payments are well-established and the procedure may be covered by private health insurance plans.

Outside the United States, reimbursement levels vary

significantly by country and by region, particularly based on whether the country or region at issue maintains a single-payor system;

In the United States, we expect to derive nearly all of our revenue initially from the sale of our FemaSeed product to fertility practices, which typically bill the patient directly or for those that have insurance

coverage, various third-party payors, including private insurance companies, health maintenance organizations and other healthcare-related organizations.

For those that file with insurance, we expect that any portion of the costs and fees

associated with our FemaSeed product that are not covered by these third-party payors, such as deductibles or copayments, will be billed directly to the patient by the provider.

Third-party payors require physicians and hospitals to identify the

product and service for which they are seeking reimbursement by using Current Procedural Terminology (CPT) codes, which are created and maintained by the American Medical Association, or AMA.

As intrauterine insemination has been widely used in

patients for decades in the United States, reimbursement codes and payments are well-established and the procedure may be covered by private health insurance plans.

Outside the United States, reimbursement levels vary significantly by country and

by region, particularly based on whether the country or region at issue maintains a single-payor system;

patient direct pay is also an option.

Annual healthcare budgets generally determine the number of intrauterine

inseminations that will be paid for by the payor in these single-payor system countries and regions.

Annual healthcare budgets generally determine the number of intrauterine inseminations that will be

paid for by the payor in these single-payor system countries and regions.

Reimbursement is obtained from a variety of sources, including government-sponsored and private health insurance plans, and combinations of both.

In the United States, we expect to derive nearly all of our revenue from the sale of our FemBloc system to gynecology offices, which typically bill various third-party payors, including

Medicare, Medicaid, private insurance companies, health maintenance organizations and other healthcare-related organizations.

In addition, we expect that any portion of the costs and fees associated with our FemBloc system that are not covered by

these third-party payors, such as deductibles or co-payments, will be billed directly to the patient by the provider.

In 2019, we obtained two CPT category III codes, one for the FemBloc system treatment and the second for the ultrasound

confirmation test.

According to the AMA, CPT Category III codes are not referred to the AMA-Specialty RVS Update Committee (RUC) for valuation because no relative value units (RVUs) are assigned to these codes.

Payment for these services or

procedures is based on the policies of payers and not on a yearly fee schedule.

We expect to seek two category I codes for the procedures and according to AMA, the CPT requirements for Category I include documenting clinical efficacy in up to five peer-reviewed

publications with minimum a of one with U.S.

In the United States, we expect to derive nearly all of our revenue from the sale of our FemBloc system to gynecology offices, which typically bill various third-party payors, including Medicare, Medicaid, private

insurance companies, health maintenance organizations and other healthcare-related organizations.

In addition, we expect that any portion of the costs and fees associated with our FemBloc system that are not covered by these third-party payors,

such as deductibles or co-payments, will be billed directly to the patient by the provider.

In 2019, we obtained two CPT category III codes, one for the FemBloc system treatment and the second for the ultrasound confirmation test.

the AMA, CPT Category III codes are not referred to the AMA-Specialty RVS Update Committee (RUC) for valuation because no relative value units (RVUs) are assigned to these codes.

Payment for these services or procedures is based on the policies

of payers and not on a yearly fee schedule.

We expect to seek two category I codes for the procedures and according to AMA, the CPT requirements for Category I include documenting clinical efficacy in up to five peer-reviewed publications with minimum a of

one with U.S.

patient populations and two with different patient populations.

Physician reimbursement under Medicare is generally based on a defined fee schedule, or the Physician Fee Schedule, through which payment

amounts are determined by the relative value of the service rendered by the physician.

Medicare generally provides reimbursement to hospitals and ambulatory surgical centers for SNM therapy under the hospital outpatient prospective payment system

and the Ambulatory Surgical Center Payment System, respectively, which reimburse to the hospital or ambulatory surgical center, as applicable, a bundled amount generally intended to cover all facility costs related to procedures performed in the

outpatient setting.

Ambulatory Payment Classification (APC) for payment on Medical Outpatient Prospective Payment System (OPPS) are used extensively by commercial payers and the FemBloc procedure is expected to map APC level 4 gynecologic

procedures with a payment of $2,498 (tubal ligation).

Reimbursement rates will vary based on several factors, including but not limited to the payor, geographic location, the procedure performed, contract terms, the facility in which the

procedure is performed and other factors.

Physician reimbursement under Medicare is generally based on a defined fee schedule, or the Physician Fee Schedule, through which payment amounts are determined by the

relative value of the service rendered by the physician.

Medicare generally provides reimbursement to hospitals and ambulatory surgical centers for SNM therapy under the hospital outpatient prospective payment system and the Ambulatory Surgical

Center Payment System, respectively, which reimburse to the hospital or ambulatory surgical center, as applicable, a bundled amount generally intended to cover all facility costs related to procedures performed in the outpatient setting.

of $2,498 (tubal ligation).

Reimbursement rates will vary based on several factors, including but not limited to the payor, geographic location, the procedure performed, contract terms, the facility in which the procedure is performed and other

We anticipate that the FemBloc system will be covered under the Affordable Care Act (ACA) as an FDA approved permanent birth control product in a unique category.

Some amendments have been

added to the ACA including religious and moral exceptions and some states and insurance companies have additional limits.

Some amendments have been added to the ACA

including religious and moral exceptions and some states and insurance companies have additional limits.

According to HealthCare.gov.

under ACA, an insured patient’s plan must cover contraceptives without charging a copayment or

coinsurance when provided by an in-network provider, even if the patient has not met their deductible.

under ACA, an insured patient’s plan must cover contraceptives without charging a copayment or coinsurance when

provided by an in-network provider, even if the patient has not met their deductible.

Outside the United States, reimbursement levels vary significantly by country and by region, particularly based on whether the country or region at issue maintains a single-payor system.

Annual healthcare budgets generally determine the number of permanent birth control procedures that will be paid for by the payor in these single-payor system countries and regions.

Reimbursement is obtained from a variety of sources, including

government-sponsored and private health insurance plans, and combinations of both.

Annual healthcare budgets

generally determine the number of permanent birth control procedures that will be paid for by the payor in these single-payor system countries and regions.

Reimbursement is obtained from a variety of sources, including government-sponsored and

private health insurance plans, and combinations of both.

Some countries or regions may require us to gather additional clinical data before granting coverage and reimbursement for our FemBloc system.

We intend to work

with payors to obtain coverage and reimbursement approval in countries and regions where it makes economic sense to do so.

We intend to work with payors to obtain

coverage and reimbursement approval in countries and regions where it makes economic sense to do so.

Intellectual Property

Our success depends in part on our ability to obtain, maintain, protect and enforce our proprietary technology and intellectual property rights, in particular, our patent rights, preserve the

confidentiality of our trade secrets, and operate without infringing the valid and enforceable patents and other proprietary rights of third parties.

We rely on a combination of patent, trademark, trade secret, copyright and other intellectual

property rights and measures to protect the intellectual property rights that we consider important to our business.

Our success depends in part on our ability to obtain, maintain, protect and enforce our proprietary technology and intellectual property rights, in particular, our patent rights, preserve the confidentiality of our

trade secrets, and operate without infringing the valid and enforceable patents and other proprietary rights of third parties.

We rely on a combination of patent, trademark, trade secret, copyright and other intellectual property rights and

measures to protect the intellectual property rights that we consider important to our business.

We also rely on know-how and continuing technological innovation to develop and maintain our competitive position.

We seek to protect our proprietary rights through a variety of methods, including confidentiality agreements and proprietary information agreements with suppliers, employees, consultants and

others who may have access to our proprietary information.

We seek to protect our proprietary rights through a variety of methods, including confidentiality agreements and proprietary information agreements with suppliers, employees, consultants and others who may have

access to our proprietary information.

However, trade secrets and proprietary information can be difficult to protect.

While we have confidence in the measures we take to protect and preserve our trade secrets and proprietary

information, such measures can be breached, and we may not have adequate remedies for any such breach.

While we have confidence in the measures we take to protect and preserve our trade secrets and proprietary information, such

measures can be breached, and we may not have adequate remedies for any such breach.

In addition, our trade secrets and proprietary information may otherwise become known or be independently discovered by competitors.

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patent applications and 17 pending foreign patent applications.

These issued patents,

and any patents granted from such applications, are expected to expire between 2022 and 2044, without taking potential patent term extensions or adjustments into account.

We believe that the patents expiring in 2022 are not material to our

These issued patents, and any patents granted

from such applications, are expected to expire between 2023 and 2046, without taking potential patent term extensions or adjustments into account.

We believe that the patents expiring in 2023 are not material to our business.

In the United States, our FemBloc patent portfolio includes two patent families.

They include granted utility and design patents providing protection until at least 2025 and 2030, including any

eligible patent term adjustments and extensions.

They include granted utility and design patents providing protection until at least 2025 and 2030, including any eligible patent term

adjustments and extensions.

The utility patent family includes a pending patent application, which if granted, could result in a patent expiring in 2025, plus any eligible patent term adjustments and extensions.

patent portfolio includes five patent families.

Our FemVue patent portfolio

includes five patent families.

The five patent families include granted utility and design patents providing protection until at least 2026 and 2028.

The two utility patent families include pending patent applications, which if

granted, could result in patents expiring in 2028, plus any eligible patent term adjustments and extensions.

The two utility patent families include pending patent applications, which if granted, could

result in patents expiring in 2028, plus any eligible patent term adjustments and extensions.

Our FemChec patent portfolio includes five patent families.

The five patent families include granted utility and design patents providing

protection until at least 2026, 2028, 2029 and 2032.

The utility patent family and one of the design patent families include pending patent applications, which if granted, could result in patents expiring in 2030 and 2035, plus any eligible

patent term adjustments and extensions.

The five patent families include granted utility and design patents providing protection

until at least 2026, 2028, 2029 and 2032.

The utility patent family and one of the design patent families include pending patent applications, which if granted, could result in patents expiring in 2030 and 2035, plus any eligible patent term

adjustments and extensions.

Our FemaSeed patent portfolio includes three patent families.

Two patent families include granted utility and design patents providing protection until at least 2025 and 2026.

The third (design) patent

family includes a pending patent application, which if granted, could result in a patent expiring in 2035.

The third (design) patent family includes

a pending patent application, which if granted, could result in a patent expiring in 2035.

Our FemCerv patent portfolio includes two patent families.

The two patent families include granted utility and design patents providing

protection until at least 2027, 2032, and 2033.

The two patent families include granted utility and design patents providing protection until at

least 2027, 2032, and 2033.

The utility patent family includes a pending patent application, which if granted, could result in a patent expiring in 2033.

Our FemEMB patent portfolio includes one patent family.

The one patent

family includes granted utility patents providing protection until at least 2033.

The one patent family includes

granted utility patents providing protection until at least 2033.

The utility patent family includes a pending patent application, which if granted, could result in a patent expiring in 2033.

Our biopolymer patent portfolio

includes one patent family.

Our biopolymer patent portfolio includes one patent

The one patent family includes a pending utility patent application, which if granted, could result in a patents expiring in 2038.

Our controlled delivery device patent portfolio includes two patent families.

patent families include pending utility and design patent applications, which if granted, could result in patents expiring in 2035 and 2039.

The two patent families

include pending utility and design patent applications, which if granted, could result in patents expiring in 2035 and 2039.

Our syringe lock patent portfolio includes one patent family.

The one patent family includes a pending

design patent application which if granted, could result in a patent expiring in 2034.

The one patent family includes a pending design patent

application which if granted, could result in a patent expiring in 2034.

There can be no assurance that the pending patent application will be granted.

Our material international patents and patent applications include granted

design and utility patents, as applicable, with similar overview detail as with the US patent application, including in Canada, China, Hong Kong, European Union, India, Japan, South Korea and Brazil.

Our material international patents and patent applications include granted design and utility

patents, as applicable, with similar overview detail as with the US patent application, including in Canada, China, Hong Kong, European Union, India, Japan, South Korea and Brazil.

The term of individual patents depends upon the legal term for patents in the countries in which they are granted.

In most countries, including the United States, the patent term is 20 years

from the earliest claimed filing date of a nonprovisional patent application in the applicable country.

In the United States, a patent’s term may, in certain cases, be lengthened by patent term adjustment, which compensates a patentee for

administrative delays by the United States Patent and Trademark Office in examining and granting a patent, or may be shortened if a patent is terminally disclaimed over a commonly owned patent or a patent naming a common inventor and having an

earlier expiration date.

We cannot be sure that our pending patent applications that we have filed or may file in the future will result in issued patents, and we can give no assurance that any patents that have issued or might issue in the

future will protect our current or future products, will provide us with any competitive advantage, and will not be challenged, invalidated, or circumvented.

In most countries, including the United States, the patent term is 20 years from the earliest

claimed filing date of a nonprovisional patent application in the applicable country.

In the United States, a patent’s term may, in certain cases, be lengthened by patent term adjustment, which compensates a patentee for administrative delays by

the United States Patent and Trademark Office in examining and granting a patent, or may be shortened if a patent is terminally disclaimed over a commonly owned patent or a patent naming a common inventor and having an earlier expiration date.

cannot be sure that our pending patent applications that we have filed or may file in the future will result in issued patents, and we can give no assurance that any patents that have issued or might issue in the future will protect our current

or future products, will provide us with any competitive advantage, and will not be challenged, invalidated, or circumvented.

For more information regarding the risks related to our intellectual property, please see the section titled “Risk Factors—Risks Related to Our Intellectual Property.”

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United States

Our products are medical devices subject to extensive and ongoing regulation by the FDA under the Federal Food, Drug, and Cosmetic Act (FDCA) and its implementing regulations, as well as other

federal and state regulatory bodies in the United States and comparable authorities in other countries under other statutes and regulations.

The laws and regulations govern, among other things, product design and development, preclinical and

clinical testing, manufacturing, packaging, labeling, storage, recordkeeping and reporting, clearance or approval, marketing, distribution, promotion, import and export and postmarketing surveillance.

Failure to comply with applicable

requirements may subject a device and/or its manufacturer to a variety of administrative sanctions, such as issuance of warning letters, import detentions, civil monetary penalties and/or judicial sanctions, such as product seizures, injunctions

and criminal prosecution.

Our products are medical devices subject to extensive and ongoing regulation by the FDA under the Federal Food, Drug, and Cosmetic Act (FDCA) and its implementing regulations, as well as other federal and state

regulatory bodies in the United States and comparable authorities in other countries under other statutes and regulations.

The laws and regulations govern, among other things, product design and development, preclinical and clinical testing,

manufacturing, packaging, labeling, storage, recordkeeping and reporting, clearance or approval, marketing, distribution, promotion, import and export and post-marketing surveillance.

Failure to comply with applicable requirements may subject a

device and/or its manufacturer to a variety of administrative sanctions, such as issuance of warning letters, import detentions, civil monetary penalties and/or judicial sanctions, such as product seizures, injunctions and criminal prosecution.

FDA’s Pre-market Review Requirements

Each medical device we seek to commercially distribute in the United States will require either a prior 510(k) clearance, unless it is exempt, a granted request for de novo classification, or

a pre-market approval from the FDA.

Medical devices are classified into one of three classes—Class I, Class II or Class III—depending on the degree of risk associated with each medical device and the extent of control needed to provide reasonable

assurance of product safety and effectiveness.

Each medical device we seek to commercially distribute in the United States will require either a prior 510(k) clearance, unless it is exempt, a granted request for de novo classification, or a pre-market approval

from the FDA.

safety and effectiveness.

Class I devices are deemed to be low risk and are subject to the general controls of the FDCA, such as provisions that relate to:

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registration and listing;

notification,

including repair, replacement, or refund;

notification, including repair,

replacement, or refund;

records and reports;

and good manufacturing practices.

Most Class I devices are classified as exempt from pre-market notification under section 510(k) of the FDCA, and therefore may be commercially

distributed without obtaining 510(k) clearance from the FDA.

Most Class I devices are classified as exempt from pre-market notification under section 510(k) of the FDCA, and therefore may be commercially distributed without

obtaining 510(k) clearance from the FDA.

Class II devices are subject to both general controls and special controls, which include performance standards, post market surveillance, patient registries and guidance documents.

most Class II devices, the manufacturer must submit to the FDA a pre-market notification requesting permission to commercially distribute the device.

Devices deemed by the FDA to pose the greatest risk, such as life-sustaining, life supporting or

implantable devices, or devices deemed not substantially equivalent to a previously cleared 510(k) device, are placed in Class III.

A Class III device cannot be marketed in the United States unless the FDA approves the device after submission of

For most Class II

devices, the manufacturer must submit to the FDA a pre-market notification requesting permission to commercially distribute the device.

Devices deemed by the FDA to pose the greatest risk, such as life-sustaining, life supporting or implantable

devices, or devices deemed not substantially equivalent to a previously cleared 510(k) device, are placed in Class III.

A Class III device cannot be marketed in the United States unless the FDA approves the device after submission of a PMA.

However, there are some Class III pre-amendment devices for which FDA has not yet called for a PMA.

These devices require a PMA only after FDA publishes a regulation calling for PMA submissions.

Prior to the PMA effective date the

manufacturer must submit a 510(k) pre-market notification and obtain clearance in order to commercially distribute these devices.

The FDA can also impose sales, marketing or other restrictions on devices in order to assure that they are used in a

safe and effective manner.

Prior to the PMA effective date the manufacturer

must submit a 510(k) pre-market notification and obtain clearance in order to commercially distribute these devices.

The FDA can also impose sales, marketing or other restrictions on devices in order to assure that they are used in a safe and

effective manner.

510(k) Clearance Pathway

When a 510(k) clearance is required, we must submit a pre-market notification to the FDA demonstrating that our proposed device is substantially equivalent to a predicate device, which may be

a previously cleared and legally marketed 510(k) device or a device that was in commercial distribution before May 28, 1976, or a device that that was de novo classified under section 513(f)(2) of the FDCA.

To demonstrate substantial equivalence,

the manufacturer must show that the proposed device has the same intended use as the predicate device, and it either has the same technological characteristics, or different technological characteristics and the information in the pre-market

notification demonstrates that the device is as safe and effective as the predicate device and does not raise different questions of safety and effectiveness.

Demonstrating substantial equivalence requires non-clinical performance data and, in

some cases, clinical data.

When a 510(k) clearance is required, we must submit a pre-market notification to the FDA demonstrating that our proposed device is substantially equivalent to a predicate device, which may be a previously cleared

and legally marketed 510(k) device or a device that was in commercial distribution before May 28, 1976, or a device that that was de novo classified under section 513(f)(2) of the FDCA.

To demonstrate substantial equivalence, the manufacturer

must show that the proposed device has the same intended use as the predicate device, and it either has the same technological characteristics, or different technological characteristics and the information in the pre-market notification

demonstrates that the device is as safe and effective as the predicate device and does not raise different questions of safety and effectiveness.

Demonstrating substantial equivalence requires non-clinical performance data and, in some cases,

clinical data.

If the FDA determines that the device is not substantially equivalent to a previously cleared device, the FDA will place the device into Class III.

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and abbreviated.

Special 510(k)s are for devices that are modified by the manufacturer legally authorized to market the device, and

where performance data are unnecessary, or if performance data are necessary, well-established methods are available to evaluate the change, and the performance data necessary to support substantially equivalent (SE) can be reviewed in a summary

or risk analysis format.

Special 510(k)s are for devices that are modified by the manufacturer legally authorized to market the device, and where performance data are

unnecessary, or if performance data are necessary, well-established methods are available to evaluate the change, and the performance data necessary to support substantially equivalent (SE) can be reviewed in a summary or risk analysis format.

Abbreviated 510(k)s are for devices that conform to a recognized standard.

The special and abbreviated 510(k)s are intended to streamline review, and the FDA intends to process special 510(k)s within 30 days of receipt.

FDA also recently established the Safety and Performance Based Pathway that is an expansion of the concept of the abbreviated 510(k) pathway for certain, well understood device types, and provides the option to use FDA-identified performance

criteria to demonstrate that a device is as safe and effective as a predicate device.

FDA also recently

established the Safety and Performance Based Pathway that is an expansion of the concept of the abbreviated 510(k) pathway for certain, well understood device types, and provides the option to use FDA-identified performance criteria to

demonstrate that a device is as safe and effective as a predicate device.

De Novo Classification

Medical device types that the FDA has not previously classified as Class I, II or III are automatically classified into Class III regardless of the level of risk they pose.

The Food and Drug

Administration Modernization Act of 1997 established a new route to market for low to moderate risk medical devices that are automatically placed into Class III due to the absence of a predicate device, called the “Request for Evaluation of

Automatic Class III Designation,” or the de novo classification procedure.

This procedure allows a manufacturer whose novel device is automatically classified into Class III to request de novo

classification of its medical device into Class I or Class II on the basis that the device presents low or moderate risk, and that general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness

for the intended use and that the probable benefits of the device outweigh the probable risks.

FDA has issued several guidance documents addressing the de novo classification process and the contents of de novo classification requests but FDA has not yet issued regulations governing the

de novo classification process.

The Food and Drug Administration

Modernization Act of 1997 established a new route to market for low to moderate risk medical devices that are automatically placed into Class III due to the absence of a predicate device, called the “Request for Evaluation of Automatic Class III

Designation,” or the de novo classification procedure.

This procedure allows a manufacturer whose novel device is automatically classified into Class III to request de novo classification of its medical

device into Class I or Class II on the basis that the device presents low or moderate risk, and that general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use and that

the probable benefits of the device outweigh the probable risks.

FDA has issued several guidance documents addressing the de novo classification process and the contents of de novo classification requests but FDA has not yet issued regulations governing the de novo

classification process.

On December 7, 2018, the FDA published a proposed rule to establish regulations for the de novo classification process.

The proposed regulations, if finalized, are intended to provide structure, clarity and

transparency on the de novo classification process, including requirements related to the format and content of de novo requests, as well as processes and criteria for accepting, granting, declining and withdrawing de novo requests.

Under the Food and Drug Administration Safety and Innovation Act (FDASIA), the FDA is required to issue an order classifying the device within 120 days following receipt of the de novo

request, but in practice the time for FDA review of de novo classification requests is significantly longer.

Under the Food and Drug Administration Reauthorization Act (FDARA), Congress implemented user fees for de novo classification requests

and FDA committed to performance goals for their review.

If the manufacturer seeks de novo classification into Class II, the manufacturer must include a draft proposal for special controls that are necessary to provide a reasonable assurance of

the safety and effectiveness of the medical device.

In addition, the FDA may decline the de novo classification request if it identifies a legally marketed predicate device, or determines that general controls or general and special controls are

insufficient to provide reasonable assurance of safety and effectiveness of the device, or that the probable benefits of the device do not outweigh the probable risks.

Devices that are classified into class I or class II in response to a de novo

classification request may be marketed and used as predicates for future premarket notification 510(k) submissions.

The proposed regulations, if finalized, are intended to provide structure, clarity and transparency on

the de novo classification process, including requirements related to the format and content of de novo requests, as well as processes and criteria for accepting, granting, declining and withdrawing de novo requests.

Under the Food and Drug Administration Safety and Innovation Act (FDASIA), the FDA is required to issue an order classifying the device within 120 days following receipt of the de novo request, but in practice the

time for FDA review of de novo classification requests is significantly longer.

Under the Food and Drug Administration Reauthorization Act (FDARA), Congress implemented user fees for de novo classification requests and FDA committed to

performance goals for their review.

If the manufacturer seeks de novo classification into Class II, the manufacturer must include a draft proposal for special controls that are necessary to provide a reasonable assurance of the safety and

effectiveness of the medical device.

In addition, the FDA may decline the de novo classification request if it identifies a legally marketed predicate device, or determines that general controls or general and special controls are insufficient to

provide reasonable assurance of safety and effectiveness of the device, or that the probable benefits of the device do not outweigh the probable risks.

Devices that are classified into class I or class II in response to a de novo classification

request may be marketed and used as predicates for future premarket notification 510(k) submissions.

Pre-market Approval Pathway

A pre-market approval application must be submitted to the FDA for all Class III devices other than preamendment Class III devices for which the FDA has not yet required a PMA.

The pre-market

approval application process is much more demanding than the 510(k) pre-market notification process.

A pre-market approval application must be supported by extensive data, including but not limited to technical, preclinical and clinical trial

data, and manufacturing and labeling information to demonstrate to the FDA’s satisfaction a reasonable assurance of safety and effectiveness of the device.

Within 45 days after submission of a PMA application, the FDA will determine whether the application is sufficiently complete to permit a substantive review and thus whether the FDA will file

the application for review.

FDA has a performance goal of issuing a decision on original PMAs that do not require input from an advisory committee within 180 FDA Days, which excludes days during which an agency request for additional information

is pending with the applicant.

The pre-market approval application

process is much more demanding than the 510(k) pre-market notification process.

A pre-market approval application must be supported by extensive data, including but not limited to technical, preclinical and clinical trial data, and manufacturing

and labeling information to demonstrate to the FDA’s satisfaction a reasonable assurance of safety and effectiveness of the device.

Within 45 days after submission of a PMA application, the FDA will determine whether the application is sufficiently complete to permit a substantive review and thus whether the FDA will file the application for

The total time for FDA review of an application generally occurs over a significantly longer period of time and can take a year, or even longer.

During this review period, the FDA may request additional information

or clarification of the information already provided.

During this review period, the FDA may request additional information or clarification of

the information already provided.

Also, an advisory panel of experts from outside the FDA may be convened to review and evaluate the application and provide recommendations to the FDA as to the approvability of the device.

Although the FDA is not bound by the advisory panel decision and may or may not accept the panel’s recommendations, the panel’s recommendations are important to the FDA’s overall decision making process.

In addition, the FDA may conduct a

preapproval inspection of the manufacturing facility to ensure compliance with the Quality System Regulation, or QSR.

Although the FDA is not

bound by the advisory panel decision and may or may not accept the panel’s recommendations, the panel’s recommendations are important to the FDA’s overall decision making process.

In addition, the FDA may conduct a preapproval inspection of the

manufacturing facility to ensure compliance with the Quality System Regulation, or QSR.

The agency also may inspect one or more clinical sites to assure compliance with FDA’s regulations.

FDA allows applicants to submit discrete sections (modules) of the PMA to FDA for review soon after completing the testing and analysis.

FDA intends the modular review approach to provide a

mechanism by which applicants may submit preclinical data and manufacturing information for review while still collecting, compiling, and analyzing the clinical data.

Therefore, a modular PMA is a compilation of sections or “modules” submitted at

different times that together become a complete application.

Additionally, the modular approach allows the applicant to potentially resolve any deficiencies noted by FDA earlier in the review process than would occur with a traditional PMA

During the PMA review, the FDA assesses whether the data and information in the PMA constitute valid scientific evidence to support a determination that there is a reasonable assurance that the

device is safe and effective for its intended use(s) based on the proposed labeling.

FDA intends the modular review approach to provide a mechanism by which

applicants may submit preclinical data and manufacturing information for review while still collecting, compiling, and analyzing the clinical data.

Therefore, a modular PMA is a compilation of sections or “modules” submitted at different times

that together become a complete application.

Additionally, the modular approach allows the applicant to potentially resolve any deficiencies noted by FDA earlier in the review process than would occur with a traditional PMA application.

During the PMA review, the FDA assesses whether the data and information in the PMA constitute valid scientific evidence to support a determination that there is a reasonable assurance that the device is safe and

effective for its intended use(s) based on the proposed labeling.

Upon completion of the PMA review, the FDA may:

(i) approve the PMA which authorizes commercial marketing with specific prescribing information for one or more

indications, and which can be more limited than those originally sought;

(ii) issue an approvable letter which indicates the FDA’s belief that the PMA is approvable and states what additional information the FDA requires, or the post-approval

commitments that must be agreed to prior to approval;

(iii) issue a not approvable letter which outlines steps required for approval, but which are typically more onerous than those in an approvable letter, and may require additional clinical

trials that are often expensive and time consuming and can delay approval for months or even years;

(i) approve the PMA which authorizes commercial marketing with specific prescribing information for one or more indications, and

which can be more limited than those originally sought;

(ii) issue an approvable letter which indicates the FDA’s belief that the PMA is approvable and states what additional information the FDA requires, or the post-approval commitments that

must be agreed to prior to approval;

(iii) issue a not approvable letter which outlines steps required for approval, but which are typically more onerous than those in an approvable letter, and may require additional clinical trials that are

often expensive and time consuming and can delay approval for months or even years;

or (iv) deny the application.

If the FDA issues an approvable or not approvable letter, the applicant has 180 days to respond, after which the

FDA’s review clock is reset.

If FDA issues a PMA approval, the approval may contain post approval conditions intended to ensure the safety and effectiveness of the device, including, among other things, restrictions on labeling, promotion, sale

and distribution, and collection of long-term follow-up data from patients in the clinical trial that supported a PMA or requirements to conduct additional clinical trials post-approval.

Certain changes to an approved device, such as changes in manufacturing facilities, methods, or quality control procedures, or changes in the design performance specifications, which affect the

safety or effectiveness of the device, require submission and approval of a PMA supplement.

Certain other changes to an approved device require the submission and approval of a new PMA, such as when the design change leads to a different intended

use, mode of operation, and technical basis of operation, or when the design change is so significant that a new generation of the device will be developed, and the originally submitted data are not applicable to the change.

If the FDA issues an approvable or not approvable letter, the applicant has 180 days to respond, after which the FDA’s review clock

and collection of long-term follow-up data from patients in the clinical trial that supported a PMA or requirements to conduct additional clinical trials post-approval.

Certain changes to an approved device, such as changes in manufacturing facilities, methods, or quality control procedures, or changes in the design performance specifications, which affect the safety or

effectiveness of the device, require submission and approval of a PMA supplement.

Certain other changes to an approved device require the submission and approval of a new PMA, such as when the design change leads to a different intended use, mode

of operation, and technical basis of operation, or when the design change is so significant that a new generation of the device will be developed, and the originally submitted data are not applicable to the change.

Clinical Trials

Clinical trials are almost always required to support pre-market approval, are often required for de novo classification, and are sometimes required for 510(k) clearance.

In the United States,

for significant risk devices, these trials require submission of an IDE application to the FDA.

The IDE application must be supported by appropriate data, such as animal and laboratory testing results, showing it is safe to test the device in

humans and that the testing protocol is scientifically sound.

In the United States, for significant risk

devices, these trials require submission of an IDE application to the FDA.

The IDE application must be supported by appropriate data, such as animal and laboratory testing results, showing it is safe to test the device in humans and that the

testing protocol is scientifically sound.

The IDE must be approved in advance by the FDA for a specific number of patients at specified study sites.

During the trial, the sponsor must comply with the FDA’s IDE requirements for

investigator selection, trial monitoring, reporting and recordkeeping.

The investigators must obtain patient informed consent, rigorously follow the investigational plan and study protocol, control the disposition of investigational devices and

comply with all reporting and recordkeeping requirements.

During the trial, the sponsor must comply with the FDA’s IDE requirements for investigator

selection, trial monitoring, reporting and recordkeeping.

The investigators must obtain patient informed consent, rigorously follow the investigational plan and study protocol, control the disposition of investigational devices and comply with

all reporting and recordkeeping requirements.

Clinical trials for significant risk devices may not begin until the IDE application is approved by the FDA.

An IDE application is considered approved 30 days after it has been received by

the FDA, unless the agency otherwise informs the sponsor via email prior to 30 calendar days from the date of receipt, that the IDE is approved, approved with conditions, or disapproved.

In addition, the study must be approved by, and conducted

under the oversight of an Institutional Review Board (IRB).

An IDE application is considered approved 30 days after it has been received by the FDA,

unless the agency otherwise informs the sponsor via email prior to 30 calendar days from the date of receipt, that the IDE is approved, approved with conditions, or disapproved.

In addition, the study must be approved by, and conducted under the

oversight of an Institutional Review Board (IRB).

An IRB is an appropriately constituted group that has been formally designated to review and monitor medical research involving subjects and which has the authority to approve, require

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Sponsors of certain clinical trials of devices are required to register with clinicaltrials.gov, a public database of clinical trial information.

Information related to the device, patient

population, phase of investigation, study sites and investigators and other aspects of the clinical trial is made public as part of the registration.

Information related to the device, patient population, phase of

investigation, study sites and investigators and other aspects of the clinical trial is made public as part of the registration.

Ongoing Regulation by the FDA

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post market surveillance regulations, which apply to certain Class II or III devices when necessary to protect the public health or to provide additional safety and efficacy data for the device.

After a device receives 510(k) clearance or is de novo classified, any modification that could significantly affect its safety or effectiveness, or that would constitute a major change in its

intended use, will require a new clearance or possibly even a new de novo classification or PMA supplement.

The FDA requires each manufacturer to make this determination initially, but the FDA can review any such decision and can disagree with a

manufacturer’s determination.

After a device receives 510(k) clearance or is de novo classified, any modification that could significantly affect its safety or effectiveness, or that would constitute a major change in its intended use, will

require a new clearance or possibly even a new de novo classification or PMA supplement.

The FDA requires each manufacturer to make this determination initially, but the FDA can review any such decision and can disagree with a manufacturer’s

determination.

If the FDA disagrees with our determination not to seek a new 510(k) clearance, the FDA may retroactively require us to seek 510(k) clearance or possibly de novo classification or PMA supplement.

The FDA could also

require us to cease marketing and distribution and/or recall the modified device until 510(k) clearance, de novo classification, or pre-market approval is obtained.

The FDA could also require us to

cease marketing and distribution and/or recall the modified device until 510(k) clearance, de novo classification, or pre-market approval is obtained.

Also, in these circumstances, we may be subject to enforcement actions.

Some changes to an approved PMA device, including changes in indications, labeling or manufacturing processes or facilities, require submission and FDA approval of a new PMA or PMA supplement,

as appropriate, before the change can be implemented.

Supplements to a PMA often require the submission of the same type of information required for an original PMA, except that the supplement is generally limited to that information needed to

support the proposed change from the device covered by the original PMA.

Some changes to an approved PMA device, including changes in indications, labeling or manufacturing processes or facilities, require submission and FDA approval of a new PMA or PMA supplement, as appropriate,

before the change can be implemented.

Supplements to a PMA often require the submission of the same type of information required for an original PMA, except that the supplement is generally limited to that information needed to support the

proposed change from the device covered by the original PMA.

The FDA uses the same procedures and actions in reviewing PMA supplements as it does in reviewing original PMAs.

FDA regulations require us to register as a medical device manufacturer with the FDA.

Additionally, the California Department of Health Services, or CDHS, requires us to register as a medical

device manufacturer within the state.

Our manufacturing processes are required to comply with the applicable portions of the QSR, which cover the methods and the facilities and controls for the design, manufacture, testing, production, processes,

controls, quality assurance, labeling, packaging, distribution, installation and servicing of finished devices intended for human use.

As a manufacturer, our facilities, records and manufacturing processes are subject to periodic scheduled or

unscheduled inspections by the FDA and the CDHS.

Additionally, the California Department of Health Services, or CDHS, requires us to register as a medical device manufacturer

within the state.

assurance, labeling, packaging, distribution, installation and servicing of finished devices intended for human use.

As a manufacturer, our facilities, records and manufacturing processes are subject to periodic scheduled or unscheduled

inspections by the FDA and the CDHS.

Our failure to maintain compliance with the QSR could result in the shutdown of, or restrictions on, our manufacturing operations and the recall or seizure of our products.

We have undergone and

expect to continue to undergo regular QSR inspections in connection with the manufacture of our products at our facilities.

We have undergone and expect to

continue to undergo regular QSR inspections in connection with the manufacture of our products at our facilities.

Further, the FDA requires us to comply with various FDA requirements regarding labeling and promotion.

Failure by us or by

our suppliers to comply with applicable regulatory requirements can result in enforcement action by the FDA or state authorities, which may include any of the following sanctions:

Failure by us or by our

suppliers to comply with applicable regulatory requirements can result in enforcement action by the FDA or state authorities, which may include any of the following sanctions:

warning or untitled letters, fines, injunctions, consent decrees and civil penalties;

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criminal prosecution.

The Medical Device Reporting laws and regulations require us to provide information to the FDA when we receive or otherwise become aware of information that reasonably suggests our device may

have caused or contributed to a death or serious injury, or has malfunctioned and the device or a similar device that we market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

In addition, the

FDA prohibits an approved device from being marketed for off-label use.

The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off

label uses may be subject to significant liability, including substantial monetary penalties and criminal prosecution.

Newly discovered or developed safety or effectiveness data may require changes to a product’s labeling, including the addition of new warnings and contraindications, and also may require the

implementation of other risk management measures.

Also, new government requirements, including those resulting from new legislation, may be established, or the FDA’s policies may change, which could delay or prevent regulatory clearance or

approval of our products under development.

The Medical Device Reporting laws and regulations require us to provide information to the FDA when we receive or otherwise become aware of information that reasonably suggests our device may have caused or

contributed to a death or serious injury, or has malfunctioned and the device or a similar device that we market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

In addition, the FDA prohibits

an approved device from being marketed for off-label use.

The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off label uses may

be subject to significant liability, including substantial monetary penalties and criminal prosecution.

Newly discovered or developed safety or effectiveness data may require changes to a product’s labeling, including the addition of new warnings and contraindications, and also may require the implementation of other

risk management measures.

Also, new government requirements, including those resulting from new legislation, may be established, or the FDA’s policies may change, which could delay or prevent regulatory clearance or approval of our products under

We are also subject to other federal, state and local laws and regulations relating to safe working conditions, laboratory and manufacturing practices.

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Our products are regulated in the European Union as medical devices under Directive 93/42/EEC on Medical Devices, also known as the Medical Devices Directive.

The Medical Devices Directive

requires medical devices to meet the essential requirements which are enumerated in the annexes to the Directive.

Compliance with these requirements is a prerequisite to be able to affix the Conformité Européene, or CE, mark to our products,

without which they cannot be sold or marketed in the EEA.

The Medical Devices Directive requires medical devices

to meet the essential requirements which are enumerated in the annexes to the Directive.

Compliance with these requirements is a prerequisite to be able to affix the Conformité Européene, or CE, mark to our products, without which they cannot be

sold or marketed in the EEA.

To demonstrate compliance with the essential requirements we must perform a conformity assessment procedure, which varies according to the type of medical device and its classification.

Except for low-risk medical devices (Class I non-sterile, non-measuring devices), where the manufacturer can issue an EC Declaration of Conformity based on a self-assessment of the conformity

of its products with the essential requirements of the EU Medical Devices Directive, a conformity assessment procedure requires the intervention of an organization accredited by a member state of the EEA to conduct conformity assessments, or a

notified body.

Except for low-risk medical devices (Class I non-sterile, non-measuring devices), where the manufacturer can issue an EC Declaration of Conformity based on a self-assessment of the conformity of its products with

the essential requirements of the EU Medical Devices Directive, a conformity assessment procedure requires the intervention of an organization accredited by a member state of the EEA to conduct conformity assessments, or a notified body.

Depending on the relevant conformity assessment procedure, the notified body would typically audit and examine the technical file and the quality system for the manufacture, design and final inspection of our devices.

body issues a certificate of conformity following successful completion of a conformity assessment procedure conducted in relation to the medical device and its manufacturer and their conformity with the essential requirements.

This certificate

entitles the manufacturer to affix the CE mark to its medical devices after having prepared and signed a related EC Declaration of Conformity.

As a general rule, demonstration of conformity of medical devices and their manufacturers with the essential requirements must be based, among other things, on the evaluation of clinical data

supporting the safety and performance of the products during normal conditions of use.

Specifically, a manufacturer must demonstrate that the device achieves its intended performance during normal conditions of use, that the known and foreseeable

risks, and any adverse events, are minimized and acceptable when weighed against the benefits of its intended performance, and that any claims made about the performance and safety of the device are supported by suitable evidence.

In April 2017, the EU adopted a new Medical Devices Regulation (EU) 2017/745, or the Medical Devices

Regulation, which will repeal and replace the Medical Devices Directive with effect from May 26, 2021.

The Medical Devices Regulation envisages, among other things, stricter controls of

medical devices, including strengthening of the conformity assessment procedures, increased expectations as regards to clinical data for devices and pre-market regulatory review of high-risk devices.

Under transitional provisions, medical devices

with notified body certificates issued under the Medical Devices Directive prior to May 26, 2021 may continue to be placed on the market for the remaining validity of the certificate, until May 27, 2024 at the latest.

After the expiry of any

applicable transitional period, only devices that have been CE marked under the Medical Devices Regulation may be placed on the market in the EEA

The notified body issues a

certificate of conformity following successful completion of a conformity assessment procedure conducted in relation to the medical device and its manufacturer and their conformity with the essential requirements.

This certificate entitles the

manufacturer to affix the CE mark to its medical devices after having prepared and signed a related EC Declaration of Conformity.

As a general rule, demonstration of conformity of medical devices and their manufacturers with the essential requirements must be based, among other things, on the evaluation of clinical data supporting the safety

and performance of the products during normal conditions of use.

Specifically, a manufacturer must demonstrate that the device achieves its intended performance during normal conditions of use, that the known and foreseeable risks, and any

adverse events, are minimized and acceptable when weighed against the benefits of its intended performance, and that any claims made about the performance and safety of the device are supported by suitable evidence.

In April 2017, the EU adopted a new Medical Devices Regulation (EU) 2017/745, or the Medical Devices Regulation, which will repeal and replace the Medical Devices Directive with effect from May 26, 2021.

Medical Devices Regulation envisages, among other things, stricter controls of medical devices, including strengthening of the conformity assessment procedures, increased expectations as regards to clinical data for devices and pre-market

regulatory review of high-risk devices.

Under transitional provisions, medical devices with notified body certificates issued under the Medical Devices Directive prior to May 26, 2021 may continue to be placed on the market for the remaining

validity of the certificate, until May 27, 2024 at the latest.

After the expiry of any applicable transitional period, only devices that have been CE marked under the Medical Devices Regulation may be placed on the market in the EEA

Other Regions

Most major markets have different levels of regulatory requirements for medical devices.

Modifications to the cleared or approved products may require a new regulatory submission in all major

The regulatory requirements, and the review time, vary significantly from country to country.

Modifications to the cleared or approved products may require a new regulatory submission in all major markets.

regulatory requirements, and the review time, vary significantly from country to country.

Products can also be marketed in other countries that have minimal requirements for medical devices.

Fraud and Abuse and Other Healthcare Regulations

Federal and state governmental agencies and equivalent foreign authorities subject the healthcare industry to intense regulatory scrutiny, including heightened civil and criminal enforcement

These laws constrain the sales, marketing and other promotional activities of medical device manufacturers by limiting the kinds of financial arrangements we may have with hospitals, physicians and other potential purchasers of our

Federal healthcare fraud and abuse laws apply to our business when a customer submits a claim for an item or service that is reimbursed under Medicare, Medicaid or other federally-funded healthcare programs.

Patient privacy statutes and

regulations by foreign, federal and state governments may also apply in the locations in which we do business.

Federal and state governmental agencies and equivalent foreign authorities subject the healthcare industry to intense regulatory scrutiny, including heightened civil and criminal enforcement efforts.

constrain the sales, marketing and other promotional activities of medical device manufacturers by limiting the kinds of financial arrangements we may have with hospitals, physicians and other potential purchasers of our products.

healthcare fraud and abuse laws apply to our business when a customer submits a claim for an item or service that is reimbursed under Medicare, Medicaid or other federally-funded healthcare programs.

Patient privacy statutes and regulations by

foreign, federal and state governments may also apply in the locations in which we do business.

Descriptions of some of the U.S.

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Federal Healthcare Anti-Kickback Statute

The federal healthcare Anti-Kickback Statute prohibits, among other things, persons or entities from knowingly and willfully soliciting, offering, receiving or paying any remuneration,

directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchasing, leasing, ordering, or arranging for or recommending the purchase, lease, or order of any good or

service for which payment may be made, in whole or in part, by federal healthcare programs, such as the Medicare and Medicaid programs.

The term “remuneration” has been broadly interpreted to include anything of value, and the government can

establish a violation of the Anti-Kickback Statute without proving that a person or entity had actual knowledge of the law or a specific intent to violate it.

In addition, the government may assert that a claim, including items or services

resulting from a violation of the Anti-Kickback Statute, constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act.

The Anti-Kickback Statute is subject to evolving interpretations and has been applied by

government enforcement officials to a number of common business arrangements in the medical device industry.

There are a number of statutory exceptions and regulatory safe harbors protecting certain business arrangements from prosecution under

the Anti-Kickback Statute;

however, those exceptions and safe harbors are drawn narrowly, and there is no exception or safe harbor for many common business activities, such as reimbursement support programs, educational and research grants or

charitable donations.

The failure of a transaction or arrangement to fit precisely within one or more applicable statutory exceptions or regulatory safe harbors does not necessarily mean that it is illegal or that prosecution will be pursued.

However, conduct and business arrangements that do not fully satisfy all requirements of an applicable safe harbor may result in increased scrutiny by government enforcement authorities and will be evaluated on a case-by-case basis based on a

cumulative review of all facts and circumstances.

The federal healthcare Anti-Kickback Statute prohibits, among other things, persons or entities from knowingly and willfully soliciting, offering, receiving or paying any remuneration, directly or indirectly,

overtly or covertly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchasing, leasing, ordering, or arranging for or recommending the purchase, lease, or order of any good or service for which payment

may be made, in whole or in part, by federal healthcare programs, such as the Medicare and Medicaid programs.

The term “remuneration” has been broadly interpreted to include anything of value, and the government can establish a violation of the

Anti-Kickback Statute without proving that a person or entity had actual knowledge of the law or a specific intent to violate it.

In addition, the government may assert that a claim, including items or services resulting from a violation of the

Anti-Kickback Statute, constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act.

The Anti-Kickback Statute is subject to evolving interpretations and has been applied by government enforcement officials to a

number of common business arrangements in the medical device industry.

There are a number of statutory exceptions and regulatory safe harbors protecting certain business arrangements from prosecution under the Anti-Kickback Statute;

those exceptions and safe harbors are drawn narrowly, and there is no exception or safe harbor for many common business activities, such as reimbursement support programs, educational and research grants or charitable donations.

The failure of a

transaction or arrangement to fit precisely within one or more applicable statutory exceptions or regulatory safe harbors does not necessarily mean that it is illegal or that prosecution will be pursued.

However, conduct and business arrangements

that do not fully satisfy all requirements of an applicable safe harbor may result in increased scrutiny by government enforcement authorities and will be evaluated on a case-by-case basis based on a cumulative review of all facts and

circumstances.

Federal Civil False Claims Act

The federal civil False Claims Act prohibits, among other things, persons or entities from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment of

government funds, or knowingly making, using or causing to be made or used a false record or statement material to a false or fraudulent claim to avoid, decrease or conceal an obligation to pay money to the federal government.

A claim including

items or services resulting from a violation of the Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act.

Actions under the False Claims Act may be brought by the government or as a qui tam action by

a private individual in the name of the government.

The federal civil False Claims Act prohibits, among other things, persons or entities from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment of government funds, or knowingly

making, using or causing to be made or used a false record or statement material to a false or fraudulent claim to avoid, decrease or conceal an obligation to pay money to the federal government.

A claim including items or services resulting from

a violation of the Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act.

Actions under the False Claims Act may be brought by the government or as a qui tam action by a private individual in the name

of the government.

These individuals, sometimes known as “relators” or, more commonly, as “whistleblowers,” may share in any amounts paid by the entity to the government in fines or settlement.

The number of

filings of qui tam actions has increased significantly in recent years.

The number of filings of qui tam actions has

increased significantly in recent years.

Qui tam actions are filed under seal and impose a mandatory duty on the U.S.

Department of Justice to investigate such allegations.

Most private citizen actions are declined

by the Department of Justice or dismissed by federal courts.

Most private citizen actions are declined by the Department of Justice or

dismissed by federal courts.

However, the investigation costs for a company can be significant and material even if the allegations are without merit.

Various states have adopted laws similar to the False Claims

Act, and many of these state laws are broader in scope and apply to all payors, and therefore, are not limited to only those claims submitted to the federal government.

Medical device manufacturers and other healthcare companies also are subject

to other federal false claims laws, including, among others, federal criminal healthcare fraud and false statement statutes that extend to non-government health benefit programs.

Various states have adopted laws similar to the False Claims Act, and many of these state laws

are broader in scope and apply to all payors, and therefore, are not limited to only those claims submitted to the federal government.

Medical device manufacturers and other healthcare companies also are subject to other federal false claims

laws, including, among others, federal criminal healthcare fraud and false statement statutes that extend to non-government health benefit programs.

Healthcare Fraud Statute

The federal Health Insurance Portability and Accountability Act (HIPAA) and its implementing regulations created federal criminal statutes that prohibit, among other things, knowingly and

willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party payors knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false,

fictitious or fraudulent statement or representation, or making or using any false writing or document knowing the same to contain any materially false, fictitious or fraudulent statement or entry, in connection with the delivery of or payment

for healthcare benefits, items or services.

The federal Health Insurance Portability and Accountability Act (HIPAA) and its implementing regulations created federal criminal statutes that prohibit, among other things, knowingly and willfully executing, or

attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party payors knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent

statement or representation, or making or using any false writing or document knowing the same to contain any materially false, fictitious or fraudulent statement or entry, in connection with the delivery of or payment for healthcare benefits,

items or services.

Federal Physician Payments Sunshine Act

The federal Physician Payments Sunshine Act requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the

Children’s Health Insurance Program to report annually with certain exceptions to CMS information related to payments or other transfers of value made to a physician or teaching hospital, or to a third party at the request of a physician or

teaching hospital, and requires applicable manufacturers and group purchasing organizations to report annually to CMS ownership and investment interests held by physicians and their immediate family members.

Beginning in 2022, applicable

manufacturers also will be required to report information regarding payments and transfers of value provided to physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists and certified nurse-midwives.

The federal Physician Payments Sunshine Act requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health

Insurance Program to report annually with certain exceptions to CMS information related to payments or other transfers of value made to a physician or teaching hospital, or to a third party at the request of a physician or teaching hospital, and

requires applicable manufacturers and group purchasing organizations to report annually to CMS ownership and investment interests held by physicians and their immediate family members.

Beginning in 2022, applicable manufacturers also will be

required to report information regarding payments and transfers of value provided to physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists and certified nurse-midwives.

Patient Data Privacy

HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (HITECH Act), and their implementing regulations impose obligations on covered entities, such as

health plans, healthcare clearinghouses and certain healthcare providers, as well as business associates that provide services involving the use or disclosure of personal health information to or on behalf of covered entities.

These obligations,

such as mandatory contractual terms, relate to safeguarding the privacy and security of protected health information.

Many states also have laws governing the privacy and security of health information in certain circumstances, many of which

differ from each other in significant ways and often are not preempted by HIPAA.

HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (HITECH Act), and their implementing regulations impose obligations on covered entities, such as health plans, healthcare

clearinghouses and certain healthcare providers, as well as business associates that provide services involving the use or disclosure of personal health information to or on behalf of covered entities.

These obligations, such as mandatory

contractual terms, relate to safeguarding the privacy and security of protected health information.

Many states also have laws governing the privacy and security of health information in certain circumstances, many of which differ from each other

in significant ways and often are not preempted by HIPAA.

Other State Laws

Certain states also mandate implementation of commercial compliance programs, impose restrictions on device manufacturer marketing practices and/or require tracking and reporting of gifts,

compensation and other remuneration to healthcare professionals and entities.

Certain states also mandate implementation of commercial compliance programs, impose restrictions on device manufacturer marketing practices and/or require tracking and reporting of gifts, compensation and other

remuneration to healthcare professionals and entities.

State and federal regulatory and enforcement agencies continue to actively investigate violations of healthcare laws and regulations, and the U.S.

Congress continues to strengthen the arsenal

of enforcement tools.

Congress continues to strengthen the arsenal of enforcement tools.

Most recently, the Bipartisan Budget Act (BBA) of 2018 increased the criminal and civil penalties that can be imposed for violating certain federal healthcare laws, including the Anti-Kickback Statute.

Enforcement agencies

also continue to pursue novel theories of liability under these laws.

In particular, government agencies recently have increased regulatory scrutiny and enforcement activity with respect to manufacturer reimbursement support activities and other

patient support programs, including bringing criminal charges or civil enforcement actions under the Anti-Kickback Statute, federal civil False Claims Act and violations of healthcare fraud and HIPAA privacy provisions.

Enforcement agencies also continue to pursue

novel theories of liability under these laws.

In particular, government agencies recently have increased regulatory scrutiny and enforcement activity with respect to manufacturer reimbursement support activities and other patient support

programs, including bringing criminal charges or civil enforcement actions under the Anti-Kickback Statute, federal civil False Claims Act and violations of healthcare fraud and HIPAA privacy provisions.

Enforcement and Penalties for Noncompliance with Fraud and Abuse Laws and Regulations

Compliance with these federal and state laws and regulations requires substantial resources.

If our operations are found to be in violation of any of the laws described above or any other

governmental regulations that apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, imprisonment, disgorgement, exclusion from participation in government healthcare programs such as the

Medicare and Medicaid programs, reputational harm, administrative burdens, diminished profits and future earnings, and the curtailment or restructuring of our operations.

Companies settling federal civil False Claims Act, Anti-Kickback Statute

and other fraud and abuse cases also may be required to enter into a Corporate Integrity Agreement with the U.S.

Department of Health and Human Services Office of Inspector General in order to avoid exclusion from participation (i.e., loss of

coverage for their products) in federal healthcare programs such as Medicare and Medicaid.

If our operations are found to be in violation of any of the laws described above or any other governmental regulations

that apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, imprisonment, disgorgement, exclusion from participation in government healthcare programs such as the Medicare and Medicaid

programs, reputational harm, administrative burdens, diminished profits and future earnings, and the curtailment or restructuring of our operations.

Companies settling federal civil False Claims Act, Anti-Kickback Statute and other fraud and

abuse cases also may be required to enter into a Corporate Integrity Agreement with the U.S.

Department of Health and Human Services Office of Inspector General in order to avoid exclusion from participation (i.e., loss of coverage for their

products) in federal healthcare programs such as Medicare and Medicaid.

Corporate Integrity Agreements typically impose substantial costs on companies to ensure compliance.

For additional information regarding obligations under federal healthcare statues and regulations, please see the section titled “Risk Factors—If we fail to comply with U.S.

federal and state

fraud and abuse laws and regulations, including those relating to kickbacks and false claims for reimbursement, we could face substantial penalties and our business operations and financial condition could be adversely affected.”

federal and state fraud and abuse laws

and regulations, including those relating to kickbacks and false claims for reimbursement, we could face substantial penalties and our business operations and financial condition could be adversely affected.”

United States Healthcare Reform

There have been and continue to be proposals by the federal government, state governments, regulators and third-party payors to control or manage the increased costs of

healthcare and, more generally, to reform the U.S.

There have been and continue to be proposals by the federal government, state governments, regulators and third-party payors to control or manage the increased costs of healthcare and, more

generally, to reform the U.S.

healthcare system.

For example, in the United States, in March 2010, the ACA was enacted.

The ACA contains a number of significant provisions, including those governing enrollment in federal healthcare programs,

reimbursement changes and fraud and abuse measures, all of which will impact existing government healthcare programs and will result in the development of new programs.

The ACA contains a number of significant provisions, including those governing enrollment in federal healthcare programs, reimbursement changes

and fraud and abuse measures, all of which will impact existing government healthcare programs and will result in the development of new programs.

Some of the provisions of the ACA have yet to be fully implemented, while certain provisions have been subject to judicial and Congressional challenges.

Congress has considered legislation

that would repeal or repeal and replace all or part of the ACA.

Congress has considered legislation that would repeal or

repeal and replace all or part of the ACA.

While Congress has not passed comprehensive repeal legislation, two bills affecting the implementation of certain taxes under the ACA have been signed into law.

The Tax Cuts and Jobs

Act of 2017, or Tax Act, includes a provision that decreased the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year, commonly referred to as

the “individual mandate,” to $0, effective January 1, 2019.

On December 14, 2018, a federal district court in Texas ruled the individual mandate is a critical and inseverable feature of the ACA, and therefore, because it was repealed as part of

the Tax Act, the remaining provisions of the ACA are invalid as well.

The Tax Cuts and Jobs Act of 2017, or Tax

Act, includes a provision that decreased the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year, commonly referred to as the “individual

mandate,” to $0, effective January 1, 2019.

On December 14, 2018, a federal district court in Texas ruled the individual mandate is a critical and inseverable feature of the ACA, and therefore, because it was repealed as part of the Tax Act, the

remaining provisions of the ACA are invalid as well.

On December 18, 2019, the Fifth Circuit U.S.

Court of Appeals held that the individual mandate is unconstitutional and remanded the case to the lower court to reconsider its

earlier invalidation of the full ACA.

Court of Appeals held that the individual mandate is unconstitutional and remanded the case to the lower court to reconsider its earlier

invalidation of the full ACA.

On March 2, 2020, the United States Supreme Court granted the petitions for writs of certiorari to review this case and held oral arguments on November 10, 2020.

In June 2021, the United States Supreme Court

held that the individual plaintiffs and states lacked standing to challenge the constitutionality of the ACA.

On January 22, 2018, former President Trump signed a continuing resolution on appropriations for fiscal year 2018 that delayed the implementation of certain ACA -mandated fees, including the

so-called “Cadillac” tax on certain high cost employer-sponsored insurance plans, the annual fee imposed on certain health insurance providers based on market share, and the medical device excise tax on non-exempt medical devices;

December 20, 2019, former President Trump signed into law the Further Consolidated Appropriations Act (H.R.

In June 2021, the United States Supreme Court held

that the individual plaintiffs and states lacked standing to challenge the constitutionality of the ACA.

On January 22, 2018, former President Trump signed a continuing resolution on appropriations for fiscal year 2018 that delayed the implementation of certain ACA-mandated fees, including the so-called “Cadillac” tax

on certain high cost employer-sponsored insurance plans, the annual fee imposed on certain health insurance providers based on market share, and the medical device excise tax on non-exempt medical devices;

however, on December 20, 2019, former

President Trump signed into law the Further Consolidated Appropriations Act (H.R.

1865), which repealed the Cadillac tax, the health insurance provider tax, and the medical device excise tax.

Other legislative changes

have been proposed and adopted in the United States since the ACA was enacted.

The BBA, among other things, amended the ACA, effective January 1, 2019, to close the coverage gap in most Medicare drug plans, commonly referred to as the “donut

In December 2018, CMS published a final rule permitting further collections and payments to and from certain ACA qualified health plans and health insurance issuers under the Affordable Care

Act risk adjustment program in response to the outcome of the federal district court litigation regarding the method CMS uses to determine this risk adjustment.

Since then, the ACA risk adjustment program payment parameters have been updated

In addition, CMS published a final rule that would give states greater flexibility, starting in 2020, in setting benchmarks for insurers in the individual and small group marketplaces, which may have the effect of relaxing the essential

health benefits required under the ACA for plans sold through such marketplaces.

Other legislative changes have been proposed and

adopted in the United States since the ACA was enacted.

The BBA, among other things, amended the ACA, effective January 1, 2019, to close the coverage gap in most Medicare drug plans, commonly referred to as the “donut hole.”

In December 2018, CMS published a final rule permitting further collections and payments to and from certain ACA qualified health plans and health insurance issuers under the Affordable Care Act risk adjustment

program in response to the outcome of the federal district court litigation regarding the method CMS uses to determine this risk adjustment.

Since then, the ACA risk adjustment program payment parameters have been updated annually.

CMS published a final rule that would give states greater flexibility, starting in 2020, in setting benchmarks for insurers in the individual and small group marketplaces, which may have the effect of relaxing the essential health benefits

required under the ACA for plans sold through such marketplaces.

In addition, other legislative changes have been proposed and adopted since the ACA was enacted.

On August 2, 2011, the Budget Control Act of 2011 was signed into law, which, among other

things, includes reductions to Medicare payments to providers of 2% per fiscal year, which went into effect on April 1, 2013 and, due to subsequent legislative amendments to the statute, including the BBA, will remain in effect through 2030

unless additional Congressional action is taken.

However, pursuant to the Coronavirus Aid, Relief and Economic Security Act, or CARES Act, and subsequent legislation, these Medicare sequester reductions are suspended from May 1, 2020 through

March 31, 2022 due to the COVID-19 pandemic.

On January 2, 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, reduced Medicare payments to several providers, including hospitals, and increased the

statute of limitations period for the government to recover overpayments to providers from three to five years.

Further, recently, under the former Trump administration, there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which

has resulted in several U.S.

On August 2, 2011, the Budget Control Act of 2011 was signed into law, which, among other things, includes reductions

to Medicare payments to providers of 2% per fiscal year, which went into effect on April 1, 2013 and, due to subsequent legislative amendments to the statute, including the BBA, will remain in effect through 2030 unless additional Congressional

action is taken.

On January 2, 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, reduced Medicare payments to several providers, including hospitals, and increased the statute of limitations period for

the government to recover overpayments to providers from three to five years.

Further, recently, under the former Trump administration, there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several

Congressional inquiries and proposed, and enacted federal and state legislation designed to bring transparency to product pricing and reduce the cost of products and services under government healthcare programs.

this time, it is unclear whether the current administration will continue to pursue legislative and/or administrative measures to control product costs.

Additionally, regional healthcare authorities and individual hospitals are increasingly using

bidding procedures to determine what products to purchase and which suppliers will be included in their healthcare programs.

At this time, it is unclear

whether the current administration will continue to pursue legislative and/or administrative measures to control product costs.

Additionally, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to

determine what products to purchase and which suppliers will be included in their healthcare programs.

Employees and Human Capital Resources

As of December 31, 2022, we employed 34 full-time employees and two part-time employees.

None of our employees are represented by a collective bargaining agreement and we have never experienced

a work stoppage.

We believe our employee relations are good.

None of our employees are represented by a collective bargaining agreement and we have never experienced a work stoppage.

believe our employee relations are good.

We recognize that attracting, motivating and retaining talent at all levels is vital to our continued success.

Our employees are a significant asset and we aim to create an equitable, inclusive

and empowering environment in which our employees can grow and advance their careers, with the overall goal of developing, expanding and retaining our workforce to support our current pipeline and future business goals.

By focusing on employee

retention and engagement, we also improve our ability to support our clinical trials, our pipeline, our platform technologies, business and operations, and also protect the long-term interests of our stakeholders.

Our success also depends on our

ability to attract, engage and retain a diverse group of employees.

Our employees are a significant asset and we aim to create an equitable, inclusive and empowering

environment in which our employees can grow and advance their careers, with the overall goal of developing, expanding and retaining our workforce to support our current pipeline and future business goals.

By focusing on employee retention and

engagement, we also improve our ability to support our clinical trials, our pipeline, our platform technologies, business and operations, and also protect the long-term interests of our stakeholders.

Our success also depends on our ability to

attract, engage and retain a diverse group of employees.

Our efforts to recruit and retain a diverse and passionate workforce include providing competitive compensation and benefits packages and ensuring we listen to our employees.

We value innovation, passion, data-driven decision making, persistence and honesty, and are building a diverse environment where our employees can thrive and be inspired to make exceptional

contributions to bring novel and proprietary diagnostic and device solutions to disrupt the approaches to women’s health worldwide.

We value innovation, passion, data-driven decision making, persistence and honesty, and are building a diverse environment where our employees can thrive and be inspired to make exceptional contributions to bring

novel and proprietary diagnostic and device solutions to disrupt the approaches to women’s health worldwide.

Our human capital resources objectives include, as applicable, identifying, recruiting, retaining, motivating and integrating our existing and future employees.

The principal purposes of our

equity incentive plans are to attract, retain and motivate selected employees, consultants and directors through grants of stock-based compensation awards and payments of cash-based performance bonus awards, in order to increase stockholder value

and the success of our company by motivating our employees to perform to the best of their abilities and achieve our objectives.

The principal purposes of our equity incentive plans

are to attract, retain and motivate selected employees, consultants and directors through grants of stock-based compensation awards and payments of cash-based performance bonus awards, in order to increase stockholder value and the success of our

company by motivating our employees to perform to the best of their abilities and achieve our objectives.

We are committed to providing a competitive and comprehensive benefits package to our employees.

Our benefits package

provides a balance of protection along with the flexibility to meet the individual health and wellness needs of our employees.

We plan to continue to refine our efforts related to optimizing our use of human capital as we grow, including

improvements in the way we hire, develop, motivate, and retain employees.

We produce all of our products and product candidates in-house at our facility in Suwanee, Georgia which, together with our research and development, controlled environment room and office

space, currently totals approximately 45,000 square feet.

Our benefits package provides a balance of

protection along with the flexibility to meet the individual health and wellness needs of our employees.

We plan to continue to refine our efforts related to optimizing our use of human capital as we grow, including improvements in the way we

hire, develop, motivate, and retain employees.

We produce all of our products and product candidates in-house at our facility in Suwanee, Georgia which, together with our research and development, controlled environment room and office space, currently totals

approximately 45,000 square feet.

We believe that our Georgia facility meets our current needs and that suitable additional alternative spaces will be available in the future on commercially reasonable terms.

Legal Proceedings

We are not currently a party to any legal proceedings the outcome of which we believe, if determined adversely to us, would individually or in the aggregate have a material adverse effect on

our business, operating results or financial condition.

We have received, and may from time to time receive, letters from third parties alleging patent infringement, violation of employment practices or trademark infringement, and we may in the

future participate in litigation to defend ourselves.

We cannot predict the results of any such disputes, and despite the potential outcomes, the existence thereof may have an adverse material impact on us due to diversion of management time and

attention as well as the financial costs related to resolving such disputes.

Available Information

We are not currently a party to any legal proceedings the outcome of which we believe, if determined adversely to us, would individually or in the aggregate have a material adverse effect on our business, operating

results or financial condition.

We have received, and may from time to time receive, letters from third parties alleging patent infringement, violation of employment practices or trademark infringement, and we may in the future participate in

litigation to defend ourselves.

We cannot predict the results of any such disputes, and despite the potential outcomes, the existence thereof may have an adverse material impact on us due to diversion of management time and attention as well as

the financial costs related to resolving such disputes.

About Us and Available Information

was incorporated in Delaware on February 19, 2004 and is headquartered in Suwanee, Georgia.

We file annual, quarterly and current reports, proxy statements and other information with the SEC.

The SEC maintains a website that contains annual, quarterly and current

repots, proxy statements and other information that issuers (including us) file electronically with the SEC.

The SEC maintains a website that contains annual, quarterly and current repots, proxy statements and other

information that issuers (including us) file electronically with the SEC.

The SEC’s website is www.sec.gov .

1 unchanged sentence

We make available, free of charge, through our website:

annual reports on Form 10-K;

our annual reports on Form 10-K;

quarterly reports Form 10-Q;

current reports on Form 8-K;

current reports on

Forms 3, 4 and 5 filed on behalf of directors and executive officers;

and any amendments to those reports filed or furnished pursuant to the Securities

Exchange Act of 1934, as amended (the “Exchange Act”), as soon as reasonably practicable after such material is electronically filed with, or furnished to, the SEC.

We also make available, through our website, our Corporate Governance

Guidelines, the charters of the Audit Committee and the Compensation Committee of our board of directors, our Code of Business Conduct and Ethics and other information and materials.

The information on our website is not incorporated by

reference into this Form 10-K.

and any amendments to those reports filed or furnished pursuant to the Securities Exchange Act of 1934, as amended (the “Exchange Act”), as soon as reasonably

practicable after such material is electronically filed with, or furnished to, the SEC.

We also make available, through our website, our Corporate Governance Guidelines, the charters of the Audit Committee and the Compensation Committee of our

board of directors, our Code of Business Conduct and Ethics and other information and materials.

The information on our website is not incorporated by reference into this Form 10-K.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business