What changed in this filing

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Item 1A. Risk Factors

2023-03-02 compared with 2022-03-28 · 258 added, 270 removed, 812 unchanged (39% of the section changed)

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profitability;

currently depend entirely on the successful and timely regulatory approval and commercialization of our current lead product candidate,

and any future product candidates, which may not receive regulatory approval or, if our current lead or any future product candidate

does receive regulatory approval, we may not be able to successfully commercialize them;

success of our current or future products, if approved, will be determined based on whether surgeons and patients in our target

markets accept them;

depend entirely on the successful and timely regulatory approval and commercialization of our current, and any future, product candidates

which may not receive regulatory approval or, if our current or future product candidates do receive regulatory approval, we may

not be able to successfully commercialize them;

success of our current or future products, if approved, will be determined based on whether surgeons and patients in our target markets

to scale up the manufacturing process of our current or future product candidates in a timely manner, or at all;

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we successfully develop product candidates, our ability to commercialize and distribute our product candidates in the United States

and internationally, depends on our ability to demonstrate the efficacy and financial viability of our products to doctors,

hospitals, insurance companies, and other stakeholders;

and internationally, depends on our ability to demonstrate the efficacy and financial viability of our products to doctors, hospitals,

insurance companies, and other stakeholders;

in external competitive market factors;

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estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for, or ability to obtain, additional

ability to obtain and maintain intellectual property protection for our product candidates;

ability to obtain and maintain intellectual property protection;

liability lawsuits against us could cause us to incur substantial liabilities, limit sales of our existing product candidates and

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ability to maintain the listing of our securities on the Nasdaq Capital Market;

in our business strategy or an inability to execute our strategy due to unanticipated changes in the medical device industry or

the impact of COVID-19 on our clinical trials.

in our business strategy or an inability to execute our strategy due to unanticipated changes in the medical device industry or the

impact of COVID-19 on our clinical trials.

Related to Our Business and Strategy

have incurred significant losses since our inception, expect to incur significant losses in the future and may never achieve or sustain

have incurred losses since our inception, expect to incur losses in the future and may never achieve or sustain

profitability.

have historically incurred substantial net losses, including net losses of $16.5 million and $9.1 million for the years ended December

31, 2021 and 2020, respectively.

As a result of our historical losses, we had an accumulated deficit of $81.9 million as of December

Our losses have resulted primarily from costs related to general and administrative expenses relating to our operations, as

well as our research programs and the development of our product candidates.

Currently, we are not generating revenue from operations,

and we expect to incur losses for the foreseeable future as we seek to obtain regulatory approval for our lead product candidate.

Additionally,

we expect that our general and administrative expenses will increase due to the additional operational costs associated with our SAVVE

study as well as the projected expansion of our operations.

We do not expect to generate significant revenue until any of our product

candidates are licensed or sold, if ever.

We may never generate significant revenue or become profitable.

Even if we do achieve profitability,

we may be unable to sustain or increase profitability on a quarterly or annual basis.

Our failure to achieve and subsequently sustain

profitability could harm our business, financial condition, results of operations and cash flows.

have historically incurred losses, including net losses of $24.7 million and $16.5 million for the years ended December 31, 2022 and

2021, respectively.

Our losses have resulted primarily from our research programs and the development of our product candidates as

well as from costs related to general and administrative expenses relating to our operations.

Currently, we are not generating

revenue from operations, and we expect to incur losses for the foreseeable future as we seek to obtain regulatory approval for our

product candidates.

Additionally, we expect that our general and administrative expenses will increase due to the additional

operational costs associated with our SAVVE and TAVVE studies, as well as the projected expansion of our operations.

expect to generate significant revenue until any of our product candidates are licensed or sold, if ever.

We may never generate

significant revenue or become profitable.

Even if we do achieve profitability, we may be unable to sustain or increase profitability

on a quarterly or annual basis.

Our failure to achieve and subsequently sustain profitability could harm our business, financial

condition, results of operations and cash flows.

currently depend entirely on the successful and timely regulatory approval and commercialization of our current lead product candidate,

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approval, we may not be able to successfully commercialize them.

currently have one product candidate, the VenoValve, and our business presently depends entirely on our success with this product candidate.

In order for our current lead and any future product candidates to succeed they need to be approved by regulatory authorities,

which may never happen.

currently have two product candidates, the VenoValve and the enVVe, and our business presently depends entirely on our success with these

product candidates.

In order for our product candidates to succeed they need to be approved by regulatory authorities, which may never

Our product candidates are based on technologies that have not been used previously in the manner we propose.

Market acceptance of our product candidates will largely depend on our ability to demonstrate their relative safety, efficacy, cost-effectiveness

and ease of use.

Market acceptance

of our product candidates will largely depend on our ability to demonstrate their relative safety, efficacy, cost-effectiveness and ease

We may not be able to successfully develop and commercialize our product candidates.

If we fail to do so, we will not

be able to generate substantial revenues, if any.

If we fail to do so, we will not be able

to generate substantial revenues, if any.

are subject to rigorous and extensive regulation by the FDA in the United States and by comparable agencies in other jurisdictions, including

the European Medicines Agency, or EMA, in the European Union, or EU.

Our lead product candidate is currently in development and we have

not received FDA approval for our product candidate.

Our product candidates may not be marketed in the United States until they have

been approved by the FDA and may not be marketed in other jurisdictions until they have received approval from the appropriate foreign

regulatory agencies.

Each product candidate requires significant research, development, preclinical testing and extensive clinical investigation

before submission of any regulatory application for marketing approval.

Our product candidates are currently in development and we

have not received FDA approval for them.

Our product candidates may not be marketed in the United States until they have been approved

by the FDA and may not be marketed in other jurisdictions until they have received approval from the appropriate foreign regulatory agencies.

Each product candidate requires significant research, development, preclinical testing and extensive clinical investigation before submission

of any regulatory application for marketing approval.

regulatory approval requires substantial time, effort and financial resources, and we may not be able to obtain approval of any of our

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the product candidates are designed to address and the regulations applicable to particular products.

Preclinical and clinical data

can be interpreted in different ways, which could delay, limit or preclude regulatory approval.

Preclinical and clinical data can

be interpreted in different ways, which could delay, limit or preclude regulatory approval.

The FDA, the EMA and other foreign regulatory

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viability may be threatened.

have experienced negative operating cash flows since our inception and have funded our operations primarily from proceeds received from

sales of our capital stock, the issuance of the convertible and non-convertible notes, and the sale of our products to larger medical

device companies.

We will need to seek additional funds in the future through equity or debt financings, or strategic alliances with

third parties, either alone or in combination with equity financings, to complete our product development initiatives.

These financings

could result in substantial dilution to the holders of our common stock, or require contractual or other restrictions on our operations

or on alternatives that may be available to us.

If we raise additional funds by issuing debt securities, these debt securities could

impose significant restrictions on our operations.

Any such required financing may not be available in amounts or on terms acceptable

to us, and the failure to procure such required financing could have a material and adverse effect on our business, financial condition

and results of operations, or threaten our ability to continue as a going concern.

have experienced negative operating cash flows since our inception and have funded our operations primarily from proceeds received

from sales of our capital stock, and the issuance of the convertible and non-convertible notes.

We will need to seek additional funds in the future through equity or debt financings, or strategic

alliances with third parties, either alone or in combination with equity financings, to complete our product development

These financings could result in substantial dilution to the holders of our common stock or require contractual or

other restrictions on our operations or on alternatives that may be available to us.

If we raise additional funds by issuing debt

securities, these debt securities could impose significant restrictions on our operations.

Any such required financing may not be

available in amounts or on terms acceptable to us, and the failure to procure such required financing could have a material and

adverse effect on our business, financial condition and results of operations, or threaten our ability to continue as a going

present and future capital requirements will be significant and will depend on many factors, including:

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harm our operating results.

COVID-19 pandemic has significantly negatively impacted our business.

The COVID-19 pandemic has

disrupted the global economy and has negatively impacted large populations including people and businesses that may be directly or

indirectly involved with the operation of our Company, the manufacturing, development, and testing of our product candidate, and the

clinical trials for our product candidate.

COVID-19 pandemic significantly negatively impacted our business.

COVID-19 pandemic disrupted the global economy and negatively impacted large populations including people and businesses that are or

may be directly or indirectly involved with the operation of our Company, the manufacturing, development, and testing of our product

candidates, and the clinical trials for our product candidates.

The full scope and economic impact of COVID-19 is still unknown.

There are many risks

from COVID-19 that could generally and negatively impact economies and healthcare providers in the countries where we do business,

the medical device industry as a whole, and development stage, pre-revenue companies such as NVNO.

To-date, the primary impacts of

COVID-19 to our operations were stay-at-home work requirements, travel restrictions limiting our ability to initiate and continue

animal studies and patient trials, suspensions of elective surgeries at trial sites limiting our ability to enroll patients in

SAVVE, and disruptions to scheduled meetings with regulatory agencies such as the FDA.

Notwithstanding these impacts, we were able

to use remote work tools, communications solutions, and other methods to continue our trials and regulatory submissions.

resurgence of COVID and the Omicron variant caused several of our activated clinical sites to put elective surgeries on hold and

prohibit potential study subjects from coming to the hospital for screening.

Labor shortages due to Omicron have also negatively

impacted hospital staffing in all departments, including clinical research.

In addition to caring for the influx of COVID patients,

hospitals become short staffed due to their own employees’ COVID sicknesses, resulting in clinical staff being reassigned to

cover the shortfall.

The lack of available clinical personnel both slows enrollment and impacts the speed at which we can activate

clinical sites.

COVID also impacts our patient population.

Patients with COVID or who have had COVID within ninety (90) days of

their screening, are excluded from our study until after the ninety (90) day period has passed.

In addition, concerns about getting

COVID impact the patients’ willingness to undergo an elective surgical procedure with a one-night hospital stay.

the COVID resurgence has slowed patient enrollment for the SAVVE clinical trial and has resulted in delays in new clinical sites

being activated for enrollment.

We are increasing the number of SAVVE sites and ensuring they are geographically dispersed to attempt

to mitigate the impact of reductions in elective surgery schedules.

At this time, we have identified the following COVID-19

related risks that we believe have a greater likelihood of negatively impacting our Company, including, but not limited

are many risks from COVID-19 and any future resurgence that could generally and negatively impact economies and healthcare providers

in the countries where we do business, the medical device industry as a whole, and development stage, pre-revenue companies such as NVNO.

the primary impacts of COVID-19 to our operations were stay-at-home work requirements, travel restrictions limiting our ability to initiate

and continue animal studies and patient trials, suspensions of elective surgeries at trial sites limiting our ability to enroll patients

in SAVVE, disruption to hospital staffs including staffing at the sites of our SAVVE trial, and disruptions to scheduled meetings with

regulatory agencies such as the FDA.

Notwithstanding these impacts, we were able to use remote work tools, communications solutions,

and other methods to continue our trials and regulatory submissions.

The resurgence of COVID and the Omicron variant in 2021 caused several

of our activated clinical sites to put elective surgeries on hold and prohibit potential study subjects from coming to the hospital for

shortages due to COVID-19 have also negatively impacted hospital staffing in all departments, including clinical research.

to caring for the influx of COVID patients, hospitals became short staffed due to their own employees’ COVID sicknesses, resulting

in clinical staff being reassigned to cover the shortfall.

The disruption to hospital staffing, and particularly to clinical staffing,

has continues to be felt.

The lack of available clinical personnel both impacted the speed at which we can activate clinical sites and

continues to slow enrollment.

also impacts our patient population.

Patients with COVID or who have had COVID within ninety (90) days of their screening, are excluded

from our study until after the ninety (90) day period has passed.

In addition, concerns about getting COVID impact the patients’

willingness to undergo an elective surgical procedure with a one-night hospital stay.

As a result, COVID-19 has, and any future resurgence

may, slow patient enrollment for the SAVVE clinical trial.

Further, although we now have all planned clinical sites activated, COVID

delayed our ability to do so, and, if additional sites are necessary, a future COVID resurgence may have a similar impact.

this time, we have identified the following COVID related risks that we believe have a greater likelihood of negatively impacting our

Company, including, but not limited to:

burden on hospitals and medical personnel resulting in the cancellation of non-essential medical procedures such as surgical procedures

needed to implant our product candidates for pre-clinical and clinical trials;

restrictions and quarantine requirements which prevent us from initiating and continuing animal studies and patient trials both inside

and outside of the United States;

restrictions which prevent patients from participating in or continuing their participation in clinical trials.

chain disruptions resulting in delays in the procurement of certain supplies and equipment that are needed to develop and test our

product candidates;

State and local shelter-in-place directives which limit our employees from accessing our facility to manufacture, develop and test

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State and local shelter-in-place directives which limit our ability to enroll sites or patients in our SAVVE trial.

restrictions and quarantine requirements which prevent us from initiating and continuing animal studies and patient trials both inside

and outside of the United States;

burden on hospitals and medical personnel resulting in the cancellation of non-essential medical procedures such as surgical procedures

needed to implant our product candidates for pre-clinical and clinical trials;

in the procurement of certain supplies and equipment that are needed to develop and test our product candidates;

restrictions which prevent patients from participating and continuing the participation in clinical trials.

may never be able to generate sufficient revenue from the commercialization of our product candidates to achieve and maintain profitability.

Our ability to operate profitably

in the future will depend upon, among other items, our ability to (i) fully develop product candidates, (ii) scale up our business and

operational structure, (iii) obtain regulatory approval of product candidates from the FDA, (iv) market and sell product candidates,

(v) successfully gain market acceptance of our product candidates, and (vi) obtain sufficient and on-time supply of components from our

third-party suppliers.

If our product candidates are never successfully commercialized, we may never receive a return on our investments

in product development, regulatory compliance, manufacturing, and quality assurance, which may cause us to fail to generate revenue

and gain economies of scale from such investments.

only utilize a few suppliers for porcine tissue for our product candidate and the loss of a supplier could have an adverse impact on

ability to operate profitably in the future will depend upon, among other items, our ability to (i) fully develop product candidates,

(ii) scale up our business and operational structure, (iii) obtain regulatory approval of product candidates from the FDA, (iv) market

and sell product candidates, (v) successfully gain market acceptance of our product candidates, and (vi) obtain sufficient and on-time

supply of components from our third-party suppliers.

If our product candidates are never successfully commercialized, we may never receive

a return on our investments in product development, regulatory compliance, manufacturing, and quality assurance, which may cause us to

fail to generate revenue and gain economies of scale from such investments.

only utilize a few suppliers for porcine tissue for our product candidates and the loss of a supplier could have an adverse impact on

our business.

rely on one domestic third-party vendor to supply porcine tissue for our product candidate.

Our ability to supply our current

and future product candidates commercially, if approved, depends, in part, on our ability to obtain this porcine

tissue in accordance with our specifications and with regulatory requirements and in sufficient quantities to meet demand.

to obtain porcine tissue may be affected by matters outside our control, including that this supplier may cancel our arrangements

on short notice or have disruptions to their operations.

we are required to establish additional or replacement suppliers for the porcine tissue, it may not be accomplished quickly and our operations

could be disrupted.

Even if we are able to find replacement suppliers, the replacement suppliers may need to be qualified and may require

additional regulatory authority approval, which could result in further delay.

In the event of a supply disruption, our product inventories

may be insufficient to supply our customers and the development of any future product candidates would be delayed, limited or prevented,

which could have an adverse impact on our business.

depend upon third-party suppliers for certain components of our product candidate, making us vulnerable to supply problems and price

rely on two domestic third-party vendors to supply porcine tissue for our product candidates.

Our ability to supply our current and future

product candidates commercially, if approved, depends, in part, on our ability to obtain this porcine tissue in accordance with our specifications

and with regulatory requirements and in sufficient quantities to meet demand.

Our ability to obtain porcine tissue may be affected by

matters outside our control, including that these suppliers may cancel our arrangements on short notice or have disruptions to their

we are required to establish additional or replacement suppliers for the porcine tissue, it may not be accomplished timely and our

operations could be disrupted.

Even if we are able to find replacement suppliers, the replacement suppliers may need to be qualified

and may require additional regulatory authority approval, which could result in further delay.

In the event of a supply disruption,

our product inventories may be insufficient to supply our customers and the development of any future product candidates would be

delayed, limited or prevented, which could have an adverse impact on our business.

depend upon third-party suppliers for certain components of our product candidates, making us vulnerable to supply problems and price

fluctuations, which could harm our business.

rely on a number of third-party suppliers to provide certain components of our product candidate.

rely on a number of third-party suppliers to provide certain components of our product candidates.

We do not have long-term supply agreements

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of operations and growth.

If we successfully develop

product candidates, we will have to demonstrate the efficacy and financial viability of our products to doctors, hospitals,

insurance companies, and other stakeholders.

we successfully develop product candidates, we will have to demonstrate the efficacy and financial viability of our products to doctors,

hospitals, insurance companies, and other stakeholders.

are multiple stakeholders that determine the success of a medical device, including doctors, hospitals, medical insurance companies,

Educating these stakeholders on the benefits of product candidates will require a significant commitment by a marketing

team and sales organization.

Surgeons and hospitals may be slow to change their practices because of familiarity with existing devices

and/or treatments, perceived risks arising from the use of new devices, lack of experience using new devices, lack of clinical data supporting

Educating these stakeholders on the benefits of product candidates will require a significant commitment by a marketing team

and sales organization.

Surgeons and hospitals may be slow to change their practices because of familiarity with existing devices and/or

treatments, perceived risks arising from the use of new devices, lack of experience using new devices, lack of clinical data supporting

the benefits of such devices or the cost of new devices.

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medical insurance companies and others that are necessary for a successful product.

unable to convince hospital facilities to approve the use of our product candidates.

In the United States, in

order for surgeons to use our product candidates, the hospital facilities where these surgeons treat patients will typically require

that the product candidates receive approval from the facility’s VAC.

VACs typically review the comparative effectiveness and

cost of medical devices used in the facility.

The makeup and evaluation processes for VACs vary considerably, and it can be a

lengthy, costly and time-consuming effort to obtain approval by the relevant VAC.

For example, even if we have an agreement

with a hospital system for the purchase of a product, in most cases, they must obtain VAC approval by each hospital

within the system to sell at that particular hospital.

Additionally, hospitals typically require separate VAC approval for each

specialty in which a product is used, which may result in multiple VAC approval processes within the same hospital even if

such product has already been approved for use by a different specialty group.

VAC approval is often needed for each different

product to be used by the surgeons in that specialty.

In addition, hospital facilities and group purchasing organizations, or GPOs,

which manage purchasing for multiple facilities, may also require us to enter into a purchasing agreement and satisfy

numerous elements of their administrative procurement process, which can also be a lengthy, costly and time-consuming effort.

do not receive access to hospital facilities in a timely manner, or at all, via these VAC and purchasing contract processes, or

otherwise, or if we are unable to secure contracts on commercially reasonable terms in a timely manner, or at all, our

costs may increase, our sales may decrease and our operating results may be harmed.

may be unable to convince hospital facilities to approve the use of our product candidates.

the United States, in order for surgeons to use our product candidates, the hospital facilities where these surgeons treat patients will

typically require that the product candidates receive approval from the facility’s VAC.

VACs typically review the comparative effectiveness

and cost of medical devices used in the facility.

The makeup and evaluation processes for VACs vary considerably, and it can be a lengthy,

costly and time-consuming effort to obtain approval by the relevant VAC.

For example, even if we have an agreement with a hospital system

for the purchase of a product, in most cases, they must obtain VAC approval by each hospital within the system to sell at that particular

Additionally, hospitals typically require separate VAC approval for each specialty in which a product is used, which may result

in multiple VAC approval processes within the same hospital even if such product has already been approved for use by a different specialty

VAC approval is often needed for each different product to be used by the surgeons in that specialty.

In addition, hospital facilities

and group purchasing organizations, or GPOs, which manage purchasing for multiple facilities, may also require us to enter into a purchasing

agreement and satisfy numerous elements of their administrative procurement process, which can also be a lengthy, costly and time-consuming

If we do not receive access to hospital facilities in a timely manner, or at all, via these VAC and purchasing contract processes,

or otherwise, or if we are unable to secure contracts on commercially reasonable terms in a timely manner, or at all, our costs may increase,

our sales may decrease and our operating results may be harmed.

long-term growth depends on our ability to develop and commercialize additional product candidates.

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adequate coverage and reimbursement for procedures performed with our product candidates.

we are unsuccessful in developing and commercializing additional devices in other areas, our ability to realize our revenue may

we are unsuccessful in developing and commercializing additional devices in other areas, our ability to realize our revenue may be impaired.

technologies, techniques or products could emerge that might offer better combinations of price and performance than the products and

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more attractive price, they may delay purchases until such product candidates are available.

We may also continue to offer older obsolete

products as we transition to new product candidates, and we may not have sufficient experience managing transitions.

We may also continue to offer older products

as we transition to new product candidates, and we may not have sufficient experience managing transitions.

If we do not successfully

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development and clinical trial purposes at our manufacturing facility in Irvine, California.

If our existing manufacturing facility

experiences a disruption, we would have no other means of manufacturing our product candidates until we are able to restore the manufacturing

capability at our current facility or develop alternative manufacturing facilities.

Additionally, any damage to or destruction of our

facilities or our equipment, prolonged power outage or contamination at our facilities would significantly impair our ability to produce

our product candidates and prepare our product candidates for clinical trials.

If our existing manufacturing facility experiences

a disruption, we would have no other means of manufacturing our product candidates until we are able to restore the manufacturing capability

at our current facility or develop alternative manufacturing facilities.

Additionally, any damage to or destruction of our facilities

or our equipment, prolonged power outage or contamination at our facilities would significantly impair our ability to produce our product

candidates and prepare our product candidates for clinical trials.

Additionally,

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potential losses and this insurance may not continue to be available to us on acceptable terms, or at all.

We currently have no

sales and marketing infrastructure and we may not be able to build a sales and marketing infrastructure sufficient for us to commercialize our current product candidate or future product candidates, if approved, and may be unable to do

so or may never generate sufficient revenue to achieve or sustain profitability.

In order to commercialize products

that are approved by regulatory agencies, we will have to increase our expenditures to undertake development or commercialization

If we are unable to successfully execute commercialization activities, we may have to curtail the development of our product

candidates, reduce or delay development programs, delay potential commercialization of our product candidates or reduce the scope of

any sales or marketing activities.

currently have no sales and marketing infrastructure and we may not be able to build a sales and marketing infrastructure sufficient

for us to commercialize our current product candidate or future product candidates, if approved, and may be unable to do so or may never

generate sufficient revenue to achieve or sustain profitability.

order to commercialize products that are approved by regulatory agencies, we will have to increase our expenditures to undertake development

or commercialization activities.

If we are unable to successfully execute commercialization activities, we may have to curtail the development

of our product candidates, reduce or delay development programs, delay potential commercialization of our product candidates or reduce

the scope of any sales or marketing activities.

it becomes necessary for us to establish a sales and marketing infrastructure, we may not be able to do so or we may not realize a positive

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litigation costs;

demand for our product candidates and any product candidates that we may develop;

demand for our product candidates and any future product candidates that we may develop;

to our reputation;

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implementing our business strategies, which could have a material adverse effect on our business, operations and financial condition.

ability to use our net operating loss carry-forwards and certain other tax attributes may be limited.

of December 31, 2021 and 2020, we had available federal net operating loss carryforwards, or NOLs, of approximately $45.7 million and

ability to use our net operating loss carryforwards and certain other tax attributes may be limited.

Company has net operating loss carryforwards (NOLs) for both federal and state income tax purposes.

As of December 31, 2022 and

2021, federal NOLs, were approximately $52.7 million and $45.7 million, and state NOL’s were approximately $52.5 million and

$45.7 million.

Pre-2018 federal NOLs carryovers of $12.0 million may be carried forward for twenty years and begin to expire in 2029.

Under the Tax Act, post-2017 federal NOLs can be carried forward indefinitely and the annual limit of deduction equals 80% of taxable

However, to the extent the Company utilizes its NOL carryforwards in the future, the tax years in which the attribute was generated

may still be adjusted upon examination by the Internal Revenue Service or state tax authorities of the future period tax return in which

the attribute is used.

As of December 31, 2021, and 2020, the Company had net operating loss carryforwards for state income tax purposes

of approximately $45.7 million and $35.0 million, respectively, which can be carried forward for twenty years and begin to expire in

of December 31, 2021, we also had federal research and development tax credit carryforwards of approximately $0.2 million which begin

to expire in 2027.

In general, under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, or the Code, a corporation

that undergoes an “ownership change” (generally defined as a cumulative change in equity ownership by “5% shareholders”

Pre-2018 federal NOLs of $12.0 million have a limited carry forward period of twenty years and begin to expire in

Federal NOLs generated after 2017 can be carried forward indefinitely.

State NOL’s can be carried forward for twenty

years and begin to expire in 2028.

The annual limit of deduction for federal purposes equals 80% of taxable income.

Additionally, for both federal and state purposes, the annual benefit the Company can derive from NOL’s is

limited because of ownership changes.

In general, a corporation that

undergoes an “ownership change” (generally defined as a cumulative change in equity ownership by “5% shareholders”

that exceeds 50 percentage points over a rolling three-year period) may be subject to limitations on its ability to utilize its NOLs

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due to the uncertainty of the ultimate realization of the future tax benefits of such assets.

the extent the Company utilizes its NOL carryforwards in the future, the tax years in which the attribute was generated may still be

adjusted upon examination by the Internal Revenue Service or state tax authorities of the future period tax return in which the attribute

of December 31, 2022, we also had federal research and development tax credit carryforwards of approximately $0.2 million which begin

to expire in 2027.

Related to Regulatory Approval and Other Governmental Regulations

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clearance or authorizations resulting in significant financial costs and reduced revenue.

product candidates may be subject to extensive governmental regulation in foreign jurisdictions, such as the EEA, and our failure

to comply with applicable requirements could cause our business, results of operations and financial condition to suffer.

product candidates may be subject to extensive governmental regulation in foreign jurisdictions, such as the EEA, and our failure to

comply with applicable requirements could cause our business, results of operations and financial condition to suffer.

the EEA, our product candidates will need to comply with the Essential Requirements set forth in Medical Device Regulation.

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from the market.

manufacturing processes, post-approval clinical data and promotional activities of any product candidate for which we obtain marketing approval will be subject to continual review and periodic inspections by the FDA and other regulatory bodies.

regulatory approval of our product candidates is granted in the United States, the approval may be subject to limitations on the indicated

uses for which the product candidates may be marketed or contain requirements for costly post-marketing testing and surveillance to monitor

the safety or effectiveness of the product.

Later discovery of previously unknown and unanticipated problems with our product candidates,

including but not limited to unanticipated severity or frequency of adverse events, delays or problems with the manufacturer or manufacturing

processes, or failure to comply with regulatory requirements, may result in restrictions on such product candidates or manufacturing

processes, withdrawal of the product candidates from the market, voluntary or mandatory recall, fines, suspension of regulatory approvals,

product seizures, injunctions or the imposition of civil or criminal penalties.

are required to report certain malfunctions, deaths and serious injuries associated with our products once approved by regulatory

bodies, which can result in voluntary corrective actions or agency enforcement actions.

manufacturing processes, post-approval clinical data and promotional activities of any product candidate for which we obtain marketing

approval will be subject to continual review and periodic inspections by the FDA and other regulatory bodies.

Even if regulatory approval

of our product candidates is granted in the United States, the approval may be subject to limitations on the indicated uses for which

the product candidates may be marketed or contain requirements for costly post-marketing testing and surveillance to monitor the safety

or effectiveness of the product.

Later discovery of previously unknown and unanticipated problems with our product candidates, including

but not limited to unanticipated severity or frequency of adverse events, delays or problems with the manufacturer or manufacturing processes,

or failure to comply with regulatory requirements, may result in restrictions on such product candidates or manufacturing processes,

withdrawal of the product candidates from the market, voluntary or mandatory recall, fines, suspension of regulatory approvals, product

seizures, injunctions or the imposition of civil or criminal penalties.

are required to report certain malfunctions, deaths and serious injuries associated with our products once approved by regulatory bodies,

which can result in voluntary corrective actions or agency enforcement actions.

manufacturers marketing medical devices in the EEA are legally bound to report incidents involving devices they produce or sell to the

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versions, the final version of the new EU Medical Device Regulation (MDR 2017/745) was published on May 5, 2017.

The official entry to

force of the MDR started on May 26, 2017 with the transition period of 3 years.

The date of application of all existing and new medical

devices under MDR is May 26, 2020;

however, Notified Bodies are currently not accepting any new CE Mark applications under MDD

(Medical Device Directives).

All existing MDD CE certificates become void on May 26, 2024.

EU requires that all existing and new medical

device undergo assessment under MDR as if they are new product application.

Notified Bodies are

currently not accepting any new CE Mark applications under MDD (Medical Device Directives).

All new medical devices, including ours,

must undergo assessment under MDR.

changes from EU Medical Device Directives (MDD) to Medical Device Regulation (MDR) are significant, with stricter clinical requirements

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established by Member States and Expert Panels appointed by European Union.

under the FDA’s Medical Device Reporting or MDR regulations, we are required to report to the FDA any incident in which our product

candidates may have caused or contributed to a death or serious injury or in which our product malfunctioned and, if the malfunction

were to recur, would likely cause or contribute to death or serious injury.

Any adverse event involving our products could result in

future voluntary corrective actions, such as product actions or customer notifications, or regulatory authority actions, such as inspection,

mandatory recall or other enforcement action.

Repeated product malfunctions may result in a voluntary or involuntary product recall,

which could divert managerial and financial resources, impair our ability to manufacture our product candidates in a cost-effective and

timely manner and have an adverse effect on our reputation, financial condition and operating results.

depending on the corrective action we take to redress a product’s deficiencies or defects, the FDA may require, or we may decide,

under either the FDA’s Medical Device Reporting or MDR regulations, we are required to report to the FDA any incident in which

our product candidates may have caused or contributed to a death or serious injury or in which our product malfunctioned and, if the

malfunction were to recur, would likely cause or contribute to death or serious injury.

Any adverse event involving our products could

result in future voluntary corrective actions, such as product actions or customer notifications, or regulatory authority actions, such

as inspection, mandatory recall or other enforcement action.

Repeated product malfunctions may result in a voluntary or involuntary product

recall, which could divert managerial and financial resources, impair our ability to manufacture our product candidates in a cost-effective

and timely manner and have an adverse effect on our reputation, financial condition and operating results.

depending on the corrective action we take to redress a product’s deficiencies or defects, the FDA may require us, or we may decide

that we will need, to obtain new approvals or clearances for the device before we may market or distribute the corrected device.

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Manufacturers are

required to submit reports to CMS by the 90 th day of each calendar year.

Failure to submit the required information may

result in civil monetary penalties up to an aggregate of $150,000 per year (and up to an aggregate of $1 million per year for “knowing

required to submit reports by the 90 th day of each calendar year.

Failure to submit the required information may result

in civil monetary penalties up to an aggregate of $150,000 per year (and up to an aggregate of $1 million per year for “knowing

failures”) for all payments, transfers of value or ownership or investment interests not reported in an annual submission,

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have a material and adverse effect on our business, results of operations and financial condition.

March 2010, the PPACA was signed into law, which includes a deductible 2.3% excise tax on any entity that manufactures or imports medical

devices offered for sale in the United States, with limited exceptions, that began on January 1, 2013.

Although a two year moratorium

was placed on the medical device excise tax in 2016 and extended through December 31, 2019, it was permanently repealed on December 20,

Other elements of the PPACA, including comparative effectiveness research, an independent payment advisory board and payment system

reforms, including shared savings pilots and other provisions, may significantly affect the payment for, and the availability of, healthcare

services and result in fundamental changes to federal healthcare reimbursement programs, any of which may materially affect numerous

aspects of our business, results of operations and financial condition.

March 2010, the PPACA was signed into law.

Initially it included a deductible 2.3% excise tax on any entity that manufactures or imports

medical devices offered for sale in the United States, with limited exceptions.

Although this excise tax was permanently repealed on

December 20, 2019, it or similar taxes, may be enacted in the future.

Other elements of the PPACA remain in force, including comparative

effectiveness research, an independent payment advisory board and payment system reforms, including shared savings pilots and other provisions,

which may significantly affect the payment for, and the availability of, healthcare services and result in fundamental changes to federal

healthcare reimbursement programs, any of which may materially affect numerous aspects of our business, results of operations and financial

addition, other legislative changes have been proposed and adopted in the United States since the PPACA was enacted.

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We have or may have other written and oral arrangements with physicians, including for research and development grants and for other

purposes as well.

could be adversely affected if regulatory agencies were to interpret our financial relationships with these physicians, who may be in

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manufacturing processes and facility are required to comply with the FDA’s QSR, which covers the procedures and documentation of

the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage, and shipping of product

Although we believe we are compliant with the QSRs, the FDA enforces the QSR through periodic announced or unannounced inspections

of manufacturing facilities.

We have been, and anticipate in the future being, subject to such inspections, as well as to inspections

by other federal and state regulatory agencies.

the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage, and shipping of product candidates.

Although we believe we are compliant with the QSRs, the FDA enforces the QSR through periodic announced or unannounced inspections of

manufacturing facilities.

We have been, and anticipate in the future being, subject to such inspections, as well as to inspections by

other federal and state regulatory agencies.

We are required to register our manufacturing facility with the FDA and list all devices

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Related to Our Intellectual Property

we are unable to adequately protect our proprietary technology or maintain issued patents that are sufficient to protect our product

candidates, others could compete against us more directly, which could harm our business, financial condition and results of operations.

success may depend in part on our success in obtaining and maintaining issued patents and other intellectual property rights in the United

States and elsewhere and protecting our proprietary technologies.

we are unable to adequately protect our proprietary technology or obtain and maintain issued patents that are sufficient to protect our

product candidates, others could compete against us more directly, which could harm our business, financial condition and results of

success may depend in part on our ability to obtain and maintain patents and other intellectual property rights in the United States

and elsewhere and protecting our proprietary technologies.

If we do not adequately protect our intellectual property and proprietary

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harm our business and ability to achieve profitability.

have filed patent applications for our VenoValve product and Implantable Vein Frame Two product with the U.S.

Patent and Trademark Office

but there are no assurances that patents will be issued.

have filed patent applications for our products and related intellectual property with the U.S.

Patent and Trademark Office and in other

jurisdictions.

As of the December 31, 2022, we have been granted seventeen (17) patents including four (4) in the United States and have

another seventeen (17) applications in various stages of review including six (6) in the United States.

patents may not have, or our pending patent applications that mature into issued patents may not include, claims with a scope sufficient

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may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights

and we may be unable to protect our rights to, or use, our technology.

and we may be unable to protect our rights to, or use of, our technology.

success will depend in part on our ability to operate without infringing the intellectual property and proprietary rights of third parties.

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liability claims;

reform measures in the United States;

reform measures in the United States and elsewhere;

or departures of key personnel;

economic or political conditions in the United States or elsewhere.

addition, the stock market in general, and the stock of medical device companies like ours in particular, have experienced extreme price

and volume fluctuations that have often been unrelated or disproportionate to the operating performance of the issuer.

These market and

industry factors may negatively affect the market price of our common stock, regardless of our actual operating performance.

addition, the stock market in general, and the stock of medical device companies like ours, have experienced extreme price and volume

fluctuations that have often been unrelated or disproportionate to the operating performance of the issuer.

These market and industry

factors may negatively affect the market price of our common stock, regardless of our actual operating performance.

have issued a significant number of options and warrants and may continue to do so in the future.

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may also result in downward pressure on the price of our common stock.

of the date of this Annual Report, we have issued and outstanding options to purchase 3,463,107 shares of our common stock with

a weighted average exercise price of $9.14, 402,082 restricted stock units subject to vesting, and warrants to purchase 6,311,705

shares of our common stock with a weighted average exercise price of $8.81.

Further, we have 619,087 shares available for issuance

under our Amended and Restated 2016 Omnibus Incentive Plan.

The number of shares subject to the Plan may be adjusted from time to time

such that shares authorized under the plan shall at all times be equal to at least 20% of the issued and

outstanding shares of the Company on a fully diluted basis.

Because the market for our common stock is thinly traded, the sales and/or

the perception that those sales may occur, could adversely affect the market price of our common stock.

Furthermore, the mere existence

of a significant number of shares of common stock issuable upon vesting and, if applicable, exercise of these securities may be perceived

by the market as having a potential dilutive effect, which could lead to a decrease in the price of our common stock.

of the date of this Annual Report, we have issued and outstanding options to purchase 3,816,452 shares of our common stock with a weighted

average exercise price of $8.90, 400,000 restricted stock units subject to vesting, and warrants to purchase 6,322,821 shares of

our common stock with a weighted average exercise price of $7.76.

Further, we have 265,742 shares available for issuance under our

Amended and Restated 2016 Omnibus Incentive Plan.

The number of shares subject to the Plan may be adjusted from time to time such that

shares authorized under the plan shall at all times be equal to at least 20% of the issued and outstanding shares of the Company on a

fully diluted basis.

Because the market for our common stock is thinly traded, the sales and/or the perception that those sales may occur,

could adversely affect the market price of our common stock.

Furthermore, the mere existence of a significant number of shares of common

stock issuable upon vesting and, if applicable, exercise of these securities may be perceived by the market as having a potential dilutive

effect, which could lead to a decrease in the price of our common stock.

will need to raise additional capital to meet our business requirements in the future, and such capital raising may be costly or difficult

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Such additional capital may not be available on reasonable terms or at all.

Any future issuance of our equity or equity-backed securities

may dilute then-current stockholders’ ownership percentages.

If we are unable to obtain required additional capital, we may have

to curtail our growth plans or cut back on existing business.

future issuance of our equity or equity-backed securities may dilute then-current stockholders’ ownership percentages.

unable to obtain required additional capital, we may have to curtail our growth plans or cut back on existing business.

may incur substantial costs in pursuing future capital financing, including investment banking fees, legal fees, accounting fees, securities

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there is no guarantee that we will be able to continue to meet the continued listing requirements of Nasdaq.

In the event we are unable

to do so, our securities may be delisted from The Nasdaq Stock Market.

Such a delisting would likely have a negative effect on the price

of our Common Stock and would impair your ability to sell or purchase our Common Stock when you wish to do so.

In the event of a delisting,

we would expect to take actions to restore our compliance with Nasdaq Marketplace Rules, but our common stock may not be listed again,

stabilize the market price or improve the liquidity of our common stock, prevent our common stock from dropping below the Nasdaq minimum

bid price requirement or prevent future non-compliance with the Nasdaq Marketplace Rules.

In the event of a deficiency

notice, we would expect to take actions to restore our compliance with Nasdaq Marketplace Rules and prevent future non-compliance.

there can be no assurance we would be able to do so.

In the event we are unable to do so, our securities may be delisted from The Nasdaq

Stock Market.

Such a delisting would likely have a negative effect on the price of our Common Stock and would impair your ability to

sell or purchase our Common Stock when you wish to do so.

are an “emerging growth company” and the reduced disclosure requirements applicable to emerging growth companies could make

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stockholder, unless the business combination is approved in a prescribed manner.

Accordingly, the DGCL may discourage, delay,

or prevent a change in control of our company.

Accordingly, the DGCL may discourage, delay, or prevent

a change in control of our company.

our amended and restated certificate of incorporation specifies that the Court of Chancery of the State of Delaware will be the sole

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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 1A. Risk Factors