What changed in this filing

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Item 1A. Risk Factors

2025-03-20 compared with 2024-04-16 · 267 added, 377 removed, 1022 unchanged (39% of the section changed)

Relating to Our Business and Our Product

business and prospects depend entirely on our current product, IB-Stim.

Even though we have received FDA clearance for our product, it

will remain subject to ongoing regulatory review.

If we are unable to maintain regulatory clearance and commercialize our product or

are significantly delayed or limited in our commercialization efforts, our business and prospects will be materially harmed.

business and prospects depend entirely on our current products, IB-Stim and RED.

Even though we have received FDA clearance for our products,

it will remain subject to ongoing regulatory review.

If we are unable to maintain regulatory clearance and commercialize our product

or are significantly delayed or limited in our commercialization efforts, our business and prospects will be materially harmed.

all of our revenues have been derived from sales and royalties from sales of IB-Stim, and we expect to develop, market, and sell other

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and our ability to generate and maintain revenues from the sale of our products will depend on a number of factors, including:

our ability to develop

and obtain additional regulatory clearances and further commercialize our products for additional indications;

our ability to expand into

new markets and future indications;

the acceptance of our products

by patients and the healthcare community, including physicians and third-party payers (both private and governmental), as therapeutically

effective and safe;

the accomplishment of various

scientific, engineering, clinical, regulatory and other goals, which we sometimes refer to as milestones, on our anticipated timeline;

the relative cost, safety

and efficacy of alternative therapies;

our ability to obtain and

maintain sufficient coverage or reimbursement by private and governmental third-party payers and to comply with applicable health

care laws and regulations;

the ability of our third-party

manufacturers to manufacture our products in sufficient quantities with acceptable quality;

our ability to provide

marketing, distribution and customer support for our products;

the potential presence

of competitive products in our active indications;

results of future clinical

studies relating to our products or other competitor products for similar indications;

compliance with applicable

laws and regulatory requirements;

the maintenance of our

existing regulatory clearance;

the consequences of any

reportable adverse events involving our products.

ability to develop and obtain additional regulatory clearances and further commercialize our products for additional indications;

ability to expand into new markets and future indications;

acceptance of our products by patients and the healthcare community, including physicians and third-party payers (both private and

governmental), as therapeutically effective and safe;

accomplishment of various scientific, engineering, clinical, regulatory and other goals, which we sometimes refer to as milestones,

on our anticipated timeline;

relative cost, safety and efficacy of alternative therapies;

ability to obtain and maintain sufficient coverage or reimbursement by private and governmental third-party payers and to comply

with applicable health care laws and regulations;

ability of our third-party manufacturers to manufacture our products in sufficient quantities with acceptable quality;

ability to provide marketing, distribution and customer support for our products;

potential presence of competitive products in our active indications;

of future clinical studies relating to our products or other competitor products for similar indications;

with applicable laws and regulatory requirements;

maintenance of our existing regulatory clearance;

consequences of any reportable adverse events involving our products.

addition, the promotion of our products is limited to approved indications, which vary by geography.

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We may experience difficulties in patient enrollment in our clinical studies for a variety of reasons,

the severity of the disease

under investigation;

the limited size and nature

of the patient population;

the patient eligibility

criteria defined in our protocol and other clinical study protocols;

the nature of the study

protocol, including the attractiveness of, or the discomforts and risks associated with, the treatments received by enrolled subjects;

difficulties and delays

in clinical studies that may occur as a result of the COVID-19 pandemic;

the ability to obtain IRB

approval at clinical study locations;

clinicians’ and patients’

perceptions as to the potential advantages, disadvantages and side effects of our products in relation to other available therapies,

including any new drugs or treatments that may be approved for the indications we are pursuing;

availability of other clinical

studies that exclude use of our products;

the possibility or perception

that enrolling in a product’s clinical study may limit the patient’s ability to enroll in future clinical studies for

other therapies due to protocol restrictions;

the possibility or perception

that our software is not secure enough to maintain patient privacy;

patient referral practices

of physicians;

the ability to monitor

patients adequately during and after treatment;

the availability of appropriate

clinical study investigators, support staff, drugs and other therapeutic supplies and proximity of patients to clinical sites;

physicians’ or our

ability to obtain and maintain patient consents;

the risk that when we collaborate

with a third-party for research of a product in a particular institution, we can expect to relinquish some or all of the control

over the future success of that study to the third-party.

severity of the disease under investigation;

limited size and nature of the patient population;

patient eligibility criteria defined in our protocol and other clinical study protocols;

nature of the study protocol, including the attractiveness of, or the discomforts and risks associated with, the treatments received

by enrolled subjects;

and delays in clinical studies that may occur as a result of the COVID-19 pandemic;

ability to obtain IRB approval at clinical study locations;

and patients’ perceptions as to the potential advantages, disadvantages and side effects of our products in relation to other

available therapies, including any new drugs or treatments that may be approved for the indications we are pursuing;

of other clinical studies that exclude use of our products;

possibility or perception that enrolling in a product’s clinical study may limit the patient’s ability to enroll in future

clinical studies for other therapies due to protocol restrictions;

possibility or perception that our software is not secure enough to maintain patient privacy;

referral practices of physicians;

ability to monitor patients adequately during and after treatment;

availability of appropriate clinical study investigators, support staff, drugs and other therapeutic supplies and proximity of patients

to clinical sites;

or our ability to obtain and maintain patient consents;

risk that when we collaborate with a third-party for research of a product in a particular institution, we can expect to relinquish

some or all of the control over the future success of that study to the third-party.

we have difficulty enrolling and retaining a sufficient number or diversity of patients to conduct our clinical studies as planned, or

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all, for a number of different reasons, including the following factors:

it may be difficult to

gain broad acceptance of our products because they are new technologies and involve a novel or derivative mechanism of action and,

as such, physicians may be reluctant to prescribe our products without prior experience or additional data or training;

physicians may be reluctant

to prescribe our products due to their perception that the supporting clinical study designs have limitations, as they are, for example,

physicians at large academic

universities and medical centers may prefer to enroll patients into clinical studies instead of prescribing our products;

it may be difficult to

gain broad acceptance at community hospitals where the number of patients seeking treatment may be more limited than at larger medical

centers, and such community hospitals may not be willing to invest in the resources necessary for their physicians to become trained

to use our products, which could lead to reluctance to prescribe our products;

patients may be reluctant

to use our products for various reasons, including a perception that the treatment is untested or difficult to use or a perception

that our software is not secure;

our products may have side

effects and our products cannot be worn in all circumstances;

each patient will use more

than one device and therefore, as the duration of the treatment course increases, the overall price will increase correspondingly

and, when used in combination with other treatments, the overall cost of treatment will be greater than using a single type of treatment.

may be difficult to gain broad acceptance of our products because they are new technologies and involve a novel or derivative mechanism

of action and, as such, physicians may be reluctant to prescribe our products without prior experience or additional data or training;

may be reluctant to prescribe our products due to their perception that the supporting clinical study designs have limitations, as

they are, for example, unblinded;

at large academic universities and medical centers may prefer to enroll patients into clinical studies instead of prescribing our

may be difficult to gain broad acceptance at community hospitals where the number of patients seeking treatment may be more limited

than at larger medical centers, and such community hospitals may not be willing to invest in the resources necessary for their physicians

to become trained to use our products, which could lead to reluctance to prescribe our products;

may be reluctant to use our products for various reasons, including a perception that the treatment is untested or difficult to use

or a perception that our software is not secure;

products may have side effects and our products cannot be worn in all circumstances;

patient will use more than one device and therefore, as the duration of the treatment course increases, the overall price will increase

correspondingly and, when used in combination with other treatments, the overall cost of treatment will be greater than using a single

type of treatment.

particular, our products may not achieve market acceptance for current or future indications because of the following additional factors:

achieving patient acceptance

could be difficult because not all patients are willing to comply with requirements of treatment with our products, and other patients

may forego our products for financial, privacy, cosmetic, visibility or mobility reasons;

achieving patient compliance

may be difficult because the recommended use of our products is 120 hours per week for three (3) consecutive weeks, and not to exceed

four (4) weeks, which to some extent restricts physical mobility because our products cannot be worn in all circumstances, and the

patient or a caregiver must ensure that it remains continuously operable and this may also impact the pool of patients to whom physicians

may be willing to prescribe our products;

there may be certain perceived

limitations to our study designs or data obtained from our clinical studies;

efficacy may also be limited

in instances where patients take a break from the device when experiencing skin rashes, or while bathing or swimming (because our

products should not be immersed in water);

patients may decline therapy

or prescribers may be unwilling to prescribe our products due to certain adverse events attributable to the device reported in clinical

studies by patients treated with our products.

patient acceptance could be difficult because not all patients are willing to comply with requirements of treatment with our products,

and other patients may forego our products for financial, privacy, cosmetic, visibility or mobility reasons;

patient compliance may be difficult because the recommended use of our products is 120 hours per week for three (3) consecutive weeks,

and not to exceed four (4) weeks, which to some extent restricts physical mobility because our products cannot be worn in all circumstances,

and the patient or a caregiver must ensure that it remains continuously operable and this may also impact the pool of patients to

whom physicians may be willing to prescribe our products;

may be certain perceived limitations to our study designs or data obtained from our clinical studies;

may also be limited in instances where patients take a break from the device when experiencing skin rashes, or while bathing or swimming

(because our products should not be immersed in water);

may decline therapy or prescribers may be unwilling to prescribe our products due to certain adverse events attributable to the device

reported in clinical studies by patients treated with our products.

addition, even if we are successful in achieving market acceptance of our products for IBS or other indications, we may be unsuccessful

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physician services used in the delivery of healthcare.

Our technology specific CAT III CPT Code (0720T) was published on December 30,

Our IB-STIM technology specific CAT III CPT Code (0720T) was published on December

30, 2021 and effective on July 1, 2022.

In September of 2024, the AMA’s CPT Editorial Panel accepted addition of Category I CPT

Code (placeholder 64X11) for PENFS and deletion of Category III CPT Code 0720T.

The finalized Category I CPT Code for PENFS, and associated

valuations, will be announced publicly in Q4 of 2025.

The new code will become effective for utilization on January 1, 2026.

RED is billable

under Category I CPT Code 91120.

We may not be able to maintain the CPT code for physician services related to our products.

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currently do not own a manufacturing facility and rely on a sole manufacturer for the production of our product .

significant disruption to the sole manufacturer’s operations or facilities could have a material adverse effect on our business,

financial condition and results of operations .

Any significant

disruption to the sole manufacturer’s operations or facilities could have a material adverse effect on our business, financial

condition and results of operations .

rely on a sole manufacturer for the production of our products.

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of our products, including the following:

pre-clinical and clinical

testing for our products may not produce the desired effect, may be inconclusive or may not be predictive of safety or efficacy results

obtained in future clinical studies, following long-term use or in much larger populations;

unanticipated adverse events

or other side effects that are not currently known may occur during our clinical studies that may preclude additional regulatory

approval or result in additional limitations to commercial use if approved;

the data collected from

our clinical studies may not reach statistical significance or otherwise not be sufficient to support FDA or other regulatory approval.

and clinical testing for our products may not produce the desired effect, may be inconclusive or may not be predictive of safety

or efficacy results obtained in future clinical studies, following long-term use or in much larger populations;

unanticipated

adverse events or other side effects that are not currently known may occur during our clinical studies that may preclude additional

regulatory approval or result in additional limitations to commercial use if approved;

data collected from our clinical studies may not reach statistical significance or otherwise not be sufficient to support FDA or

other regulatory approval.

unacceptable side effects arise in the development of our products for future indications, we could suspend or terminate our clinical

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Physicians may decide not to recommend our treatments for a variety of reasons including:

timing of market introduction

of competitive products;

demonstration of clinical

safety and efficacy compared to other products;

of market introduction of competitive products;

demonstration

of clinical safety and efficacy compared to other products;

cost-effectiveness;

limited or no coverage

by third-party payers;

convenience and ease of

administration;

prevalence and severity

of adverse side effects;

restrictions in the label

of the device;

other potential advantages

of alternative treatment methods;

ineffective marketing and

distribution support of its products.

or no coverage by third-party payers;

and ease of administration;

and severity of adverse side effects;

in the label of the device;

potential advantages of alternative treatment methods;

marketing and distribution support of its products.

any of our product candidates is approved but fails to achieve market acceptance or such market is smaller than anticipated, we may not

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of new patients, and other delays or losses of materials and results.

COVID-19 pandemic could materially adversely impact our business .

the COVID-19 pandemic continues around the globe, we have experienced and will likely continue to experience disruptions that could severely

impact our business and clinical studies, which could include:

delays and/or difficulties

in onboarding active patients and enrolling patients in our clinical studies;

delays and/or difficulties

in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff;

declines in prescriptions

written due to a perception that our products are difficult to administer remotely or if patients are unwilling to travel to treatment

sites or receive in-home treatment assistance from us or other caregivers;

reductions in third-party

reimbursements, which could materially affect our revenue, as most of our patients rely on third-party payers to cover the cost of

our products and a material number of our patients could lose access to their private health insurance plan if they or someone in

their family lose their job;

diversion of healthcare

resources away from conducting clinical studies, including the diversion of hospitals serving as our clinical study sites and hospital

staff supporting the conduct of our clinical studies;

interruption of key clinical

study activities, such as clinical study site monitoring, due to limitations on travel imposed or recommended by federal or state

governments, employers and others;

staff disruptions and turnover

internally and at treatment sites and third-party providers who provide support, either directly as a result of illness or indirectly

as a result of vaccine mandates and other changes in terms of employment;

delays in receiving approval

from local regulatory authorities or IRBs to initiate our planned clinical studies;

delays in clinical sites

receiving the supplies and materials needed to conduct our clinical studies;

interruption in shipping

that may affect the transport of active patient and clinical study materials;

changes in local regulations

as part of a response to the COVID-19 outbreak that may require us to change the ways in which our clinical studies are conducted,

which may result in unexpected costs, or to discontinue the clinical studies altogether;

delays in necessary interactions

with local regulators, ethics committees and other important agencies and contractors due to limitations in employee resources or

forced furlough of government employees;

disruption of our supply

chain as our suppliers and common carriers are unable to meet our requirements to provide us the materials we need for clinical study

and active patient care needs;

indirect consequences of

the COVID-19 pandemic on the economy in general, such as an increase in bankruptcies of our key suppliers, or the inability of our

third-party payers to meet their obligations reimburse us in a timely fashion or at all;

postponements and cancellations

of key conferences and meetings and travel restrictions could interfere with our ability to interact with key thought leaders in

the field, leading to a disruption in the rate of adoption of our technology;

access restrictions at

offices, hospitals, and treatment centers, and stakeholder illness could interfere with the ability of our sales force to engage

in face-to-face visits with providers, leading to a disruption in the rate of adoption of our technology;

increases in expenditures

for technology and other tools necessary to provide patient care in an environment where both patient and care-giver travel is restricted

and access to in-person interaction is limited;

refusal of the FDA to accept

data from clinical studies in affected geographies outside the United States;

patient delays in seeking

or receiving treatment, either due to fear of infection or lack of access to treatment and study sites, leading to fewer diagnoses

of the indications our products are approved to treat or more advanced procession of the disease, which may contraindicate the use

of our products or disqualify the patient from participating in a given study.

global status of the COVID-19 pandemic continues to rapidly evolve.

The extent to which the pandemic may impact our business and clinical

studies will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the ultimate

geographic spread of the disease, the duration of the pandemic, travel restrictions and social distancing guidelines, business closures

or business disruptions and the effectiveness of actions taken to contain and treat the disease.

The response to the pandemic may result

in permanent changes to the environment in which we operate as described above in ways we are unable to predict.

The COVID-19 pandemic

may also have the effect of heightening many of the other risks described herein.

A pandemic could materially adversely impact our business .

pandemic could disruption and impact our business and clinical studies, which could include:

and/or difficulties in onboarding active patients and enrolling patients in our clinical studies;

and/or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site

in prescriptions written due to a perception that our products are difficult to administer remotely or if patients are unwilling

to travel to treatment sites or receive in-home treatment assistance from us or other caregivers;

in third-party reimbursements, which could materially affect our revenue, as most of our patients rely on third-party payers to cover

the cost of our products and a material number of our patients could lose access to their private health insurance plan if they or

someone in their family lose their job;

of healthcare resources away from conducting clinical studies, including the diversion of hospitals serving as our clinical study

sites and hospital staff supporting the conduct of our clinical studies;

of key clinical study activities, such as clinical study site monitoring, due to limitations on travel imposed or recommended by

federal or state governments, employers and others;

disruptions and turnover internally and at treatment sites and third-party providers who provide support, either directly as a result

of illness or indirectly as a result of vaccine mandates and other changes in terms of employment;

in receiving approval from local regulatory authorities or IRBs to initiate our planned clinical studies;

in clinical sites receiving the supplies and materials needed to conduct our clinical studies;

in shipping that may affect the transport of active patient and clinical study materials;

in local regulations as part of a response to a pandemic that may require us to change the ways in which our clinical

studies are conducted, which may result in unexpected costs, or to discontinue the clinical studies altogether;

in necessary interactions with local regulators, ethics committees and other important agencies and contractors due to limitations

in employee resources or forced furlough of government employees;

of our supply chain as our suppliers and common carriers are unable to meet our requirements to provide us the materials we need

for clinical study and active patient care needs;

consequences of a pandemic on the economy in general, such as an increase in bankruptcies of our key suppliers, or the

inability of our third-party payers to meet their obligations reimburse us in a timely fashion or at all;

postponements

and cancellations of key conferences and meetings and travel restrictions could interfere with our ability to interact with key thought

leaders in the field, leading to a disruption in the rate of adoption of our technology;

restrictions at offices, hospitals, and treatment centers, and stakeholder illness could interfere with the ability of our sales

force to engage in face-to-face visits with providers, leading to a disruption in the rate of adoption of our technology;

in expenditures for technology and other tools necessary to provide patient care in an environment where both patient and care-giver

travel is restricted and access to in-person interaction is limited;

of the FDA to accept data from clinical studies in affected geographies outside the United States;

delays in seeking or receiving treatment, either due to fear of infection or lack of access to treatment and study sites, leading

to fewer diagnoses of the indications our products are approved to treat or more advanced procession of the disease, which may contraindicate

the use of our products or disqualify the patient from participating in a given study.

The extent to which a pandemic may

impact our business and clinical studies will depend on future developments, which are highly uncertain and cannot be predicted with

confidence, such as the ultimate geographic spread of the disease, the duration of the pandemic, travel restrictions and social distancing

guidelines, business closures or business disruptions and the effectiveness of actions taken to contain and treat the disease.

to a pandemic may result in permanent changes to the environment in which we operate as described above in ways we are unable to predict.

A pandemic may also have the effect of heightening many of the other risks described herein.

medical technology entails significant technical, regulatory and business risks .

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cause us to miss valuable opportunities.

have material weaknesses in our internal control over financing reporting.

If we fail to establish and maintain proper and effective

internal control over financial reporting, our operating results and our ability to operate our business could be harmed.

that we have adequate internal financial and accounting controls and procedures in place so that we can produce accurate financial

statements on a timely basis is a costly and time-consuming effort that needs to be re-evaluated frequently.

Our internal control

over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and

the preparation of financial statements in accordance with generally accepted accounting principles.

Due to accounting resource

constraints, we have had limited review controls.

These constraints have resulted in (1) a lack of segregation of duties, since we

have a limited administrative staff, (2) lack of internal controls structure review and (3) misapplication of U.S.

of these constraints and the restatement our unaudited financial statements as of and for the three and nine month periods ended

September 30, 2023, management concluded material weaknesses in our internal control over financial reporting existed as of December

31 2023 and, accordingly, our internal control over financial reporting and disclosure controls and procedures were not

effective as of such date.

Specifically, management identified a material accounting error that understated extinguishment of debt

expense and net loss in the Statements of Operations and understated additional paid in capital in the Balance Sheet as of and for

the three and nine month periods ended September 30, 2023 as described and restated in Note 19 to the audited financial statements

included in this Form 10-K.

management is composed of a small number of individuals resulting in a situation where limitations on segregation of duties exist.

responsibility for accounting entries and the creation of financial statements is held by a single person, though the Company engages

multiple accounting consultants for accounting, tax and audit support.

To remedy this situation, we would need to hire additional staff

or financial consultant support.

document, review and improve our internal controls and procedures for compliance with Section 404 of the Sarbanes-Oxley Act, which require

had material weaknesses in our internal control over financing reporting during the years ended December 31, 2024 and 2023, that are

unremediated as of December 31, 2024.

If we fail to establish and maintain proper and effective internal control over financial

reporting, our operating results and our ability to operate our business could be harmed.

that we have adequate internal financial and accounting controls and procedures in place so that we can produce accurate financial statements

on a timely basis is a costly and time-consuming effort that needs to be re-evaluated frequently.

Our internal control over financial

reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation

of financial statements in accordance with generally accepted accounting principles.

document, review and improve our internal controls and procedures for compliance with Section 404 of the Sarbanes-Oxley Act, which requires

annual management assessment of the effectiveness of our internal control over financial reporting.

To comply with the requirements of

being a public company, the Company has undertaken various actions, and will take additional actions, such as remediating the material

weaknesses described above, implementing additional internal controls and procedures and hiring internal audit staff or financial consultants.

Testing and maintaining internal controls can divert our management’s attention from other matters that are important to the operation

of our business.

Additionally, when evaluating internal controls over financial reporting, the Company may identify additional material

weaknesses that it may not be able to remediate in time to meet the applicable deadline imposed upon us for compliance with the requirements

of Section 404 of the Sarbanes-Oxley Act.

If the Company identifies any additional material weaknesses in its internal control over financial

reporting or is unable to remediate the material weakness described above or comply with the requirements of Section 404 of the Sarbanes-Oxley

Act in a timely manner or if the Company’s independent registered public accounting firm is unable to express an unqualified opinion

being a public company, the Company has undertaken various actions to implement internal controls and procedures.

Testing and maintaining

internal controls can divert our management’s attention from other matters that are important to the operation of our business.

Additionally, when evaluating internal controls over financial reporting, the Company may identify material weaknesses that it may not

be able to remediate in time to meet the applicable deadline imposed upon us for compliance with the requirements of Section 404 of the

Sarbanes-Oxley Act.

If the Company identifies any additional material weaknesses in its internal control over financial reporting or

is unable to remediate the material weakness described above or comply with the requirements of Section 404 of the Sarbanes-Oxley Act

in a timely manner or if the Company’s independent registered public accounting firm is unable to express an unqualified opinion

as to the effectiveness of our internal control over financial reporting once it is no longer an emerging growth company, or if the Company

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the SEC or other regulatory authorities, which could require additional financial and management resources.

addition, if the Company fails to remediate any material weakness, including the material weaknesses described above, our financial statements

could be inaccurate and the Company could face restricted access to capital markets.

Our small size and internal control deficiencies

may adversely affect our financial condition, results of operation and access to capital.

our internal control over financial reporting will not prevent or detect all errors and all fraud.

A control system, no matter how well

designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met.

of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements due to

error or fraud will not occur or that all control issues and instances of fraud will be detected.

If we cannot provide reliable

financial reports or prevent fraud, we may not be able to manage our business as effectively as we would if an effective control environment

existed, and our business and reputation with investors may be harmed.

addition, if the Company fails to remediate any identified material weakness, our financial statements could be inaccurate and the Company

could face restricted access to capital markets.

Our small size and internal control deficiencies may adversely affect our financial

condition, results of operation and access to capital.

Moreover, our internal control over financial

reporting will not prevent or detect all errors and all fraud.

A control system, no matter how well designed and operated, can provide

only reasonable, not absolute, assurance that the control system’s objectives will be met.

Because of the inherent limitations

in all control systems, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur

or that all control issues and instances of fraud will be detected.

If we cannot provide reliable financial reports or prevent

fraud, we may not be able to manage our business as effectively as we would if an effective control environment existed, and our business

and reputation with investors may be harmed.

Related to Legal and Regulatory Matters

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of the merits or eventual outcome, liability claims may result in:

decreased demand for our

injury to our reputation;

withdrawal of clinical

study participants and inability to continue clinical studies;

initiation of investigations

by regulators;

costs to prepare for and

defend the related litigation;

a diversion of management’s

time and our resources;

substantial monetary awards

to study participants or patients;

product recalls, withdrawals

or labeling, marketing or promotional restrictions;

loss of revenues;

exhaustion of any available

insurance and our capital resources;

the inability to commercialize

any device candidate;

a decline in our share

demand for our products;

to our reputation;

of clinical study participants and inability to continue clinical studies;

of investigations by regulators;

to prepare for and defend the related litigation;

diversion of management’s time and our resources;

monetary awards to study participants or patients;

recalls, withdrawals or labeling, marketing or promotional restrictions;

of any available insurance and our capital resources;

inability to commercialize any device candidate;

decline in our share price.

liability claims could divert management’s attention from our core business, be expensive to defend and result in sizable damage

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Our products and our systems

and infrastructure face certain risks, including from cyber security breaches and data leakage .

and infrastructure face certain risks, including cyber security breaches and data leakage .

increasingly rely upon technology systems and infrastructure.

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FDA or regulatory agencies in other jurisdictions might delay or terminate our clinical studies of a device candidate for various reasons,

the device candidate may

have unforeseen adverse side effects or may not appear to be more effective than current therapies;

we may not agree with the

FDA, a regulatory authority in another jurisdiction or an ethics committee regarding the protocol for the conduct of a clinical study;

new therapies may become

the standard of care while we are conducting our clinical studies, which may require us to revise or amend our clinical study protocols

or terminate a clinical study;

fatalities may occur during

a clinical study due to medical problems that may or may not be related to clinical study treatments.

device candidate may have unforeseen adverse side effects or may not appear to be more effective than current therapies;

may not agree with the FDA, a regulatory authority in another jurisdiction or an ethics committee regarding the protocol for the

conduct of a clinical study;

therapies may become the standard of care while we are conducting our clinical studies, which may require us to revise or amend our

clinical study protocols or terminate a clinical study;

may occur during a clinical study due to medical problems that may or may not be related to clinical study treatments.

the process of obtaining and maintaining regulatory approvals in the U.S.

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in other jurisdictions and notified bodies, which may include any of the following sanctions:

untitled letters, warning

letters, fines, injunctions, consent decrees and civil penalties;

unanticipated expenditures

to address or defend such actions;

patient notification, or

orders for repair, replacement or refunds;

voluntary or mandatory

recall, withdrawal or seizure of our current or future devices;

administrative detention

by the FDA or other regulatory authority in another jurisdiction of medical devices believed to be adulterated or misbranded;

operating restrictions,

suspension or shutdown of production;

refusal or delay of our

requests for approval for new intended uses for or modifications to our products or for approval of new devices;

refusal or delay in obtaining

CE Certificates for new intended uses for or modifications to our products;

suspension, variation or

withdrawal of the CE Certificates granted by our notified body in the EU;

prohibition or restriction

of products being placed on the market;

operating restrictions;

suspension or withdrawal

of approvals that have already been granted;

refusal to grant export

approval for our products or any device candidates;

criminal prosecution.

letters, warning letters, fines, injunctions, consent decrees and civil penalties;

unanticipated

expenditures to address or defend such actions;

notification, or orders for repair, replacement or refunds;

or mandatory recall, withdrawal or seizure of our current or future devices;

administrative

detention by the FDA or other regulatory authority in another jurisdiction of medical devices believed to be adulterated or misbranded;

restrictions, suspension or shutdown of production;

or delay of our requests for approval for new intended uses for or modifications to our products or for approval of new devices;

or delay in obtaining CE Certificates for new intended uses for or modifications to our products;

variation or withdrawal of the CE Certificates granted by our notified body in the EU;

or restriction of products being placed on the market;

restrictions;

or withdrawal of approvals that have already been granted;

to grant export approval for our products or any device candidates;

occurrence of any of these events could have a material adverse effect on our business, prospects, financial condition and results of

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Act and FDA regulations include, but are not limited to, the following:

Anti-Kickback Statute, an intent-based federal criminal statute which prohibits knowingly and willfully offering, providing, soliciting

or receiving remuneration of any kind to induce or reward, or in return for, referrals or the purchase, lease, order or recommendation

or arranging of any items or services reimbursable by a federal healthcare program;

the Federal Civil False

Claims Act, which imposes civil penalties, including through civil whistleblower or “qui tam” actions, for knowingly

submitting or causing the submission of false or fraudulent claims of payment to the federal government, knowingly making, using

or causing to be made or used a false statement or record material to payment of a false claim or avoiding, decreasing or concealing

an obligation to pay money to the federal government;

the Federal Criminal False

Claims Act, which is similar to the Federal Civil False Claims Act and imposes criminal liability on those that make or present a

false, fictitious or fraudulent claim to the federal government;

Medicare laws and regulations

that prescribe requirements for coverage and reimbursement, and laws prohibiting false claims or unduly influencing selection of

products for reimbursement under Medicare and Medicaid;

healthcare fraud statutes

that prohibit false statements and improper claims to any third-party payer;

the Federal Physician Self-Referral

Law, commonly known as the Stark law, which, absent an applicable exception, prohibits physicians from referring Medicare and Medicaid

patients to an entity for the provision of certain designated health services (“DHS”), if the physician (or a member

of the physician’s immediate family) has an impermissible financial relationship with that entity and prohibits the DHS entity

from billing for such improperly referred services;

the Federal Beneficiary

Anti-Inducement Statute, which prohibits the offering of any remuneration to a beneficiary of Medicare or Medicaid that is likely

to influence that beneficiary’s choice of provider or supplier.

This can include, but is not limited to, inappropriate provision

of patient services including financial assistance.

federal Anti-Kickback Statute, an intent-based federal criminal statute which prohibits knowingly and willfully offering, providing,

soliciting or receiving remuneration of any kind to induce or reward, or in return for, referrals or the purchase, lease, order or

recommendation or arranging of any items or services reimbursable by a federal healthcare program;

Federal Civil False Claims Act, which imposes civil penalties, including through civil whistleblower or “qui tam” actions,

for knowingly submitting or causing the submission of false or fraudulent claims of payment to the federal government, knowingly

making, using or causing to be made or used a false statement or record material to payment of a false claim or avoiding, decreasing

or concealing an obligation to pay money to the federal government;

Federal Criminal False Claims Act, which is similar to the Federal Civil False Claims Act and imposes criminal liability on those

that make or present a false, fictitious or fraudulent claim to the federal government;

laws and regulations that prescribe requirements for coverage and reimbursement, and laws prohibiting false claims or unduly influencing

selection of products for reimbursement under Medicare and Medicaid;

fraud statutes that prohibit false statements and improper claims to any third-party payer;

Federal Physician Self-Referral Law, commonly known as the Stark law, which, absent an applicable exception, prohibits physicians

from referring Medicare and Medicaid patients to an entity for the provision of certain designated health services (“DHS”),

if the physician (or a member of the physician’s immediate family) has an impermissible financial relationship with that entity

and prohibits the DHS entity from billing for such improperly referred services;

Federal Beneficiary Anti-Inducement Statute, which prohibits the offering of any remuneration to a beneficiary of Medicare or Medicaid

that is likely to influence that beneficiary’s choice of provider or supplier.

This can include, but is not limited to, inappropriate

provision of patient services including financial assistance.

Recent government investigations have focused on this particular prohibition.

There are established exceptions from liability, but we cannot guarantee that all of our practices will fall squarely within those

Foreign Corrupt

Practices Act, which can be used to prosecute companies in the U.S.

for arrangements with physicians or other parties outside the

if the physician or party is a government official of another country and the arrangement violates the law of that country;

the Federal Trade Commission

Act, the Lanham Act and similar federal and state laws regulating truthfulness in advertising and consumer protection;

the Federal Physician Payments

Sunshine Act, the French Sunshine Act and similar state and foreign laws, which require periodic reporting of payments and other

transfers of value made to U.S.

and French-licensed physicians, teaching hospitals, and in the U.S., physician assistants, nurse

practitioners, clinical nurse specialists, certified nurse anesthetists, and certified nurse-midwives.

Foreign Corrupt Practices Act, which can be used to prosecute companies in the U.S.

for arrangements with physicians or other

parties outside the U.S.

if the physician or party is a government official of another country and the arrangement violates the law

of that country;

Federal Trade Commission Act, the Lanham Act and similar federal and state laws regulating truthfulness in advertising and consumer

Federal Physician Payments Sunshine Act, the French Sunshine Act and similar state and foreign laws, which require periodic reporting

of payments and other transfers of value made to U.S.

and French-licensed physicians, teaching hospitals, and in the U.S., physician

assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, and certified nurse-midwives.

laws exist in the EU, individual EU member states and other countries.

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imposed sanctions, including:

restrictions on the products,

manufacturers, or manufacturing processes;

warning letters;

civil or criminal penalties;

product seizures or detentions;

pressure to initiate voluntary

product recalls;

suspension or withdrawal

of regulatory clearances and/or approvals;

refusal to approve pending

applications for marketing clearances and/or approval of new products or supplements to approved applications.

on the products, manufacturers, or manufacturing processes;

or criminal penalties;

seizures or detentions;

to initiate voluntary product recalls;

or withdrawal of regulatory clearances and/or approvals;

to approve pending applications for marketing clearances and/or approval of new products or supplements to approved applications.

property litigation and infringement claims could cause us to incur significant expenses or prevent us from selling certain of our products.

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depend extensively on our patents and proprietary technology and the patents, and we must protect those assets in order to preserve our

we expect to seek patent protection for any devices, in silico products (if any), systems, and processes we discover

and/or for any specific use we discover for new or previously known compounds, devices, biologics, products, systems, or processes, any

or all of these may not be subject to effective patent protection.

In addition, our issued patents may be declared invalid or our competitors

may find ways to avoid the claims in the patents.

we expect to seek patent protection for any devices, in silico products (if any), systems, and processes we discover and/or for

any specific use we discover for new or previously known compounds, devices, biologics, products, systems, or processes, any or all of

these may not be subject to effective patent protection.

In addition, our issued patents may be declared invalid or our competitors may

find ways to avoid the claims in the patents.

success will depend, in part, on our ability to obtain patents, protect our trade secrets and proprietary knowledge and operate without

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stock, and therefore stockholders may have difficulty selling their shares.

are subject to ongoing public reporting requirements that are less rigorous than Exchange Act rules for companies that are

not emerging growth companies, and our stockholders could receive less information than they might expect to receive from more mature

public companies.

are required to publicly report on an ongoing basis as an “emerging growth company” (as defined in the JOBS Act) under

the reporting rules set forth under the Exchange Act.

For so long as we remain an emerging growth company, we may take advantage

of certain exemptions from various reporting requirements that are applicable to other Exchange Act reporting companies that

are not emerging growth companies, including but not limited to:

not being required to comply

with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act;

being permitted to comply

with reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements;

being exempt from the requirement

to hold a non-binding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously

are subject to ongoing public reporting requirements that are less rigorous than Exchange Act rules for companies that are not emerging

growth companies, and our stockholders could receive less information than they might expect to receive from more mature public companies.

are required to publicly report on an ongoing basis as an “emerging growth company” (as defined in the JOBS Act) under the

reporting rules set forth under the Exchange Act.

For so long as we remain an emerging growth company, we may take advantage of certain

exemptions from various reporting requirements that are applicable to other Exchange Act reporting companies that are not emerging growth

companies, including but not limited to:

being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act;

permitted to comply with reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements;

exempt from the requirement to hold a non-binding advisory vote on executive compensation and stockholder approval of any golden

parachute payments not previously approved.

expect to take advantage of these reporting exemptions until we are no longer an emerging growth company.

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as of any June 30 before that time, we would cease to be an emerging growth company as of the following December 31.

we are subject to ongoing public reporting requirements that are less rigorous than Exchange Act rules for companies that are

not emerging growth companies, our stockholders could receive less information than they might expect to receive from more mature public

We cannot predict if investors will find our common stock less attractive if we elect to rely on these exemptions, or if taking

advantage of these exemptions would result in less active trading or more volatility in the price of our common stock.

we are subject to ongoing public reporting requirements that are less rigorous than Exchange Act rules for companies that are not emerging

growth companies, our stockholders could receive less information than they might expect to receive from more mature public companies.

We cannot predict if investors will find our common stock less attractive if we elect to rely on these exemptions, or if taking advantage

of these exemptions would result in less active trading or more volatility in the price of our common stock.

the Company is a “smaller reporting company,” we may take advantage of certain scaled disclosures available to us, resulting

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are a “smaller reporting company” as defined in the Exchange Act.

As a smaller reporting company, we may take advantage

of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures

As a smaller reporting company, we may take advantage of

certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures

for so long as (i) our common stock held by non-affiliates is less than $250 million measured on the last business day of our second

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requirements that could have an adverse effect on our public shareholders.

NYSE American rules, a “smaller reporting company,” as defined in Rule 12b-2 under the Exchange Act, is not

subject to certain corporate governance requirements otherwise applicable to companies listed on NYSE American.

For example, a smaller

reporting company is exempt from the requirement of having a compensation committee composed solely of directors meeting certain enhanced

independence standards, as long as the compensation committee has at least two members who do meet such standards.

Although we have determined

not to avail ourselves of this or other exemptions from NYSE American requirements that are or may be afforded to smaller reporting companies

NYSE American rules, a “smaller reporting company,” as defined in Rule 12b-2 under the Exchange Act, is not subject to certain

corporate governance requirements otherwise applicable to companies listed on NYSE American.

For example, a smaller reporting company

is exempt from the requirement of having a compensation committee composed solely of directors meeting certain enhanced independence

standards, as long as the compensation committee has at least two members who do meet such standards.

Although we have determined not

to avail ourselves of this or other exemptions from NYSE American requirements that are or may be afforded to smaller reporting companies

while we will seek to maintain our shares on NYSE American, in the future we may elect to rely on any or all of these exemptions.

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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