What changed in this filing

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Item 1A. Risk Factors

2026-03-26 compared with 2025-02-28 · 481 added, 326 removed, 678 unchanged (54% of the section changed)

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You should carefully consider these risk factors and the other reports and documents filed by us with the SEC.

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

profitability;

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

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;

ability to retain and recruit key personnel, including the development of a sales and marketing infrastructure;

on third party suppliers for certain components of our product candidates;

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;

in external competitive market factors;

Uncertainties

in generating sustained revenue or achieving profitability;

Unanticipated

working capital or other cash requirements;

in FDA regulations, including testing procedures, for medical devices and related promotional and marketing activities;

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

limit commercialization of any products that we may develop;

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.

We have incurred significant

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

Our estimates of our expenses,

ongoing losses, future revenue, capital requirements and our needs for, or ability to obtain, additional financing;

We depend entirely on the

successful and timely regulatory approval and commercialization of our current, and any future, product candidates which, similar

to the VenoValve, 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;

The success of our current

or future products, if approved, will be determined based on whether surgeons and patients in our target markets accept them;

Failure to scale up the

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

Our ability to retain and

recruit key personnel, including the development of a sales and marketing infrastructure;

Reliance on third party

suppliers for certain components of our product candidates;

If 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;

Changes in external competitive

market factors;

Uncertainties in generating

sustained revenue or achieving profitability;

Unanticipated working capital

or other cash requirements;

Changes in FDA regulations,

including testing procedures, for medical devices and related promotional and marketing activities;

Our ability to obtain and

maintain intellectual property protection;

Product liability lawsuits

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

of any products that we may develop;

Our ability to maintain

the listing of our securities on the Nasdaq Capital Market;

Changes in our business

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

Related to Our Business and Strategy

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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 clinical studies, as well as the

anticipated expansion of our operations to commercialize our products if we receive FDA approval.

We do not expect to generate significant revenue until we are able to commercialize one or more of our product candidates after

receiving FDA approval, or if any of our product candidates are

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 clinical studies, as well as the anticipated expansion

of our operations to commercialize our products if we receive FDA approval.

We do not expect to generate significant revenue until we

are able to commercialize one or more of our product candidates after receiving FDA approval, or if 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 product candidates, and

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 product candidate, and

any future product candidates, which may not receive regulatory approval or, if any of our product candidates do receive regulatory approval,

we may not be able to successfully commercialize them.

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

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.

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

In order for our product candidate to succeed it needs to be approved by regulatory authorities, which may never happen.

product candidate is 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.

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

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 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

Our product candidate is currently in development, and we have not

received FDA approval for it.

Our product candidate 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.

product candidate requires significant research, development, pre-clinical testing and extensive clinical investigation before submission

of any regulatory application for marketing approval.

For example, on August 19, 2025, the Company received a not-approvable letter

from the FDA in response to its PMA application for the VenoValve.

While the enVVe System is different than the VenoValve in that it

is a non-surgical, transcatheter based replacement venous valve, the enVVe System may also not receive FDA approval.

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

product candidates on a timely basis, or at all.

The number, size, design and focus of preclinical and clinical trials that will be required

for approval by the FDA, the EMA or any other foreign regulatory agency varies depending on the device, the disease or condition that

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.

The FDA, the EMA and other foreign regulatory

agencies can delay, limit or deny approval of a product for many reasons, including, but not limited to:

product candidate may not be shown to be safe or effective;

clinical and other benefits of a product candidate may not outweigh its safety risks;

may not be able to enroll enough patients to complete our product studies;

trial results may be negative or inconclusive, or adverse medical events may occur during a clinical trial;

patients may expire from reasons unrelated to our product, impairing our trials;

results of clinical trials may not meet the level of statistical significance required by regulatory agencies for approval;

agencies may interpret data from pre-clinical and clinical trials in different ways than we do;

agencies may not approve the manufacturing process or determine that the manufacturing is not in accordance with current good manufacturing

practices, or cGMPs;

product candidate may fail to comply with regulatory requirements;

agencies might change their approval policies or adopt new regulations.

our product candidates are not approved at all or quickly enough to provide net revenues to defray our operating expenses, our business,

financial condition, operating results and prospects could be harmed.

The number, size, design and focus of pre-clinical and clinical trials that will be

required for approval by the FDA, the EMA or any other foreign regulatory agency varies depending on the device, the disease or condition

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

Pre-clinical 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 agencies can delay, limit or deny approval of a product for many reasons, including, but not limited to:

a product candidate may

not be shown to be safe or effective;

the clinical and other

benefits of a product candidate may not outweigh its safety risks;

we may not be able to enroll

enough patients to complete our product studies;

clinical trial results

may be negative or inconclusive, or adverse medical events may occur during a clinical trial;

trial patients may expire

from reasons unrelated to our product, impairing our trials;

the results of clinical

trials may not meet the level of statistical significance required by regulatory agencies for approval;

regulatory agencies may

interpret data from pre-clinical and clinical trials in different ways than we do;

regulatory agencies may

not approve the manufacturing process or determine that the manufacturing is not in accordance with current good manufacturing practices,

a product candidate may

fail to comply with regulatory requirements;

regulatory agencies might

change their approval policies or adopt new regulations.

example, with respect to the VenoValve, the FDA indicated that the favorable rVCSS data generated by the study to show clinical improvement,

together with the improvements in pain scores and venous specific quality of life indicators was not sufficient on its own to determine

favorability of the benefit risk profile for the VenoValve.

The FDA also referenced the use of a hemodynamic measurement that correlates

with patient improvement, concerns about bias and the possibility that clinical improvement occurred as a result of the patients being

enrolled in a study and safety concerns attributed to the VenoValve open surgical procedure, and that required re-hospitalizations.

our current and future product candidates are not approved at all or quickly enough to provide net revenues to defray our operating expenses,

our business, financial condition, operating results and prospects could be harmed.

we are unable to successfully raise additional capital, our future clinical trials and product development could be limited and our long-term

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

progress and results of our development efforts for our product candidates;

costs, timing and outcome of regulatory review of our product candidates;

costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights

and defending any intellectual property-related claims;

effect of competing technological and market developments;

the cost associated with commercialization of our product candidates once

approved by the FDA;

acceptance of our product candidates;

rate of progress in establishing coverage and reimbursement arrangements with domestic and international commercial third-party payors

and government payors;

ability to achieve revenue growth and improve gross margins;

extent to which we acquire or in-license other products and technologies;

accounting, insurance and other professional and business-related costs.

the progress and results

of our development efforts for our product candidates;

the costs, timing and outcome

of regulatory review of our product candidates;

the costs and timing of

preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any

intellectual property-related claims;

the effect of competing

technological and market developments;

the cost associated with

commercialization of our product candidates once approved by the FDA;

market acceptance of our

product candidates;

the rate of progress in

establishing coverage and reimbursement arrangements with domestic and international commercial third-party payors and government

the ability to achieve

revenue growth and improve gross margins;

the extent to which we

acquire or in-license other products and technologies;

legal, accounting, insurance

and other professional and business-related costs.

may not be able to acquire additional funds on acceptable terms, or at all.

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harm our business, including:

of supply resulting from modifications to, or discontinuation of, a supplier’s operations;

in product shipments resulting from defects, reliability issues or changes in components from suppliers;

fluctuations due to a lack of long-term supply arrangements for key components with our suppliers;

in manufacturing components, which could negatively impact the effectiveness or safety of our product candidates or cause delays

in shipment of our product candidates;

production of components, which could significantly delay our production and sales and impair operating margins;

to obtain adequate supplies in a timely manner or on commercially reasonable terms;

locating and qualifying alternative suppliers, especially with respect to our sole-source supplies;

in production and sales caused by switching components, which may require product redesign and/or new regulatory submissions;

due to evaluation and testing of devices from alternative suppliers and corresponding regulatory qualifications;

delivery of components due to our suppliers supplying products for a range of customers;

failure of our suppliers to comply with strictly enforced regulatory requirements, which could result in disruption of supply or

increased expenses;

of suppliers to fulfill orders and meet requirements due to financial hardships.

interruption of supply

resulting from modifications to, or discontinuation of, a supplier’s operations;

delays in product shipments

resulting from defects, reliability issues or changes in components from suppliers;

price fluctuations due

to a lack of long-term supply arrangements for key components with our suppliers;

errors in manufacturing

components, which could negatively impact the effectiveness or safety of our product candidates or cause delays in shipment of our

product candidates;

discontinued production

of components, which could significantly delay our production and sales and impair operating margins;

inability to obtain adequate

supplies in a timely manner or on commercially reasonable terms;

difficulty locating and

qualifying alternative suppliers, especially with respect to our sole-source supplies;

delays in production and

sales caused by switching components, which may require product redesign and/or new regulatory submissions;

delays due to evaluation

and testing of devices from alternative suppliers and corresponding regulatory qualifications;

non-timely delivery of

components due to our suppliers supplying products for a range of customers;

the failure of our suppliers

to comply with strictly enforced regulatory requirements, which could result in disruption of supply or increased expenses;

inability of suppliers

to fulfill orders and meet requirements due to financial hardships.

addition, there are a limited number of suppliers and third-party manufacturers that operate under the FDA’s Quality System Regulation,

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of operations and growth.

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, which at this time will likely take several years at a minimum, 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,

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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 value analysis committee (VAC).

typically review the comparative effectiveness and cost of medical devices used in the facility.

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 value analysis committee (“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.

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

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.

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.

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.

face significant competition and our business prospects will depend on our ability to develop and commercialize our current product candidates

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New technologies, techniques

or products could emerge that might make our products obsolete or offer better combinations of price and performance than the products that we plan to offer.

Therefore, it is important to our business that we continue to develop and enhance our product candidate

offerings and potentially introduce new product candidates.

or products could emerge that might make our products obsolete or offer better combinations of price and performance than the products

that we plan to offer.

Therefore, it is important to our business that we continue to develop and enhance our product candidate offerings

and potentially introduce new product candidates.

new product candidates is expensive and time-consuming.

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of any new product candidates or enhancements to existing product candidates will depend on several factors, including our ability to:

identify and anticipate surgeon and patient needs;

and introduce new product candidates or enhancements in a timely manner;

an effective and dedicated sales and marketing team;

infringing upon the intellectual property rights of others;

if required, the safety and efficacy of new product candidates with data from preclinical studies and clinical trials;

the necessary regulatory clearances or approvals for new product candidates or enhancements;

fully FDA-compliant with marketing of new product candidates or modified product candidates;

adequate training to potential users of our product candidates;

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

properly identify and anticipate

surgeon and patient needs;

develop and introduce new

product candidates or enhancements in a timely manner;

develop an effective and

dedicated sales and marketing team;

avoid infringing upon the

intellectual property rights of others;

demonstrate, if required,

the safety and efficacy of new product candidates with data from pre-clinical studies and clinical trials;

obtain the necessary regulatory

clearances or approvals for new product candidates or enhancements;

be fully FDA-compliant

with marketing of new product candidates or modified product candidates;

provide adequate training

to potential users of our product candidates;

receive 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 be impaired.

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Regardless of the merit or eventual outcome, product liability claims may result in:

litigation costs;

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

to our reputation;

of clinical trial participants;

monetary awards to trial participants, patients or other claimants;

inability to commercialize any product candidates that we may develop.

significant litigation

decreased demand for our

product candidates and any future product candidates that we may develop;

damage to our reputation;

withdrawal of clinical

trial participants;

substantial monetary awards

to trial participants, patients or other claimants;

loss of revenue;

the inability to commercialize

any product candidates that we may develop.

we maintain liability insurance, the coverage limits of our insurance policies may not be adequate, and one or more successful claims

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

Company has incurred significant operating losses which have generated significant net operating loss carry-forwards for both

federal and state purposes.

Other than federal NOL carryforwards generated after 2017, our NOL carryforwards will expire if not used

over the next five years.

Our ability to realize the benefits of these NOL carryforwards will depend on our ability to generate

Company has incurred significant operating losses which have generated net operating loss carry-forwards for both federal and state purposes.

Other than federal NOL carryforwards generated after 2017, our NOL carryforwards will expire if not used over the next four years.

ability to realize the benefits of these NOL carryforwards will depend on our ability to generate income.

our ability to realize the benefits of NOL carryforwards are limited because of ownership changes.

In general, a corporation that

undergoes an “ownership change” (generally defined as a greater than 50% change (by value) in its equity ownership over

a rolling three-year period) may be subject to limitations on its ability to utilize its NOLs and certain credit carryforwards to

offset future taxable income and taxes.

We have analyzed the tax impacts of ownership changes that occurred in 2018, 2021, 2023 and

While those ownership changes have resulted in limits to the amount of NOLs that may be used in a given year, these are all

post 2017 NOLs and are carried forward indefinitely.

Future changes in our stock ownership, as well as other changes that may be

outside of our control, could result in additional ownership changes.

Our NOLs and credit carryforwards may also be limited under

similar provisions of state law.

We have recorded a full valuation allowance related to our NOLs and other deferred tax assets 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

In general, a corporation that undergoes

an “ownership change” (generally defined as a greater than 50% change (by value) in its equity ownership over a rolling three

(3) year period) may be subject to limitations on its ability to utilize its NOLs and certain credit carryforwards to offset future taxable

income and taxes.

We have analyzed the tax impacts of ownership changes that occurred in 2018, 2021, 2023, 2024, and in 2025.

ownership changes may have resulted in limits to the amount of NOLs that can be used in a given year, these are all post 2017 NOLs and

are carried forward indefinitely.

changes in our stock ownership, as well as other changes that may be outside of our control, could result in additional ownership changes.

Our NOLs and credit carryforwards may also be limited under similar provisions of state law.

We have recorded a full valuation allowance

related to our NOLs and other deferred tax assets due to the uncertainty of the ultimate realization of the future tax benefits of such

Related to Regulatory Approval and Other Governmental Regulations

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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

Company received a not-approvable letter from the FDA.

August 19, 2025, the Company received a not-approvable letter from the FDA in response to its PMA application for the VenoValve.

letter indicated that the FDA completed its review of the VenoValve PMA application and determined that it is unable to approve the PMA

for the VenoValve in its current form.

In particular, the FDA indicated that the favorable rVCSS data generated by the study to show

clinical improvement, together with the improvements in pain scores and venous specific quality of life indicators was not sufficient

on its own to determine favorability of the benefit risk profile for the VenoValve.

Without a specific hemodynamic measurement that correlates

with patient improvement, the FDA raised concerns about bias and the possibility that clinical improvement occurred as a result of the

patients being enrolled in a study.

The FDA also focused on safety concerns which were attributed to the VenoValve open surgical procedure,

and that required re-hospitalizations.

September 18, 2025, the Company filed a request for supervisory appeal of the not-approvable letter from the Center for Devices and Radiological

Health (CDRH) of the FDA received on August 19, 2025, in response to its PMA application for the VenoValve.

The FDA provides several

internal informal and formal mechanisms to challenge staff decisions, including scientific controversies.

One mechanism is a request

for supervisory review in which an appeal is made to the next line of supervision.

These appeals involve a formal substantive request,

an in-person meeting, and a decision.

It also often includes multiple interactions even after an initial appeal decision is made.

Agency reviews are based on information already in the administrative file.

October 2025, the Company completed an in-person meeting with the FDA.

In addition to representatives from an outside firm specializing

in FDA matters and appeals and representatives from the Company, the meeting also included a patient advocate from VenoValve U.S.

study as well as one of the Company’s primary investigators from the trial.

Several employees from the FDA attended the meeting

including the Director of the Center for Devices and Radiological Health, who elected to hear the appeal and who will be issuing the

appeal decision.

The FDA meeting provided the Company with the opportunity to put the major adverse events—those tied to the SAVVE

study’s safety endpoints—into the proper context.

It also allowed the Company to re-emphasize the multiple physician-and

patient-reported clinical benefits that comprise the totality of the evidence from the study, supported by firsthand perspectives shared

by both the SAVVE study patient and investigator in attendance.

Because there are no established industry or regulatory standards to

determine the effectiveness for a replacement venous valve, it is necessary for the Company and the Agency to establish a new regulatory

pathway for VenoValve effectiveness.

November 13, 2025, the Company received an unfavorable decision from the FDA in response to its supervisory appeal of the not-approvable

The supervisory appeal upheld the review staff decision in the not-approvable letter that the VenoValve did not meet the standard

of reasonable assurance of safety and effectiveness.

light of receiving a not-approvable letter from the FDA and an unfavorable decision from the FDA in response to its supervisory appeal

of the not-approvable letter, there can be no assurances that the Company will ever get regulatory approval for the VenoValve or for

the enVVe System.

product candidates will 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.

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the United States, our product candidates are regulated as medical devices.

Before our medical device product candidates may be

marketed in the United States, we must submit, and the FDA must approve a PMA application.

For the PMA approval process, the FDA

must determine that a proposed device is safe and effective for its intended use based, in part, on extensive data, including, but

not limited to, technical, pre-clinical, clinical trial, manufacturing and labeling data.

In addition, modifications to products

that are approved through a PMA application generally require FDA approval.

The time required to obtain approval, clearance or

license by the FDA to market a new therapy is unpredictable but typically takes years and depends upon many factors, including the

substantial discretion of the FDA.

This timeline may be further extended as a result of the recent reduction in workforce that has taken place within

the federal government, including at the FDA.

Before our medical device product candidates may be marketed

in the United States, we must submit, and the FDA must approve a PMA application.

For the PMA approval process, the FDA must determine

that a proposed device is safe and effective for its intended use based, in part, on extensive data, including, but not limited to, technical,

pre-clinical, clinical trial, manufacturing and labeling data.

In addition, modifications to products that are approved through a PMA

application generally require FDA approval.

The time required to obtain approval, clearance or license by the FDA to market a new therapy

is unpredictable but typically takes years and depends upon many factors, including the substantial discretion of the FDA, especially

after the Company received a not-approvable letter from the FDA related to the VenoValve.

This timeline may be further extended as a

result of the recent reduction in workforce that has taken place within the federal government, including at the FDA.

product candidates could fail to receive regulatory approval, clearance or license for many reasons, including the following:

FDA may disagree with the design or implementation of our clinical trials or study endpoints;

may be unable to demonstrate to the satisfaction of the FDA that our product candidates are safe and effective for their proposed

indications or that our product candidates provide significant clinical benefits;

results of our clinical trials may not meet the level of statistical significance required by the FDA for approval, clearance or

license or may not support approval of a label that could command a price sufficient for us to be profitable;

FDA may disagree with our interpretation of data from preclinical studies or clinical trials;

opportunity for bias in the clinical trials as a result of the open-label design may not be adequately handled and may cause our

trial to fail;

product candidates may be subject to an FDA advisory committee review, which may be requested at the sole discretion of the FDA,

and which may result in unexpected delays or hurdles to approval;

FDA may determine that the manufacturing processes at our facilities or facilities of third-party manufacturers with which we contract

for clinical and commercial supplies are inadequate;

FDA may determine we cannot continue our clinical trials due to adverse patient reactions including patient deaths for reasons unrelated

to our products;

approval, clearance or license policies or regulations of the FDA may significantly change in a manner rendering our clinical data

insufficient for approval.

the FDA may disagree with

the design or implementation of our clinical trials or study endpoints;

we may be unable to demonstrate

to the satisfaction of the FDA that our product candidates are safe and effective for their proposed indications or that our product

candidates provide significant clinical benefits;

the results of our clinical

trials may not meet the level of statistical significance required by the FDA for approval, clearance or license or may not support

approval of a label that could command a price sufficient for us to be profitable;

the FDA may disagree with

our interpretation of data from pre-clinical studies or clinical trials;

the opportunity for bias

in the clinical trials as a result of the open-label design may not be adequately handled and may cause our trial to fail;

our product candidates

may be subject to an FDA advisory committee review, which may be requested at the sole discretion of the FDA, and which may result

in unexpected delays or hurdles to approval;

the FDA may determine that

the manufacturing processes at our facilities or facilities of third-party manufacturers with which we contract for clinical and

commercial supplies are inadequate;

the FDA may determine we

cannot continue our clinical trials due to adverse patient reactions including patient deaths for reasons unrelated to our products;

the approval, clearance

or license policies or regulations of the FDA may significantly change in a manner rendering our clinical data insufficient for approval.

example, with respect to the VenoValve, the FDA indicated that the favorable rVCSS data generated by the study to show clinical improvement,

together with the improvements in pain scores and venous specific quality of life indicators was not sufficient on its own to determine

favorability of the benefit risk profile for the VenoValve.

The FDA also referenced the use of a hemodynamic measurement that correlates

with patient improvement, concerns about bias and the possibility that clinical improvement occurred as a result of the patients being

enrolled in a study and safety concerns attributed to the VenoValve open surgical procedure, and that required re-hospitalizations.

if we were to obtain approval, clearance or license, the FDA may grant approval, clearance or license contingent on the performance of

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Such changes could, among other things, require:

testing prior to obtaining clearance or approval;

to manufacturing methods;

replacement or discontinuance of our systems or future products;

record keeping.

additional testing prior

to obtaining clearance or approval;

changes to manufacturing

recall, replacement or

discontinuance of our systems or future products;

additional record keeping.

of these changes could require substantial time and cost and could harm our business and our financial results.

39 unchanged sentences

These laws include:

federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering

or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase,

order or recommendation of, any good or service for which payment may be made under federal healthcare programs, such as the Medicare

and Medicaid programs.

A person or entity does not need to have actual knowledge of the federal Anti-Kickback Statute or specific

intent to violate it to have committed a violation.

In addition, the government may assert that a claim including items or services

resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False

Violations of the federal Anti-kickback Statute may result in substantial civil or criminal penalties, including criminal

fines of up to $25,000, imprisonment of up to five years, civil penalties under the Civil Monetary Penalties Law of up to $50,000

for each violation, plus three times the remuneration involved, civil penalties under the federal False Claims Act of up to $11,000

for each claim submitted, plus three times the amounts paid for such claims and exclusion from participation in the Medicare and

Medicaid programs;

federal False Claims Act, which prohibits, among other things, individuals or entities from knowingly presenting, or causing to be

presented, claims for payment from Medicare, Medicaid or other federal third-party payors that are false or fraudulent.

under the False Claims Act, known as “qui tam” actions, can be brought by any individual on behalf of the government

and such individuals, commonly known as “whistleblowers,” may share in any amounts paid by the entity to the government

in fines or settlement.

When an entity is determined to have violated the False Claims Act, the government may impose penalties of

not less than $5,500 and not more than $11,000, plus three times the amount of the damages that the government sustains due to the

submission of a false claim and exclude the entity from participation in Medicare, Medicaid and other federal healthcare programs;

federal Civil Monetary Penalties Law, which prohibits, among other things, offering or transferring remuneration to a federal healthcare

beneficiary that a person knows or should know is likely to influence the beneficiary’s decision to order or receive items

or services reimbursable by the government from a particular provider or supplier;

as amended by the HITECH Act, and their respective implementing regulations, which governs the conduct of certain electronic healthcare

transactions and protects the security and privacy of protected health information.

Failure to comply with the HIPAA privacy and

security standards can result in civil monetary penalties up to $50,000 per violation, not to exceed $1.5 million per calendar year

for non-compliance of an identical provision, and, in certain circumstances, criminal penalties with fines up to $250,000 per violation

and/or imprisonment.

State attorneys general can bring a civil action to enjoin a HIPAA violation or to obtain statutory damages

up to $25,000 per violation on behalf of residents of his or her state.

HIPAA also imposes criminal penalties for fraud against any

healthcare benefit program and for obtaining money or property from a healthcare benefit program through false pretenses and provides

for broad prosecutorial subpoena authority and authorizes certain property forfeiture upon conviction of a federal healthcare offense.

Significantly, the HIPAA provisions apply not only to federal programs, but also to private health benefit programs.

HIPAA also broadened

the authority of the U.S.

the federal Anti-Kickback

Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration,

directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation

of, any good or service for which payment may be made under federal healthcare programs, such as the Medicare and Medicaid programs.

A person or entity does not need to have actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it to

have committed a violation.

In addition, the government may assert that a claim including items or services resulting from a violation

of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act.

Violations of

the federal Anti-kickback Statute may result in substantial civil or criminal penalties, including criminal fines of up to $25,000,

imprisonment of up to five years, civil penalties under the Civil Monetary Penalties Law of up to $50,000 for each violation, plus

three times the remuneration involved, civil penalties under the federal False Claims Act of up to $11,000 for each claim submitted,

plus three times the amounts paid for such claims and exclusion from participation in the Medicare and Medicaid programs;

the federal False Claims

Act, which prohibits, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for

payment from Medicare, Medicaid or other federal third-party payors that are false or fraudulent.

Suits filed under the False Claims

Act, known as “qui tam” actions, can be brought by any individual on behalf of the government and such individuals, commonly

known as “whistleblowers,” may share in any amounts paid by the entity to the government in fines or settlement.

an entity is determined to have violated the False Claims Act, the government may impose penalties of not less than $5,500 and not

more than $11,000, plus three times the amount of the damages that the government sustains due to the submission of a false claim

and exclude the entity from participation in Medicare, Medicaid and other federal healthcare programs;

the federal Civil Monetary

Penalties Law, which prohibits, among other things, offering or transferring remuneration to a federal healthcare beneficiary that

a person knows or should know is likely to influence the beneficiary’s decision to order or receive items or services reimbursable

by the government from a particular provider or supplier;

HIPAA, as amended by the

HITECH Act, and their respective implementing regulations, which governs the conduct of certain electronic healthcare transactions

and protects the security and privacy of protected health information.

Failure to comply with the HIPAA privacy and security standards

can result in civil monetary penalties up to $50,000 per violation, not to exceed $1.5 million per calendar year for non-compliance

of an identical provision, and, in certain circumstances, criminal penalties with fines up to $250,000 per violation and/or imprisonment.

State attorneys general can bring a civil action to enjoin a HIPAA violation or to obtain statutory damages up to $25,000 per violation

on behalf of residents of his or her state.

HIPAA also imposes criminal penalties for fraud against any healthcare benefit program

and for obtaining money or property from a healthcare benefit program through false pretenses and provides for broad prosecutorial

subpoena authority and authorizes certain property forfeiture upon conviction of a federal healthcare offense.

Significantly, the

HIPAA provisions apply not only to federal programs, but also to private health benefit programs.

HIPAA also broadened the authority

Office of Inspector General of the U.S.

Department of Health and Human Services to exclude participants

from federal healthcare programs;

federal physician sunshine requirements under the Patient Protection and Affordable Care Act, or PPACA, which requires certain manufacturers

of drugs, devices, biologics and medical supplies to report annually to the U.S.

Department of Health and Human Services information

related to payments and other transfers of value to physicians, which is defined broadly to include other healthcare providers and

teaching hospitals and ownership and investment interests held by physicians and their immediate family members.

Manufacturers are

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,

and may result in liability under other federal laws or regulations;

state and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply

to items or services reimbursed by any third- party payor, including commercial insurers;

state laws that require device companies

to comply with the industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal

government or otherwise restrict payments that may be made to healthcare providers and other potential referral sources;

that require device manufacturers to report information related to payments and other transfers of value to physicians and other

healthcare providers or marketing expenditures;

and state laws governing the privacy and security of health information in certain

circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance

Any failure by us to ensure that our employees and agents comply with applicable state and foreign laws and regulations

could result in substantial penalties or restrictions on our ability to conduct business in those jurisdictions, and our results

of operations and financial condition could be materially and adversely affected.

Department of Health and Human Services to exclude participants from federal

healthcare programs;

the federal physician sunshine

requirements under the Patient Protection and Affordable Care Act, or PPACA, which requires certain manufacturers of drugs, devices,

biologics and medical supplies to report annually to the U.S.

Department of Health and Human Services information related to payments

and other transfers of value to physicians, which is defined broadly to include other healthcare providers and teaching hospitals

and ownership and investment interests held by physicians and their immediate family members.

Manufacturers are 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, and may result in

liability under other federal laws or regulations;

analogous state and foreign

law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services

reimbursed by any third- party payor, including commercial insurers;

state laws that require device companies to comply with the

industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government or

otherwise restrict payments that may be made to healthcare providers and other potential referral sources;

state laws that require

device manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers

or marketing expenditures;

and state laws governing the privacy and security of health information in certain circumstances, many

of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

by us to ensure that our employees and agents comply with applicable state and foreign laws and regulations could result in substantial

penalties or restrictions on our ability to conduct business in those jurisdictions, and our results of operations and financial

condition could be materially and adversely affected.

risk of our being found in violation of these laws is increased by the fact that many of them have not been fully interpreted by the

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

On August 2, 2011,

2011, the Budget Control Act of 2011 created measures for spending reductions by Congress.

A Joint Select Committee on Deficit Reduction, tasked

with recommending a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, was unable to reach required

goals, thereby triggering the legislation’s automatic reduction to several government programs.

This includes aggregate reductions

of Medicare payments to providers up to 2% per fiscal year, which went into effect on April 1, 2013, and will remain in effect through

2024 unless additional Congressional action is taken.

On January 2, 2013, the American Taxpayer Relief Act of 2012, or the ATRA, was

signed into law which further reduced Medicare payments to certain providers, including hospitals.

A Joint Select Committee on Deficit

Reduction, tasked with recommending a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, was

unable to reach required goals, thereby triggering the legislation’s automatic reduction to several government programs.

includes aggregate reductions of Medicare payments to providers up to 2% per fiscal year, which went into effect on April 1, 2013.

The 2% reduction in Medicare payments to providers, originally triggered by the Budget Control Act of 2011, has been extended

multiple times.

Most recently, the Consolidated Appropriations Act, 2023 extended this 2% sequester through fiscal year 2032.

January 2, 2013, the American Taxpayer Relief Act of 2012, or the ATRA, was signed into law which further reduced Medicare payments

to certain providers, including hospitals.

expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts

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among other things:

administrative

or judicially imposed sanctions;

or the imposition of civil penalties;

or seizure of our product candidates;

or partial suspension of production or distribution;

FDA’s refusal to grant future clearance or pre-market approval for our product candidates;

or suspension of marketing clearances or approvals;

to permit the import or export of our product candidates;

prosecution of us or our employees.

administrative or judicially

imposed sanctions;

injunctions or the imposition

of civil penalties;

recall or seizure of our

product candidates;

total or partial suspension

of production or distribution;

the FDA’s refusal

to grant future clearance or pre-market approval for our product candidates;

withdrawal or suspension

of marketing clearances or approvals;

clinical holds;

warning letters;

refusal to permit the import

or export of our product candidates;

criminal prosecution of

us or our employees.

of these actions, in combination or alone, could prevent us from marketing, distributing, or selling our products and would likely harm

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jurisdictions.

As of the December 31, 2024, we have been granted thirty-nine (39) patents including eight (8) in the United States and

have another twenty-four (24) applications in various stages of review including five (5) in the United States].

As of the December 31, 2025, we have been granted forty-two (42) patents including nine (9) in the United States and have

another twenty-one (21) 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

12 unchanged sentences

patents that we may own may not provide any protection against competitors.

Furthermore, an adverse decision in an interference proceeding

can result in a third party receiving the patent right sought by us, which in turn could affect our ability to commercialize our implant

though an issued patent is presumed valid and enforceable, its issuance is not conclusive as to its validity or its enforceability and

52 unchanged sentences

gain a competitive advantage.

We may become involved in litigation, interference proceedings, oppositions, reexamination, protest or

other potentially adverse intellectual property proceedings as a result of alleged infringement by us of the rights of others or as a

result of priority of invention disputes with third parties, either in the United States or internationally.

We may also become a party

to patent infringement claims and litigation or interference proceedings declared by the USPTO to determine the priority of inventions.

Third parties may also challenge the validity of any of our issued patents and we may initiate proceedings to enforce our patent rights

and prevent others from infringing on our intellectual property rights.

Any claims relating to the infringement of third-party proprietary

rights or proprietary determinations, even if not meritorious, could result in costly litigation, lengthy governmental proceedings, diversion

of our management’s attention and resources, or entrance into royalty or license agreements that are not advantageous to us.

any of these circumstances, we may need to spend significant amounts of money, time and effort defending our position.

Some of our competitors

may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources.

In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect

on our ability to raise the funds necessary to continue our operations.

We may become involved in litigation, oppositions, reexamination, protest or other potentially adverse

intellectual property proceedings as a result of alleged infringement by us of the rights of others or as a result of priority of invention

disputes with third parties, either in the United States or internationally.

We may also become a party to patent infringement claims

and litigation declared by the USPTO to determine the priority of inventions.

Third parties may also challenge the validity of any of

our issued patents and we may initiate proceedings to enforce our patent rights and prevent others from infringing on our intellectual

property rights.

Any claims relating to the infringement of third-party proprietary rights or proprietary determinations, even if not

meritorious, could result in costly litigation, lengthy governmental proceedings, diversion of our management’s attention and resources,

or entrance into royalty or license agreements that are not advantageous to us.

In any of these circumstances, we may need to spend significant

amounts of money, time and effort defending our position.

Some of our competitors may be able to sustain the costs of complex patent

litigation more effectively than we can because they have substantially greater resources.

In addition, any uncertainties resulting from

the initiation and continuation of any litigation could have a material adverse effect on our ability to raise the funds necessary to

continue our operations.

if we are successful in these proceedings, we may incur substantial costs and divert management time and attention in pursuing these

4 unchanged sentences

Related to Ownership of Our Securities

trading price of our securities has been and is likely to continue to be volatile and could be subject to wide fluctuations in

response to a variety of factors.

trading price of our securities has been and is likely to continue to be volatile and could be subject to wide fluctuations in

response to a variety of factors, which include:

we achieve our anticipated corporate objectives;

or anticipated fluctuations in our financial condition and operating results;

in financial or operational estimates or projections;

development status of our product candidates and when our product candidates receive regulatory approval if at all;

execution of our sales and marketing, manufacturing and other aspects of our business plan;

of third parties on whom we rely to manufacture our product candidate components and product candidates, including their ability

to comply with regulatory requirements;

results of our preclinical studies and clinical trials;

of operations that vary from those of our competitors and the expectations of securities analysts and investors;

announcement of significant contracts, acquisitions or capital commitments;

announcements

by our competitors of competing products or other initiatives;

announcements

by third parties of significant claims or proceedings against us;

and reimbursement developments in the United States and internationally;

sales of our common stock to meet our business requirements;

liability claims;

reform measures in the United States and elsewhere;

or departures of key personnel;

economic or political conditions in the United States or elsewhere.

trading price of our securities has been and is likely to continue to be volatile and could be subject to wide fluctuations in response

to a variety of factors.

trading price of our securities has been and is likely to continue to be volatile and could be subject to wide fluctuations in response

to a variety of factors, which include:

whether we achieve our

anticipated corporate objectives;

actual or anticipated fluctuations

in our financial condition and operating results;

changes in financial or

operational estimates or projections;

the development status

of our product candidates and when our product candidates receive regulatory approval if at all (for example, receiving a not-approvable

letter from the FDA related to any product candidate);

our execution of our sales

and marketing, manufacturing and other aspects of our business plan;

performance of third parties

on whom we rely to manufacture our product candidate components and product candidates, including their ability to comply with regulatory

requirements;

the results of our pre-clinical

studies and clinical trials;

results of operations that

vary from those of our competitors and the expectations of securities analysts and investors;

our announcement of significant

contracts, acquisitions or capital commitments;

announcements by our competitors

of competing products or other initiatives;

announcements by third

parties of significant claims or proceedings against us;

regulatory and reimbursement

developments in the United States and internationally;

future sales of our common

stock to meet our business requirements;

product liability claims;

healthcare reform measures

in the United States and elsewhere;

receiving a deficiency

notice from Nasdaq;

additions or departures

of key personnel;

general 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, have experienced extreme price and volume

6 unchanged sentences

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 5,921,699 shares of our common stock with a weighted

average exercise price of $7.17, 400,000 restricted stock units subject to vesting, and warrants to purchase 12,662,953 shares of our

common stock with a weighted average exercise price of $6.11.

Further, we have 828,798 shares available for issuance under our Amended

and Restated 2016 Omnibus Incentive Plan.

of March 24, 2026, we have issued and outstanding options to purchase 181,996 shares of our common stock with a weighted

average exercise price of $220.41 and warrants to purchase 177,921 shares of our common stock with a weighted average exercise price

Further, we have 38,154 shares available for issuance under our Amended and Restated 2016 Omnibus Incentive Plan.

number of shares subject to the Plan is automatically adjusted from time to time when the Company issues additional shares of common

58 unchanged sentences

are not limited to:

classified board of directors so that not all directors are elected at one time;

prohibition on stockholder action through written consent;

cumulative voting in the election of directors;

exclusive right of our board of directors to elect a director to fill a vacancy created by the expansion of the board of directors

or the resignation, death or removal of a director;

requirement that special meetings of the stockholders may be called only by our chairman of the board, chief executive officer or

president, or by a resolution adopted by a majority of our board of directors;

advance notice requirement for stockholder proposals and nominations;

authority of our board of directors to issue preferred stock with such terms as our board of directors may determine;

requirement of approval of not less than 50% of all outstanding shares of our capital stock entitled to vote to amend any bylaws

by stockholder action, or to amend specific provisions of our amended and restated certificate of incorporation.

a classified board of directors

so that not all directors are elected at one time;

a prohibition on stockholder

action through written consent;

no cumulative voting in

the election of directors;

the exclusive right of

our board of directors to elect a director to fill a vacancy created by the expansion of the board of directors or the resignation,

death or removal of a director;

a requirement that special

meetings of the stockholders may be called only by our chairman of the board, chief executive officer or president, or by a resolution

adopted by a majority of our board of directors;

an advance notice requirement

for stockholder proposals and nominations;

the authority of our board

of directors to issue preferred stock with such terms as our board of directors may determine;

a requirement of approval

of not less than 50% of all outstanding shares of our capital stock entitled to vote to amend any bylaws by stockholder action, or

to amend specific provisions of our amended and restated certificate of incorporation.

addition, the Delaware General Corporate Law, or DGCL, prohibits a publicly held Delaware corporation from engaging in a business combination

22 unchanged sentences

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