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Item 1A. Risk Factors

2025-02-28 compared with 2024-02-29 · 320 added, 412 removed, 684 unchanged (52% 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.

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 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.

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.

Related to Our Business and Strategy

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

have historically incurred losses, including net losses of $23.5 million and $24.7 million for the years ended December 31, 2023 and 2022,

respectively.

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

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

Currently, we are not generating revenue from operations,

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

Additionally,

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

and TAVVE studies, as well as the anticipated expansion of our operations.

We do not expect to generate significant revenue until any

of our product candidates are licensed or sold, if ever.

have historically incurred losses and expect to continue incurring losses going forward.

Our losses have resulted primarily from our

research programs and the development of our product candidates as well as from costs related to general and administrative expenses

relating to our operations.

Currently, we are not generating revenue from operations, and we expect to incur losses for the

foreseeable future as we seek to obtain regulatory approval for our product candidates.

Additionally, we expect that our general and

administrative expenses will increase due to the additional operational costs associated with our 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.

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

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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.

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,

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

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;

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.

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.

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

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

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

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

FDA and foreign regulators, (iv) market and sell product candidates, (v) successfully gain market acceptance of our product

candidates by doctors and patients, and (vi) obtain sufficient and on-time supply of components from our third-party suppliers.

If our product candidates

are never successfully commercialized, we may never receive a return on our investments in product development, regulatory

compliance, manufacturing, and quality assurance, which may cause us to fail to generate revenue and gain economies of scale from

such investments.

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

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

regulators, (iv) market and sell product candidates, (v) successfully gain market acceptance of our product candidates by doctors and

patients, and (vi) obtain sufficient and on-time supply of components from our third-party suppliers.

If our product candidates are never

successfully commercialized, we may never receive a return on our investments in product development, regulatory compliance, manufacturing,

and quality assurance, which may cause us to fail to generate revenue and gain economies of scale from such investments.

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

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harm our business, including:

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.

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.

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

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

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

VACs typically review the comparative effectiveness

and cost of medical devices used in the facility.

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

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

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

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

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

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

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

In addition, hospital facilities

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

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

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

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

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

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

candidates and may also depend on our ability to develop additional 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 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.

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

and may also depend on our ability to develop additional product candidates.

medical device industry is highly competitive and subject to rapid change and technological advancements.

New technologies,

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

the products and services 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.

Developing new product candidates is expensive and

time-consuming.

Even if we are successful in developing additional product candidates, the success of any new product candidates or

enhancements to existing product candidates will depend on several factors, including our ability to:

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 preclinical 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.

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.

new product candidates is expensive and time-consuming.

Even if we are successful in developing additional product candidates, the success

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.

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

Existing markets for surgical devices are characterized by rapid technological change and innovation.

It is critical to our success that we anticipate changes in technology and customer requirements and physician, hospital and healthcare

provider practices.

It is also important that we successfully introduce new, enhanced and competitive product candidates to meet our

prospective customers’ needs on a timely and cost-effective basis.

At the same time, however, we must carefully manage our introduction

of new product candidates.

If potential customers believe that such product candidates will offer enhanced features or be sold for a

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

We may also continue to offer older products

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

If we do not successfully

innovate and introduce new technology into our anticipated product lines or successfully manage the transitions of our technology to

new product offerings, our revenue, results of operations and business could be adversely impacted.

markets for surgical devices are characterized by rapid technological change and innovation.

It is critical to our success that we anticipate

changes in technology and customer requirements and physician, hospital and healthcare provider practices.

It is also important that

we successfully introduce new, enhanced and competitive product candidates to meet our prospective customers’ needs on a timely

and cost-effective basis.

At the same time, however, we must carefully manage our introduction of new product candidates.

customers believe that such product candidates will offer enhanced features or be sold for a more attractive price, they may delay purchases

until such product candidates are available.

We may also continue to offer older products as we transition to new product candidates,

and we may not have sufficient experience managing transitions.

If we do not successfully innovate and introduce new technology into

our anticipated product lines or successfully manage the transitions of our technology to new product offerings, our revenue, results

of operations and business could be adversely impacted.

competitors may be able to respond more quickly and effectively than we can to new or changing opportunities, technologies, industry

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Additionally,

to produce our product candidates in the quantities that we anticipate will be required for commercialization, we will have to

increase or “scale up” our production process over the current level of production.

We may encounter difficulties in

scaling up our production, including issues involving yields, controlling and anticipating costs, quality control and assurance,

supply and shortages of qualified personnel.

If our scaled-up production process is not efficient or results in a product that does

not meet quality or other standards, we may be unable to meet market demand and our revenues, business and financial prospects would

be adversely affected.

Further, third parties with whom we may develop relationships may not have the ability to produce the

quantities of the materials we may require for clinical trials or commercial sales or may be unable to do so at prices that allow us

to price our products competitively.

to produce our product candidates in the quantities that we anticipate will be required for commercialization, we will have to increase

or “scale up” our production process over the current level of production.

We may encounter difficulties in scaling up our

production, including issues involving yields, controlling and anticipating costs, quality control and assurance, supply and shortages

of qualified personnel.

If our scaled-up production process is not efficient or results in a product that does not meet quality or other

standards, we may be unable to meet market demand and our revenues, business and financial prospects would be adversely affected.

third parties with whom we may develop relationships may not have the ability to produce the quantities of the materials we may require

for clinical trials or commercial sales or may be unable to do so at prices that allow us to price our products competitively.

facility and equipment would be costly to replace and could require substantial lead time to repair or replace.

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

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

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

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

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

significant litigation costs;

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.

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.

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

As of December 31, 2023 and 2022,

federal NOLs, were approximately $61.7 million and $52.7 million, and state NOL’s were approximately $61.1 million and $52.5 million.

Pre-2018 federal NOLs of $12.0 million have a limited carry forward period of twenty years and begin to expire in 2029.

generated after 2017 can be carried forward indefinitely.

State NOL’s can be carried forward for twenty years and begin to expire

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

Additionally, for both federal and state purposes,

the annual benefit the Company can derive from NOL’s is limited because of ownership changes.

general, a corporation that undergoes an “ownership change” (generally defined as a cumulative change in equity ownership

by “5% shareholders” that exceeds 50 percentage points over a rolling three-year period) may be subject to limitations on

its ability to utilize its NOLs 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 and in 2023.

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.

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

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

of December 31, 2023, we also had federal research and development tax credit carryforwards of approximately $0.2 million which begin

to expire in 2027.

Related to Regulatory Approval and Other Governmental Regulations

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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.

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.

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

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 preclinical 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.

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.

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:

additional testing prior

to obtaining clearance or approval;

changes to manufacturing

recall, replacement or

discontinuance of our systems or future products;

additional record keeping.

testing prior to obtaining clearance or approval;

to manufacturing methods;

replacement or discontinuance of our systems or future products;

record keeping.

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

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These laws include:

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

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.

Office of Inspector General of the U.S.

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.

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.

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

112 unchanged sentences

among other things:

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

clinical holds;

warning letters;

refusal to permit the import or export of our product

criminal prosecution of us or our employees.

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.

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

Patent and Trademark Office and in

other jurisdictions.

As of the December 31, 2023, we have been granted twenty-six (26) patents including seven (7) in the United

States and have another seventeen 17 applications in various stages of review including seven (7) in the United

Patent and Trademark Office and in other

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].

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

89 unchanged sentences

Related to Ownership of Our Securities

trading price of our securities is likely to be volatile and could be subject to wide fluctuations in response to a variety of factors.

trading price of our securities is likely 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;

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 preclinical

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;

additions or departures

of key personnel;

general 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:

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.

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

7 unchanged sentences

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 $7.86, 400,000 restricted stock units subject to vesting, and warrants to purchase 17,129,415 shares of

our common stock with a weighted average exercise price of $6.49.

Further, we have 1,768,753 shares available for issuance under our

Amended and Restated 2016 Omnibus Incentive Plan.

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

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

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.

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

stock or securities that are convertible or exercisable into shares of common stock (other than pursuant to the Plan) such that shares

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

fully diluted basis.

55 unchanged sentences

are not limited to:

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.

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.

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