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Set forth below is a summary of the risks and uncertainties affecting our business that we currently believe to be material.
+Added: Our future operating results could differ materially from the results described in this Annual Report due to the risks and uncertainties described below.
We caution you to read the following risk factors, which have affected, and/or in the future could affect, our business, prospects, operating results, and financial condition.
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Further, competitors may introduce placental-based membrane products in the future at lower prices, adding new features or gaining additional reimbursement coverage, or utilize sales and marketing practices that negatively impact the industry.
−Removed: Further, they may copy our products outside the United States.
+Added: Further, they may copy our products inside or outside the United States.
The presence of this competition may lead to pricing pressure, which could have an adverse effect on our business, results of operations and financial condition.
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Many of our products depend on the availability of tissue from human donors, and any disruption in supply could adversely affect our business.
−Removed: The success of our human tissue products depends upon, among other factors, the availability of tissue from human donors.
+Added: The commercial success of our human tissue products depends upon, among other factors, the availability of tissue from human donors.
Any failure to obtain tissue from our sources will interfere with our ability to effectively meet demand for our products incorporating human tissue.
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Our revenues depend on adequate reimbursement from public and private insurers and health systems and changes to the ways in which our products are reimbursed in various sites of service could adversely impact our financial results.
−Removed: Our success depends on the extent to which our customers receive adequate reimbursement for the costs of our products and related treatments from third-party payers, including government healthcare programs, such as Medicare and Medicaid, as well as private insurers and health systems.
−Removed: Government and other third-party payers attempt to contain healthcare costs by limiting both coverage and the level of reimbursement of medical products, particularly new products.
−Removed: Therefore, significant
−Removed: uncertainty may exist as to the reimbursement status of new healthcare products by third-party payers.
−Removed: Although EPIFIX and EPICORD have coverage with the majority of large payers, a significant number of public and private insurers currently do not cover or reimburse our other products.
The reimbursement landscape for our products varies depending upon the site in which the products are administered.
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Even if we do succeed in obtaining widespread coverage and reimbursement rates or policies for our products, future changes in coverage or reimbursement rates or policies could have a negative impact on our business, financial condition and results of operations.
−Removed: Further, we have experienced some reluctance by payers to cover our products under certain circumstances, including for applications other than those for which we have published clinical efficacy data.
−Removed: Since 2022, several wide-ranging proposals have been published for public comment, including relating to payment methodology within the physician office, with potential to change how CMS reimburses for skin substitute products at a national level.
−Removed: Changes in the coverage and reimbursement environment as described above could result in declines in our revenue that would adversely affect our business, financial condition and results of operation.
+Added: At the end of 2025, CMS announced sweeping changes related to the reimbursement of skin substitutes, beginning January 1, 2026.
+Added: These changes include:
+Added: 1) reimbursing skin substitute products uniformly across the HOPD and physician office and associated care settings and 2) changing the reimbursement rate for skin substitutes from the “ASP+6%” methodology to a flat rate at $127.14 per square centimeter in these care settings, subject to geographic adjustments.
+Added: The specific policies were put into effect in the PFS and OPPS.
+Added: Historically, third-party payors often rely on the coverage policies and payment limitations imposed by Medicare and other government payors, in setting their own coverage policies and reimbursement rates.
+Added: Our inability to promptly obtain coverage and profitable payment rates from hospital budget, government-funded and private payors, could have a material adverse effect on our operating results, our ability to raise capital needed to commercialize products and our overall financial condition.
+Added: Healthcare reform measures such as the 2026 reimbursement changes may result in additional reductions in Medicare and other healthcare funding, more rigorous coverage criteria, new payment methodologies and additional downward pressure on the price that we receive for any approved product.
+Added: Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors.
+Added: The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our product offerings.
+Added: In the past, we have also experienced some reluctance by payers to cover our products under certain circumstances, including for applications other than those for which we have published clinical efficacy data.
+Added: We continue to publish additional scientific, clinical and health outcomes literature in support of the use of products more broadly, but there can be no assurance that these publications and associated efforts will influence coverage determinations or reimbursement amounts.
+Added: Given the unknowns of the new reimbursement landscape, we may need to tighten inventory management to minimize losses from unused products and also revisit pricing strategies in light of the new reimbursement model.
+Added: Changes in the coverage and reimbursement environment as described above and the impact it could have on clinical practice and physician behavior, which will only become clear as implementation progresses, could result in declines in our revenue that would adversely affect our business, financial condition and results of operation.
Our revenue, results of operations and cash flows may suffer upon the loss of a Group Purchasing Organization or Integrated Delivery Network.
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These customers purchase our product through GPO and IDN arrangements in part because of the favorable pricing and terms and conditions.
−Removed: If our agreement with any GPO or IDN is terminated or expires without being extended, renewed or renegotiated, this could adversely affect our revenue, results of operations and cash flows.
+Added: If, as a result of competition, pricing, or any other reason, our agreement with any GPO or IDN is terminated or expires without being extended, renewed or renegotiated, this could adversely affect our revenue, results of operations and cash flows.
We contract with and are dependent upon independent sales agents and distributors.
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However, if our processing facilities were to become unavailable, this could have a material adverse effect on our business, financial condition and results of operations during the period of such unavailability.
+Added: We do not own our processing facilities and our business could be harmed if we are not able to renew our leases or relocate on favorable terms.
+Added: Our ability to negotiate a favorable extension or a new lease for an alternative facility depends on factors beyond our control, including landlord disputes or increases in local real estate market rates.
+Added: If we were unable to renew our leases or relocate on favorable terms, this could have a material adverse effect on our business, financial condition and results of operations.
To be commercially successful, we must educate physicians, where appropriate, how and when our products are proper alternatives to existing treatments and that our products should be used in their procedures.
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Physicians may be hesitant to change their existing medical treatment practices for the following reasons, among others:
−Removed: • their lack of experience with advanced therapeutics, such as our placenta-based allografts or xenografts;
−Removed: • lack of evidence supporting additional patient benefits of advanced therapeutics, such as our placenta-based allografts or xenografts, over conventional methods in certain therapeutic applications;
+Added: • their lack of experience with advanced therapeutics, such as our placenta-based allografts, xenografts or other advanced therapies;
+Added: • lack of evidence supporting additional patient benefits of advanced therapeutics, such as our placenta-based allografts, xenografts or other advanced therapies, over conventional methods in certain therapeutic applications;
• perceived liability risks generally associated with the use of new products and procedures;
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• the time that must be dedicated to physician training in the use of our products.
+Added: If we are unsuccessful in educating physicians to maintain or increase adoption of our products, it could have an adverse effect on our business and results of operations.
If we cannot successfully address quality issues that may arise with our products, our brand reputation could suffer, and our business, financial condition, and results of operations could be adversely impacted.
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Although we have established internal procedures to minimize risks that may arise from quality issues, we may not be able to eliminate or mitigate occurrences of these issues and associated liabilities.
−Removed: If the quality of our products does not meet the expectations of physicians or patients, then our brand reputation could suffer and our business could be adversely impacted.
+Added: If the quality of our products does not meet the expectations of physicians or patients, then our brand reputation could suffer and our business could be
+Added: adversely impacted.
We must also ensure any promotional claims made for our products comport with government regulations.
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While we have had a low product complaint and adverse event rate historically, our business exposes us to the risk of product liability claims that are inherent in the manufacturing, processing and marketing of human tissue products.
−Removed: We may be subject
−Removed: to such claims if our products cause, or appear to have caused, an injury.
+Added: We may be subject to such claims if our products cause, or appear to have caused, an injury.
Claims may be made by patients, healthcare providers or others selling our products.
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We measure these controls and their success through a cybersecurity framework that is based on industry standards.
+Added: Refer to Item 1C, Cybersecurity , for additional discussion.
While we have invested in the protection of our data and technology, there can be no guarantees that our efforts will prevent all service interruptions or security breaches.
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However, this insurance may not be sufficient to cover the financial, legal or reputational losses that may result from an interruption or breach of our systems.
+Added: Increased use of artificial intelligence (“AI”) and related technologies in the medical device industry could subject us to new risks and uncertainties, and our failure to effectively evaluate or adopt such technologies could adversely affect our business.
+Added: Artificial intelligence, machine learning, and other automated technologies are being increasingly explored and adopted across the medical device industry, including in product development, manufacturing, quality systems, regulatory processes, clinical support, and commercial activities.
+Added: We may evaluate or elect to adopt AI technologies in the future as part of our efforts to remain competitive and operate efficiently.
+Added: The adoption of AI technologies could subject us to evolving and uncertain regulatory requirements.
+Added: Regulatory authorities, including the FDA and international counterparts, are actively assessing the appropriate oversight of AI-enabled tools and products.
+Added: New or revised regulations, guidance, or enforcement practices could impose additional compliance obligations, increase development and validation costs, limit permissible uses of AI, or delay the deployment of AI-enabled solutions.
+Added: The use of AI also presents operational, legal, and reputational risks.
+Added: AI systems may produce inaccurate, incomplete, or biased outputs, and reliance on such outputs could negatively affect business decisions, product development, manufacturing processes, or regulatory and quality activities.
+Added: In addition, the use of AI may increase our exposure to cybersecurity, data privacy, and intellectual property risks, particularly where third-party tools, datasets, or platforms are involved.
+Added: Moreover, if competitors more effectively or more rapidly adopt AI technologies, they may achieve operational efficiencies, cost advantages, improved product offerings, or enhanced customer engagement that we are unable to match.
+Added: Conversely, if
+Added: we adopt AI without appropriate governance, controls, or expertise, we could incur increased costs, operational disruptions, or reputational harm.
+Added: Our ability to successfully assess whether, when, and how to adopt AI technologies, and to manage the associated risks, will depend on a number of factors that are difficult to predict.
+Added: Any failure to appropriately respond to the increasing role of AI in our industry could adversely affect our business, results of operations, or competitive position.
We may expand or contract our business through acquisitions, divestitures, licenses, investments, and other commercial arrangements with other companies or technologies, which may adversely affect our business, results of operations and financial condition.
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A portion of our revenues and accounts receivable come from government accounts.
−Removed: Some of our revenues are derived from sales, both direct and through a distributor, to the government.
+Added: Some of our revenues are derived from sales to the government.
Any disruption of our products on the FSS or any change in the way the government purchases products like ours or the price it is willing to pay for our products could adversely affect our business, results of operations and financial condition.
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Adoption of our products in new geographic regions could take longer and cost more than we anticipate.
−Removed: Risks inherent in international operations also include, among others, potential adverse tax consequences, greater difficulty in enforcing intellectual property rights, risks associated with the Foreign Corrupt Practices Act and local anti-bribery law compliance, and other international regulations.
+Added: Risks inherent in international operations also include, among others, potential
+Added: adverse tax consequences, greater difficulty in enforcing intellectual property rights, risks associated with the Foreign Corrupt Practices Act and local anti-bribery law compliance, and other international regulations.
These regulations may limit our ability to market, sell, distribute or otherwise transfer our products to prohibited countries or persons.
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The FDA has in the past determined, and may in the future determine, that certain of our products that are, or are derived from, human cells or tissues, do not qualify for regulation solely under Section 361, and may require that we revise our labeling and marketing claims for these products or that we suspend sales of such products until FDA pre-market clearance or approval is obtained, which could adversely affect our business, results of operations, and financial condition.
−Removed: Many of the products we manufacture and process are derived from human tissue.
+Added: Currently, all of the products we manufacture and process are derived from human tissue.
Amniotic and other birth tissue have in the past generally been regulated as HCT/P and were therefore eligible to be subject to regulation solely under Section 361 (“ Section 361 HCT/P ”) depending on whether the specific product at issue and the claims made for it were consistent with the applicable criteria.
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Obtaining clearances or approvals is time consuming, expensive, and uncertain.
−Removed: Furthermore, even if we are granted
−Removed: regulatory clearances or approvals, they may include significant limitations on the indicated uses of the product, which may limit the potential customers for the product.
+Added: Furthermore, even if we are granted regulatory clearances or approvals, they may include significant limitations on the indicated uses of the product, which may limit the potential customers for the product.
If we are unable to obtain required FDA clearance or approval for a product or are unduly delayed in doing so, or the uses of that product were limited, our business could suffer.
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However, clearance or approval may not be granted with respect to any of our products or enhancements and further FDA review may add delays that could adversely affect our ability to market such products or enhancements.
−Removed: The process of obtaining formal FDA clearance or approval, such as a 510(k), BLA, or equivalent, including clinical trial development and execution as well as manufacturing processes, requires the expenditure of substantial time, effort and financial resources and may take years to complete, including costs incurred on top of those fees incurred as part of conducting various clinical studies.
+Added: The process of obtaining formal FDA clearance or approval, such as a 510(k), Biological License Application (“ BLA ”), or equivalent, including clinical trial development and execution as well as manufacturing processes, requires the expenditure of substantial time, effort and financial resources and may take years to complete, including costs incurred on top of those fees incurred as part of conducting various clinical studies.
The fee for filing such submissions and program fees payable with respect to any establishment that manufactures biologics are substantial.
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Finally, we and other manufacturers of skin substitutes are required to provide average sales price (“ ASP ”) information to CMS on a quarterly basis.
−Removed: The Medicare payment rates are updated quarterly based on this ASP information.
If a manufacturer is found to have made a misrepresentation in the reporting of ASP, such manufacturer is subject to civil monetary penalties of up to $10,000 for each misrepresentation for each day in which the misrepresentation was applied, and potential False Claims Act liability.
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We may be subject to fines, penalties, injunctions and other sanctions if we are deemed to be promoting the use of our products for unapproved, or off-label, uses.
−Removed: As a general rule, FDA regulations require that the marketing of 361 HCT/Ps only be for appropriate homologous uses, and that the promotion of pre-approved biological products or devices only be for FDA-approved indications.
+Added: As a general rule, FDA regulations require that the marketing of Section 361 HCT/Ps only be for appropriate homologous uses, and that the promotion of pre-approved biological products or devices only be for FDA-approved indications.
Generally, unless the products are approved by the FDA for alternative uses, the FDA contends that we may not make claims about the safety or effectiveness of our products, or promote them as safe or effective for uses other than those specifically approved by the FDA.
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In addition, as a result of an enforcement action against us or any of our executive officers, we could be excluded from participation in government healthcare programs such as Medicare and Medicaid.
−Removed: Nevertheless, while we believe we are fully in compliance with the FDA's Guidance on HCT/Ps, there can be no assurance that we have correctly interpreted the FDA Guidance, or that we will not need to discontinue marketing a product and/or may be subject to fines, penalties, injunctions, and other sanctions if we are deemed to be promoting the use of our products for unapproved uses.
+Added: Nevertheless, while we believe we are fully in compliance with the FDA's Guidance on HCT/Ps, there can be no assurance that we have correctly interpreted the FDA’s Guidance, or that we will not need to discontinue marketing a product and/or may be subject to fines, penalties, injunctions, and other sanctions if we are deemed to be promoting the use of our products for unapproved uses.
Such regulatory penalties by the FDA could adversely affect our business and results of operations.
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Many states have similar fraud and abuse laws, imposing substantial penalties for violations.
−Removed: A finding of a violation of one or more
−Removed: of these laws, or even a government investigation or inquiry into the same, would likely result in a material adverse effect on the market price of our Common Stock, as well as on our business, results of operations, and financial condition.
+Added: A finding of a violation of one or more of these laws, or even a government investigation or inquiry into the same, would likely result in a material adverse effect on the market price of our Common Stock, as well as on our business, results of operations, and financial condition.
We are subject to the AKS as amended by the Patient Protection and Affordable Care Act (the “ PPACA ”).
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The FCA also allows a private individual or entity to sue on behalf of the government to recover civil penalties and treble damages as a whistleblower.
−Removed: FCA liability is potentially significant in the healthcare industry because the statute provides for treble damages and mandatory penalties of between $13,946 and $27,894 per false claim or statement for penalties assessed after February 12, 2024, with respect to violations occurring after November 2, 2015.
+Added: FCA liability is potentially significant in the healthcare industry because the statute provides for treble damages and mandatory penalties of between $14,308 and $28,619 per false claim or statement for penalties assessed after July 3, 2025, with respect to violations occurring after November 2, 2015.
Manufacturers can be held liable under the FCA even when they do not submit claims directly to government payers if they are deemed to “cause” the submission of false or fraudulent claims.
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healthcare system.
−Removed: Notably, the COVID-19 pandemic had a significant impact on the nation’s health sector expenditures, beginning in 2020, primarily driven by increased federal spending, including financial assistance to providers to make up for lost revenue through the Provider Relief Fund, the Paycheck Protection Program, and increased federal public health spending such as spending for vaccine development, COVID testing, and health facility preparedness.
−Removed: As a result, growth in federal government spending on healthcare increased 36% in 2020.
Within our industry, Medicare expenditures on skin substitute products have increased dramatically from 2019, when annual spending on these products administered in private physician offices and associated care settings was approximately $0.5 billion.
−Removed: By 2023, annual expenditures for this class of products totaled over $4 billion, and more recently, spending by Medicare has reached an excess of $1 billion per month in the category.
+Added: By 2024, annual expenditures for this class of products totaled approximately $10 billion, and more recently, spending by Medicare approached a $15 billion annual run rate.
As a result, CMS and the MACs have sought ways to implement coverage and payment reform in order to curb the dramatically increasing expenditures in our industry.
−Removed: CMS could alter the reimbursement dynamics in outpatient care settings through the Physician Fee Schedule (“PFS”), which is published on an annual basis and regulates payments to healthcare providers for services furnished in these settings.
−Removed: In 2022, CMS, through its publication of the PFS proposals for CY 2023, indicated that it was considering a revision of the payment system for skin substitutes.
−Removed: Specifically, CMS proposed to change the terminology of skin substitutes to ‘wound care management products’, and to treat and pay for these products as incident to supplies under the PFS beginning on January 1, 2024.
−Removed: Ultimately, CMS decided to provide interested parties with more opportunities to comment on the specific details of changes in coding and payment mechanisms prior to finalizing any changes.
−Removed: To date, CMS has not altered the existing policies.
−Removed: In August 2023, three MACs issued updated LCDs entitled:
−Removed: “Skin Substitute Grafts/Cellular and/or Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers,” which would regulate our products’ Medicare coverage in the private physician office and associated care settings.
−Removed: Following a comment period and lengthy discussions with industry and clinician stakeholders, these LCDs were ultimately withdrawn ahead of their scheduled effective date.
−Removed: In November 2024, all seven MACs proposed revised LCDs in unison with support from CMS, which took into consideration many of the findings and commentary from the withdrawn 2023 LCDs.
−Removed: These LCDs are scheduled to become effective on April 13, 2025.
−Removed: In the past, LCDs have been delayed or terminated.
−Removed: If these LCDs were to be delayed or terminated, they may not go into effect in April 2025.
+Added: At the end of 2025, CMS announced sweeping changes related to the reimbursement of skin substitutes, beginning January 1, 2026.
+Added: These changes include:
+Added: 1) reimbursing skin substitute products uniformly across the HOPD and physician office and associated care settings and 2) changing the reimbursement rate for skin substitutes from the “ASP+6%” methodology to a flat rate at $127.14 per square centimeter in these care settings, subject to geographic adjustments.
+Added: The specific policies were put into effect in the PFS and OPPS.
Changes to the manner and amounts Medicare reimburses for our products could have an impact on their utilization.
−Removed: We believe that substantial uncertainty remains regarding the specific reform measures and proposed legislation that could impact our industry.
+Added: We believe that substantial uncertainty and unknowns remain regarding the specific reform measures and proposed legislation that could impact our industry.
Any changes will likely take time to unfold and could have an impact on coverage and reimbursement for healthcare items and services, including our products.
−Removed: Furthermore, we believe that substantial uncertainty remains regarding the net effect of the PPACA, or its repeal and potential replacement, on our business, including uncertainty over how benefit plans purchased on exchanges will cover our products, how the expansion or contraction of the Medicaid program will affect access to our products, the effect of risk-sharing payment models such as Accountable Care Organizations and other value-based purchasing programs on coverage for our
−Removed: products, and the effect of the general increase or decrease in federal oversight of healthcare payers.
+Added: Furthermore, we believe that substantial uncertainty remains regarding the net effect of the PPACA, or its repeal and potential replacement, on our business, including uncertainty over how benefit plans purchased on exchanges will cover our products, how the expansion or contraction of the Medicaid program will affect access to our products, the effect of risk-sharing payment models such as Accountable Care Organizations and other value-based purchasing programs on coverage for our products, and the effect of the general increase or decrease in federal oversight of healthcare payers.
The taxes imposed and the expansion in government’s role in the U.S.
1 unchanged sentence
We may fail to obtain or maintain foreign regulatory approvals to market our products in other countries.
−Removed: We currently market our products in a small number of foreign countries, including in Japan.
+Added: We currently market our products in a limited number of foreign countries, including in Japan.
Foreign jurisdictions require separate regulatory approvals and compliance with numerous and varying regulatory requirements.
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We may not be able to file for regulatory approvals or certifications and may not receive necessary approvals to commercialize our products in any foreign jurisdiction.
−Removed: Furthermore, many foreign jurisdictions operate under socialized medical care, and obtaining reimbursement for our products under that construct may also prove difficult.
+Added: Furthermore, many foreign jurisdictions operate under socialized medical care, and obtaining reimbursement for our products under that construct may
+Added: also prove difficult.
If we fail to receive necessary approvals, certifications, or reimbursements necessary to commercialize our products in foreign jurisdictions on a timely basis, or at all, our business, results of operations and financial condition could be adversely affected.
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Our ability to protect our intellectual property and proprietary technology through patents and other means is uncertain and may be inadequate, which could have an adverse effect on our business, results of operations and financial condition.
−Removed: Our success depends significantly on our ability to protect our proprietary rights to the technologies used in our products.
+Added: Our success depends on our ability to protect our proprietary rights to the technologies used in our products.
We rely on patent protection, as well as a combination of copyright, trade secret and trademark laws and nondisclosure, confidentiality and other contractual restrictions to protect our proprietary technology, including our licensed technology.
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The failure to obtain and maintain patents or protect our intellectual property rights could have an adverse effect on our business, results of operations, and financial condition.
−Removed: Whether a patent claim is valid is a complex matter of science, facts and law, and therefore we cannot be certain that, if challenged in a court of law, or through an administrative proceeding, our patent claims would be upheld.
+Added: Whether a patent claim is valid is a complex matter of science, facts and law, and therefore we cannot be certain that, if challenged in a court of law, or through an administrative proceeding, our
+Added: patent claims would be upheld.
If any of those patent claims are invalidated or determined to be unenforceable, our competitive advantage may be reduced or eliminated.
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Some of our employees were previously employed at other medical device, pharmaceutical or tissue companies.
−Removed: We may also hire additional employees who are currently employed at other medical device, pharmaceutical or tissue companies, including our competitors.
+Added: We may also hire additional employees who are currently employed at other medical device, pharmaceutical or tissue companies, including
+Added: our competitors.
Additionally, consultants or other independent agents with which we may contract may be or have been in a contractual arrangement with one or more of our competitors.
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Our indebtedness may adversely affect our financial health.
−Removed: As of December 2024, the Company had aggregate borrowings outstanding of $19.0 million under its Term Loan Facility, pursuant to its Citizens Credit Agreement (as defined below in Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations ).
+Added: As of December 2025, we had aggregate borrowings outstanding of $ 18.0 million under our Term Loan Facility, pursuant to our Citizens Credit Agreement (as defined below in Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations ).
Our outstanding debt may limit our ability to borrow additional funds or may adversely affect the terms on which such additional funds may be available.
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Additionally, the Citizens Credit Agreement includes certain customary restrictive covenants, including, but not limited to, limitations on indebtedness, liens, fundamental changes, dispositions, investments, loans, advances, guarantees, acquisitions, dividends and other restricted payments, transactions with affiliates, swap transactions, sale and leaseback transactions, prepayments on subordinated debt, and amendments to organizational and other material agreements.
−Removed: The Citizens Credit Agreement also contains certain customary events of default, including, without limitation, (i) failure to pay interest or principal when due, (i) failure to provide notice of certain material events and (iii) failure to perform or observe certain covenants under the Citizens Credit Agreement or any related loan documents (subject to a 30-day grace period in certain circumstances).
+Added: The Citizens Credit Agreement also contains certain customary events of default, including, without limitation, (i) failure to pay interest or principal when due, (ii) failure to provide notice of certain material events and (iii) failure to perform or observe certain covenants under the Citizens Credit Agreement or any related loan documents (subject to a 30-day grace period in certain circumstances).
If an event of default occurs and is continuing, the agent under the agreement may, and at the direction of the lenders, take one or more of the following actions:
2 unchanged sentences
EW Healthcare Partners and its interests may conflict with those of our other shareholders.
−Removed: As of December 31, 2024, EW Healthcare Partners and their affiliates owned approximately 19.3% of our Common Stock (calculated on the basis described in Item 12, “ Security Ownership Of Certain Beneficial Owners And Management” below).
+Added: As of December 31, 2025, EW Healthcare Partners and their affiliates beneficially owned approximately 19% of our Common Stock.
Also, for as long as EW Healthcare Partners and its affiliates collectively hold at least (i) 10% of the outstanding shares of our Common Stock, EW Healthcare Partners has the right to select two individuals that the Company must include among its nominees to serve on our Board and (ii) 5% (but less than 10%) of the outstanding shares of our outstanding Common Stock, EW Healthcare Partners has the right to select one individual that the Company must include among its nominees to serve on our Board.
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We have never declared or paid cash dividends on our Common Stock.
−Removed: We currently expect to use available funds and any future earnings;
−Removed: in the development, operation and expansion of our business;
−Removed: to repay debt;
−Removed: and, to the extent authorized by our Board, repurchasing our Common Stock.
+Added: We currently expect to deploy our capital toward various goals, including the development, operation and expansion of our business, the repayment of debt, and, to the extent authorized by our Board, potential repurchases of our Common Stock.
We do not anticipate paying any cash dividends on our Common Stock in the foreseeable future.
As a result, capital appreciation, if any, of our Common Stock will be an investor’s only source of potential gain from our Common Stock for the foreseeable future.
+Added: Our capital allocation decisions, including decisions regarding share repurchases, investments in inorganic opportunities, and other capital allocation activities, may not achieve their intended benefits and could adversely affect our financial condition and stock price.
+Added: We regularly evaluate opportunities to deploy capital, including investing in our business, pursuing strategic acquisitions, reducing indebtedness, returning capital to shareholders through dividends or share repurchases, or retaining capital for future flexibility.
+Added: Our capital allocation decisions are subject to significant judgment and are influenced by a number of factors, including market conditions, our financial performance and liquidity, tax considerations, regulatory requirements, and the availability of alternative or inorganic investment opportunities.
+Added: In February 2026, our Board authorized us to periodically repurchase up to $100.0 million of our common shares (the “ Share Repurchase Plan ” through February 2028.
+Added: The Share Repurchase Plan does not obligate the Company to repurchase any number of shares and may be suspended or discontinued at any time.
+Added: Share repurchases are one method with which we may return capital to stockholders.
+Added: However, there can be no assurance that any repurchases will enhance long-term shareholder value.
+Added: Repurchases, if any, may be executed at prices that are higher than the market price of our common stock at a later date, or at times when other uses of capital would have produced greater returns.
+Added: In addition, repurchases reduce the amount of cash available for other purposes, including investments in organic growth, acquisitions, debt repayment, or other strategic initiatives, which could limit our ability to respond to changing business conditions.
+Added: In addition, share repurchases may be subject to excise taxes, which could further restrict our ability to deploy capital toward other purposes.
Certain provisions of Florida law and anti-takeover provisions in our organizational documents may discourage or prevent a change of control, even if an acquisition would be beneficial to shareholders, which could affect our share price adversely and prevent attempts by shareholders to remove current management.
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.