What the changes say
- Elutia sold its entire cardiac device business on October 1, 2025, shifting its future results to rely on Women's Health, NXT-41x, and Cardiovascular products.
- The company received Nasdaq deficiency notices regarding its minimum bid price below $1.00 and market value requirements.
What changed since the prior 10-K
New
- NewRisks Related to Our Business
Our future results largely depend upon our ability to successfully develop, commercialize, market and sell breast reconstruction biologic products
Following the October 1, 2025 sale of the CIED Business, including CanGaroo and EluPro, our future results depend on Women's Health and Cardiovascular businesses.
- NewRisks Related to Our Business
If we fail to successfully develop, commercialize, market and sell NXT-41x, the Company’s business and financial condition may be materially adversely affected
If NXT-41x and remaining legacy products fail to replace lost contributions from the sold CIED Business, our financial condition will be adversely affected.
- NewRisks Related to Our Business
time-consuming and expensive, may result in interruptions in our operations and product delivery, could affect the performance specifications of our products or could require that we modify the design of those systems
Supplier refusals to extend credit or disruptions at sole-source suppliers could significantly disrupt our ability to purchase equipment, supplies, and components.
- NewRisks Related to Our Business
If our research and development facility is damaged or becomes inoperable, we will be unable to continue to research and develop our product candidates and delays in our product development could result in an adverse effect on our business
All research and development takes place at our single, non-redundant facility in Gaithersburg, Maryland, leaving us vulnerable to disruptions.
- NewRisks Related to Our Business
reputation, any of which could have a material and adverse effect on our business, financial condition and results of operations
Cyberattacks resulting in the unauthorized disclosure of sensitive patient or employee data could trigger legal liability, regulatory sanctions, and reputation damage.
- NewRisks Related to Government Regulation
required, we cannot assure you that we will be able to obtain 510(k) clearances with respect to such product candidates or modifications to previously cleared products
The FDA or foreign regulators may delay, limit, or deny 510(k) clearances or require additional clinical testing for our product candidates.
- NewRisks Related to Intellectual Property
be cognizant going forward of the timing from invention to filing of a patent application and be diligent in filing patent applications, but circumstances could prevent us from promptly filing patent applications on our inventions
The Leahy-Smith Act establishes the PTAB, providing a low-cost administrative venue for third parties to challenge the validity of our U.S. patents.
- NewRisks Related to Intellectual Property
patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours
We may fail to apply for or receive patent term extensions under the Hatch-Waxman Amendments for patents covering our FDA-approved products.
- NewRisks Related to Intellectual Property
parties owning such intellectual property rights could seek either an injunction prohibiting our sales, or, with respect to our sales, an obligation on our part to pay royalties or other forms of compensation and damages
We do not always control the prosecution, maintenance, or enforcement of patents acquired or licensed from third parties like Cook.
- NewRisks Related to Our Common Stock
We may not be able to maintain a listing of our Class A common stock on the Nasdaq Capital Market
We received Nasdaq notices for trading below the $1.00 minimum bid price and failing the market value requirement, though we later regained the market value compliance.
- NewRisks Related to Our Common Stock
day of our second fiscal quarter and our annual revenues are $100 million or more during our most recently completed fiscal year, or (ii) the market value of the voting and non-voting shares held by non-affiliates is $700 million or more measured on the last business day of our second fiscal quarter
Operating as a public company no longer qualifying as an emerging growth company imposes significant legal, accounting, and compliance costs.
Dropped
- DroppedRisks Related to Our Business
Our future results depend upon our ability to successfully commercialize, market and sell our newly approved EluPro antibacterial envelope device and the success of a smaller suite of established products than has historically been the case
Success dependent on commercializing newly approved EluPro antibacterial envelope device.
- DroppedRisks Related to Our Business
We have identified conditions and events that raise substantial doubt regarding our ability to continue as a going concern
- DroppedRisks Related to Our Business
Our indebtedness and our Revenue Interest Obligation to Ligand Pharmaceuticals Incorporated may limit our flexibility in operating our business and adversely affect our financial health and competitive position
Substantial doubt regarding going concern due to recurring net losses and accumulated deficit.
- DroppedRisks Related to Our Business
The loss of one or more significant commercial partners, a material reduction in their purchases of our product or their inability to perform their contractual obligations, including, for example, committed purchase requirements could adversely affect our business, financial condition and results of operations
Indebtedness under SWK Loan Facility and Revenue Interest Obligation to Ligand Pharmaceuticals.
- DroppedRisks Related to Our Business
The processing of porcine tissue for our products is technically complex, requiring high levels of quality control and precision, which subjects us to increased production risks
- DroppedRisks Related to Our Business
If our facilities are damaged or become inoperable, we will be unable to continue to research, develop and supply our products and, as a result, there will be an adverse effect on our business until we are able to secure new facilities and rebuild our inventory
- DroppedRisks Related to Our Business
we may from time to time make certain pricing, service or marketing decisions (e.g., reduce prices) that could have a material and adverse effect on our business, financial condition and results of operations. Due to the foregoing factors, our revenue and operating results are and will remain difficult to forecast
- DroppedRisks Related to Our Business
As we conduct clinical studies designed to generate long-term data on some of our existing products, the data we generate may not be consistent with our existing data and may demonstrate less favorable safety or efficacy
- DroppedRisks Related to Government Regulation
the FDA may not approve our products for desired indications or could mandate clinical studies for modifications. Any delays or failures in obtaining required clearances or approvals may impede the timely introduction of new or enhanced products, adversely affecting our future growth and operating results
- DroppedRisks Related to Intellectual Property
of the patent laws in the United States and other countries may diminish the value of our owned or licensed patents or narrow the scope of our patent protection
- DroppedRisks Related to Intellectual Property
products or technologies, we may have to withdraw existing products from the market or may be unable to commercialize one or more of our products
- DroppedRisks Related to Intellectual Property
We may be unable to enforce our intellectual property rights throughout the world
Loss of significant commercial partners or independent sales agents.
- DroppedRisks Related to Intellectual Property
Outside of the United States we cannot be certain that any country’s patent or trademark office will not implement new rules that could seriously affect how we draft, file, prosecute and maintain patents, trademarks and patent and trademark applications
- DroppedRisks Related to Our Common Stock
Our principal stockholders have significant voting power and may take actions that may not be in the best interests of our other stockholders
- DroppedRisks Related to Our Common Stock
A significant portion of our total outstanding shares are eligible to be sold into the market in the near future, which could cause the market price of our Class A common stock to drop significantly, even if our business is doing well
- DroppedRisks Related to Our Common Stock
The dual class structure of our common stock and the option of the holders of shares of our Class B common stock to convert into shares of our Class A common stock may limit your ability to influence corporate matters
Reworded
- 83% rewrittenRisks Related to Our Common Stock
We are a “smaller reporting company,” and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors
Updated to reflect that the company ceased being an emerging growth company on December 31, 2025, but remains a smaller reporting company.
Was: We are an “emerging growth company” and a “smaller reporting company,” and the reduced disclosure requirements applicable to emerging growth companies and smaller reporting companies may make our common stock less attractive to investors
- 81% rewrittenRisks Related to Intellectual Property
If we do not obtain patent term extension in the United States under the Hatch-Waxman Amendments, thereby potentially extending the term of marketing exclusivity for our product candidates, our business may be materially harmed
Updated to reference patent term extensions under the Hatch-Waxman Amendments rather than general patent lifespan and expiration risks.
Was: If we do not obtain patent term extension in the United States under the Hatch-Waxman Amendments and in foreign countries under similar legislation, thereby potentially extending the term of marketing exclusivity for our product candidates, our business may be materially harmed
- 78% rewrittenRisks Related to Our Business
Changes in tax laws, unfavorable resolution of tax contingencies or exposure to additional income tax liabilities could have a material impact on our results of operations or financial condition
Retained standard tax compliance risk language without substantive changes to specific rates or figures.
- 63% rewrittenRisks Related to Intellectual Property
Recent changes in U.S. patent laws may limit our ability to obtain, defend and/or enforce our patents
Retained standard Leahy-Smith Act patent reform risk language without substantive changes.
- 61% rewrittenRisks Related to Intellectual Property
We depend on certain technologies that are licensed to us. We do not control the intellectual property rights covering these technologies, and any loss of our rights to these technologies or the rights licensed to us could prevent us from selling our products and adversely impact our business
Removed specific references to EluPro and CanGaroo in licensing arrangements with Cook, leaving only general Cardiovascular products.
- 60% rewrittenRisks Related to Our Business
Our operating results may fluctuate significantly from quarter to quarter and year to year due to the seasonality of our business, as well as a variety of other factors, many of which are outside of our control
Removed the specific mention of fourth-quarter seasonal sales increases due to hospital budget cycles.
- 59% rewrittenRisks Related to Intellectual Property
If we are unable to obtain, maintain and adequately protect our intellectual property rights, our competitive position could be harmed or we could be required to incur significant expenses to enforce or defend our rights
Retained general intellectual property protection risk language without substantive changes.
- 51% rewrittenRisks Related to Government Regulation
These laws and regulations, among other things, constrain our business, marketing and other promotional activities by limiting the kinds of financial arrangements we may have with hospitals, physicians or other potential purchasers of our products, as well as independent sales agents and distributors
Retained healthcare regulatory compliance and anti-kickback scrutiny language without substantive changes.
- 51% rewrittenRisks Related to Our Business
Our success depends on our ability to retain and motivate key management personnel and other employees and consultants, to attract, retain and motivate additional qualified personnel and to effectively navigate changes in our senior management team
- 50% rewrittenRisks Related to Our Business
Our net sales are generated through independent sales agents, which subjects us to various risks
Was: A substantial portion of our net sales is generated through our commercial partners and independent sales agents, which subjects us to various risks
- 43% rewrittenRisks Related to Our Business
Our success depends on the continued and future acceptance of our products by the medical community
- 40% rewrittenRisks Related to Our Common Stock
You may be diluted by the future issuance of additional common stock in connection with any future public or private offerings of our securities, our incentive plans, acquisitions or otherwise
- 40% rewrittenRisks Related to Our Business
We may not realize all of the potential consideration associated with the sale of our Orthobiologics Business
- 24% rewrittenRisks Related to Our Business
Our long-term growth depends on our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product offerings
- 22% rewrittenRisks Related to Our Business
We have incurred operating losses and may continue to do so in the near-term, and we cannot assure that we will be able to generate sufficient revenue to achieve or sustain profitability
Was: We have incurred operating losses and may continue to do so in the near-term, and we cannot assure you that we will be able to generate sufficient revenue to achieve or sustain profitability
- 21% rewrittenRisks Related to Intellectual Property
Litigation or other proceedings or third-party claims of intellectual property infringement, misappropriation or other violations could require us to spend significant time and money, prevent us from selling our products and adversely affect our stock price
- 20% rewrittenRisks Related to Our Business
Our ability to use certain tax attributes to offset future income tax liabilities may be subject to limitations
All 68 risk factors
Headings as the filing states them, in filing order.
Risks Related to Our Business
- 01Our future results largely depend upon our ability to successfully develop, commercialize, market and sell breast reconstruction biologic productsNew
- 02If we fail to successfully develop, commercialize, market and sell NXT-41x, the Company’s business and financial condition may be materially adversely affectedNew
- 03We have incurred operating losses and may continue to do so in the near-term, and we cannot assure that we will be able to generate sufficient revenue to achieve or sustain profitability22% rewritten
- 04We face significant litigation related to our FiberCel and Viable Bone Matrix recalls and have no more insurance coverage on the FiberCel recall
- 05We face the risk of product liability claims and may not be able to obtain or maintain adequate product liability insurance
- 06Our future capital needs are uncertain, and we may need to raise funds in the future, and such funds may not be available on acceptable terms or at all
- 07Adverse changes in general domestic and global economic conditions and instability and disruption of credit markets could adversely affect our business, financial condition, results of operations and liquidity
- 08Our long-term growth depends on our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product offerings24% rewritten
- 09We may not realize all of the potential consideration associated with the sale of our Orthobiologics Business40% rewritten
- 10time-consuming and expensive, may result in interruptions in our operations and product delivery, could affect the performance specifications of our products or could require that we modify the design of those systemsNew
- 11Our net sales are generated through independent sales agents, which subjects us to various risks50% rewritten
- 12Our future growth depends on physician awareness of the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our products
- 13Our success depends on the continued and future acceptance of our products by the medical community43% rewritten
- 14We may need to continue to expand our organization and managing growth may be more difficult than we expect
- 15We face significant and continuing competition from other companies, some of which have longer operating histories, more established products and/or greater resources than we do, which could adversely affect our business, financial condition and results of operations
- 16Pricing pressure as a result of cost-containment efforts of our customers, purchasing groups, third-party payors and governmental organizations could adversely affect our sales and profitability
- 17Performance issues, service interruptions or price increases by our shipping carriers could adversely affect our business, harm our reputation and impair our ability to provide our products on a timely basis or at all
- 18If our research and development facility is damaged or becomes inoperable, we will be unable to continue to research and develop our product candidates and delays in our product development could result in an adverse effect on our businessNew
- 19Increased prices for raw materials or supplies used in our products could adversely affect our business, financial condition and results of operations
- 20If we are not able to accurately forecast demand for our products and manage our inventory, our margins could decrease and we could lose sales, either of which could have a material adverse effect on our business, financial condition and results of operations
- 21If hospitals and other healthcare providers are unable to obtain coverage or adequate reimbursement for procedures performed with our products, it is unlikely our products will be widely used
- 22We bear the risk of warranty claims on our products
- 23Our operating results may fluctuate significantly from quarter to quarter and year to year due to the seasonality of our business, as well as a variety of other factors, many of which are outside of our control60% rewritten
- 24reputation, any of which could have a material and adverse effect on our business, financial condition and results of operationsNew
- 25Our success depends on our ability to retain and motivate key management personnel and other employees and consultants, to attract, retain and motivate additional qualified personnel and to effectively navigate changes in our senior management team51% rewritten
- 26Our officers, employees, independent contractors, principal investigators, consultants and independent sales agents may engage in misconduct or activities that are improper under other laws and regulations, which would create liability for us
- 27Our estimates of market opportunity and forecasts of market and sales growth may prove to be inaccurate, and even if the markets in which we compete achieve the forecasted growth, our business could fail to grow at similar rates, if at all
- 28Our ability to use certain tax attributes to offset future income tax liabilities may be subject to limitations20% rewritten
- 29Changes in tax laws, unfavorable resolution of tax contingencies or exposure to additional income tax liabilities could have a material impact on our results of operations or financial condition78% rewritten
- 30New lines of business and new products and services may subject us to additional risks
- 31We may from time to time evaluate opportunities to make acquisitions of, investments in, and licenses or other commercial arrangements involving, other companies or technologies, and to enter into other strategic transactions. These transactions entail significant risks
Risks Related to Government Regulation
- 32required, we cannot assure you that we will be able to obtain 510(k) clearances with respect to such product candidates or modifications to previously cleared productsNew
- 33with post-marketing regulatory requirements could subject us to enforcement actions, including substantial penalties, and might require us to recall or withdraw a product from the market
- 34Any of these sanctions could result in higher than anticipated costs or lower than anticipated sales and have a material adverse effect on our reputation, business, financial condition and results of operations
- 35Our HCT/P product is subject to extensive government regulation, and our failure to comply with these requirements could cause our business to suffer
- 36We are bound by federal, state, and foreign fraud and abuse laws, violations of which could result in significant penalties. Challenges or investigations into our practices under these laws may lead to adverse publicity, incurring substantial response costs and potential harm to our business
- 37These laws and regulations, among other things, constrain our business, marketing and other promotional activities by limiting the kinds of financial arrangements we may have with hospitals, physicians or other potential purchasers of our products, as well as independent sales agents and distributors51% rewritten
- 38Healthcare policy changes, including recently enacted legislation reforming the U.S. healthcare system, could harm our cash flows, financial condition and results of operations
- 39Actual or perceived failure to comply with data protection laws and regulations could lead to government enforcement actions, private litigation and/or adverse publicity and could negatively affect our business
Risks Related to Intellectual Property
- 40If we are unable to obtain, maintain and adequately protect our intellectual property rights, our competitive position could be harmed or we could be required to incur significant expenses to enforce or defend our rights59% rewritten
- 41We may not enter into invention assignment and confidentiality agreements with all of our employees and contractors and such agreements could be ineffective or breached
- 42The patent protection we obtain for our products may not be sufficient enough to provide us with any competitive advantage or our patents may be challenged
- 43Litigation or other proceedings or third-party claims of intellectual property infringement, misappropriation or other violations could require us to spend significant time and money, prevent us from selling our products and adversely affect our stock price21% rewritten
- 44If we are unable to protect the confidentiality of our trade secrets, our business and competitive position could be harmed
- 45Third parties may assert ownership or commercial rights to inventions we develop
- 46Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secrets
- 47Recent changes in U.S. patent laws may limit our ability to obtain, defend and/or enforce our patents63% rewritten
- 48be cognizant going forward of the timing from invention to filing of a patent application and be diligent in filing patent applications, but circumstances could prevent us from promptly filing patent applications on our inventionsNew
- 49Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
- 50If we do not obtain patent term extension in the United States under the Hatch-Waxman Amendments, thereby potentially extending the term of marketing exclusivity for our product candidates, our business may be materially harmed81% rewritten
- 51patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to oursNew
- 52We depend on certain technologies that are licensed to us. We do not control the intellectual property rights covering these technologies, and any loss of our rights to these technologies or the rights licensed to us could prevent us from selling our products and adversely impact our business61% rewritten
- 53parties owning such intellectual property rights could seek either an injunction prohibiting our sales, or, with respect to our sales, an obligation on our part to pay royalties or other forms of compensation and damagesNew
- 54We may not be able to protect and enforce our trademarks and trade names, or build name recognition in our markets of interest, thereby harming our competitive position
Risks Related to Our Common Stock
- 55We may not be able to maintain a listing of our Class A common stock on the Nasdaq Capital MarketNew
- 56We expect that the price of our Class A common stock will fluctuate substantially. You may not be able to sell the shares you purchase at or above the price you paid for such shares, and our common stock could be subject to delisting if its price falls too low
- 57You may be diluted by the future issuance of additional common stock in connection with any future public or private offerings of our securities, our incentive plans, acquisitions or otherwise40% rewritten
- 58We are a “smaller reporting company,” and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors83% rewritten
- 59day of our second fiscal quarter and our annual revenues are $100 million or more during our most recently completed fiscal year, or (ii) the market value of the voting and non-voting shares held by non-affiliates is $700 million or more measured on the last business day of our second fiscal quarterNew
- 60Provisions in our certificate of incorporation and bylaws and under Delaware law could make an acquisition of our company, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management
- 61Our certificate of incorporation designates specific courts as the exclusive forum for certain litigation that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees
- 62Because we do not anticipate paying any cash dividends on our common stock in the foreseeable future, capital appreciation, if any, would be your sole source of gain
- 63We could be subject to securities class action litigation
- 64Changes in accounting standards and subjective assumptions, estimates and judgments by management related to complex accounting matters could significantly affect our business, financial condition and results of operations
- 65Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud
- 66As a public company, we are required to evaluate our internal control over financial reporting in a manner that meets the standards of publicly traded companies required by Section 404(a) of the Sarbanes-Oxley Act, or Section 404
- 67If our operating and financial performance in any given period does not meet the guidance we provide to the public, the market price of our Class A common stock may decline
- 68If securities or industry analysts do not publish research or reports about our business, or if they issue an adverse or misleading opinion regarding our Class A common stock, our stock price and trading volume would likely decline
Other Elutia 10-Ks
- FY2024 10-K risk factors73 risks
Elutia faces going concern doubts after posting a 2024 net loss of $53.9 million alongside $23.9 million in debt.
Filed Mar 11, 2025
About this page
The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.