ELUT

MKT CAP $518KP/E 0.8DIV YIELD —FCF YIELD -8891.60%REV TTM —NET INCOME $51.8MNET DEBT $6.2M52W 0.50 – 1.22SEC XBRL · TTM TO Invalid Date

How ELUT rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025

Text kept

57%

of sentences unchanged

Added

163

new sentences

Dropped

317

sentences removed

Length

−5,377

words, now 31,481

New in FY2025

Risk Factors - Risks 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. ” Culture of Inclusion We are committed to fostering an equitable and inclusive workplace that is free from discrimination, harassment, bias and prejudice and where every individual feels valued and included.
We foster an inclusive environment through respect, collaboration, and open communication.
We also aim to treat all individuals with respect and dignity and to provide all our employees with equal opportunity and fair treatment based on merit.
Compensation and Benefits We strive to offer competitive pay and benefits designed to attract and retain exceptional talent and drive company performance.
Available Information We file annual, quarterly and current reports, proxy statements and other information with the SEC.
See “Forward-Looking Statements.” Risks Related to Our Business Our future results largely depend upon our ability to successfully develop, commercialize, market and sell breast reconstruction biologic products. We have focused much of our attention recently on EluPro, which was cleared for marketing by the U.S.
Food and Drug Administration (“ FDA ”) in June 2024 and was indicated for use with implantable electronic devices including cardiac and neurostimulator devices.
On October 1, 2025, we completed the sale of all of our assets related to its business of researching, developing, administering, operating, commercializing, manufacturing, selling and marketing cardiac implantable electronic device (“ CIED ”) products, including its CanGaroo, CanGaroo RM, EluPro and CIED envelope products, including next generation CIED envelope products (collectively the “ CIED Business ”).
Consequently, our future results now depend on the success of our Women’s Health and Cardiovascular businesses.
There can be no guarantee, however, that we will be able to increase the sales or profitability of the remaining businesses sufficiently to replace or exceed the financial contribution, or potential financial contribution, from the sold CIED Business. Elutia’s current strategy principally focuses on applying the Company’s drug-eluting biologics platform to advance NXT-41x, a biomatrix that seeks to improve the interaction between implanted medical devices and patients by reducing complications associated with surgery, including infection, migration, erosion, implant rejection, and fibrosis.
We believe the development, commercialization and marketing efforts with respect to NXT-41x will require significant investments in time and resources.
Although the sale of the CIED Business has resulted in significant cash net proceeds to the Company, there can be no assurance that these resources, or other resources we may raise or have access to in the future, will be sufficient to make the necessary investments in order to develop and commercially exploit NXT-41x, or that if made, such investments will yield the results sought. Moreover, there is no guarantee that the FDA approvals we may seek will be granted on a timely basis, or at all, or that other actions or approvals are not required. If we fail to successfully develop, commercialize, market and sell NXT-41x, the Company’s business and financial condition may be materially adversely affected. Our enhanced reliance in the wake of the disposition of the CIED Business on a smaller suite of existing products and on future products poses risks to the Company’s growth.
If the financial contribution from remaining legacy products and NXT-41x and other potential future drug-eluting biomatrix products fail to replace lost contribution from the CIED Business, or otherwise fail to meet expectations, the Company’s business and financial condition may be materially adversely affected. 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. For the years ended December 31, 2025 and 2024, we had losses from continuing operations of $26.9 million and $30.7 million, respectively.
Because of the numerous risks and uncertainties affecting product sales and our ongoing commercialization and product development efforts, we are unable to predict with any certainty whether we will be able to increase sales of our products or the timing or amount of ongoing expenditures we will be required to incur.
As discussed below under “ We face the risk of product liability claims and may not be able to obtain or maintain adequate product liability insurance”, we have recorded a total estimated contingent liability of $11.2 million related to the resolution of all FiberCel and VBM lawsuits, comprised of $6.8 million for FiberCel and $4.4 million for VBM as of December 31, 2025.
As of December 31, 2025, insurance remains available to cover the cost of the VBM liability and related defense costs.
However, conversely, we have no more insurance to cover the cost of the FiberCel liability and the related defense costs as of December 31, 2025.
As of December 31, 2025, five unsettled lawsuits or claims related to the FiberCel Recall and 11 unsettled lawsuits and claims related to the VBM Recall remain outstanding .
These lawsuits and claims are described in further detail in See Part II, Item 1, “Legal Proceedings” and Note 17 to the consolidated financial statements included elsewhere in this Annual Report. We are, and may in the future be, subject to product liability claims and lawsuits, including additional claims or lawsuits from the FiberCel and VBM Recalls noted above, and potential class actions or mass tort claims, alleging that our products have resulted or could result in an unsafe condition or injury.
For example, we rely on physicians and other healthcare providers to use our products properly and correctly.
As of December 31, 2025, we have exhausted our insurance coverage for the FiberCel Recall product liability losses, meaning the remaining contingent liability estimated at $6.8 million at December 31, 2025 is entirely our financial responsibility.
As of December 31, 2025, we have recorded insurance receivables of $4.8 million on our balance sheet as a loss recovery resulting from our insurance coverage for the VBM Recall. As described above, our future FiberCel Recall litigation costs and obligations are now fully our financial responsibility and are expected to have a material adverse effect on our cash flow and financial position.
One or more product liability claims could have a significant adverse effect on our business, financial condition and results of operations.
Our 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.
Our future capital needs are uncertain and, as such, we may seek to raise additional capital through equity offerings, debt financings, collaborations or other arrangements to finance our ongoing operations, including our efforts to develop, commercialize and market NXT-41 and NXT-41x , our next-generation biologic scaffolds combined with local antibiotic delivery, or as all or part of the consideration paid for acquisitions and strategic investments that we may make in the future.
Any future funding requirements will depend on many factors, including, among other things: ● the cost of our research and development activities and the cost of commercializing new products or technologies; ● our ability to commercialize, market and sell our anticipated future products; ● continued patient, physician and market acceptance of our current products; ● the scope, rate of progress and cost of our current and future pre-clinical and clinical studies; ● the cost and timing of expanding our sales and marketing capabilities; ● the cost of filing and prosecuting patent applications and maintaining, defending and enforcing our patent or other intellectual property rights; ● the cost of defending, in litigation or otherwise, any claims that we infringe, misappropriate or otherwise violate third-party patents or other intellectual property rights; ● the costs of defending against or damages payable (to the extent above the applicable insurance coverage), for example, in connection with lawsuits and claims involving the FiberCel Recall or VBM Recall; ● the cost and timing of additional regulatory approvals or certifications; ● costs associated with any product recall; ● the effect of competing technological and market developments; ● the expenses we incur in manufacturing and selling our products; ● the costs of developing and commercializing new products or technologies; ● the extent to which we acquire or invest in products, technologies and businesses, although we currently have no commitments or agreements relating to any of these types of transactions; ● the costs of operating as a public company; and ● unanticipated general, legal and administrative expenses. In addition, our operating plan may change as a result of a number of factors, including those set forth above and other factors currently unknown to us, and we may need additional funds sooner than anticipated.
During the year ended December 31, 2025, global markets continued to experience significant volatility, driven by concerns over persistent inflation, rising interest rates, slowing economic growth, government shutdowns and geopolitical uncertainty.
Our long-term growth depends on our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product offerings.
Our industry is highly competitive and subject to rapid change and technological advancements.
Even if we are successful in developing additional products, the success of any new product offering or enhancements to any of our existing products will depend on several factors, including our ability to: ● properly identify and anticipate physician and patient needs; ● develop and introduce new products and product enhancements in a timely manner; ● distinguish our products from those of our competitors; ● develop an effective and dedicated sales and marketing team; ● enter into successful agreements with commercial partners, independent sales agents and other third parties where it is beneficial for us to do so; ● adequately protect our intellectual property, avoid infringing, misappropriating or otherwise violating the intellectual property rights of third parties and obtain and maintain necessary intellectual property licenses from third parties; ● demonstrate, if required, the safety and efficacy of new products with data from pre-clinical and clinical studies; ● obtain the necessary regulatory clearances, certifications or approvals for new products, product enhancements and expanded indications; ● maintain full compliance with FDA medical devices regulations and other regulatory requirements applicable to new devices or products or modifications of existing devices or products; ● provide adequate training to potential users of our products; ● receive adequate coverage and reimbursement for our products; and ● otherwise compete effectively against products and enhancements developed by our competitors. If we are not successful in expanding our indications and developing, acquiring and commercializing new products and product enhancements, our ability to increase our net sales may be impaired, which could have a material adverse effect on our business, financial condition and results of operations.
In addition, our research and development efforts may require a substantial investment of time and resources before we are able to determine the commercial viability of a new product, technology or other innovation. Even if we are successful in obtaining the required regulatory clearance, there can be no assurances that we will be able to achieve market acceptance or that we will be able to realize the intended benefits from commercializing this product candidate.
In order for Elutia to capitalize on such clearance, we will have to invest time and resources into commercializing and marketing this product candidate in order to increase its sales and market penetration, and to leverage our drug-eluting bioenvelope technology into potential adjacent applications.
See other risk factor entitled “— We regularly 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.
In the sale, we received $14.6 million, and we may earn up to an additional $20.0 million, in the aggregate, in the form of earn-out payments.
Additionally, the purchase agreement provided for a customary indemnity holdback in the amount of $1.5 million to be retained by Berkeley for 24 months after the closing of the transaction.
In March 2026, the indemnity holdback was resolved with Berkeley remitting $0.4 million to Elutia. There can be no assurance that we will be able to realize the expected benefits of the transaction, or that we will receive all of the potential consideration associated with the earn-out payments.
If we are unable to or do not realize the expected strategic, economic, or other benefits of the transaction, it could adversely affect our business and financial position.
Because we depend upon a limited number of third-party suppliers and manufacturers and, in certain cases, exclusive suppliers for products essential to our business, we may incur significant product development costs and experience material delivery delays if we lose any significant supplier, which could materially and adversely affect our business, financial condition and results of operations. We obtain some of our raw materials from a limited group of suppliers and, for reasons of quality assurance, cost-effectiveness, availability or constraints resulting from regulatory requirements, we rely on a single supplier, Cook, to source the SIS ECM biomaterial used to manufacture our Cardiovascular products.
At present, Berkeley is our single source of supply for SimpliDerm. For us to be successful, our suppliers must be able to provide us with products and components in substantial quantities, in compliance with regulatory requirements, in accordance with agreed upon specifications, at acceptable costs and on a timely basis.
Our net sales are generated through independent sales agents, which subjects us to various risks. We currently rely on the efforts of our independent sales agents to generate our Women’s Health and Cardiovascular sales, and we expect to continue to rely on these third parties to generate these sales in the future.

and 123 more.

Gone since FY2024

Risk Factors - Risks 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. ” Compensation and Benefits We strive to offer competitive pay and benefits designed to attract and retain exceptional talent and drive company performance.
Product Recalls FiberCel Recall On June 2, 2021, we issued a voluntary recall pertaining to a single donor lot of our FiberCel Fiber Viable Bone Matrix, a bone repair product formerly distributed by Medtronic PLC, after learning of post-surgical infections reported in several patients treated with the product, including some patients that tested positive for tuberculosis (the “FiberCel Recall”).
After the recall, we worked with the FDA and the U.S.
Centers for Disease Control and Prevention (“CDC”) to identify and secure all unused product, ascertain the medical status of patients treated with the recalled product, understand whether there is any relationship between the post-surgical infections and the recalled product lot and determine the medical cause of these infections.
We identified the 154 units comprising the single product lot in question.
Based on information from the CDC, 136 units within this product lot were implanted into 113 patients and the remaining 18 units were returned to either us or the CDC.
The CDC advised us that the CDC, working with state health agencies, contacted all patients treated with the recalled lot of FiberCel to help ensure they were directed to appropriate medical treatment and informed us that all patients were started on standard four-drug treatment for tuberculosis.
Samples of the recalled product underwent polymerase chain reaction (“PCR”) analysis by a lab contracted by the CDC and tested positive for the presence of Mycobacterium tuberculosis (“MTB”).
Cell culture testing of the recalled product was also conducted by the same lab that showed the presence of MTB, and this testing corroborated the PCR testing results. Viable Bone Matrix Recall In July 2023, we announced a voluntary recall of a single lot of one of our viable bone matrix (“VBM”) products and the market withdrawal of all of our VBM products produced after a specified date (the “VBM Recall”).
Notice of the voluntary recall was issued to centers after we learned of post-surgical MTB infections in two patients treated with product from a single donor lot of our VBM product.
Consistent with the FiberCel Recall, after the VBM Recall, we worked with the FDA and CDC to identify and secure all unused product, ascertain the medical status of patients treated with the recalled product, understand whether there is any relationship between the post-surgical infections and the recalled product lot and determine the medical cause of these infections.
Prior to release, samples from this specific lot had tested negative for MTB by an independent laboratory using a nucleic acid test that is designed to specifically detect the MTB organism.
Additionally, in August and September 2023, c ell culture testing of the recalled product was conducted by the same lab and showed no presence of MTB.
In October 2023, the CDC received the results of several MTB tests on the recalled VBM lot.
Three cultures and five nucleic acid tests resulted in no detection of MTB, and two other cultures of the recalled VBM lot detected MTB.
Based on our discussions with the CDC, we believe that a total of 36 patients were treated with product from the single donor lot. All VBM products, which includes FiberCel, were divested by us in connection with the sale of our Orthobiologics Business to Berkeley in November 2023.
Berkeley did not assume any liabilities related to the FiberCel Recall or VBM Recall, our market withdrawal of all of our viable bone matrix products, or any claims or lawsuits related thereto. The FiberCel Recall and VBM Recall are described in further detail in Part I, Item 3, “Legal Proceedings” and Note 17 to the consolidated financial statements, included elsewhere in this Annual Report. Available Information We file annual, quarterly and current reports, proxy statements and other information with the SEC.
See “Forward-Looking Statements.” Risks 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.
The Company has focused much of its attention recently on EluPro, which was cleared for marketing by the U.S.
Food and Drug Administration (“FDA”) in June 2024 and is indicated for use with implantable electronic devices including cardiac and neurostimulator devices.
We believe the Company’s success is highly dependent on the successful commercialization, marketing and sale of EluPro, as well as the extension of our drug-eluting biomatrix (“DEB”) technology into potential adjacent applications.
Alongside EluPro, we continue to market the CanGaroo bioenvelope, our first generation product, which uses the same biomatrix but does not contain antibiotics.
Our Device Protection products, EluPro and CanGaroo, are sold through both our internal sales force and independent sales agents and our commercial partner, Boston Scientific Corporation.
We believe the commercialization and marketing efforts with respect to EluPro will require significant investments in time and resources.
However, there can be no assurance that we will have or be able to obtain sufficient resources to make the necessary investments in order to increase the sales and market penetration for EluPro, or that if made, such investments will yield the results sought.
If we fail to successfully commercialize, market and sell EluPro, the Company’s business and financial condition may be materially adversely affected.
On November 8, 2023, we sold our Orthobiologics Business for consideration of $14.6 million up front, as adjusted, and up to $20 million payable in the form of earn-out payments over the five years following the closing.
The purchaser did not assume any liabilities related to the FiberCel or VBM Recalls, or any claims or lawsuits related thereto.
Our former Orthobiologics segment accounted for 52% and 39% of our consolidated net sales and gross profit, respectively in the year ended December 31, 2022.
Our future results depend on the success of our Device Protection, Women’s Health and Cardiovascular businesses.
There can be no guarantee, however, that we will be able to increase the sales or profitability of the remaining businesses sufficiently to replace or exceed the financial contribution from the Orthobiologics Business.
Our enhanced reliance in the wake of the disposition of the Orthobiologics Business on a smaller suite of existing products and on future products may pose risks to the Company’s growth.
If the financial contribution from remaining legacy products and other DEB products fail to replace lost contribution from the Orthobiologics Business, or otherwise fail to meet expectations, the Company’s business and financial condition may be materially adversely affected.
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.
For the years ended December 31, 2024 and 2023, we had net losses of $53.9 million and $37.7 million, respectively.
Because of the numerous risks and uncertainties affecting product sales and our ongoing commercialization and product development efforts, including our ability to commercialize our flagship Device Protection product, EluPro, we are unable to predict with any certainty whether we will be able to increase sales of our products or the timing or amount of ongoing expenditures we will be required to incur.
We have identified conditions and events that raise substantial doubt regarding our ability to continue as a going concern.
We have incurred net losses since our inception in 2015.
For the year ended December 31, 2024, we had a net loss of $53.9 million and as of December 31, 2024, we had an accumulated deficit of $229.6 million.
To date, we have financed our operations primarily through amounts borrowed under our credit facilities, sales of our products, proceeds from offerings and sales of our common stock and more recently, through the sale of our Orthobiologics Business.

and 277 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

Watch ELUT. Know when insiders buy.

One email the day a filing lands. Free.