Conference call today at 5:00 p.m. ET / 2:00 p.m. PT

GAITHERSBURG, Md., Nov. 06, 2025 (GLOBE NEWSWIRE) — Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix technologies, today provided a business update and financial results for the third quarter of 2025.

Business Highlights:

• BioEnvelope Business Sold to Boston Scientific Corporation for $88 Million: Transaction closed October 1, 2025, with proceeds used to eliminate debt and fund NXT-41x development program.
• Advancing Next-Generation Antibiotic-Eluting Biomatrix for Plastic and Reconstructive Surgery: Leveraging its proven drug-eluting biologics platform, Elutia is progressing NXT-41x, a biomatrix that addresses infections and associated complications following mastectomy in the 1.5 billion U.S. market. FDA clearance of the base matrix anticipated in 2H26 and drug-eluting version anticipated in 1H27.
• Addressing Significant Problem with Serious Unmet Need: With one in three patients facing serious complications from breast reconstruction, combined with the high cost of treatment, Elutia is harnessing its drug-eluting platform solution to attack the most prevalent cause of implant failure.
• Strengthened Balance Sheet: Completed sale of the BioEnvelope business provides capital to fully fund development and launch of NXT-41x platform without the need for shareholder dilution.
• Medtech Leader Joins Board: Guido J. Neels, Operating Partner at EW Healthcare Partners and former Chief Operating Officer of Guidant Corporation, appointed to the Company’s Board of Directors.
• Scientific Evidence: Data published in Frontiers in Cardiovascular Medicine show that drug-eluting biologic materials support healthy, vascularized tissue regeneration while providing local drug delivery, demonstrating the platform’s potential for surgical applications.
• Legacy Litigation Substantially Resolved: Settled an additional seven FiberCel cases, leaving only six cases unresolved and significantly reducing expected litigation expenses going forward.

“Behind every breast reconstruction is a woman overcoming cancer,” said Dr. Randy Mills, Chief Executive Officer of Elutia. “Incredibly, infection remains one of the biggest barriers to recovery, impacting 15–20% of reconstruction cases. Our antibiotic-eluting technology is designed to prevent infection from occurring in the first place. The Elutia CRU is laser-focused on this goal, fully resourced, and moving fast to deliver a game-changing solution that helps women everywhere thrive without compromise.”

Third Quarter 2025 Financial Results

For the three-month period ended September 30, 2025, as compared to the same period of 2024:

• Overall net sales were $3.3 million, compared to $3.7 million in Q3 2024. Net sales in both periods exclude contributions from the BioEnvelope business.
• Net sales of SimpliDerm were $2.4 million, compared to $3.1 million in Q3 2024.
• Net sales of Cardiovascular products were $0.9 million, compared to $0.6 million in Q3 2024.
• Gross margin on a GAAP basis was 55.8%, compared to 48.9%
• Adjusted gross margin (a non-GAAP measure which excludes non-cash amortization of intangibles) was 63.9%, compared to 56.3%. A reconciliation of GAAP gross margin to adjusted gross margin is included in the accompanying financial tables.
• Total operating expenses were $7.1 million, compared to $11.0 million.
• Loss from operations was $5.2 million, compared to $9.2 million.
• Net loss from continuing operations was $0.4 million, compared to net income of $3.3 million.
• Net loss from discontinued operations was $3.5 million, compared to net loss of $2.1 million.
• Adjusted EBITDA (a non-GAAP measure that excludes from net loss certain non-operating, non-cash and non-recurring items) was a loss of $2.7 million, approximately the same compared to the year ago period. A reconciliation of net loss to adjusted EBITDA is included in the accompanying financial tables.
• Cash balance as of September 30, 2025, was $4.7 million. On October 1, 2025, Elutia received $80.3 million in connection with the closing of the BioEnvelope business divestiture to Boston Scientific Corporation. Approximately $27.8 million of the proceeds were used at closing to pay in full and terminate Elutia’s loan facility with SWK Funding, LLC. Additionally, $8 million is held in escrow for a period of twelve months as a customary indemnity holdback.

Conference Call

Elutia will host a conference call today at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time to discuss its third quarter 2025 financial results and performance.

The conference call can be accessed using the following information:

Webcast: Click here
Dial-In: Click here

To receive the dial-in number, as well as your personalized PIN, you must register at the above link. Once registered, you will also have the option to have the system dial-out to you once the conference call begins. If you forget your PIN prior to the conference call, you can simply re-register.

Please log in approximately 10 minutes prior to the scheduled start time. A live and archived webcast of the event will be available on the “Investors” section of the Elutia website at http://investors.elutia.com/.

About Elutia
Elutia develops and commercializes drug-eluting biomatrix products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Elutia’s mission is humanizing medicine so patients can thrive without compromise. For more information, visit www.Elutia.com.

Non-GAAP Disclosure

In addition to the Company’s financial results determined in accordance with U.S. GAAP, the Company provides non-GAAP measures that it determines to be useful in evaluating its operating performance and liquidity. The Company presents in this press release the following non-GAAP financial measures: earnings before interest, taxes, depreciation and amortization (“EBITDA”), adjusted earnings before interest, taxes, depreciation and amortization (“adjusted EBITDA”), adjusted gross margin and adjusted gross profit. The Company defines EBITDA as GAAP net loss excluding interest expense, income tax expense, depreciation and amortization, and the Company defines adjusted EBITDA as EBITDA excluding loss from discontinued operations, stock-based compensation, FiberCel and VBM litigation costs, loss or gain on revaluation of warrant liability, warrant issuance expenses and loss or gain on revaluation of revenue interest obligation. The Company defines adjusted gross profit and adjusted gross margin as GAAP gross profit and GAAP gross margin, respectively, excluding amortization of acquired intangible assets. The amortization of these intangible assets will recur in future periods until such intangible assets have been fully amortized. Management believes that presentation of non-GAAP financial measures provides useful supplemental information to investors and facilitates the analysis of the Company’s core operating results and comparison of operating results across reporting periods. The Company uses this non-GAAP financial information to establish budgets, manage the Company’s business, and set incentive and compensation arrangements. Non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance. However, non-GAAP financial information is presented for supplemental information purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with U.S. GAAP. For a reconciliation of these non-GAAP measures to GAAP, see below “Non-GAAP Reconciliations of EBITDA and Adjusted EBITDA” and “Non-GAAP Reconciliations of Adjusted Gross Profit and Adjusted Gross Margin.”

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” “promise” or similar references to future periods. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including any statements and information concerning our future interactions with the U.S. Food and Drug Administration (“FDA”) regarding NXT-41x; expectations for FDA clearance of NXT-41x, including the timing and anticipated success thereof; preparations for the launch of NXT-41x, including the timing and anticipated success thereof; , the size of the breast reduction market and the potential of the Company’s next-generation drug-eluting biomatrix pipeline to compete in that market, expectations for future sales growth and cash flow gains for ProxiCor, Tyke, and VasCure, and any statements regarding future liability with respect to the FiberCel litigation. These forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to us. Such beliefs and assumptions may or may not prove to be correct. Additionally, such forward-looking statements are subject to a number of known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in the forward-looking statements, including, but not limited to the following: our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product offerings, including NXT-41 and NXT-41x; our ability to obtain regulatory approval or other marketing authorizations by the U.S. Food and Drug Administration and comparable foreign authorities for our products and product candidates, including NXT-41 and NXT-41x; our ability to achieve or sustain profitability; our ability to maintain the listing of our common stock on the Nasdaq Capital Market; the risk of product liability claims and our ability to obtain or maintain adequate product liability insurance; our ability to defend against the various lawsuits related to FiberCel and other bone viable matrix products and avoid a material adverse financial consequence; our ability to raise funds in the future in the amounts and at the times needed; the continued and future acceptance of our products by the medical community; our dependence on independent sales agents to generate a substantial portion of our net sales; our dependence on a limited number of third-party suppliers and manufacturers, which, in certain cases are exclusive suppliers for products essential to our business; our ability to successfully realize the anticipated benefits of the October 2025 sale of our CIED business and the November 2024 sale of Orthobiologics business; physician awareness of the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our products; our ability to compete against other companies, most of which have longer operating histories, more established products and/or greater resources than we do; pricing 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; our ability to obtain, maintain and adequately protect our intellectual property rights.; and other important factors which can be found in the “Risk Factors” section of Elutia’s public filings with the Securities and Exchange Commission (“SEC”), including Elutia’s Annual Report on Form 10-K for the year ended December 31, 2024, as such factors may be updated from time to time in Elutia’s other filings with the SEC, including Elutia’s Quarterly Reports on Form 10-Q, accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Elutia’s website at https://investors.elutia.com. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. Any forward-looking statement made by Elutia in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, Elutia expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Investors:
Matt Steinberg
FINN Partners
matt.steinberg@finnpartners.com

This press release was published by a CLEAR® Verified individual.

The post Elutia Reports Third Quarter 2025 Financial Results; Closes $88 Million Sale of BioEnvelope Business to Boston Scientific Corporation; Funds NXT-41x Development appeared first on Elutia.

The conference call can be accessed using the following information:

Webcast: Click here

Dial-In: Click here

To receive the dial-in number, as well as your personalized PIN, you must register at the above link. Once registered, you will also have the option to have the system dial-out to you once the conference call begins. If you forget your PIN prior to the conference call, you can simply re-register.

Please log in approximately 10 minutes prior to the scheduled start time. A live and archived webcast of the event will be available on the “Investors” section of the Elutia website at http://investors.elutia.com/.

About Elutia
Elutia develops and commercializes drug-eluting biomatrix products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Elutia’s mission is humanizing medicine so patients can thrive without compromise. For more information, visit www.Elutia.com.

Investors:
Matt Steinberg
FINN Partners
matt.steinberg@finnpartners.com

This press release was published by a CLEAR® Verified individual.

The post Elutia to Report Third Quarter 2025 Financial Results on Thursday, November 6, 2025 appeared first on Elutia.

LD Micro Main Event XIX Conference
Presentation Date: Tuesday, October 21, 2025
Presentation Time: 1:00 p.m. PT (4:00 p.m. ET)
Webcast: Click here

Elutia management will also participate in 1×1 investor meetings. Institutional investors interested in scheduling a meeting may contact an LD Micro representative or email IR@elutia.com.

About Elutia
Elutia develops and commercializes drug-eluting biomatrix products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Elutia’s mission is humanizing medicine so patients can thrive without compromise. For more information, visit www.Elutia.com.

Investors:
Matt Steinberg
FINN Partners
matt.steinberg@finnpartners.com

This press release was published by a CLEAR® Verified individual.

The post Elutia to Present at the LD Micro Main Event XIX Conference on Tuesday, October 21 appeared first on Elutia.

GAITHERSBURG, Md., Oct. 10, 2025 (GLOBE NEWSWIRE) — Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix technologies, announced the appointment of Guido J. Neels to the Company’s Board of Directors. Mr. Neels will also serve as a member of the audit committee of the Board. In conjunction with Mr. Neels’ appointment, W. Matthew Zuga and Maybelle Jordan have both stepped down as members of Elutia’s Board.

“Randy and I are excited to welcome Guido to our Board of Directors and the Elutia CRU,” said Kevin Rakin, Executive Chairman of Elutia. “Guido’s extensive medical technology leadership experience encompasses a broad range of managerial and strategic roles. His insights will be invaluable as we embark on building significant shareholder value, leveraging our demonstrated drug-eluting biomatrix technology, following our recent EluPro divestiture. We also thank Matt Zuga and Maybelle Jordan for their years of service and wise counsel to Elutia.”

With more than 40 years of business experience and leadership, Mr. Neels is an Operating Partner at EW Healthcare Partners (EW) and played a key role in building and leading EW’s medical device investment practice. He currently serves on the Board of Directors of EW growth equity portfolio companies Bioventus and Enercon Technologies, as well as on the Board of Impulse Dynamics and Corvista.

Prior to joining EW, Mr. Neels served as Chief Operating Officer of Guidant Corporation. Mr. Neels was responsible for the operations of Guidant’s four operating units, Cardiac Rhythm Management, Vascular Intervention, Cardiac Surgery, and Endovascular Solutions and was responsible for sales operations, corporate communications, corporate marketing, investor relations and government relations. He also served as Vice President of Global Marketing of the Vascular Intervention Division and later as Vice President of Guidant Europe, Canada and Africa. Prior to joining Guidant, Mr. Neels held general management, sales and marketing positions at Eli Lilly & Company in the U.S. and Europe. Mr. Neels holds a Business Engineering degree from the University of Leuven in Belgium and a Master of Business Administration degree from Stanford University.

“I am honored to join Elutia’s Board during this pivotal moment in the Company’s strategic transformation,” said Mr. Neels. “Elutia’s pioneering technology has established that it improves patient outcomes and now has a clear path to drive its next phase of innovation into breast reconstruction. I look forward to contributing to Elutia’s exciting future and helping the company fulfill its mission.”

About Elutia
Elutia develops and commercializes drug-eluting biomatrix products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Elutia’s mission is humanizing medicine so patients can thrive without compromise. For more information, visit www.Elutia.com.

Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” “promise” or similar references to future periods. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements. Forward-looking statements contained in this press release include, without limitation, any statements we make regarding the future success of Elutia’s next-generation drug-eluting biomatrix pipeline, including anticipated timing and success thereof, and the potential for building shareholder value. These forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to us. Such beliefs and assumptions may or may not prove to be correct. Additionally, such forward-looking statements are subject to a number of known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in the forward-looking statements, including, but not limited to the following: the risk that clinical research data may not match preclinical study data, or the risk that early clinical data may not be predictive of longer-term experience with a medical device, including Elutia’s biologic envelope products; risks associated with shifting focus to our drug-eluting biomatrix solutions in the breast reconstruction area and away from our CIED business; risks regarding delays in completing the proposed disposition of the CIED business, or to meet any of the other closing conditions to the proposed transaction on a timely basis or at all; our ability to successfully execute or achieve expected benefits from the divestiture of our CIED business; our ability to continue as a going concern; our ability to obtain regulatory approval or other marketing authorizations by the FDA and comparable foreign authorities for our products and product candidates, including our next-generation drug-eluting biomatrix pipeline; our ability to raise capital in the amounts and at the times needed, and on acceptable terms; our ability to manage our substantial indebtedness and other obligations, such as our revenue interest obligation to Ligand Pharmaceuticals, including our ability to negotiate waivers or similar accommodations as needed; our ability to achieve or sustain profitability; the risk of product liability claims and our ability to obtain or maintain adequate product liability insurance; our ability to defend against the various lawsuits and claims related to our recalled FiberCel and other viable bone matrix products and avoid a material adverse financial consequence from those lawsuits and claims; our ability to prevail in lawsuits and claims seeking indemnity, contribution and insurance coverage for FiberCel and other viable bone matrix product liabilities; the continued and future acceptance of our products by the medical community; our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product offerings; our dependence on our commercial partners and independent sales agents to generate a substantial portion of our net sales; our dependence on a limited number of third-party suppliers and manufacturers, which, in certain cases are exclusive suppliers for products essential to our business; our ability to successfully realize the anticipated benefits of the previous sale of our Orthobiologics business; physician awareness of the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our products; our ability to compete against other companies, most of which have longer operating histories, more established products and/or greater resources than we do; pricing pressure as a result of cost-containment efforts of our customers, purchasing groups, third-party payors and governmental organizations that could adversely affect our sales and profitability; our ability to obtain, maintain and adequately protect our intellectual property rights; and other important factors which can be found in the “Risk Factors” section of Elutia’s public filings with the Securities and Exchange Commission (“SEC”), including Elutia’s Annual Report on Form 10-K for the year ended December 31, 2024, as such factors may be updated from time to time in Elutia’s other filings with the SEC, including Elutia’s Quarterly Reports on Form 10-Q, accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Elutia’s website at https://investors.elutia.com. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. Any forward-looking statement made by Elutia in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, Elutia expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Investors:
Matt Steinberg
FINN Partners
matt.steinberg@finnpartners.com

This press release was published by a CLEAR® Verified individual.

The post Elutia Appoints Accomplished MedTech Veteran Guido J. Neels to Board of Directors appeared first on Elutia.

– Biologics for breast reconstruction represents $1.5 billion U.S. total addressable market –

GAITHERSBURG, Md., Oct. 01, 2025 (GLOBE NEWSWIRE) — Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix technologies, today announced the closing of the sale of its BioEnvelope business, including the EluPro™ and CanGaroo® bioenvelopes, to Boston Scientific Corporation (NYSE: BSX) for $88 million in cash.

With this closing, Elutia will leverage its proven drug-eluting biologics platform with a more concentrated focus on advancing NXT-41x, a biomatrix that directly addresses the root causes of reconstruction infections following mastectomy. NXT-41x combines excellent handling, optimal biologics, and powerful, extended antibiotic release to provide protection while supporting tissue regeneration.

“With our significantly strengthened financial position, we plan to bring NXT-41x to market in the first half of 2027,” said Dr. Randy Mills, CEO of Elutia. “We are confident we have the people, technology, and resources to reshape the breast reconstruction treatment paradigm and accelerate our path to positive cash flow. I want to thank the entire Elutia CRU for their relentless work to enable patients everywhere to thrive without compromise.”

Each year, more than 150,000 breast reconstruction procedures are performed in the U.S., and approximately one in three patients suffer serious complications. These complications often result in multiple surgeries, delays in treatment and additional health risks. With biologics accounting for 65% of implant-based costs, an improved treatment option has the potential to capture a significant share of the estimated $1.5 billion U.S. market opportunity.

About Elutia

Elutia develops and commercializes drug-eluting biomatrix products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Elutia’s mission is humanizing medicine so patients can thrive without compromise. For more information, visit www.Elutia.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” “promise” or similar references to future periods. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including any statements and information regarding the future success of new products in Elutia’s breast reconstruction business and whether the proceeds of the BioEnvelope business sale will be sufficient to develop and commercialize Elutia’s pipeline. These forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to us. Such beliefs and assumptions may or may not prove to be correct. Additionally, such forward-looking statements are subject to a number of known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in the forward-looking statements, including, but not limited to the following: risks associated with shifting focus to our drug-eluting biomatrix solutions in the breast reconstruction area and away from our BioEnvelope business; our ability to successfully execute or achieve expected benefits from the divestiture of our BioEnvelope business; our ability to continue as a going concern; our ability to achieve or sustain profitability; risk of product liability claims and our ability to obtain or maintain adequate product liability insurance; our ability to defend against the various lawsuits related to our former FiberCel and VBM products and avoid a material adverse financial consequence; our ability to raise funds in the future in the amounts and at the times needed; our ability to manage our significant indebtedness and other obligations, such as our Revenue Interest Obligation to Ligand Pharmaceuticals Incorporated, including our ability to negotiate waivers and similar accommodations as needed; the continued and future acceptance of our products by the medical community; our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product offerings; our dependence on our commercial partners and independent sales agents to generate a substantial portion of our net sales; our dependence on a limited number of third-party suppliers and manufacturers, which, in certain cases are exclusive suppliers for products essential to our business; our ability to successfully realize the anticipated benefits of the previous sale of our Orthobiologics business; physician awareness of the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our products; our ability to compete against other companies, most of which have longer operating histories, more established products and/or greater resources than we do; pricing 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; our ability to obtain regulatory approval or other marketing authorizations by the U.S. Food and Drug Administration and comparable foreign authorities for our products and product candidates; and our ability to obtain, maintain and adequately protect our intellectual property rights; and other important factors which can be found in the “Risk Factors” section of Elutia’s public filings with the Securities and Exchange Commission (“SEC”), including Elutia’s Annual Report on Form 10-K for the year ended December 31, 2024, as such factors may be updated from time to time in Elutia’s other filings with the SEC, including Elutia’s Quarterly Reports on Form 10-Q, accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Elutia’s website at https://investors.elutia.com. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. Any forward-looking statement made by Elutia in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, Elutia expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Investors:
Matt Steinberg
FINN Partners
matt.steinberg@finnpartners.com

This press release was published by a CLEAR® Verified individual.

The post Elutia Announces Closing of BioEnvelope Business Sale to Boston Scientific Corporation for $88 Million appeared first on Elutia.

GAITHERSBURG, Md., Sept. 16, 2025 (GLOBE NEWSWIRE) — Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix technologies, today announced the publication of clinical and preclinical data supporting the clinical utility of a biologic envelope that secures cardiac implantable electronic devices (CIEDs), promotes tissue remodeling, and addresses bacterial colonization through localized antibiotic delivery. The data are published in the current issue of Frontiers in Cardiovascular Medicine.

The publication includes data from the HEAL study (NCT04645173), a multicenter observational clinical evaluation of patients undergoing CIED reoperations. This study found that patients previously implanted with an engineered extracellular matrix (ECM) envelope had 43% lower overall procedural difficulty, including 46% easier generator mobilization and 41% easier lead mobilization compared with patients previously implanted without envelopes or with non-biologic envelopes.

“These results suggest that biologic envelopes not only facilitate placement and stabilize the device initially but also preserve surgical access to the pocket over time,” said Dr. Benjamin D’Souza, Associate Professor of Medicine at the University of Pennsylvania and Section Chief of Cardiac Electrophysiology at Penn Presbyterian Medical Center. “That is especially relevant for patients likely to undergo future reinterventions.”

The publication also details preclinical studies showing complete eradication of bacterial inoculates commonly implicated in CIED-related complications. The antibiotic-eluting envelope eliminated pathogens, such as MRSA, while maintaining regenerative function. Pharmacokinetic assessments confirmed sustained local antibiotic concentrations for up to two weeks.

“The drug-eluting biomatrix technology developed by Elutia is an effective solution for two long-standing CIED procedural challenges — eliminating the bacteria that can cause near-term, post-operative complications and reducing long-term procedural difficulties,” said Dr. Michelle LeRoux Williams, PhD, Chief Scientific Officer at Elutia. “Elutia is committed to transforming our drug-eluting biomatrix technologies into innovative products that address real-world clinical needs and improve patient outcomes.”

The combination of regenerative ECM and broad-spectrum, synergistic antibiotics, like rifampin and minocycline, is a powerful platform for future drug-eluting biologics—particularly in surgical settings where tissue remodeling and infection control intersect. Building on this foundation, Elutia is advancing a next-generation pipeline targeting higher-risk procedures, such as breast reconstruction where one in three patients suffer serious complications after reconstruction. This research lays the groundwork for a future in which the body’s healing response is managed as carefully as the device itself.

About Elutia
Elutia develops and commercializes drug-eluting biomatrix products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Elutia’s mission is humanizing medicine so patients can thrive without compromise. For more information, visit www.Elutia.com.

Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” “promise” or similar references to future periods. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements. Forward-looking statements contained in this press release include, without limitation, any statements we make regarding the future success of Elutia’s next-generation drug-eluting biomatrix pipeline, including anticipated timing and success thereof, and the potential for ECM envelopes to facilitate medical device implantation, stabilization and future reintervention. These forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to us. Such beliefs and assumptions may or may not prove to be correct. Additionally, such forward-looking statements are subject to a number of known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in the forward-looking statements, including, but not limited to the following: the risk that clinical research data may not match preclinical study data, or the risk that early clinical data may not be predictive of longer-term experience with a medical device, including Elutia’s biologic envelope products; risks associated with shifting focus to our drug-eluting biomatrix solutions in the breast reconstruction area and away from our CIED business; risks regarding delays in completing the proposed disposition of the CIED business, or to meet any of the other closing conditions to the proposed transaction on a timely basis or at all; our ability to successfully execute or achieve expected benefits from the divestiture of our CIED business; our ability to continue as a going concern; our ability to obtain regulatory approval or other marketing authorizations by the FDA and comparable foreign authorities for our products and product candidates, including our next-generation drug-eluting biomatrix pipeline; our ability to raise capital in the amounts and at the times needed, and on acceptable terms; our ability to manage our substantial indebtedness and other obligations, such as our revenue interest obligation to Ligand Pharmaceuticals, including our ability to negotiate waivers or similar accommodations as needed; our ability to achieve or sustain profitability; the risk of product liability claims and our ability to obtain or maintain adequate product liability insurance; our ability to defend against the various lawsuits and claims related to our recalled FiberCel and other viable bone matrix products and avoid a material adverse financial consequence from those lawsuits and claims; our ability to prevail in lawsuits and claims seeking indemnity, contribution and insurance coverage for FiberCel and other viable bone matrix product liabilities; the continued and future acceptance of our products by the medical community; our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product offerings; our dependence on our commercial partners and independent sales agents to generate a substantial portion of our net sales; our dependence on a limited number of third-party suppliers and manufacturers, which, in certain cases are exclusive suppliers for products essential to our business; our ability to successfully realize the anticipated benefits of the previous sale of our Orthobiologics business; physician awareness of the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our products; our ability to compete against other companies, most of which have longer operating histories, more established products and/or greater resources than we do; pricing pressure as a result of cost-containment efforts of our customers, purchasing groups, third-party payors and governmental organizations that could adversely affect our sales and profitability; our ability to obtain, maintain and adequately protect our intellectual property rights; and other important factors which can be found in the “Risk Factors” section of Elutia’s public filings with the Securities and Exchange Commission (“SEC”), including Elutia’s Annual Report on Form 10-K for the year ended December 31, 2024, as such factors may be updated from time to time in Elutia’s other filings with the SEC, including Elutia’s Quarterly Reports on Form 10-Q, accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Elutia’s website at https://investors.elutia.com. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. Any forward-looking statement made by Elutia in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, Elutia expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Investors:
Matt Steinberg
FINN Partners
matt.steinberg@finnpartners.com

The post Elutia Announces Newly Published Clinical Data Demonstrating that Biologic Envelopes Support CIED Stabilization and Ease of Reoperation appeared first on Elutia.

– Company to provide update at the H.C. Wainwright 27th Annual Global Investment Conference on Wednesday, September 10 at 9:30 a.m. ET –

GAITHERSBURG, Md., Sept. 09, 2025 (GLOBE NEWSWIRE) — Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix technologies, today announced it has entered into a definitive agreement to sell its EluPro™ and CanGaroo® bioenvelopes, designed to protect patients receiving implantable medical devices, to Boston Scientific Corporation (NYSE: BSX) for $88 million in cash. The transaction underscores the value of Elutia’s proprietary drug-eluting biologic technology platform and enables the Company to complete development and commercialization of its near-term blockbuster pipeline without the need for shareholder dilution.

“EluPro has clearly demonstrated that our proprietary drug-eluting biologics platform works at scale,” said Dr. Randy Mills, CEO of Elutia. “With the successful launch of EluPro, seven national group purchasing organization contracts secured and more than 160 value analysis committee approvals, we have shown that we can develop, manufacture and commercialize these highly regulated breakthrough products, and that they are valued by physicians.

“Now, with a transformed balance sheet, an established commercial engine and a proven team, we are ready to repeat our success with NXT-41x. This novel technology is designed to transform the $1.5 billion breast reconstruction market and help women recovering from breast cancer to thrive without compromise,” added Dr. Mills.

The deal is expected to close in the fourth quarter of 2025, subject to customary closing conditions.

Transformative Impact for Shareholders

The transaction marks a pivotal advance for Elutia, strengthening the Company’s financial position and unlocking long-term shareholder value:

• Balance Sheet Transformation – Positions Elutia to eliminate outstanding debt, substantially resolve litigation from the Company’s previously divested Orthobiologics business, and leaves the Company with a significantly reduced burn rate.
• Non-Dilutive Funding – Fully funds advancement and commercialization of NXT-41 and NXT-41x, creating a clear path to cash-flow positive operations without shareholder dilution.
• Focus – Enables Elutia to dedicate its resources toward advancing its SimpliDerm franchise and first-in-class drug-eluting pipeline in the $1.5 billion U.S. breast reconstruction market. Elutia will directly leverage its considerable experience developing EluPro to address this even larger unmet clinical need and market opportunity.

BofA Securities is acting as financial advisor to Elutia in the sale of its BioEnvelope business.

Company Presentation

Members of the Company’s management team will provide a company update at the H.C. Wainwright 27th Annual Global Investment Conference. The presentation will begin on Wednesday, September 10 at 9:30 a.m. Eastern Time / 6:30 a.m. Pacific Time. A webcast of the presentation can be accessed by clicking here.

Please log in approximately 10 minutes prior to the scheduled start time. A live and archived webcast of the event will be available on the “Investors” section of the Elutia website at http://investors.elutia.com/.

About Elutia

Elutia develops and commercializes drug-eluting biomatrix products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Elutia’s mission is humanizing medicine so patients can thrive without compromise. For more information, visit www.Elutia.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” “promise” or similar references to future periods. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including any statements and information concerning the market reception of EluPro, including the timing and anticipated success thereof. These forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to us. Such beliefs and assumptions may or may not prove to be correct. Additionally, such forward-looking statements are subject to a number of known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in the forward-looking statements, including, but not limited to the following: our ability to successfully commercialize, market and sell our EluPro product; our ability to continue as a going concern; our ability to achieve or sustain profitability; the risk of product liability claims and our ability to obtain or maintain adequate product liability insurance; our ability to defend against the various lawsuits and claims related to our recalled FiberCel and other viable bone matrix products and avoid a material adverse financial consequence from those lawsuits and claims; our ability to prevail in lawsuits and claims seeking indemnity, contribution and insurance coverage for FiberCel and other viable bone matrix product liabilities; the continued and future acceptance of our products by the medical community; our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product offerings; our dependence on our commercial partners and independent sales agents to generate a substantial portion of our net sales; our dependence on a limited number of third-party suppliers and manufacturers, which, in certain cases are exclusive suppliers for products essential to our business; our ability to successfully realize the anticipated benefits of the November 2023 sale of our Orthobiologics business; physician awareness of the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our products; our ability to compete against other companies, most of which have longer operating histories, more established products and/or greater resources than we do; pricing pressure as a result of cost-containment efforts of our customers, purchasing groups, third-party payors and governmental organizations that could adversely affect our sales and profitability; our ability to obtain regulatory approval or other marketing authorizations by the FDA and comparable foreign authorities for our products and product candidates; our ability to obtain, maintain and adequately protect our intellectual property rights; and other important factors which can be found in the “Risk Factors” section of Elutia’s public filings with the Securities and Exchange Commission (“SEC”), including Elutia’s Annual Report on Form 10-K for the year ended December 31, 2024, as such factors may be updated from time to time in Elutia’s other filings with the SEC, including Elutia’s Quarterly Reports on Form 10-Q, accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Elutia’s website at https://investors.elutia.com. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. Any forward-looking statement made by Elutia in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, Elutia expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Investors:
Matt Steinberg
FINN Partners
matt.steinberg@finnpartners.com

The post Elutia Announces Sale of BioEnvelope Business to Boston Scientific Corporation for $88 Million appeared first on Elutia.

The annual Innovative Technology Exchange offers selected suppliers the unique opportunity to demonstrate their product or service to supply chain and clinical leaders from Vizient’s hospital clients and subject matter experts who serve on their supply councils. Each product or service will showcase how it improves clinical outcomes, enhances safety or drives incremental improvements to healthcare delivery or business models.

As the first and only FDA-cleared antibiotic-eluting bioenvelope designed for use with cardiac implantable electronic devices (CIEDs) and neurostimulators, EluPro combines a natural biologic scaffold with antibiotics that elute over time. This dual approach promotes healthy tissue regeneration while delivering antimicrobial protection directly to the surgical site. Its soft, conforming biologic material offers excellent handling and allows for easy insertion of the CIED, enhancing procedural efficiency and the standard of care.

“We are thrilled to showcase EluPro with healthcare leaders at the Vizient Innovative Technology Exchange,” said Dr. Kimberly Mulligan, GM and VP of Elutia’s Cardiovascular Division. “EluPro is a prime example of how innovation can transform patient care by addressing critical post-surgical complications like infection, migration, and erosion. We look forward to demonstrating how this first-of-its-kind technology can help hospitals improve patient safety and deliver clinical and economic value.”

“The Innovative Technology Exchange fosters a unique opportunity for healthcare providers to interact with products and services that have the potential to impact the healthcare industry and improve clinical care or the business model of organizations,” said Kelly Flaharty, senior director of contract services, Vizient. “We are pleased to invite Elutia to the Exchange.”

The annual Innovative Technology Exchange is part of Vizient’s Innovative Technology Program that includes product review of supplier-submitted technologies by provider-led councils. Since 2003, Vizient has reviewed over 1,700 product submissions as part of its Innovative Technology Program.

To learn more, visit www.elutia.com/products/elupro/.

About Elutia
Elutia develops and commercializes drug-eluting biomatrix products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Elutia’s mission is humanizing medicine so patients can thrive without compromise. For more information, visit

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” “promise” or similar references to future periods. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements. Forward-looking statements contained in this press release include, without limitation, any statements we make regarding the market reception of EluPro, including the timing and anticipated success thereof. These forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to us. Such beliefs and assumptions may or may not prove to be correct. Additionally, such forward-looking statements are subject to a number of known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in the forward-looking statements, including, but not limited to the following: our ability to continue as a going concern; our ability to successfully commercialize, market and sell our EluPro product; our ability to obtain regulatory approval or other marketing authorizations by the FDA and comparable foreign authorities for our products and product candidates, including our next-generation drug-eluting biomatrix pipeline; our ability to raise capital in the amounts and at the times needed, and on acceptable terms; our ability to manage our substantial indebtedness and other obligations, such as our revenue interest obligation to Ligand Pharmaceuticals, including our ability to negotiate waivers or similar accommodations as needed; our ability to achieve or sustain profitability; the risk of product liability claims and our ability to obtain or maintain adequate product liability insurance; our ability to defend against the various lawsuits and claims related to our recalled FiberCel and other viable bone matrix products and avoid a material adverse financial consequence from those lawsuits and claims; our ability to prevail in lawsuits and claims seeking indemnity, contribution and insurance coverage for FiberCel and other viable bone matrix product liabilities; the continued and future acceptance of our products by the medical community; our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product offerings; our dependence on our commercial partners and independent sales agents to generate a substantial portion of our net sales; our dependence on a limited number of third-party suppliers and manufacturers, which, in certain cases are exclusive suppliers for products essential to our business; our ability to successfully realize the anticipated benefits of the November 2023 sale of our Orthobiologics business; physician awareness of the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our products; our ability to compete against other companies, most of which have longer operating histories, more established products and/or greater resources than we do; pricing pressure as a result of cost-containment efforts of our customers, purchasing groups, third-party payors and governmental organizations that could adversely affect our sales and profitability; our ability to obtain, maintain and adequately protect our intellectual property rights; and other important factors which can be found in the “Risk Factors” section of Elutia’s public filings with the Securities and Exchange Commission (“SEC”), including Elutia’s Annual Report on Form 10-K for the year ended December 31, 2024, as such factors may be updated from time to time in Elutia’s other filings with the SEC, including Elutia’s Quarterly Reports on Form 10-Q, accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Elutia’s website at https://investors.elutia.com. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. Any forward-looking statement made by Elutia in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, Elutia expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Investors:
Matt Steinberg
FINN Partners
matt.steinberg@finnpartners.com

The post Elutia Selected to Exhibit EluPro™ Antibiotic Eluting BioEnvelope at Vizient Innovative Technology Exchange appeared first on Elutia.

Cantor Global Healthcare Conference
Format: Fireside Chat and 1×1 Meetings
Fireside Chat Date and Time: Thursday, September 4, 2025, 9:45 a.m. ET
Webcast Link: Click Here

H.C. Wainwright 27th Annual Global Investment Conference
Format: Presentation and 1×1 Meetings
Presentation Date and Time: Wednesday, September 10, 2025, 9:30 a.m. ET
Webcast Link: Click Here

Lake Street Capital Markets 9th Annual Best Ideas Growth Conference
Format: 1×1 Meetings
Date: Thursday, September 11, 2025

Institutional investors interested in scheduling a meeting may contact their Cantor, H.C. Wainwright, or Lake Street representative or email IR@elutia.com.

About Elutia
Elutia develops and commercializes drug-eluting biomatrix products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Elutia’s mission is humanizing medicine so patients can thrive without compromise. For more information, visit www.Elutia.com.

Investors:
Matt Steinberg
FINN Partners
matt.steinberg@finnpartners.com

The post Elutia to Participate in Upcoming Investor Conferences appeared first on Elutia.

Conference call today at 5:00 p.m. ET / 2:00 p.m. PT

GAITHERSBURG, Md., Aug. 14, 2025 (GLOBE NEWSWIRE) — Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix technologies, today provided a business update and financial results for the second quarter of 2025. Since full launch in January 2025, EluPro has rapidly established itself as the preferred antibiotic bioenvelope choice in cardiac implantable electronic device procedures, delivering robust revenue growth and expanding access through national group purchasing organization (GPO) contracts, value analysis committee (VAC) approvals, and a strategic distribution partnership with Boston Scientific. The Company also advanced its next-generation drug-eluting biomatrix pipeline, featuring the NXT-41 platform for breast reconstruction with initial product launch planned for the second half of 2026.

Business Highlights:

• EluPro Momentum: Second quarter 2025 revenue up 49% sequentially. Total BioEnvelope revenue reached $3.5 million, up 33% year-over-year, with EluPro now contributing about two-thirds of total BioEnvelope sales.
• Robust Market Access of EluPro: VAC approvals now more than 160 centers, averaging about 12 new approvals monthly; customer base has grown more than 15x since launch.
• Strong Clinical Demand: EluPro customers are delivering meaningfully higher value than our legacy BioEnvelope platform, CanGaroo. In the second quarter, average sales per EluPro customer were 130% higher than for CanGaroo customers, reflecting stronger procedure penetration.
• Efficient Selling Model: Strong demand across both direct and distributor channels, fueling rapid market adoption and efficient entry into new geographies. Distributor-led growth now accounts for approximately 33% of EluPro sales.
• Innovation Recognition and Scientific Evidence: EluPro honored with two prestigious awards for Innovation and Product Launches at the 2025 Medical Device Network Excellence Awards; scientific leadership demonstrated by five peer-reviewed publications on EluPro.
• Legacy Litigation Substantially Resolved: Settled an additional 27 cases, bringing total FiberCel settlements to 97 of 110 and significantly reducing expected litigation expenses going forward.
• Cardiovascular Portfolio Update: Regained direct control of our sales of ProxiCor™, Tyke™, and VasCure™ in May 2025 with a seamless transition. Generated $736K in revenue in the first partial quarter of direct sales and expect continued sales growth and cash flow gains through an expanding distributor network.
• Pipeline Advancing: Progressing NXT-41x, a next-gen antibiotic biomatrix for breast reconstruction. Targeting FDA clearance of the base matrix in 2H26 and drug-eluting version in 1H27. Leveraging proven drug-delivery technology to address a $1.5 billion market with high complication rates.

“EluPro’s performance continues to exceed expectations, and we now believe BioEnvelope sales will be approaching a $20 million annualized run rate by year-end,” said Dr. Randy Mills, CEO of Elutia. “Since its launch earlier this year, EluPro has expanded into more than 160 VAC-approved hospitals, with our commercial team rapidly growing its nationwide footprint. On the business development front, we are evaluating multiple transactions and expect to share more soon. With our first drug-eluting biologic proving to be a commercial success, we are rapidly advancing our NXT-41 platform, our next-generation antibiotic biomatrix for breast reconstruction. With FDA clearance of the base matrix expected in 2H26 and the drug-eluting version in 1H27, we are targeting a $1.5 billion market where one in three patients faces serious complications, and where NXT-41x can set a new standard of care so patients can thrive without compromise.”

Second Quarter 2025 Financial Results

For the three-month period ended June 30, 2025, as compared to the same period of 2024:

• Net sales for BioEnvelope products, including both EluPro and CanGaroo, increased by 33%, totaling $3.5 million compared to $2.6 million in Q2 2024, reflecting strong and accelerating sales of EluPro.
• Net sales of SimpliDerm were $2.0 million, compared to $2.6 million in Q2 2024.
• Net sales of Cardiovascular products were $0.7 million, compared to $1.1 million in Q2 2024.
• Overall net sales were $6.3 million, about the same compared to Q2 2024.
• Gross margin on a GAAP basis was 48.8%, compared to 44.5%
• Adjusted gross margin (a non-GAAP measure which excludes non-cash amortization of intangibles) was 62.4%, compared to 58.0%. A reconciliation of GAAP gross margin to adjusted gross margin is included in the accompanying financial tables.
• Total operating expenses were $12.9 million, compared to $11.3 million.
• Loss from operations was $9.9 million, compared to $8.5 million.
• Net loss was $9.6 million, compared to $28.2 million.
• Adjusted EBITDA (a non-GAAP measure that excludes from net loss certain non-operating, non-cash and non-recurring items) was a loss of $3.8 million, compared to a loss of $2.6 million. A reconciliation of net loss to adjusted EBITDA is included in the accompanying financial tables.
• Cash balance as of June 30, 2025, was $8.5 million.

Conference Call

Elutia will host a conference call today at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time to discuss its second quarter 2025 financial results and performance.

The conference call can be accessed using the following information:

Webcast: Click here
U.S. Investors: 877-407-8029
International Investors: 201-689-8029
Conference ID: 13754773

About Elutia
Elutia develops and commercializes drug-eluting biomatrix products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Elutia’s mission is humanizing medicine so patients can thrive without compromise. For more information, visit www.Elutia.com.

Non-GAAP Disclosure

In addition to the Company’s financial results determined in accordance with U.S. GAAP, the Company provides non-GAAP measures that it determines to be useful in evaluating its operating performance and liquidity. The Company presents in this press release the following non-GAAP financial measures: earnings before interest, taxes, depreciation and amortization (“EBITDA”), adjusted earnings before interest, taxes, depreciation and amortization (“adjusted EBITDA”), adjusted gross margin and adjusted gross profit. The Company defines EBITDA as GAAP net loss excluding interest expense, income tax expense, depreciation and amortization, and the Company defines adjusted EBITDA as EBITDA excluding stock-based compensation, FiberCel and VBM litigation costs, loss or gain on revaluation of warrant liability, warrant issuance expenses and loss or gain on revaluation of revenue interest obligation. The Company defines adjusted gross profit and adjusted gross margin as GAAP gross profit and GAAP gross margin, respectively, excluding amortization of acquired intangible assets. The amortization of these intangible assets will recur in future periods until such intangible assets have been fully amortized. Management believes that presentation of non-GAAP financial measures provides useful supplemental information to investors and facilitates the analysis of the Company’s core operating results and comparison of operating results across reporting periods. The Company uses this non-GAAP financial information to establish budgets, manage the Company’s business, and set incentive and compensation arrangements. Non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance. However, non-GAAP financial information is presented for supplemental information purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with U.S. GAAP. For a reconciliation of these non-GAAP measures to GAAP, see below “Non-GAAP Reconciliations of EBITDA and Adjusted EBITDA” and “Non-GAAP Reconciliations of Adjusted Gross Profit and Adjusted Gross Margin.”

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” “promise” or similar references to future periods. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including any statements and information concerning the market reception of EluPro, including the timing and anticipated success thereof, expectations regarding the Company’s next-generation drug-eluting biomatrix pipeline, including anticipated FDA clearance and the timing and anticipated success thereof, the size of the breast reduction market and the potential of the Company’s next-generation drug-eluting biomatrix pipeline to compete in that market, and any statements regarding future liability with respect to the FiberCel litigation. These forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to us. Such beliefs and assumptions may or may not prove to be correct. Additionally, such forward-looking statements are subject to a number of known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in the forward-looking statements, including, but not limited to the following: our ability to continue as a going concern; our ability to successfully commercialize, market and sell our EluPro product; our ability to obtain regulatory approval or other marketing authorizations by the FDA and comparable foreign authorities for our products and product candidates, including our next-generation drug-eluting biomatrix pipeline; our ability to raise capital in the amounts and at the times needed, and on acceptable terms; our ability to manage our substantial indebtedness and other obligations, such as our revenue interest obligation to Ligand Pharmaceuticals, including our ability to negotiate waivers or similar accommodations as needed; our ability to achieve or sustain profitability; the risk of product liability claims and our ability to obtain or maintain adequate product liability insurance; our ability to defend against the various lawsuits and claims related to our recalled FiberCel and other viable bone matrix products and avoid a material adverse financial consequence from those lawsuits and claims; our ability to prevail in lawsuits and claims seeking indemnity, contribution and insurance coverage for FiberCel and other viable bone matrix product liabilities; the continued and future acceptance of our products by the medical community; our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product offerings; our dependence on our commercial partners and independent sales agents to generate a substantial portion of our net sales; our dependence on a limited number of third-party suppliers and manufacturers, which, in certain cases are exclusive suppliers for products essential to our business; our ability to successfully realize the anticipated benefits of the November 2023 sale of our Orthobiologics business; physician awareness of the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our products; our ability to compete against other companies, most of which have longer operating histories, more established products and/or greater resources than we do; pricing pressure as a result of cost-containment efforts of our customers, purchasing groups, third-party payors and governmental organizations that could adversely affect our sales and profitability; our ability to obtain, maintain and adequately protect our intellectual property rights; and other important factors which can be found in the “Risk Factors” section of Elutia’s public filings with the Securities and Exchange Commission (“SEC”), including Elutia’s Annual Report on Form 10-K for the year ended December 31, 2024, as such factors may be updated from time to time in Elutia’s other filings with the SEC, including Elutia’s Quarterly Reports on Form 10-Q, accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Elutia’s website at https://investors.elutia.com. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. Any forward-looking statement made by Elutia in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, Elutia expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Investors:
Matt Steinberg
FINN Partners
matt.steinberg@finnpartners.com

The post Elutia Delivers Robust Growth on the Strength of EluPro™ Market Adoption appeared first on Elutia.