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Elutia Reports Preliminary Fourth Quarter 2025 Results, Strengthened Financial Position, and Upcoming NXT-41x Milestones

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Elutia (Nasdaq: ELUT) reported preliminary Q4 2025 results and corporate updates on its NXT-41x program.

Key items: Q4 net sales ~$3.3M (+16% YoY); sale of BioEnvelope to Boston Scientific for $88M completed October 2025; $26.9M of secured debt repaid in Q4; cash and escrowed proceeds totaled $44.3M at 12/31/2025 (cash on hand ~$36.3M plus $8.0M escrow). Elutia plans an FDA filing for NXT-41 in H1 2026 with potential clearance H2 2026 and anticipates FDA clearance of antibiotic-eluting NXT-41x in H1 2027.

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Positive

  • Q4 2025 net sales of approximately $3.3M (+16% YoY)
  • Divestiture of BioEnvelope for $88.0M (October 2025) strengthening liquidity
  • Eliminated $26.9M secured debt, reducing future interest expense
  • Total cash and escrowed proceeds of $44.3M at year-end 2025

Negative

  • Reported financials are preliminary and may change materially after audit
  • $8.0M of proceeds held in escrow and subject to indemnification adjustments
  • Cash on hand ~$36.3M may limit runway absent additional financing or revenue

News Market Reaction

-4.76% 1.6x vol
21 alerts
-4.76% News Effect
+8.4% Peak Tracked
-8.4% Trough Tracked
-$2M Valuation Impact
$38M Market Cap
1.6x Rel. Volume

On the day this news was published, ELUT declined 4.76%, reflecting a moderate negative market reaction. Argus tracked a peak move of +8.4% during that session. Argus tracked a trough of -8.4% from its starting point during tracking. Our momentum scanner triggered 21 alerts that day, indicating elevated trading interest and price volatility. This price movement removed approximately $2M from the company's valuation, bringing the market cap to $38M at that time. Trading volume was above average at 1.6x the daily average, suggesting increased trading activity.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Q4 2025 net sales: $3.3M Revenue growth: 16% Debt repaid: $26.9M +5 more
8 metrics
Q4 2025 net sales $3.3M Preliminary net sales, 16% increase vs. Q4 2024 (ex-BioEnvelope)
Revenue growth 16% Fourth quarter 2025 revenue increase year-over-year
Debt repaid $26.9M Secured loan principal, interest, and exit fees to SWK eliminated in Q4
Cash on hand $36.3M Cash as of December 31, 2025
Cash & escrow $44.3M Total cash and escrowed proceeds at year-end 2025
BioEnvelope sale $88M EluPro divested to Boston Scientific in October 2025
Shares outstanding 42.8M Class A common shares outstanding at December 31, 2025
Infection rate 15–25% Post-operative infection rate in current breast reconstruction market

Market Reality Check

Price: $0.9922 Vol: Volume 795,614 is 1.35x t...
normal vol
$0.9922 Last Close
Volume Volume 795,614 is 1.35x the 20-day average of 588,785 ahead of this update. normal
Technical Shares at 0.723 trade below the 200-day MA of 1.53, well off the 3.6544 52-week high.

Peers on Argus

ELUT gained 4.71% while peers were mixed: SRTS up 7.45%, CTSO roughly flat, and ...
1 Down

ELUT gained 4.71% while peers were mixed: SRTS up 7.45%, CTSO roughly flat, and MDAI, TELA, WOK down (WOK flagged in momentum at -6.88%). Moves do not show a unified sector trend.

Common Catalyst Some peers, such as CTSO, also issued preliminary quarterly results, but price reactions appear company-specific.

Historical Context

5 past events · Latest: Nov 06 (Positive)
Pattern 5 events
Date Event Sentiment Move Catalyst
Nov 06 Earnings & divestiture Positive -5.0% Q3 2025 results plus $88M BioEnvelope sale and debt reduction.
Oct 23 Earnings preview Neutral -0.7% Announcement of Q3 2025 earnings release and conference call details.
Oct 14 Investor conference Neutral +0.9% LD Micro conference presentation and 1x1 investor meeting availability.
Oct 10 Board change Positive +0.8% Appointment of experienced MedTech executive Guido Neels to board and audit committee.
Oct 01 Asset sale close Positive -0.6% Closing of $88M BioEnvelope sale to Boston Scientific to fund NXT‑41x focus.
Pattern Detected

Recent news shows a mixed pattern: positive strategic and earnings updates have sometimes been followed by declines (e.g., Q3 2025 at -5%), while other governance and conference items saw modest gains. Overall, reactions to news have alternated between alignment and divergence.

Recent Company History

Over the last few months, Elutia has refocused around its drug‑eluting biomatrix platform. In October 2025, it closed the $88M BioEnvelope sale to Boston Scientific and later reported Q3 2025 earnings, using proceeds to reduce debt and fund NXT‑41x. Board refreshment and conference appearances highlighted this strategic shift. Today’s preliminary Q4 2025 update continues that trajectory, emphasizing revenue growth, debt elimination, and cash on hand to advance NXT‑41x.

Market Pulse Summary

This announcement highlights preliminary Q4 2025 net sales of $3.3M with 16% year-over-year growth a...
Analysis

This announcement highlights preliminary Q4 2025 net sales of $3.3M with 16% year-over-year growth and repayment of $26.9M in secured debt, leaving year-end cash and escrow of $44.3M. It also outlines FDA filing and clearance timelines for NXT‑41 and NXT‑41x. Investors may watch upcoming regulatory milestones, actual audited results versus these preliminary figures, and continued funding of NXT‑41x development relative to the targeted $1.5B breast reconstruction market.

Key Terms

drug-eluting biomatrix, antibiotic-eluting biomatrix, FDA filing, FDA clearance, +1 more
5 terms
drug-eluting biomatrix medical
"Elutia Inc. (Nasdaq: ELUT) … a pioneer in drug-eluting biomatrix technologies"
A drug-eluting biomatrix is a medical implant or coating made of biocompatible material that slowly releases a drug at a controlled rate where it is placed in the body, like a sponge that steadily releases medicine into surrounding tissue. For investors, it matters because such technology can improve treatment effectiveness, reduce side effects and repeat procedures, and therefore influence product value, regulatory risk and long-term revenue potential for medical-device and pharmaceutical companies.
antibiotic-eluting biomatrix medical
"NXT-41x is Elutia’s next-generation antibiotic-eluting biomatrix"
A soft or solid medical material that either coats an implant or is placed in a wound and slowly releases antibiotics over time to prevent or treat infection. Think of it as a slow-release bandage or sponge that delivers drugs where they are needed instead of relying on pills. For investors, this matters because the approach can improve patient outcomes, influence regulatory approval and reimbursement, and create commercial differentiation or liability risks that affect a product’s market value.
FDA filing regulatory
"Upcoming milestones include submission of an FDA filing for NXT-41"
An FDA filing is a formal submission to the U.S. Food and Drug Administration that provides evidence a drug, medical device, or diagnostic is safe and effective for its intended use; it's like applying for a building permit that shows the plans and safety tests before construction can begin. For investors, an FDA filing signals a company is seeking permission to sell a health product in a large market, and the outcome can sharply affect future revenue prospects, timelines, and the risk profile of the investment.
FDA clearance regulatory
"with anticipated FDA clearance in the second half of 2026"
FDA clearance is the U.S. Food and Drug Administration’s official permission to market certain medical devices or diagnostic tests after reviewing evidence that they are as safe and effective as similar products already on the market. For investors, it’s like a product passing a required safety inspection — it reduces regulatory uncertainty, speeds commercial rollout, and can directly affect sales prospects, valuation, and partnership opportunities.
pre-funded warrants financial
"the Company had 42.8 million shares … and 4.5 million pre-funded warrants"
Pre-funded warrants are financial instruments that give investors the right to purchase a company's stock at a set price, but with most or all of the purchase price paid upfront. They function like a coupon or gift card for stock, allowing investors to buy shares later at a fixed price, which can be beneficial if they want to avoid future price increases. This makes them important for investors seeking flexibility and certainty in their investment plans.

AI-generated analysis. Not financial advice.

Fourth quarter revenue up 16% year-over-year, $26.9M of secured debt eliminated, and total cash and escrowed proceeds of $44.3M at year-end

GAITHERSBURG, Md., Jan. 12, 2026 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix technologies, today provided a corporate update and outlined upcoming development milestones for NXT-41x, its next-generation antibiotic-eluting biomatrix program in plastic and reconstructive surgery.

NXT-41x is Elutia’s next-generation antibiotic-eluting biomatrix, built on the Company’s technology platform that was clinically and commercially validated with EluPro, indicated for use with pacemaker placement. EluPro was divested to Boston Scientific in October of 2025 for $88 million. The Company believes the NXT-41x platform has the potential to significantly improve outcomes in breast reconstruction, a $1.5 billion market currently with a post-operative infection rate of 15-25%.

Elutia is advancing development of its NXT-41 biomatrix platform and remains on track for planned regulatory milestones. Upcoming milestones include submission of an FDA filing for NXT-41, the Company’s novel base matrix, in the first half of 2026, with anticipated FDA clearance in the second half of 2026. Building on this foundation, Elutia anticipates FDA clearance for NXT-41x, the antibiotic-eluting version of the biomatrix, in the first half of 2027.

Preliminary Fourth Quarter 2025 Financial Results

  • Preliminary net sales. For the fourth quarter of 2025, preliminary net sales were approximately $3.3 million, representing a 16 percent increase compared to the fourth quarter of 2024. Net sales for both the fourth quarters of 2025 and 2024 exclude contributions from the divested BioEnvelope business.
  • Debt repayment. During the fourth quarter, the Company repaid the full $26.9 million outstanding principal, accrued interest, and accrued exit fees associated with its loan from SWK Holdings, significantly reducing interest expense.
  • Cash position. As of December 31, 2025, cash on hand was approximately $36.3 million. An additional $8.0 million related to the BioEnvelope divestiture is being held in escrow and is expected to be released during 2026 (subject to adjustment for indemnification claims, if any).
  • Capital structure. As of December 31, 2025, the Company had 42.8 million shares of Class A common stock outstanding, 4.5 million pre-funded warrants to purchase shares of Class A common stock, and no Class B common stock outstanding.

“The success of EluPro was transformational for Elutia,” said Dr. Randy Mills, Chief Executive Officer. “It validated the technical and commercial capability of our drug-eluting platform and enabled us to enter plastic and reconstructive surgery, where complication rates in breast reconstruction remain unacceptably high. We enter 2026 with a strong balance sheet and the capital required to develop and commercialize NXT-41x. With an experienced team and a focused strategy, we are positioned to execute and advance our mission so that patients can thrive without compromise.”

Preliminary Information
The financial information presented in this press release is preliminary and may change. The Company’s accounting closing procedures and independent audit with respect to the estimated financial information provided in this press release are not yet complete, and as a result, the Company’s final results may vary materially from the preliminary results included in this press release. The preliminary financial information included in this press release reflects the Company's current estimates based on information available as of the date of this press release, has been prepared by Company management, and is not audited. This preliminary financial information should not be viewed as a substitute for full financial statements prepared in accordance with GAAP.

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 our future interactions with the U.S. Food and Drug Administration (“FDA”) regarding NXT-41 and NXT-41x; expectations for FDA clearance of NXT-41 and NXT-41x, including the timing and anticipated success thereof; preparations for the launch of NXT-41x, including the timing and anticipated success thereof; the sufficiency of our current capital resources to develop and commercialize NXT-41X; the size of the breast reconstruction market and the potential of the Company’s next-generation drug-eluting biomatrix products to compete in that market. 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 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 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:
David Carey
FINN Partners
david.carey@finnpartners.com


FAQ

What were Elutia (ELUT) preliminary Q4 2025 net sales and YoY change?

Q4 2025 net sales were approximately $3.3M, a 16% increase versus Q4 2024.

How much did Elutia receive from the BioEnvelope divestiture and when was it sold?

BioEnvelope was divested to Boston Scientific in October 2025 for $88.0M.

How much secured debt did Elutia repay in Q4 2025 and what is the cash position?

Elutia repaid the full $26.9M outstanding secured loan; cash on hand was ~$36.3M plus $8.0M in escrow, totaling $44.3M.

What are the FDA milestone timelines for NXT-41 and NXT-41x (ELUT)?

Elutia plans an FDA filing for NXT-41 in H1 2026 with anticipated clearance in H2 2026, and anticipates FDA clearance for NXT-41x in H1 2027.

Are Elutia’s Q4 2025 financial results final and audited?

No; the financial information is preliminary, unaudited and may change after closing procedures and independent audit.

How many Elutia shares and warrants were outstanding as of December 31, 2025?

As of 12/31/2025 there were 42.8M Class A shares outstanding and 4.5M pre-funded warrants; no Class B shares outstanding.
Elutia Inc.

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