Elutia Strengthens Drug-Eluting Biomatrix Platform with Peer-Reviewed Publication of Novel EluPro™ Testing Method
- New testing method reduces validation time from 14 days to 30 hours, accelerating development and lowering costs
- Method supports EluPro, the first and only FDA-cleared antibiotic-eluting bioenvelope in the market
- Testing protocol meets FDA requirements for establishing manufacturing consistency and control
- None.
Insights
Elutia's new testing method accelerates product development, reduces costs, and strengthens their competitive position in drug-eluting biomatrices.
Elutia has made a significant technical advancement with their newly published validation method for measuring antibiotic release from biologic envelopes. This innovation directly addresses a critical bottleneck in combination product development. The method's ability to compress testing time from 14 days to just 30 hours represents approximately 90% reduction in testing duration, which has substantial implications for both R&D efficiency and cost reduction.
The method's validation for capturing the biphasic release profile of minocycline and rifampin is particularly notable. Drug-eluting technologies must balance immediate therapeutic delivery with sustained release, and accurately measuring both phases is technically challenging. By solving this measurement problem, Elutia strengthens their entire technological platform and enhances their regulatory position.
From a regulatory perspective, this advancement directly addresses FDA requirements for demonstrating manufacturing consistency and control in combination products. Having FDA-validated testing methods gives Elutia a competitive advantage in the regulatory approval process for future products while supporting their existing EluPro portfolio.
The timing is strategically significant as it follows their January 2025 commercial launch of EluPro. This testing methodology will likely accelerate their development pipeline, potentially bringing new products to market faster while reducing development costs. For a company specializing in drug-eluting biomatrices, having proprietary, validated testing methods creates a technical moat that competitors must overcome.
— Innovative approach accelerates new product development and testing —
SILVER SPRING, Md., May 28, 2025 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix technologies, today announced the publication of a peer-reviewed article describing the first validated method for measuring antibiotic release from a biologic envelope. The novel method demonstrates in vitro elution that closely replicates preclinical studies, offering an approach to characterize drug release while enabling faster, lower cost development and testing of the EluPro portfolio. The article appears in the current issue of Dissolution Technologies.
Drug release testing is a critical element of product development and regulatory evaluation for combination products, which integrate drugs and devices. The U.S. Food and Drug Administration (FDA) considers drug elution performance essential for establishing manufacturing consistency and control. Elutia’s new method delivers reliable data in 30 hours—for results comparable to 14-day in vivo protocols—allowing for faster iteration and lower resource usage. It captures the biphasic release profile of minocycline and rifampin, including both the immediate and sustained release phases.
“This work reflects Elutia’s leadership in developing high-performing drug-eluting biomatrices grounded in rigorous science,” said Dana Yoo, Ph.D., Vice President of Development at Elutia. “Having a robust, validated in vitro method supports the product lifecycle for EluPro—the first and only FDA-cleared antibiotic-eluting bioenvelope—and accelerates the development of future drug-eluting biologic matrices in our pipeline.”
EluPro, an antibiotic-eluting bioenvelope designed for use with cardiac implantable electronic devices (CIEDs) and neurostimulators, was commercially launched in the United States in January 2025. Its unique combination of trusted antibiotics and a soft, regenerative biomatrix supports healing while naturally conforming to pocket anatomy and the cardiac implant, addressing device-related complications. The antibiotic-eluting disc delivers consistent and reproducible drug release, providing local drug delivery without compromising the biomatrix’s regenerative properties.
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 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, and the development, testing and anticipated success of the EluPro portfolio. 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
This press release was published by a CLEAR® Verified individual.
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