Elutia Advances Scientific Leadership with Publication of New Study on Antibiotic-Eluting Biologic Envelope

Rhea-AI Summary

Elutia (Nasdaq: ELUT) has published new preclinical data in Antibiotics journal, demonstrating the effectiveness of its antibiotic-eluting biologic envelope for cardiac implanted electronic devices (CIEDs). The study shows:

The envelope demonstrated complete bacterial eradication across seven different Gram positive and negative organisms, including Staphylococcus aureus, MRSA, and Staphylococcus epidermidis. The technology features rapid initial antibiotic elution followed by gradual release over 14 days.

This research complements the 2024 Garrigos study, validating antimicrobial performance in vivo. The company's product, EluPro, is the first FDA-cleared antibiotic-eluting bioenvelope for CIEDs and neurostimulators, launched commercially in January 2025.

Positive

• First-to-market advantage with FDA-cleared antibiotic-eluting bioenvelope
• Successful preclinical data showing complete bacterial eradication
• Product already commercially launched in January 2025

Negative

• None.

— Rigorous testing demonstrates robust antimicrobial performance against bacterial strains relevant to cardiac implanted electronic device (CIED) infections —

SILVER SPRING, Md., March 25, 2025 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix technologies, today announced the publication of new preclinical data in the current issue of Antibiotics, further demonstrating the antimicrobial performance of its antibiotic-eluting biologic envelope designed to protect CIEDs from bacterial infections.

“These findings highlight the antibiotic-eluting bioenvelope as a comprehensive approach to protecting against bacterial strains associated with CIED infections,” said Dr. M. Rizwan Sohail, Professor of Medicine at Baylor College of Medicine and an author on the publication. “The study demonstrated complete eradication of bacteria even with only a fraction of the drug remaining, in a soft, conforming bioenvelope for overall device protection.”

The study utilized an innovative approach to correlate in vivo and in vitro results, establishing a new tool for assessing the antimicrobial effectiveness of implantable biomaterials. Data showed rapid initial elution of antibiotics followed by more gradual elution over 14 days. Broad spectrum activity was shown across seven different Gram positive and Gram negative organisms, including Staphylococcus aureus, methicillin-resistant Staphylococcus aureus (MRSA), and Staphylococcus epidermidis, with complete eradication of all tested strains. This study serves as a companion to the seminal Garrigos study published in 2024, which showed antimicrobial performance in a challenging in vivo model.

“The study underscores our commitment to scientific excellence in developing first-in-class solutions to address bacterial infections and improve patient outcomes,” said Michelle LeRoux Williams, Ph.D., Elutia’s Chief Scientific Officer. “The results demonstrate the robust antimicrobial performance of antibiotic-eluting biologic envelopes in a rigorous model. We believe these new data will help EluPro become the standard of care for CIED procedures.”

EluPro, the first and only FDA-cleared antibiotic-eluting bioenvelope designed for use with CIEDs and neurostimulators, was commercially launched in the United States in January 2025.

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. Forward-looking statements contained in this press release include, without limitation, any statements we make regarding the adoption our EluPro device or it becoming the standard of care for CIED procedures. 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; 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 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 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, 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

FAQ

What are the key findings of Elutia's (ELUT) new antibiotic envelope study?

The study showed complete bacterial eradication across 7 different organisms, with rapid initial antibiotic elution followed by gradual release over 14 days.

When was Elutia's (ELUT) EluPro product commercially launched?

EluPro was commercially launched in the United States in January 2025.

What bacterial strains does Elutia's (ELUT) antibiotic envelope protect against?

The envelope protects against Staphylococcus aureus, methicillin-resistant Staphylococcus aureus (MRSA), Staphylococcus epidermidis, and other Gram positive and negative organisms.

What is unique about Elutia's (ELUT) EluPro product in the medical device market?

EluPro is the first and only FDA-cleared antibiotic-eluting bioenvelope designed for use with cardiac implanted electronic devices and neurostimulators.