New Evidence Supports the Value of Elutia’s Antibiotic-Eluting Platform for Implantable Devices

Rhea-AI Summary

Elutia (NASDAQ: ELUT) announced new study results supporting the effectiveness of its EluPro BioEnvelope, an antibiotic-eluting device for cardiac implantable electronic devices (CIEDs). The study, published in the Journal of Functional Biomaterials, demonstrated that EluPro's biomatrix effectively controls inflammation and supports vascularization.

Research from the Cumming School of Medicine showed that EluPro stimulates early proangiogenic signals and reduces fibrosis over time. The study revealed significantly higher levels of growth and wound healing factors compared to controls (p<0.001), with long-term animal studies demonstrating improved blood vessel formation and reduced inflammation over a 26-week period.

EluPro, which received FDA clearance and was commercially launched in the United States in January 2025, is the first and only antibiotic-eluting bioenvelope approved for use with CIEDs and neurostimulators.

Positive

• First and only FDA-cleared antibiotic-eluting bioenvelope for CIEDs and neurostimulators
• Demonstrated significantly higher levels of growth and wound healing factors compared to controls (p<0.001)
• Showed superior healing response with reduced inflammation and scarring over 26-week period
• Successfully launched commercially in January 2025

Negative

• None.

Insights

Medical Device Research Analyst

Elutia's EluPro research shows superior healing effects over conventional materials, strengthening its market position in the growing CIED sector.

The newly published study in the Journal of Functional Biomaterials provides significant validation for Elutia's EluPro BioEnvelope technology. The research demonstrates that the company's antibiotic-eluting envelope for cardiac implantable electronic devices (CIEDs) promotes healthier tissue integration through early proangiogenic signaling while simultaneously reducing fibrosis.

The data shows quantifiable superiority over synthetic alternatives, with fibroblasts releasing significantly higher levels of growth and wound healing factors in the biomatrix environment (p<0.001). Long-term animal studies further validated these findings over a 26-week period, showing enhanced blood vessel formation and reduced inflammation and scarring.

This research provides essential clinical differentiation for EluPro, which received FDA clearance and was commercially launched in January 2025. The technology addresses two critical challenges in CIED implantation: infection risk and fibrotic encapsulation, which can lead to device malfunction and patient complications.

From a market perspective, this validation comes at a strategic time as the CIED market continues to grow with an aging population and expanding indications for pacemakers and defibrillators. The company's indication that it plans to expand this platform to other high-impact applications suggests a broader commercial strategy that could substantially expand Elutia's addressable market.

— The EluPro BioEnvelope findings demonstrate the bioactive properties and superior healing response compared to synthetic materials for cardiac implantable electronic devices (CIEDs) —

GAITHERSBURG, Md., July 01, 2025 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix technologies, today announced the publication of a new study describing the bioinductive effects of its antibiotic-eluting CIED biologic envelope in the Journal of Functional Biomaterials. Researchers from the Department of Cardiac Sciences at the Cumming School of Medicine found that the biomatrix in EluPro controlled inflammation and supported vascularization, key to a healthy device pocket with less scarring and risk of infection.

Formation of a fibrotic capsule and bacterial colonization are known precursors to pocket infection, which can compromise both near-term procedural success and long-term pocket health following CIED implantation. The preclinical study demonstrated that EluPro stimulates early proangiogenic signals and reduced fibrosis over time.

“What’s compelling is that we’re seeing not just a signal, but a clear biological effect,” said Dr. Paul W.M. Fedak, a professor and cardiac surgeon-scientist, and Director, Libin Cardiovascular Institute, Cumming School of Medicine, University of Calgary. “The EluPro BioEnvelope initiates early proangiogenic signaling that promotes vascularization and healthier tissue integration — while simultaneously reducing fibrosis over time. This dual regenerative and protective response represents a meaningful step forward in improving outcomes for patients with implantable cardiac devices.”

In mechanistic studies, fibroblasts, cells critical for tissue repair and healing, released significantly higher levels of growth and wound healing factors in the biomatrix environment compared to controls (p<0.001). These effects were further supported by long-term animal studies, where the biomatrix promoted blood vessel formation (angiogenesis) and reduced inflammation and scarring over a 26-week period. In contrast, synthetic polymer materials exhibited persistent inflammation and fibrosis.

“These findings support the potential of our proprietary drug-eluting biomaterial platform to address the root causes of implant-related complications,” said Michelle LeRoux Williams, Ph.D., Elutia’s Chief Scientific Officer. “EluPro supports healthy, non-pathologic healing and delivers targeted antibiotic protection. We’re committed to expanding this platform to other high-impact indications where patients can benefit from more active, biologic solutions.”

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 future success of EluPro and the potential of Elutia’s proprietary drug-eluting biomaterial platform, including expectations regarding surgeon and patient confidence in choosing such products. 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

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

FAQ

What are the key findings of Elutia's (ELUT) EluPro BioEnvelope study?

The study showed that EluPro's biomatrix controls inflammation, supports vascularization, stimulates early proangiogenic signals, and reduces fibrosis over time, with significantly higher levels of growth and wound healing factors compared to controls (p<0.001).

When did Elutia (ELUT) launch EluPro commercially in the United States?

EluPro was commercially launched in the United States in January 2025 following FDA clearance.

What makes Elutia's (ELUT) EluPro unique in the medical device market?

EluPro is the first and only FDA-cleared antibiotic-eluting bioenvelope designed specifically for use with cardiac implantable electronic devices (CIEDs) and neurostimulators.

How long was the animal study period for Elutia's (ELUT) EluPro device?

The long-term animal studies demonstrated improved blood vessel formation and reduced inflammation over a 26-week period.

What are the main benefits of Elutia's (ELUT) EluPro BioEnvelope?

EluPro supports healthy, non-pathologic healing, delivers targeted antibiotic protection, promotes blood vessel formation, and reduces inflammation and scarring compared to synthetic materials.