Elutia Announces First Patient Implant of EluPro™, the World’s First Drug-Eluting BioEnvelope for Cardiac Pacemakers and Neurostimulators

Elutia Inc. Press Release

SILVER SPRING, Md., Sept. 05, 2024 — Elutia Inc., a pioneer in drug-eluting biomatrix products, announced a landmark achievement with the first-ever patient implant of EluPro, the world’s first antibiotic-eluting biologic envelope cleared by the U.S. Food and Drug Administration (FDA). The groundbreaking procedure was performed by John Catanzaro, MD, MBA, Chief, Division of Cardiology, Director, Cardiology Services, and Program Director of Clinical Cardiac Electrophysiology Fellowship at East Carolina University Health Medical Center in Greenville, North Carolina.

“We are honored to be the first facility to implant EluPro,” said Dr. Catanzaro. “With its combination of proven antibiotics and biomatrix with demonstrated regenerative benefits, EluPro offers a more natural solution to reduce post-operative complications. This is a significant advancement in patient care, providing enhanced protection and peace of mind for patients needing a pacemaker or defibrillator.”

Achieving this milestone demonstrates Elutia’s ability to deliver on its commitment to advancing healthcare with innovative solutions that address device complications.

“Our mission is to humanize medicine so patients can thrive without compromise, and today, we made significant progress toward fulfilling that promise,” said Dr. Randy Mills, Elutia’s Chief Executive Officer. “Today’s milestone is a testament to the team’s relentless pursuit of better patient outcomes and I want to thank the entire Elutia CRU. With EluPro, physicians finally have a biologic antibiotic-eluting envelope to protect their patients, and we look forward to its full commercial launch in January 2025.”

EluPro is designed to prevent post-operative complications in patients with cardiac implantable devices such as pacemakers and internal defibrillators. Cleared by the FDA in June 2024, it is also approved for use with additional devices, including neuromodulators and neurostimulators for pain management, epilepsy, incontinence, and sleep apnea.

The launch of EluPro presents a major opportunity in the $600 million U.S. implantable electronic device protection market, which has previously been served by a single competitor with a synthetic envelope. In addition to establishing a strong presence in the broader $8 billion cardiac rhythm management market, Elutia is also targeting adjacent neurostimulation and modulation sectors, which represent another $8 billion opportunity.

For more information about EluPro, visit https://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.