Elutia launches EluPro™ Nationwide amid strong early demand.

Elutia Inc., a pioneer in drug-eluting biomatrix technologies, announced the U.S. commercial launch of EluPro™, the first and only FDA-cleared antibiotic-eluting biomatrix designed for use with cardiac implantable electronic devices (CIEDs) and neurostimulators.

“EluPro is an exciting innovation that addresses two critical challenges for patients with implantable devices: preventing infection and promoting healthy healing of the surgical pocket,” said Sunil Kapur, M.D., Cardiac Electrophysiologist at Brigham and Women’s Hospital. “The unique combination of powerful antibiotic protection and natural biomatrix technology represents a significant step forward in improving outcomes for patients. I am eager to see this technology benefit the field of electrophysiology.”

This full launch follows a successful pilot program in which EluPro was introduced at select hospitals, demonstrating strong physician adoption and positive patient outcomes. During this initial phase, Elutia has submitted EluPro for approval with 136 hospital value analysis committees (VACs), initiated sales at 70 institutions and established key relationships with four prominent group purchasing organizations (GPOs), including Premier and S3P. In an early indication of positive customer reception, envelope orders have increased over 50% in accounts following EluPro VAC approval.

"The launch of EluPro represents a significant advance in care for patients with CIEDs and neurostimulators," announced Dr. Randy Mills, CEO of Elutia. "Our successful pilot program confirmed EluPro’s substantial potential, marked by expeditious navigation of GPO and value analysis committee approvals and strong initial demand by physicians. I am proud of the Elutia CRU for their relentless efforts as we expand EluPro’s reach to benefit all patients in need of our groundbreaking technology."

Each year, more than 600,000 CIEDs are implanted in the U.S., with complication rates of 5-7%, including infections linked to higher morbidity and mortality. EluPro is cleared for use across all major CIED brands including pacemakers and implantable defibrillators, as well as for a wide range of neurostimulation devices. Unlike synthetic alternatives, EluPro addresses this critical need by combining the trusted antibiotics rifampin and minocycline with a soft, regenerative biomatrix that promotes healing, and mitigates other complications such as migration and erosion. The CIED protection market is valued at $600 million in the U.S.