Elutia announces FDA clearance of EluPro: the first antibiotic-eluting bioenvelope designed to protect patients with pacemakers and implantable defibrillators

June 17, 2024 — Elutia Inc., a pioneer in drug-eluting biomatrix products, today announced that its antibiotic-eluting bioenvelope, EluPro (called CanGaroo during development), has received clearance from the Food and United States Drug Administration (FDA). . Specially designed to prevent post-operative complications for devices such as pacemakers and defibrillators, EluPro incorporates powerful antibiotic therapy combined with advanced tissue engineering to create a BioEnvelope that, over time, regenerates into a protective pocket of the tissue’s own of the patient. Infection, migration, and skin erosion are among the most common complications encountered during pacemaker surgery, occurring in five to seven percent of cases. These cause significant morbidity and mortality for patients, increase length of hospitalization, and can add more than $50,000 to health care costs per event. In development since 2019 and protected by intellectual property extending beyond 2032, EluPro is the only biologics offering in the $600 million U.S. implantable electronic device protection market.

The company also announced that EluPro has received approval for indications beyond cardiac implantable electronic devices (CIEDs), including neurostimulators and neuromodulators used for pain management, epilepsy, incontinence and Sleep Apnea. These additional markets, estimated at $8 billion globally, were not previously served by a drug-eluting biomatrix and present significant additional growth opportunities for EluPro.

“When I implant a pacemaker or defibrillator, it is crucial to minimize the risk of future complications,” said Dr. Benjamin D’Souza, associate professor of medicine at the University of Pennsylvania and section chief of electrophysiology. heart at Penn Presbyterian Medical Center. “However, the body’s natural immunity may treat the device as a foreign body contributing to inflammation, causing device migration, potential skin erosion, or sometimes causing serious infection. These are the specific problems EluPro was designed to address. It combines the remodeling properties of regenerative medicine via extracellular matrix along with the delivery of long-acting antibiotics to create a healthy environment for each device implantation.

The EluPro BioEnvelope is constructed from reinforced layers of natural extracellular tissue matrix and designed to create a conformal envelope with optimal stability for implantable electronic devices. The walls of EluPro are embedded with powerful antibiotics rifampin and minocycline, designed for prolonged delivery directly into the surgical site long after closure. This unique combination of drug and biomatrix promotes the regeneration of a healthy, vascularized pocket from the patient’s own tissues, thereby mitigating a long-term foreign body response.

“Postoperative infections, migrations and erosions can cause significant morbidity and mortality for patients receiving a pacemaker or defibrillator. That’s why we developed the antibiotic-eluting BioEnvelope,” said Dr. Randy Mills, President and CEO of Elutia. “While the approval of EluPro represents a major inflection point in value for Elutia, we believe it is just the tip of the iceberg. We have created a platform to protect patients from the foreign body reaction that can inevitably develop with any long-term implantable device. We intend to rapidly expand our product offerings to additional indications as we fulfill our mission to humanize medicine so that patients can thrive without compromise.

EluPro represents a significant opportunity in the $600 million U.S. implantable electronic device protection market previously served by a single competitor. With more than 600,000 devices implanted each year in the United States, EluPro addresses significant complications resulting from these procedures. Elutia plans to launch EluPro in the domestic CIED market in the second half of 2024 and is prioritizing adjacent markets in the field of neurostimulation and modulation, where implantable medical devices result in high rates of treatable complications.

For more information: www.Elutia.com