Elutia Inc. received FDA clearance for EluPro, an Antibiotic-Eluting BioEnvelope for cardiac and neurostimulator devices, enhancing patient outcomes, reducing complications, and opening significant new markets, solidifying its leadership in implantable electronic device protection and healthcare innovation.

United States: Elutia Inc., a leader in the development of drug-eluting biomatrix products, has achieved a significant milestone with the FDA clearance of its pioneering Antibiotic-Eluting BioEnvelope, EluPro (formerly known as CanGaroo RM). This innovative device is specifically designed to enhance patient outcomes following implantation of cardiac pacemakers and defibrillators, addressing common complications such as infection, migration, and skin erosion which impact up to five to seven percent of cases.

The clearance marks a pivotal moment for Elutia, as EluPro integrates advanced antibiotic therapy with cutting-edge tissue engineering. The BioEnvelope is engineered to gradually transform into a protective pocket of the patient's own tissue over time, mitigating long-term complications associated with foreign body response. This approach not only improves patient morbidity and mortality outcomes but also reduces hospitalization duration and healthcare costs, estimated to add over USD 50,000 per incident.

Development of EluPro commenced in 2019, underpinned by robust intellectual property protections extending beyond 2032, positioning it uniquely in the USD 600 million U.S. market for implantable electronic device protection. Beyond cardiac devices, EluPro has also received clearance for use with neurostimulators and neuromodulators used in conditions such as pain management, epilepsy, incontinence, and sleep apnea, expanding its market potential significantly into an estimated USD 8 billion global market previously underserved by drug-eluting biomatrix solutions.

The construction of EluPro involves layers of reinforced natural extracellular tissue matrix, ensuring optimal stability and conformity around implantable electronic devices. Infused with potent antibiotics rifampin and minocycline, EluPro facilitates sustained drug delivery directly to the surgical site long after closure, promoting the regeneration of healthy, vascularized tissue and reducing the risk of infection.

With more than 600,000 devices implanted annually in the U.S., EluPro addresses a critical need in improving the safety and efficacy of these procedures. Elutia plans to launch EluPro nationwide in the second half of 2024, focusing initially on the cardiac implantable electronic device (CIED) market while exploring opportunities in adjacent neurostimulation and modulation markets where complications from implantable devices are prevalent.

Elutia's mission is to advance humanized medicine by enhancing the compatibility between medical devices and patient physiology. By leveraging its expertise in drug-eluting biomatrix technology, Elutia aims to empower patients with implantable technologies that minimize risks and maximize therapeutic benefits. The company's strategic expansion into new markets underscores its commitment to addressing unmet medical needs and driving innovation in healthcare.

Dr. Benjamin D’Souza, Associate Professor of Medicine at the University of Pennsylvania and Section Chief of Cardiac Electrophysiology at Penn Presbyterian Medical Center said, “When I implant a pacemaker or defibrillator, minimizing the risk of any future complications is crucial. However, the body’s natural immunity can treat the device like a foreign object contributing to inflammation, causing device migration, potentially eroding through the skin, or sometimes causing a serious infection. Those are the specific problems EluPro was designed to solve. It combines the remodeling properties of regenerative medicine through extracellular matrix along with long-acting antibiotic delivery to create a healthy environment for every device implantation.”

Dr. Randy Mills, Elutia’s Chief Executive Officer Said, “post-operative infection, migration and erosion can result in significant morbidity and mortality for patients receiving a pacemaker or defibrillator. That is why we developed the antibiotic-eluting BioEnvelope. While the approval of EluPro is a major value inflection for Elutia, we believe it is just the tip of the iceberg. We have created a platform to protect patients from the foreign body response that can inevitably develop with any long-term implantable device. We intend to rapidly extend our product offering to other indications as we fulfill our mission to humanize medicine so patients can thrive without compromise.”