Elutia Submits CanGarooRM® Antibiotic-Eluting Biomatrix for FDA Clearance

SILVER SPRING, Md., Dec. 18, 2023 -- Elutia Inc. (Nasdaq: ELUT) today announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its next-generation drug-eluting biomatrix product, CanGarooRM®. Tailored for use with cardiac implantable electronic devices (CIEDs), such as pacemakers and internal defibrillators, CanGarooRM addresses a $600 million market, currently served by only one competitor. The decision to file came after the Company received feedback from a pre-submission meeting with the FDA. The Company anticipates an approval decision in the first half of 2024 and is now preparing for commercial launch.

Dr. Michelle LeRoux Williams, Chief Scientific Officer of Elutia, highlighted the milestone, stating, “The CanGarooRM submission is a pivotal moment in advancing our antibiotic-eluting technology for patients with pacemakers and cardiac implants. Our goal has been to provide the FDA the high-quality data they need to reach a favorable decision, and I believe our research and regulatory teams have prepared a submission package that does just that. I offer my sincere thanks to all involved.”

CanGarooRM is a bioenvelope that stabilizes cardiovascular implantable electronic devices (CIED) such as pacemakers and neurostimulators. The envelope is made of a natural biomaterial that promotes a regenerative healing response, resulting in healthy vascularized tissue. CanGarooRM also contains a slow-release formulation of the powerful antibiotics, rifampin and minocycline, which have been shown to reduce bacterial colonization across a wide range of pathogens in preclinical testing.

Infections linked to pacemaker implantation present a significant medical challenge, impacting patient outcomes and escalating healthcare costs. On average, CIED infections elevate in-hospital mortality risk more than two-fold and add over $50,000 in healthcare expenses per event.

“We believe the clearance of CanGarooRM will be a transformational event for Elutia and allow patients to thrive without compromise,” said Dr. Randy Mills, President and CEO of Elutia. “The regenerative properties from our proprietary biologic matrix combined with the therapeutic effects of antibiotics create what we believe will be the best-in-class envelope in the established CIED market. Longer-term we plan to leverage this platform by developing products for adjacent markets with similar unmet needs, such as neurostimulation, wound care, and breast reconstruction.”

About Elutia

Elutia develops and commercializes biologic 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.