Elutia Inc. 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, CanGaroo. 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. 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.