Elutia (Nasdaq:ELUT) announced today that it submitted a 510(k) premarket notification to the FDA for its drug-eluting biomatrix.
The company designed its next-generation CanGarooRM for use with cardiac implantable electronic devices like pacemakers and defibrillators. A bioenvelope, CanGarooRM stabilizes the implantable devices.
Made from a natural biomaterial that promotes a regenerative healing response, the biomatrix helps lead to healthy, vascularized tissue. It also contains a slow-release formulation of rifampin and minocycline. These powerful antibiotics have demonstrated the ability to reduce bacterial colonization across a range of pathogens in preclinical testing.
The porcine small intestine submucosa extracellular matrix creates a healthy pocket for implanted devices. Its Simpliderm pre-hydrated human acellular dermal matrix supports soft tissue repair in breast reconstruction. It enhances and supports the angiogenic process, providing a more pliable matrix. The implant results in a lower risk of inflammatory response, fast integration and rapid revascularization. In September, Elutia raised $26 million to support its technology.
Elutia said in a news release that it decided to file for clearance after receiving feedback from a pre-submission meeting with the FDA. It anticipates an approval decision in the first half of 2024. Elutia also said it began preparations for a commercial launch ahead of the expected decision.
“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.”