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NXT-41 is a next-generation biologic scaffold developed by Elutia (formerly Aziyo Biologics) as part of its proprietary drug-eluting biologics platform. It is a "base biologic" matrix composed of porcine small intestine submucosa (SIS), designed to provide a regenerative extracellular matrix (ECM) that supports tissue repair and remodeling. NXT-41 is primarily intended for use as an envelope for implanted medical devices, such as cardiac implantable electronic devices (CIEDs) and neurostimulators, to promote healthy tissue integration and reduce the risk of complications. It serves as the structural foundation for NXT-41x, a drug-eluting version of the scaffold that incorporates gentamicin to prevent post-operative infections. Elutia submitted a 510(k) application for NXT-41 to the FDA in 2024, with clearance anticipated in the second half of 2026.
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