Elutia Inc.

Elutia said it expects FDA clearance for its NXT-41x product in the first half of 2027 and reiterated expectations for NXT-41 clearance in the fourth quarter of 2026. The company also announced up to $26 million of additional capital with no equity offering and a definitive agreement to sell SimpliDerm for up to $11 million. Second quarter net sales were $2.4 million, down from $2.7 million a year earlier, while GAAP gross margin improved to 59.6% from 52.9%. Management said it targets gross margins greater than 80% at scale and expects at least $300 million of revenue capacity at launch. A blinded survey of 50 plastic and reconstructive surgeons found 96% expressed interest in adopting NXT-41x and 92% would champion it at their hospital's value analysis committee.

Elutia has signed a definitive agreement to sell its SimpliDerm human acellular dermal matrix business to Cellution Biologics for total consideration of up to $11 million. Elutia will receive $8 million in cash at closing, along with up to $3 million in technology transfer and commercial milestone payments over the next 18 months. The deal is expected to close in the second half of 2026, subject to customary closing conditions. The divestiture aligns with Elutia's strategy to focus resources on NXT-41x, its antibiotic-eluting biomatrix in development for the $1.5 billion U.S. plastic and reconstructive surgery market. Proceeds further strengthen Elutia's balance sheet without equity dilution and provide additional capital to support a planned commercial launch in 2027. Elutia stock closed Thursday at $0.95, down 1.03%, and fell a further 3.52% in pre-market trading to $0.91.