Conexeu Sciences Tracks Q1 2027 FDA 510(k) Filing for Ten Minute Tissue Wound Device

Conexeu Sciences Inc. (CNXU) said it remains on track to submit an FDA 510(k) premarket notification for its lead wound care device candidate, Ten Minute Tissue, in the first quarter of 2027, as it advances manufacturing scale-up, regulatory testing and preclinical work. The company said multiple scaled-up batches of CXU material met predefined specifications for key material characteristics and product performance measures. It is producing representative samples to support planned preclinical, biocompatibility, chemical characterization and stability testing, alongside preclinical wound model studies to support substantial equivalence to an identified predicate device. Conexeu said it has received FDA feedback through the Q-Submission process and is incorporating the agency's guidance into development and regulatory planning. Ten Minute Tissue, based on the CXU extracellular matrix platform, remains liquid at room temperature before gelling at body temperature in about 10 minutes. CNXU shares closed Friday at $3.12, up 0.65%. In premarket trading, the stock rose 4.17% to $3.25.