Conexeu Sciences Advances Ten Minute Tissue™ Toward Planned FDA 510(k) Submission
Conexeu Sciences reports progress on manufacturing scale-up, preclinical testing, and regulatory preparations for a planned FDA 510(k) premarket notification for Ten Minute Tissue™ with an intended submission in the first quarter of 2027. The company says multiple scaled-up batches met predefined specifications and that it has engaged the FDA through the Q-Submission process.