Conexeu Sciences Issues Update On Regulatory And Manufacturing Program Supporting Planned FDA 510(k) Premarket Notification For Ten Minute Tissue, Lead Wound Care Device Candidate

Conexeu Sciences Inc. is advancing its regulatory and manufacturing program for its lead wound care device, Ten Minute Tissue™, with plans to submit a 510(k) premarket notification to the FDA in the first quarter of 2027. The company has successfully produced multiple scaled-up batches of its CXU™ material that met predefined specifications, which is crucial for both regulatory testing and future commercial production. This manufacturing scale-up is seen as a key step in transitioning the product from development to potential commercialization.