• Company advances manufacturing scale-up, regulatory testing and preclinical work supporting its planned FDA 510(k) submission in the first quarter of 2027.
     
  • Multiple scaled-up batches of CXU™ material met predefined specifications, supporting both regulatory testing and future commercial production.



RENO, Nev., Oct. 06, 2026 (GLOBE NEWSWIRE) -- Conexeu Sciences Inc. (NASDAQ:CNXU) ("Conexeu" or the "Company"), a preclinical-stage medical device and regenerative medicine company advancing CXU™, an investigational tissue-restoration platform, today provided an update on the regulatory and manufacturing program supporting its planned U.S. Food and Drug Administration ("FDA") 510(k) premarket notification for Ten Minute Tissue™, its lead wound care device candidate, as well as on the Company's broader preparations for commercialization.

The Company is conducting manufacturing, testing, and preclinical work intended to support its planned FDA 510(k) submission. Conexeu remains on track to make the submission in the first calendar quarter of 2027.

The Company views manufacturing scale-up as a key stage in the transition of Ten Minute Tissue™ from a development-stage product candidate toward a potential commercial product. Establishing a controlled and reproducible manufacturing process is expected to support not only the generation of representative materials for regulatory testing, but also the development of supply capabilities intended to meet future market demand subject to FDA clearance.

Recent manufacturing activities represent an important step forward in the program. Following process-development work, multiple scaled-up batches of CXU™ material met predefined Company specifications for key material characteristics and product performance measures.