Conexeu Sciences Advances Ten Minute Tissue™ Toward Planned FDA 510(k) Submission
Key Highlights
- ➤Q1 2027 FDA 510(k) submission remains on track for Ten Minute Tissue™
- ➤Multiple scaled-up CXU™ batches met predefined material and performance specifications
- ➤Preclinical wound studies advance toward substantial-equivalence evidence for FDA review
- ➤FDA Q-Submission feedback incorporated into ongoing regulatory planning
- ➤Ten Minute Tissue™ remains investigational and is not FDA-cleared or approved
Expert Statements
Miles Harrison, President and CEO of Conexeu
“We have moved from process development to implementing a controlled manufacturing process”
Miles Harrison, President and CEO of Conexeu
“That progress is important for two reasons. First, it supports the regulatory testing required to advance our planned FDA 510(k) submission. Second, it moves us closer to establishing the scalable manufacturing infrastructure needed to support commercialization. We believe manufacturing scale-up is one of the critical bridges between regulatory development and our ability to ultimately bring our lead device to market.”
Brian Pilcher, Chief Medical Officer of Conexeu
“Wherever appropriate, we are running these workstreams at the same time rather than one after another, using representative test materials made with our controlled manufacturing process”
Brian Pilcher, Chief Medical Officer of Conexeu
“This approach keeps our planned first-quarter 2027 submission on track while maintaining the consistency that regulatory testing requires.”
* 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.
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