- Conexeu Sciences has transferred standardized formulation methods for its CXU™ wound care device candidate to its CDMO and is advancing manufacturing scale-up activities to support regulatory testing.
- The company continues preparations for a planned FDA 510(k) premarket notification submission in the first quarter of 2027.
Conexeu Sciences Inc. announced progress in manufacturing scale-up and formulation standardization activities for its lead CXU™ wound care device candidate as it prepares for a planned 510(k) premarket notification submission to the U.S. Food and Drug Administration (FDA) in the first quarter of 2027. The company said it has transferred standardized formulation methods to its CDMO and is advancing manufacturing activities intended to support production for regulatory testing.
According to the company, the program continued its transition during 2026 from research-stage development to manufacturing, testing, and regulatory execution activities. Conexeu said the manufacturing program is expected to support production of materials for analytical, chemical characterization, biocompatibility, sterilization, packaging, and other testing associated with the planned submission.
The company also reported receiving FDA pre-submission feedback through the Q-Submission process for its initial wound care indication. Conexeu noted that such feedback is advisory and does not represent a determination of substantial equivalence, marketing clearance, or approval. Manufacturing, testing, packaging, sterilization, and documentation activities are ongoing to support the planned 510(k) submission.
“Advancing a medical device platform toward regulatory submission requires far more than promising early science. It requires disciplined execution across manufacturing, analytical characterization, quality systems, preclinical testing, and regulatory strategy.”
Miles Harrison, CEO and President of Conexeu Sciences
Conexeu’s lead product candidate is based on its proprietary CXU™ extracellular matrix platform, designed as a thermosensitive extracellular matrix that remains flowable during preparation and application before transitioning into a gel scaffold at body temperature. The company said it is also evaluating manufacturing strategies to support future commercial-scale production, subject to successful development activities and receipt of required regulatory clearances. Conexeu continues to target a first-quarter 2027 510(k) submission, although timing may be affected by testing results, manufacturing execution, supplier readiness, and regulatory considerations.
