Conexeu Sciences Inc. (NASDAQ: CNXU) reported progress in manufacturing scale-up and standardized formulation methods for its CXU wound care device candidate. The company transferred standardized formulation methods to its contract development and manufacturing organization and is advancing manufacturing activities to support production for regulatory testing.

The company continues preparations for a planned 510(k) premarket notification submission to the U.S. Food and Drug Administration during the first quarter of 2027. Conexeu received FDA pre-submission feedback through the Q-Submission process that informed development planning for its wound care indication.

"Advancing a medical device platform toward regulatory submission requires far more than promising early science," said Miles Harrison, CEO and President of Conexeu Sciences. "It requires disciplined execution across manufacturing, analytical characterization, quality systems, preclinical testing, and regulatory strategy."

The manufacturing program is expected to support production of materials for analytical, chemical characterization, biocompatibility, sterilization, packaging, and other testing activities associated with the planned submission. The company is also developing manufacturing controls and documentation to support production scale-up.

Conexeu's product candidate is based on its CXU extracellular matrix platform, designed as a thermosensitive material that remains flowable during preparation and application, then transitions into a gel scaffold at body temperature. The company is evaluating manufacturing strategies to support future commercial scale production, pending successful completion of development activities and regulatory clearances.

The timing of the 510(k) submission may be affected by the results and timing of ongoing testing, manufacturing execution, supplier readiness, and regulatory considerations. A 510(k) is a premarket submission made to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.