Conex Completes 12-Month P.R.O.O.F Preclinical Study, Targets Q1 2027 510(k) for Wound Care

Conex completed its 12-month P.R.O.O.F preclinical study for the CXU platform, meeting tissue-restoration and injectable performance benchmarks.

Key Highlights:

• P.R.O.O.F study complete, providing the preclinical evidence base to advance CXU toward medical aesthetics.
• 12-month results met objectives: cheek (small-volume) and 200cc-equivalent (large-volume) tissue restoration.
• CXU met injectability and volumizing benchmarks required for aesthetic injectables; full results for publication underway.
• Company plans a predicate-based 510(k) submission for a wound-care device in Q1 2027 to enable initial commercial pathway.
• Platform protected by patents in 40+ jurisdictions; wound-care clearance expected to support later expansion into aesthetics.

Original SEC Filing:

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