Conexeu Completes 12-Month P.R.O.O.F Study, Targets Q1 2027 510(k)
CNXU•Conexeu Sciences completed the P.R.O.O.F. phase of its 12-month preclinical CXU program, achieving facial, body and mechanical performance objectives across three evidence pillars. The company now plans a predicate-based 510(k) submission for its lead injectable aesthetic device candidate in Q1 2027 following required testing and documentation.
1. P.R.O.O.F Phase Completion
Conexeu finalized its 12-month P.R.O.O.F. (Performance and Regeneration Outcomes of Flowable Collagen) preclinical study for the CXU platform, reporting that it met predefined objectives across small-volume facial, large-volume body and mechanical performance pillars. The study used intradermal and subcutaneous animal models with histologic assessments, though detailed quantitative results remain reserved for peer-review.
2. Regulatory Pathway to 510(k)
With milestone objectives achieved, Conexeu plans to submit a predicate-based 510(k) application for its lead injectable aesthetic device candidate in Q1 2027. This regulatory step will depend on completing required biocompatibility testing, manufacturing scale-up, documentation and FDA review protocols.
3. Single-Formulation Platform Strategy
The CXU platform is anchored by a single collagen-based formulation and corresponding intellectual property framework designed to support host-tissue integration. Beyond medical aesthetics, the company has explored this scaffold in wound care and dental soft tissue, positioning the formulation as a versatile regenerative tissue solution.
