Conexeu Sciences Inc.
For the period ended Jul 7, 2026. Filed Jul 7, 2026.
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A notice of a major event between regular reports, such as results, a deal or a change of executives. It is often the first formal record of the news.
Jul 7, 2026 · Filed Jul 7, 2026
Contents
Study Highlights
P.R.O.O.F study complete, marking an important catalyst. Conexeu has completed its P.R.O.O.F (Performance and Regeneration Outcomes of Flowable Collagen) preclinical program, which provides the evidence base behind the CXU™ platform's development direction and the Company's planned move into the medical aesthetics injectable market.
What the study showed. Conexeu's 12-month preclinical study demonstrated: (i) objectives met for tissue restoration in a small-volume facial model, specifically the cheek; (ii) objectives met for tissue restoration in a large-volume, 200cc-equivalent model; and (iii) performance benchmarks met for a deliverable injectable. Full 12-month results are being prepared for peer-reviewed publication.
What the benchmarks mean. To meet the minimum market standard for an aesthetic injectable, a material must clear two key mechanical thresholds: (i) injectability, meaning it can flow through a fine-gauge needle for precise placement; and (ii) volumizing performance, meaning it can hold shape and fullness after placement. CXU™ met both benchmarks. Full 12-month results are being prepared for peer-reviewed publication.
The demand driver. The GLP-1 weight-loss drug market, the category behind Ozempic® and Wegovy®, reached roughly $79 billion in 2025 and is projected to more than double to approximately $190 billion by 2035.²,³
The opening. The same weight-loss wave driving GLP-1 adoption has also exposed a tissue-restoration gap that today's aesthetics tools were not specifically designed to fill. That market gap is expected to nearly triple, from approximately $0.7 billion to $2.0 billion by 2030.³,⁴
One platform, and a faster first path. CXU™ is being developed as a platform, not a single product. It is based on one formulation protected by a multi-jurisdictional patent estate spanning more than 40 jurisdictions, including the U.S., EU, Japan, and Australia, with protection pending in Canada. The Company plans to enter through a predicate-based 510(k) pathway in wound care, which targets a 90-day FDA review rather than the multi-year studies typically required for a new category, with submission planned for Q1 2027. That first clearance is expected to provide the foundation for the Company's planned expansion into aesthetics.
"Our first regulatory step is a predicate-based 510(k) in wound care, which is intended to serve as the foundation for our planned move into aesthetics," said Miles Harrison, President and CEO of Conexeu Sciences. "GLP-1 is one of the defining medical stories of a generation. Its success has created an entirely new patient profile: people whose bodies have changed faster than the aesthetics industry was built to address. We believe no existing injectable was designed specifically for that gap. This phase of our preclinical program gives us an evidence base to continue advancing CXU™ toward that opportunity."
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The Catalyst: What P.R.O.O.F Means
P.R.O.O.F, or Performance and Regeneration Outcomes of Flowable Collagen, is Conexeu's 12-month preclinical study and an important milestone in the development of the CXU™ platform. It does not represent a commercial launch or regulatory clearance. Instead, it marks the point at which the Company has completed a preclinical evidence package intended to support its continued advancement toward medical aesthetics.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.