CXU™ formula already evaluated with human collagen in the 12-month P.R.O.O.F.™ preclinical study; first pilot batch of Conexeu’s own human collagen met predefined Company specifications
Highlights
Conexeu has launched a human collagen initiative at its Vancouver research and development facility, for its aesthetics program, focused on potential tissue-restoration applications associated with aging and significant weight loss, including GLP-1-associated weight loss.
- The patented CXU™ formula has already been evaluated with human collagen from various sources in the 12-month P.R.O.O.F.™ preclinical study, which met its objectives in facial and large-volume models.
- Conexeu’s first pilot batch of its own human collagen met predefined Company specifications, a first step toward controlling quality from the ingredient to the finished device.
- CXU™ is being developed as a temporary collagen-based scaffold intended to provide structural support while host tissue interacts with and remodels the matrix, a different design concept from conventional dermal fillers used primarily for volumization or biostimulation.
- Conexeu continues to target its planned FDA 510(k) submission for device candidate CXU™ in the first calendar quarter of 2027, subject to successful completion of required testing, manufacturing activities and regulatory documentation.
RENO, Nev., Nov. 10, 2026 (GLOBE NEWSWIRE) — Conexeu Sciences Inc. (Nasdaq: CNXU) (“Conexeu” or the “Company”), a preclinical-stage medical device and regenerative medicine company advancing CXU™, an investigational tissue-restoration platform, today announced a human collagen program for regenerative aesthetics, starting with the production of its first pilot batch of human type I collagen.
Demand for tissue restoration is rising with aging and with GLP-1 weight loss. The GLP-1 drug market was estimated at roughly $79 billion in 2025 and is projected to reach about $190 billion by 2035,[1] and aesthetic provider revenue tied to GLP-1 weight loss is projected to grow from about $0.7 billion in 2025 to $2.0 billion by 2030.[2] FDA-approved dermal fillers work by filling space, prompting the body to make new collagen, or both, and FDA has approved collagen-prompting fillers since the mid-2000s.[3][4][5] CXU™ is designed to work differently, as a temporary scaffold the body remodels into its own tissue.
“GLP-1 has created a new patient profile: people whose bodies have changed faster than today’s aesthetic injectables were built to address, and restoring that tissue takes more than volume,” said Miles Harrison, President and Chief Executive Officer of Conexeu Sciences. “Human collagen is an important ingredient, but on its own it does not recreate the complexity of native extracellular matrix. We believe the patented CXU™ formula provides a broader ECM framework than collagen alone and may offer a differentiated scaffold-based approach to aesthetics, based on more than a decade of university research and more than two years of development at Conexeu. That is why we believe we are well positioned to bring human collagen into aesthetics.”
Human collagen has been used in aesthetics before, as a single-component filler. Conexeu uses collagen as the foundation of CXU™, a multi-component scaffold formulation designed to mimic the body’s own matrix, the framework that holds tissue together.
Ten Minute Tissue™, our lead device candidate, continues to target a planned 510(k) submission in the first calendar quarter of 2027, subject to successful completion of required testing, manufacturing activities and regulatory documentation, and informs the Company’s human collagen program. Subject to FDA clearance, wound care is expected to be the Company’s first commercial indication, and any CXU™ product made with human collagen would require separate regulatory review.
The evidence
In the 12-month P.R.O.O.F.™ (Performance and Regeneration Outcomes of Flowable Collagen) preclinical study, the CXU™ formula, prepared with human collagen from various third-party sources, met its objectives in a small-volume injectable model and a 200cc-equivalent large-volume injectable model, and met predefined benchmarks for injectability and volumizing performance.[6][7] Full results are being prepared for peer-reviewed publication.
To the Company’s knowledge, GMP-grade human type I collagen suitable for injectable devices is not yet broadly available at commercial scale. In physicochemical characterization testing, Conexeu’s first pilot batch of its own human type I collagen met predefined Company specifications for identity and structure, including the protein pattern expected for type I collagen and fibril formation, the self-assembly step that comes before gel formation.[8]
“CXU™ is designed to go in as a liquid, set into a gel at body temperature, and become a temporary scaffold that the body’s own cells move into and remodel. In our 12-month P.R.O.O.F.™ study, the formula met its objectives with human collagen from multiple sources. Our first pilot batch is an early step toward making human collagen ourselves, to our own specifications,” said Dr. Claudia Chavez-Munoz, Chief Scientific Officer of Conexeu Sciences.
The human collagen described in this release is a development-stage material. It is not part of any device submitted to, or cleared or approved by, the FDA. In addition, P.R.O.O.F.™ is a preclinical, animal-model study, and preclinical results are not necessarily predictive of results in humans. Characterization results are from internal, unpublished testing of a single pilot batch and have not been independently verified or peer-reviewed.
About Conexeu Sciences Inc.
Architecting Bioregeneration™. Conexeu Sciences is a preclinical-stage medical device and regenerative medicine company. Our patented extracellular matrix (ECM) platform, CXU™, is built on a single structural principle and is designed to support bioregeneration: one formula, one device, designed to scale across multiple addressable markets.
Conexeu is targeting large, multi-billion-dollar end markets, including wound care, periodontal applications, and facial and body tissue restoration, including the tissue changes that can follow GLP-1 weight loss, with further expansion opportunities in 3D printing and biofabrication workflows and the veterinary market. The Company is advancing a predicate-based U.S. regulatory strategy with an anticipated 510(k) submission in the first calendar quarter of 2027 for its initial indication, subject to regulatory review.
Conexeu is led by an experienced leadership team with deep expertise in biomaterials, regenerative medicine, and medical device commercialization and development.
About CXU™
CXU™ is designed to support soft tissue lost through injury, aging, and the tissue changes that can follow GLP-1 weight loss. The Company’s lead device candidate, Ten Minute Tissue™, is a thermosensitive scaffold that remains fluid at room temperature and is designed to transition to a stable gel in situ at body temperature within approximately ten minutes. In preclinical research, Ten Minute Tissue™ has been characterized for host cell infiltration, vascular ingrowth, organized remodeling, and a low-inflammatory profile, conditions intended to support restoration.[9]
The platform is grounded in more than a decade of university preclinical research and protected by a multi-jurisdictional patent estate spanning more than 40 jurisdictions (U.S., EU, Japan, and Australia, with protection pending in Canada). Conexeu owns the platform IP, holding all rights, title, and interest, with no royalty or licensing obligations, and intends to expand across new indications and markets.
Sources
[1] Morgan Stanley, weight-loss drug (GLP-1) market outlook (roughly $79B in 2025 to approximately $190B by 2035).
[2] Boston Consulting Group, Five Growth Imperatives for Medical Aesthetics in Times of Uncertainty, August 2025 (GLP-1-related aesthetic provider revenue $0.7B in 2025 to $2.0B by 2030).
[3] Haddad S, Galadari H, Patil A, Goldust M, Al Salam S, Guida S. Evaluation of the biostimulatory effects and the level of neocollagenesis of dermal fillers: a review. Int J Dermatol. 2022;61(10):1284-1288. doi:10.1111/ijd.16229
[4] US Food and Drug Administration. Summary of Safety and Effectiveness Data, PMA P030050/S039 (Sculptra). April 18, 2023. https://www.accessdata.fda.gov/cdrh_docs/pdf3/P030050S039B.pdf
[5] US Food and Drug Administration. Premarket Approval P050052, Radiesse. Decision date December 22, 2006. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P050052
[6] Conexeu Sciences, “A $190 Billion Weight-Loss Boom Has Exposed a Tissue-Restoration Gap Today’s Injectables Were Not Built to Fill,” GlobeNewswire, July 7, 2026. https://www.globenewswire.com/news-release/2026/07/07/3323250/0/en/a-190-billion-weight-loss-boom-has-exposed-a-tissue-restoration-gap-today-s-injectables-were-not-built-to-fill.html
[7] Conexeu Sciences, “The GLP-1s Are Creating Another Boom, a New $2 Billion Opportunity Exists in Aesthetics. Conexeu Is Building for It,” GlobeNewswire, July 14, 2026. https://www.theglobeandmail.com/investing/markets/stocks/CNXU/pressreleases/3272625/the-glp-1s-are-creating-another-boom-a-new-2-billion-opportunity-exists-in-aesthetics-conexeu-is-building-for-it/
[8] Supporting data is on file with the Company.
[9] Hartwell R., Leung V., Chavez-Munoz C., et al. A novel hydrogel-collagen composite improves functionality of an injectable extracellular matrix. Acta Biomaterialia (2011); 7; 3060-3069 (The cited study is preclinical. Preclinical results are not necessarily predictive of clinical outcomes. Ten Minute Tissue™ is an investigational device and has not been cleared or approved by the U.S. Food and Drug Administration. The cited study did not evaluate CXU™ specifically in wound care indications; wound care applications represent the design-intent application of the underlying CXU™ platform, and supporting evidence in indication-specific preclinical models is being developed by the Company).
Trademarks. CXU™, Ten Minute Tissue™, and Architecting Bioregeneration™ are trademarks of Conexeu Sciences Inc. Radiesse® is a registered trademark of its respective owner.
Investor and Media Contacts:
Media@Conexeu.com
(424) 333-5622 Ext. 5
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josh.barer@astrpartners.com
908-578-6478
Safe Harbor Statement
Except for the statements of historical fact contained herein, the information presented in this news release constitutes “forward-looking statements” as such term is used in applicable United States securities laws. These statements relate to analysis and other information that are based on forecasts or future results, estimates of amounts not yet determinable, and assumptions of management, including, but not limited to, statements regarding the Company’s human collagen program, including the production, testing, scale-up, sterile processing and potential use of human type I collagen in the CXU™ platform, regulatory pathway, submission timing, category development and platform expansion. Any other statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions or future events or performance (often, but not always, using words or phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “estimates” or “intends”, or stating that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved) are not statements of historical fact and should be viewed as “forward-looking statements”. We have based these forward-looking statements on our current expectations about future events or performance. While we believe these expectations are reasonable, such forward-looking statements are inherently subject to risks and uncertainties, many of which are beyond our control. Our actual future results may differ materially from those discussed or implied in our forward-looking statements for various reasons. Factors that could contribute to such differences include, but are not limited to: international, national and local general economic and market conditions; demographic changes; the early-stage, preclinical nature of the Company’s device candidates, including B.R.E.A.S.T.™ and Ten Minute Tissue™, and the inherent uncertainty of preclinical and clinical development, including the possibility that preclinical results may not be predictive of clinical outcomes; preclinical study objectives described as met may not result in clinical benefit, regulatory clearance, or commercial success; third party market estimates disclosed herein, including GLP-1, aesthetics and injectable market figures may prove inaccurate or may not reflect the Company’s addressable market; the investigational status of CXU™, which is not cleared or approved for marketing in any jurisdiction, and that no assurance can be given that any such clearance or approval will be obtained; risks associated with the Company’s planned 510(k) submission, including the possibility that the submission may not be completed within the anticipated first-quarter 2027 timeframe or at all; the risk that the FDA may not accept the 510(k) submission as filed, may request additional information, data, or testing, or may determine that the device is not substantially equivalent to the identified predicate device; the risk that marketing clearance for the CXU™ wound-care device may not be obtained, may be delayed, or may be subject to conditions or limitations that affect the Company’s commercial plans; changes in FDA regulatory policy, guidance, or review standards applicable to 510(k) submissions or the Company’s identified predicate devices; the ability of the Company to sustain, manage or forecast its growth; the ability of the Company to develop and commercialize its products; the ability of the Company to raise capital to complete its plans and fund its operations; the risk that the Company’s human collagen program may not achieve the yield, consistency, purity, sterility or scale required for use in a medical device; the risk that results from internal testing of an initial batch may not be reproduced in subsequent batches or in independent testing; the risk that any CXU™ product incorporating human collagen will require separate regulatory review and may not be cleared or approved; risks related to the sourcing, qualification and regulatory requirements applicable to human-derived biological materials; the continued availability of key leadership personnel; adverse publicity; competition and changes in the advanced wound care market, medical aesthetics market and tissue engineering and reconstruction; fluctuations and difficulty in forecasting operating results; business disruptions, such as technological failures and/or cybersecurity breaches; and the other risks described in the Company’s filings with the SEC, including under “Risk Factors” in its most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. There can be no assurance that such statements will prove to be accurate as actual results, and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements contained in this news release and in any document referred to in this news release. The forward-looking statements included in this release are made only as of the date hereof. For forward-looking statements in this news release, the Company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The Company assumes no obligation to update or supplement any forward-looking statements whether as a result of new information, future events or otherwise. This news release shall not constitute an offer to sell or the solicitation of any offer to buy our securities.
