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Conexeu is led by an experienced leadership team with deep expertise in biomaterials, regenerative medicine, and medical device commercialization and development.
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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 extracellular matrix (ECM) 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 constructive remodeling.2
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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.
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Conexeu is led by an experienced leadership team with deep expertise in biomaterials, regenerative medicine, and medical device commercialization and development.
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Forward-Looking Statements
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Certain statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including statements regarding regulatory pathway, submission timing, category development, and platform expansion. CXU™ is an investigational device and is not cleared or approved for marketing in the United States or any other jurisdiction. Preclinical data are not peer-reviewed and are not predictive of clinical outcomes. Market figures cited are third-party projections that vary by source and are not presented as Conexeu addressable revenue. Actual results may differ materially. The Company assumes no obligation to update forward-looking statements except as required by law.
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References And Trademarks
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1. Steven Harris, MBBCh, MSc, Leonie Schelke, MD, PhD, and Peter Velthuis, MD, PhD, “Defining Regeneration, Repair, and Remodelling in Aesthetic Medicine,” Plastic and Reconstructive Surgery, Advance Online Article, 2026, doi:10.1097/PRS.0000000000013177.
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2. Peer-reviewed preclinical publications characterizing the CXU™ ECM platform: Hartwell R., et al., Tissue Engineering Part A (2015) 21(5); 1085–1094; Forbes D., et al., Journal of Burn Care & Research (2019) 40(5); 550–557; Pourghadiri A., et al., Advances in Wound Care (2021) 10(3); 113–121; Pakyari M., et al., Experimental Dermatology (2021) 31; 715–724; Alnojeidi H., et al., Gels (2022) 8; 49; Amiri N., et al., Gels (2023) 9; 542.
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Trademarks. CXU™, Ten-Minute Tissue™, and Architecting Bioregeneration™ are trademarks of Conexeu Sciences Inc.
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Media Contact
Gateway Group
[email protected]
949.574.3860
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Cautionary Statement
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CXU™ and the Company’s device candidates, including Ten-Minute Tissue™, are investigational and have not been cleared or approved by the U.S. Food and Drug Administration, licensed or authorized for sale by Health Canada, or otherwise authorized for commercial use by any regulatory authority.
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Safe Harbor Statement
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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 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 commercial viability of the contemplated processing plant; 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. 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.
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English (US)