- Company advances manufacturing scale-up, regulatory testing and preclinical work supporting its planned FDA 510(k) submission in the first quarter of 2027.
- Multiple scaled-up batches of CXU™ material met predefined specifications, supporting both regulatory testing and future commercial production.
RENO, Nev., Oct. 06, 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 provided an update on the regulatory and manufacturing program supporting its planned U.S. Food and Drug Administration (“FDA”) 510(k) premarket notification for Ten Minute Tissue™, its lead wound care device candidate, as well as on the Company’s broader preparations for commercialization.
The Company is conducting manufacturing, testing, and preclinical work intended to support its planned FDA 510(k) submission. Conexeu remains on track to make the submission in the first calendar quarter of 2027.
The Company views manufacturing scale-up as a key stage in the transition of Ten Minute Tissue™ from a development-stage product candidate toward a potential commercial product. Establishing a controlled and reproducible manufacturing process is expected to support not only the generation of representative materials for regulatory testing, but also the development of supply capabilities intended to meet future market demand subject to FDA clearance.
Recent manufacturing activities represent an important step forward in the program. Following process-development work, multiple scaled-up batches of CXU™ material met predefined Company specifications for key material characteristics and product performance measures.
“We have moved from process development to implementing a controlled manufacturing process,” said Miles Harrison, President and CEO of Conexeu. “That progress is important for two reasons. First, it supports the regulatory testing required to advance our planned FDA 510(k) submission. Second, it moves us closer to establishing the scalable manufacturing infrastructure needed to support commercialization. We believe manufacturing scale-up is one of the critical bridges between regulatory development and our ability to ultimately bring our lead device to market.”
Advancing the Ten Minute Tissue™ Regulatory and Manufacturing Program
Conexeu’s current regulatory and development activities include:
- Manufacturing process development and scale-up. Recent activities have demonstrated reproducible performance of CXU™ material across multiple scaled-up batches.
- Regulatory test-material production. The Company is expanding production of representative Ten Minute Tissue™ test samples, made to reflect the final product, to support planned preclinical, biocompatibility, chemical characterization, stability and other regulatory testing.
- Progress toward commercial manufacturing readiness. Conexeu is evaluating and developing manufacturing processes, supplier relationships and production capabilities intended to support the transition from development-scale production to larger-volume, controlled manufacturing subject to regulatory clearance.
- Preclinical wound evaluation. Conexeu is advancing its preclinical (non-human) wound model study program, including pilot studies, intended to generate data supporting substantial equivalence to an identified predicate device (a comparable device already legally sold in the U.S.).
- Biocompatibility and product characterization. Workstreams include biocompatibility (how the material interacts with tissues), chemical characterization (a detailed analysis of the material’s chemical makeup), product performance and other testing expected to support the Company’s FDA 510(k) submission.
- Sterilization, packaging and stability. The Company continues work on sterilization, packaging integrity and the product container systems, as well as stability testing (how the product holds up in storage over time), in parallel with preclinical work.
- FDA engagement. Conexeu has received feedback from the FDA through the agency’s Q-Submission process and is incorporating that advisory feedback into its ongoing development and regulatory planning.
“Wherever appropriate, we are running these workstreams at the same time rather than one after another, using representative test materials made with our controlled manufacturing process,” said Brian Pilcher, Ph.D., Chief Medical Officer of Conexeu. “This approach keeps our planned first-quarter 2027 submission on track while maintaining the consistency that regulatory testing requires.”
About Ten Minute Tissue™
Ten Minute Tissue™ is built on the Company’s CXU™ platform, which is based on the extracellular matrix (ECM), the natural framework that holds the body’s tissues together. Conexeu plans to focus its commercial strategy on wound care, where it believes two features of Ten Minute Tissue™ set it apart: it can be applied as a liquid, and it is designed to turn into a gel at body temperature within about ten minutes, the feature that gives the device candidate its name [1] [7] [9]. Many difficult wounds are irregularly shaped. Examples include deep tissue openings left after skin cancer removal (known as Mohs surgery), surgical wounds that have split back open, burns, and wounds that form channels beneath the skin. Because Ten Minute Tissue™ is designed to flow into place and then set, it is intended to fill gaps and channels that sheets, meshes, and powders may not fully reach, and to stay in close contact with the entire wound surface. Once set, it is designed to act as a framework, or “scaffold,” that the body’s own cells can move into, intended to support natural tissue repair [3] [5] [6] [7] [9] [10].
About the FDA 510(k) Pathway
Conexeu intends to seek FDA clearance for Ten Minute Tissue™ in wound care through the 510(k) premarket notification pathway. Under a 510(k), a company submits evidence that its device is substantially equivalent to a device already legally marketed in the U.S., meaning it has the same intended use and is at least as safe and effective. The FDA’s performance goal is to reach a decision within 90 days of active FDA review, a clock that pauses while the company responds to any FDA questions. The 510(k) pathway is generally shorter than the FDA’s premarket approval (PMA) process for higher-risk devices, which typically relies on clinical trials that can take years to complete.
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 early 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 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. [1]
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] 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. [2] Hosseini-Tabatabaei A., Jalili R., Hartwell R., et al. Embedding islet in a liquid scaffold increases islet viability and function. Canadian Journal of Diabetes (2013); 37; 27-35 [3] Hartwell R., Poormasjedi-Meibod M.S., Chavez-Munoz C., et al. An in-situ forming skin substitute improves healing outcome in a hypertrophic scar model. Tissue Engineering Part A (2015); 21(5); 1085-1094. [4] Hosseini-Tabatabaei A., Jalili R., Khosravi-Maharlooei M., et al. Immunoprotection and functional improvement of allogeneic islets in diabetic mice, using stable indoleamine 2,3-dioxygenase producing scaffold. Transplantation (2015); 99; 1342-1348. [5] Hartwell R., Chan B., Elliott K., et al. Polyvinyl alcohol-graft-polyethylene glycol hydrogels improve utility and biofunctionality of injectable collagen biomaterials. Biomedical Materials (2016); 11; 035013. [6] Forbes D., Russ B., Kilani R.T., et al. Liquid dermal scaffold with adipose-derived stem cells improves tissue quality in a murine model of impaired wound healing. Journal of Burn Care & Research (2019); 40(5); 550-557. [7] Pourghadiri A., Alnojeidi H., Jalili R., et al. In situ forming nutritional and temperature sensitive scaffold improves the aesthetic outcome of meshed split-thickness skin grafts in a porcine model. Advances in Wound Care (2021); 10(3); 113-122. [8] Pangli H., Vatanpour S., Hortamani S., et al. Incorporation of silver nanoparticles in hydrogel matrices for controlling wound infection. Journal of Burn Care & Research (2021); 42(4); 785-793. [9] Pakyari M., Jalili R., Kilani R.T., et al. Studying the in vivo application of a liquid dermal scaffold in promoting wound healing. Experimental Dermatology (2021); 31; 715-724. [10] Alnojeidi H., Kilani R.T., Ghahary A. Evaluating the biocompatibility of an injectable wound matrix in a murine model. Gels (2022); 8, 49.
All cited studies [1]–[10] are 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. None of the cited studies evaluated CXU™ specifically in the wound care indications described (post-Mohs defects, dehiscent, burn, or tunneling wounds); these 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.
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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 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; 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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