RENO, Nev., Oct. 06, 2026 (GLOBE NEWSWIRE) -- Wall Street Investor News Commentary - The global advanced wound care market is valued at $13.37 billion in 2025 and is projected to reach $19.32 billion by 2030, a compound annual growth rate of 7.6%, according to MarketsandMarkets. The firm points to chronic disease, an aging population and traumatic injuries as the main drivers, noting that diabetic foot ulcers affect roughly a quarter of patients with diabetes and are a leading cause of hospitalization. Active Companies from around the markets with current developments this week include: Conexeu Sciences Inc. (Nasdaq: CNXU), Solventum Corporation (NYSE: SOLV), Vericel Corporation (Nasdaq: VCEL), Axogen, Inc. (Nasdaq: AXGN), Eli Lilly and Company (NYSE: LLY).
North America holds the largest share of that market today, according to the same report, which also credits strengthened reimbursement frameworks with supporting broader adoption of advanced therapies. The category spans negative pressure wound therapy, advanced dressings, skin substitutes and biologic matrices, and the large players in it are reporting steady growth.
Some of the hardest cases remain difficult because of their shape. Deep tissue openings left after skin cancer removal, surgical wounds that have split back open, burns, and wounds that tunnel beneath the skin are irregular, and sheets, meshes and powders may not fully reach every surface. That gap has drawn developers toward materials that can be applied as a liquid and then set in place.
For a medical device developer, the route to market for that kind of product often runs through the FDA’s 510(k) premarket notification pathway, which requires a company to show its device is substantially equivalent to one already legally marketed in the U.S. The FDA’s performance goal is a decision within 90 days of active review, and the pathway is generally shorter than the premarket approval process for higher-risk devices. Getting there depends on manufacturing that is controlled and reproducible, which is where one Nasdaq-listed developer just reported progress.
Conexeu Sciences Inc. (Nasdaq: CNXU) Advances Ten Minute Tissue™ Toward Planned FDA 510(k) Submission
- Planned FDA 510(k) submission for Ten Minute Tissue™ remains on track for the first calendar quarter of 2027
- Multiple scaled-up batches of CXU™ material met predefined Company specifications for key material characteristics and product performance
- Expanded production of representative test samples to support preclinical, biocompatibility, chemical characterization, stability and other regulatory testing
- FDA feedback received through the Q-Submission process is being incorporated into development and regulatory planning
- Workstreams running in parallel where appropriate, using test materials made with the controlled manufacturing process
Conexeu Sciences Inc. (Nasdaq: CNXU), a preclinical-stage medical device and regenerative medicine company advancing CXU™, an investigational extracellular matrix platform designed to support tissue restoration, has provided an update on the regulatory and manufacturing program supporting its planned FDA 510(k) premarket notification for Ten Minute Tissue™, its lead wound care device candidate. The Company says it remains on track to make the submission in the first calendar quarter of 2027.
Following process-development work, multiple scaled-up batches of CXU™ material met predefined Company specifications for key material characteristics and product performance measures. Conexeu 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, supporting both the representative materials needed for regulatory testing and the supply capabilities intended to meet future demand, subject to FDA clearance.
“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.”
The Company’s current program covers manufacturing process development and scale-up, production of representative test samples made to reflect the final product, and progress toward commercial manufacturing readiness, including supplier relationships and production capabilities. Alongside that, Conexeu is advancing a preclinical wound model study program, including pilot studies, intended to generate data supporting substantial equivalence to an identified predicate device, together with biocompatibility, chemical characterization, sterilization, packaging and stability work.
“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.”
Ten Minute Tissue™ is built on the CXU™ platform, which is based on the extracellular matrix, 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 set the device candidate apart: it can be applied as a liquid, and it is designed to turn into a gel at body temperature within about ten minutes. Because it is designed to flow into place and then set, it is intended to fill gaps and channels in irregularly shaped wounds and to act as a scaffold that the body’s own cells can move into.
Conexeu Sciences Inc. (Nasdaq: CNXU) is a preclinical-stage medical device and regenerative medicine company. Its patented extracellular matrix platform, CXU™, is designed to support bioregeneration and is protected by patents issued in the U.S., EU, Japan and Australia, with a patent pending in Canada, with the Company holding all rights, title and interest and no royalty or licensing obligations. Conexeu is targeting markets including wound care, periodontal applications, and facial and body tissue restoration, a category where the success of GLP-1 weight-loss therapies is creating new demand.
CONTINUED... Read this and more news for Conexeu Sciences Inc. (Nasdaq: CNXU) at: wsi.news
In other industry developments and happenings in the market this week include:
Solventum Corporation (NYSE: SOLV)
Solventum, whose MedSurg business includes negative pressure wound therapy and advanced dressings, reported second quarter 2026 sales of $2.2 billion, with organic growth of 9.5%. Advanced Wound Care sales were $537 million, up 14.9% as reported and 7.1% organically, within a MedSurg segment that grew 12.7% to $1.372 billion.
Adjusted diluted EPS rose 50.9% to $2.55, and the company raised its full-year 2026 guidance, lifting organic sales growth to 2.5% to 3.0% and adjusted EPS to $7.10 to $7.20.
Vericel Corporation (Nasdaq: VCEL)
Vericel, which markets the Epicel® and NexoBrid® burn care products alongside its MACI® cartilage repair implant, reported second quarter 2026 total revenue of $77.5 million, up 22%, with Burn Care revenue of $12.0 million, up 22%, and MACI revenue of $65.5 million, up 23%. The company reported net income of $2.2 million and raised its full-year revenue guidance to $330 million to $340 million, including Burn Care revenue of $46 million to $50 million.
“The Company delivered excellent financial and business results in the second quarter as we continue to generate top-tier revenue and profit growth as well as significant free cash flow,” said CEO Nick Colangelo. Vericel also authorized a $200 million share repurchase program.
Axogen, Inc. (Nasdaq: AXGN)
Axogen, a developer of technologies for peripheral nerve regeneration and repair, reported second quarter 2026 revenue of $69.7 million, up 23.1%, with its Breast segment growing more than 50% year over year. The company raised full-year 2026 revenue guidance to at least $279 million, or growth of at least 24%, and expects gross margin of at least 73% and positive free cash flow.
“We are pleased with our second-quarter revenue performance and the progress we’re making across each of Axogen’s strategic plan priorities,” said Michael Dale, President and CEO.
Eli Lilly and Company (NYSE: LLY)
Lilly, whose GLP-1 medicines are reshaping the weight-loss market and creating new demand in adjacent aesthetic markets, reported second quarter 2026 revenue of $23.0 billion, up 48%. Mounjaro® revenue reached $9.9 billion, up 91%, and Zepbound® revenue reached $4.9 billion, up 46%. The company raised its full-year 2026 revenue guidance to $85.0 billion to $87.0 billion.
“Lilly’s momentum continues, as we delivered 48% revenue growth and raised our full-year guidance. At the same time, Lilly is building for the future,” said Chair and CEO David A. Ricks.
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References to Solventum Corporation, Vericel Corporation, Axogen, Inc. and Eli Lilly and Company are provided solely as market and sector context. Those companies are not peers, competitors, or financial comparables of Conexeu Sciences Inc., none of them is involved in this article, and their commercial products, results, scale and share performance are not indicative of Conexeu Sciences Inc.’s prospects. Conexeu Sciences Inc. has no products cleared for sale and no product revenue. No partnership, affiliation, or endorsement is implied. Market-size figures cited are third-party projections for the advanced wound care market as a whole and do not represent revenue addressable by, or attributable to, any company named in this article.
Cautionary Note Regarding Investigational Devices and Preclinical Results. Ten Minute Tissue™ and the CXU™ platform are investigational and have not been cleared or approved by the U.S. Food and Drug Administration or any other regulator. All studies cited in support of the platform are preclinical, and preclinical results are not necessarily predictive of clinical outcomes. According to the Company, none of the cited studies evaluated CXU™ specifically in the wound care indications described, and supporting evidence in indication-specific preclinical models is being developed. The manufacturing specifications referenced are the Company’s own predefined specifications. FDA feedback received through the Q-Submission process is advisory and does not indicate that clearance will be granted. The planned first-quarter 2027 510(k) submission is a target, and there is no assurance it will be made on that timeline, accepted, or cleared.
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Trademarks. CXU™, Ten Minute Tissue™ and Architecting Bioregeneration™ are trademarks of Conexeu Sciences Inc. All other marks referenced in this article are the property of their respective owners.
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