This pioneering clearance integrates two cutting-edge wound care solutions into a unified approach for promoting active healing, aiming to simplify treatment processes and enhance results for patients
The approval links innovative synthetic electrospun fiber matrix technology with a leading negative pressure wound therapy system to support optimized healing

/PRNewswire/ -- Solventum (NYSE: SOLV), a leader in advanced wound healing, announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the combined application of Restrata Synthetic Electrospun Fiber Matrix and Solventum V.A.C. Therapy. Following Solventum's acquisition of Acera Surgical in December 2025, this regulatory achievement unites two advanced technologies into one pathway to support active wound healing.

"We are dedicated to providing meaningful innovation that assists healthcare providers in overcoming clinical challenges and helps patients resume their everyday activities," said Kelley Moffett, president of Advanced Wound Care at Solventum. "By pairing Restrata Matrix technology with our established V.A.C. Therapy, we offer clinicians an effective method to simplify care and promote improved patient outcomes."

Restrata Matrix and V.A.C. Therapy are designed to aid various phases of the healing process:

Restrata is a fully synthetic, completely resorbable matrix crafted to aid soft tissue healing. It promotes tissue formation via structural signals instead of growth factors to establish the base for soft tissue repair. Designed to function in difficult wound settings and withstand enzymatic breakdown, Restrata Matrix permits cellular infiltration, neovascularization and structured collagen deposition. It breaks down through hydrolysis over time, resulting in native tissue remaining.

V.A.C. Therapy provides negative pressure wound therapy (NPWT) to establish conditions that encourage wound healing. When paired with dressings such as Solventum V.A.C. Peel and Place Dressing, V.A.C. Therapy maintains close contact between the matrix and the wound bed. Macrostrain approximates wound edges while microstrain promotes cell proliferation, angiogenesis and granulation tissue formation. It enhances perfusion, decreases edema and eliminates fluid and infectious material for up to seven days per application.

"Complex wounds demand that clinicians support tissue repair while sustaining an appropriate healing setting," said Matthew MacEwan, Ph.D., chief science officer and co-founder of Acera Surgical. "This indication merges those requirements into a single method, supplying clinicians with an additional option to aid healing more efficiently throughout the care period."

Used together, Restrata Matrix delivers structural support for soft tissue repair, while V.A.C. Therapy helps generate an optimized setting that aids tissue integration. Restrata Matrix's completely synthetic nature allows resistance to enzymatic breakdown and matches V.A.C. Peel and Place Dressing's application duration of up to seven days, whereas many collagen-based dressings break down early and thus are not ideal for combined use. Together, these therapies may enable fewer dressing changes, reduced interference with the healing setting and a more reliable workflow for care teams. Solventum is devoted to broadening use of advanced wound healing technologies to help enhance patient outcomes and promote more efficient care.

"Restrata Matrix and V.A.C. Therapy can perform well even in the most complex wound settings," said Dr. Luis Fernandez, professor of surgery at The University of Texas at Tyler. "With Restrata Matrix, I regularly observe notable granulation tissue development within several days, even in the toughest cases. Pairing Restrata Matrix with V.A.C. Therapy creates an increased chance to encourage healing and improve patient outcomes."

To learn more about this next generation of advanced wound healing, visit Solventum's advanced wound healing resources.

About Solventum
At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers' toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better - while empowering healthcare professionals to perform at their best. See how at Solventum.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934 that are subject to risks and uncertainties. Solventum intends the forward-looking statements to be covered by the safe harbor provisions for forward-looking statements in those sections. Forward-looking statements include all statements that are not historical facts, but instead represent only Solventum's beliefs regarding future goals, plans and expectations about its prospects for the future and other events, many of which, by their nature, are inherently uncertain and outside of Solventum's control. Forward-looking statements include those containing such words as "anticipates," "believes," "can," "continue," "could," "estimates," "expects," "forecasts," "goal," "guidance," "intends," "may," "outlook," "plans," "potential," "predicts," "projects," "seeks," "sees," "should," "targets," "will," "would," or other words of similar meaning by using future dates. Among the factors that could cause actual results to differ materially from those described in Solventum's forward-looking statements are: demand for and market acceptance of Solventum's products; the highly competitive environment Solventum operates in; operational execution risks; manufacturing, supply chain and product quality issues; relationships with healthcare professionals; changes in reimbursement practices; changes in laws, regulations, and government clearance processes; ability to enforce and protect Solventum's intellectual property; security incidents and other disruptions to information technology infrastructure; artificial intelligence risks; general economic conditions; and other risks and uncertainties described in Solventum's filings with the U.S. Securities and Exchange Commission. A further description of these factors is located under "Cautionary Note Concerning Forward-Looking Statements" and "Risk Factors" in Solventum's periodic reports on file with the U.S. Securities and Exchange Commission, including the most recent annual report on Form 10-K and our subsequent quarterly reports on Form 10-Q. Solventum assumes no obligation to update any forward-looking statements discussed herein as a result of new information, future events or otherwise, except as required by applicable law.

*Restrata Synthetic Electrospun Fiber Matrix is indicated for use in combination with the Solventum V.A.C. Ulta Therapy Unit and Solventum V.A.C. Peel and Place Dressing and Kit and Solventum V.A.C. Granufoam Dressing and Kit.

NOTE: Specific indications, contraindications, warnings, precautions and safety information exist for these products and therapies. Please consult a clinician and product instructions for use prior to application. Rx only.

Dr. Luis Fernandez is a paid consultant of Solventum.

SOURCE Solventum