Solventum Announces FDA 510(k) Clearance for Combined Use of Restrata™ Matrix and Solventum™ V.A.C.® Therapy*

The clearance connects wound-care technologies following Solventum's December 2025 acquisition of Acera Surgical.

Rhea-AI Summary

Solventum (SOLV) received FDA 510(k) clearance for the combined use of Restrata Synthetic Electrospun Fiber Matrix and V.A.C. Therapy.

The clearance follows Solventum's acquisition of Acera Surgical in December 2025. Restrata is a fully resorbable synthetic matrix that provides structural support for soft tissue repair. V.A.C. Therapy applies negative pressure to create an environment that supports wound healing and helps maintain contact between the matrix and wound bed.

Restrata's resistance to enzymatic degradation aligns with the V.A.C. Peel and Place Dressing's wear time of up to seven days. Solventum said the combination may allow fewer dressing changes, less disruption to the healing environment and a more predictable workflow for care teams.

Positive

• Minor pointFDA 510(k) clearance permits combined use of Restrata Matrix and Solventum V.A.C. Therapy.

Negative

• None.

Key Figures

Application duration: Up to seven days per application

Application duration

Up to seven days per application

V.A.C. Therapy

Key Terms

510(k) clearance, negative pressure wound therapy, neovascularization, hydrolysis

4 terms

510(k) clearance regulatory

"FDA (FDA) has granted 510(k) clearance"

A 510(k) clearance is a U.S. regulatory approval that lets a medical device be sold because it is shown to be substantially similar to an already-legal device; think of it as a passport saying the new product is close enough to a known item to enter the market without a full, lengthy review. For investors, 510(k) clearance signals faster, lower-cost market access and reduced regulatory risk compared with new, untested device pathways, which can materially affect timelines, costs and revenue prospects.

negative pressure wound therapy medical

"V.A.C.® Therapy delivers negative pressure wound therapy (NPWT)"

Negative pressure wound therapy is a medical treatment that uses a sealed dressing and gentle suction (like a small, controlled vacuum under a bandage) to remove fluid, reduce swelling and promote faster tissue repair in wounds. For investors, it matters because the devices, consumable dressings and clinical adoption drive predictable, recurring revenue and reimbursement decisions; better healing outcomes can expand market share and affect healthcare spending.

neovascularization medical

"cellular infiltration, neovascularization and organized collagen deposition"

The growth of new blood vessels into tissue, often triggered by injury, disease, or tumors; think of it as the body sending a construction crew to build new roads (vessels) where extra blood flow is needed. For investors, neovascularization matters because drugs, medical devices, and diagnostics that block, promote, or measure this process can determine treatment effectiveness, safety profiles, regulatory approval, and market potential in areas such as eye disease, cancer, and wound healing.

hydrolysis technical

"It degrades via hydrolysis over time"

Hydrolysis is a chemical process where a water molecule breaks a larger molecule into smaller pieces, like scissors cutting a chain link. For investors it matters because hydrolysis can change a drug, chemical or product over time — affecting shelf life, manufacturing yields, safety, regulatory approval and environmental breakdown — and thus can alter costs, revenue forecasts and regulatory risk.

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• First-of-its-kind clearance combines two advanced wound care technologies into one path for active healing to help streamline care and improve patient outcomes
• Clearance pairs innovative synthetic electrospun fiber matrix technology with an industry-leading negative pressure wound therapy to optimize healing

EAGAN, Minn., Oct. 19, 2026 /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 use of Restrata™ Synthetic Electrospun Fiber Matrix and Solventum™ V.A.C.^® Therapy*. Following Solventum's acquisition of Acera Surgical in December 2025, this regulatory milestone brings two advanced technologies together into one path to support active wound healing.

"We're focused on delivering meaningful innovation that helps healthcare providers address clinical challenges and supports patients as they return to daily life," said Kelley Moffett, president of Advanced Wound Care at Solventum. "By combining Restrata™ Matrix's technology with our trusted V.A.C.^® Therapy, we're giving clinicians an effective way to streamline care and support better patient outcomes."

Restrata Matrix and V.A.C.^® Therapy are engineered to support various stages of the healing journey:

• Restrata is a 100% synthetic, fully resorbable matrix engineered to support soft tissue healing. It supports tissue formation through structural cues rather than growth factors to create the foundation for soft tissue repair. Built to perform in challenging wound environments and resist enzymatic degradation, Restrata Matrix allows for cellular infiltration, neovascularization and organized collagen deposition. It degrades via hydrolysis over time, leaving native tissue behind.

• V.A.C.^® Therapy delivers negative pressure wound therapy (NPWT) to create an environment that promotes wound healing. When used with dressings like Solventum™ V.A.C.^® Peel and Place Dressing, V.A.C.^® Therapy helps maintain close contact between the matrix and the wound bed. Macrostrain draws wound edges together while microstrain stimulates cell proliferation, angiogenesis and granulation tissue formation. It promotes perfusion, reduces edema and removes fluid and infectious material for up to seven days per application.

"Complex wounds require clinicians to support tissue repair while also maintaining the right healing environment," said Matthew MacEwan, Ph.D., chief science officer and co-founder of Acera Surgical. "This indication brings those needs together in a single approach, giving clinicians another option to support healing more effectively across the course of care."

Applied together, Restrata Matrix provides structural support for soft tissue repair, while V.A.C.^® Therapy helps create an optimized environment that supports tissue integration. Restrata Matrix's fully synthetic profile enables resistance to enzymatic degradation and aligns with V.A.C.^® Peel and Place Dressing's wear time of up to seven days, whereas many collagen-based dressings degrade prematurely and therefore aren't optimal for concomitant use. Together, these therapies may allow for fewer dressing changes, less disruption to the healing environment and a more predictable workflow for care teams. Solventum is committed to expanding adoption of advanced wound healing technologies to help improve patient outcomes and advance more efficient care.

"Restrata Matrix and V.A.C.^® Therapy can succeed even in the most complex wound environments," said Dr. Luis Fernandez, professor of surgery at The University of Texas at Tyler. "With Restrata Matrix, I consistently see significant granulation tissue growth within a few days, even in the most challenging cases. Combining Restrata Matrix with V.A.C.^® Therapy provides an even greater opportunity to promote healing and improve patient outcomes."

To learn more about this next generation of advanced wound healing, visit go.Solventum.com/AdvancedWoundHealing.

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 & 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.

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SOURCE Solventum

FAQ

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What did the FDA clear for Solventum's Restrata Matrix and V.A.C. Therapy?

The FDA granted 510(k) clearance for combined use of Restrata Synthetic Electrospun Fiber Matrix and Solventum V.A.C. Therapy. The combination pairs a synthetic matrix supporting soft tissue repair with negative pressure wound therapy.