Acera Surgical Broadens Reach of Restrata® with New FDA Clearance for Soft Tissue Reinforcement

ST. LOUIS, June 25, 2025 /PRNewswire/ -- Acera Surgical, a pioneer in synthetic electrospun materials for soft tissue repair, today announced it has received an additional U.S. Food and Drug Administration (FDA) 510(k) clearance for Restrata^®, a fully synthetic, fully resorbable electrospun matrix. This new clearance broadens the clinical utility of the Restrata platform, now supporting soft tissue reinforcement applications in addition to its previously cleared indications for wound healing. This clearance applies to both Restrata Sheet and Restrata Meshed products.

The expanded indications allow for implantation of Restrata to reinforce soft tissue where weakness exists, including beneath primary skin closures in plastic and reconstructive procedures, as well as in closures at risk of dehiscence or wound breakdown.

"This clearance marks a significant step forward, not only for our clinical partners but also for the broader commercial trajectory of the Restrata platform," said Mike Finegan, Chief Executive Officer of Acera Surgical. "By addressing both soft tissue healing and reinforcement, we're delivering a truly versatile solution that meets a diverse set of surgical needs with one synthetic, resorbable technology."

Invented and manufactured in the United States, Restrata is engineered by electrospinning bioresorbable synthetic polymers, each with well-established safety profiles, into a matrix form. Once implanted, the device provides structural support to surrounding soft tissues before fully resorbing within three to four weeks, offering acute reinforcement to soft tissue during the critical healing phase when risk of post-operative complications, such as dehiscence, are highest.

"Surgical site dehiscence and wound breakdown represents a significant challenge, particularly in orthopedic and reconstructive surgery," said Dr. Matthew MacEwan, Co-Founder and Chief Scientific Officer of Acera Surgical. "Restrata addresses this unmet clinical need by providing early mechanical support to protect closures when they're most vulnerable, then resorbing as native tissue strength returns."

With this latest FDA clearance, Acera Surgical now offers one product, Restrata, with two indications, supporting the full continuum of soft tissue reconstruction "head-to-toe, in-and-out." From external wound healing to internal soft tissue reinforcement, this clearance positions the company for continued clinical adoption, expansion into new surgical specialties, and accelerating commercial growth.

About Acera Surgical
Acera Surgical, headquartered in St. Louis, Missouri, is a bioscience company and leader in electrospun technology innovation for regenerative medicine. The company develops and commercializes Restrata, a fully synthetic electrospun fiber matrix that mimics native human extracellular architecture to support soft tissue healing across a range of surgical applications.

For more information, visit www.acera-surgical.com.

Media Contact:
Leslie Branon
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SOURCE Acera Surgical, Inc.