FDA Clears Resivant Medical’s First Two Tissue Adhesive Products

Resivant Medical has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Cutiva Topical Skin Adhesive and Cutiva PLUS Skin Closure System, which combines an adhesive mesh patch with high-viscosity Cutiva liquid adhesive.

The FDA clearance, according to the company, represents a significant advancement in medical tissue adhesive and wound closure technology and marks the first major adhesive advancement in more than 25 years.

“The Cutiva platform signifies a fundamental breakthrough in cyanoacrylate adhesive technology for surgical incision and traumatic laceration closure. Cutiva adhesive´s chemistry maintains a clean incision site without the need for additional dressings and is formulated to significantly reduce the level of exposure to skin irritants,” Resivant Medical CEO Darren Obrigkeit said.

Resivant’s proprietary Cutiva adhesive features a formulation that merges the high-strength bond of super glue with the advantages of crosslinked silicone rubber. The result is a skin adhesive that provides robust wound closure, enhanced flexibility,
durability, and improved patient safety and comfort, Resivant Medical claims.

All Cutiva products are dispensed from a new, easy-to-use, single-handed applicator and form a protective microbial barrier over the incision. The high-viscosity, no-run liquid adhesive remains in place, preventing unwanted spreading and ensuring controlled
application. The Cutiva PLUS system, comprised of surgical mesh and the adhesive, allows for easy removal without damaging the surrounding skin and is suitable for a wide range of surgical specialties.

Resivant Medical has developed adhesive technology that enhances usability and performance for both patients and healthcare professionals. Its range of skin closure adhesive products is designed for topical application on wounds and surgical incisions. The global skin closure market, encompassing both traditional and advanced surgical closure methods is valued at approximately $6.2 billion and is anticipated to experience significant future growth.