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Resivant Medical Receives FDA Clearance for Two Novel High-Viscosity Tissue Adhesive Products Cutiva™ Topical Skin Adhesive and Cutiva™ PLUS Skin Closure System
Akron, Ohio | August 23, 2024 | PRNewswire
Resivant Medical announced today it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its first two products, Cutiva™ Topical Skin Adhesive, and Cutiva PLUS™ Skin Closure System, which combines an adhesive mesh patch with high-viscosity Cutiva™ liquid adhesive. This achievement represents a significant advancement in medical tissue adhesive and wound closure technology and marks the first major adhesive advancement in over 25 years.
“The Cutiva platform signifies a fundamental breakthrough in cyanoacrylate adhesive technology for surgical incision and traumatic laceration closure. Cutiva adhesive’s unique 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,” says Darren Obrigkeit, CEO, Resivant Medical.
Resivant’s proprietary Cutiva adhesive features an innovative formulation that merges the high-strength bond of super glue with the advantages of crosslinked silicone rubber. The outcome is a skin adhesive that provides robust wound closure, enhanced flexibility, durability, and improved patient safety and comfort.
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 novel adhesive, allows for easy removal without damaging the surrounding skin and is suitable for a wide range of surgical specialties.
About Resivant Medical:
Resivant Medical, a pioneer in the field of medical adhesives, has developed groundbreaking 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 USD $6.2 billion in 2024 and is anticipated to experience significant growth in the coming years.