Resivant Medical has completed the first patient procedures using its Cutiva PLUS Skin Closure System, marking the first clinical deployment of the company’s crosslinked silicone-cyanoacrylate platform after several years of regulatory and manufacturing development. The initial cases were performed on June 22 and June 23, 2026 by orthopedic foot and ankle surgeon David Friscia at Eisenhower Health in Rancho Mirage, California, and Resivant reported that the procedures were completed without complications. The company announced the milestone on August 18 after transferring the adhesive chemistry to commercial-scale manufacturing and is now onboarding additional clinical sites ahead of a broader launch.
The device itself is not newly FDA cleared. FDA granted traditional 510(k) clearance to Cutiva Topical Skin Adhesive and Cutiva PLUS in August 2024 under K234114, classifying the products as tissue adhesives for topical approximation of skin, while a later 2025 clearance addressed labeling modifications. What is new is the transition from regulatory authorization and manufacturing scale-up into actual patient use, a stage at which Resivant will begin learning whether the material’s theoretical flexibility and skin-contact profile create meaningful clinical advantages over mature cyanoacrylate products already used throughout surgery.
What is different about Cutiva PLUS if surgeons already use cyanoacrylate glue?
Cyanoacrylate tissue adhesives polymerize rapidly when applied to skin, creating a strong film that holds approximated wound edges together and can act as a barrier over the incision. The technology became widely adopted because it can reduce or eliminate external sutures and staples in appropriate wounds, simplify postoperative care and avoid a later visit solely for removal of closure material.
Resivant’s design does not abandon cyanoacrylate. FDA’s technical documentation identifies the cleared Cutiva products as 2-octyl cyanoacrylate-based systems, while Resivant incorporates silicone chemistry into the adhesive formulation to create what it describes as a crosslinked silicone-cyanoacrylate network. Cutiva PLUS then combines the liquid adhesive with a self-adhering polyester mesh that spans the approximated incision before the adhesive is dispensed.
The intended engineering advantage is to preserve the high bonding strength associated with cyanoacrylate while making the cured material more flexible. That could matter in locations such as feet, ankles, knees or other joints where skin experiences repeated movement after surgery and where an excessively rigid adhesive film may be subjected to substantial mechanical stress.
Why are skin reactions an important unresolved issue for surgical adhesives?
2-octyl cyanoacrylate has a long clinical history, but allergic contact dermatitis is an increasingly recognized complication. A 2026 systematic review and meta-analysis covering more than 25,000 patients in analytic cohorts estimated a pooled allergic contact dermatitis incidence of approximately 4%, although rates varied substantially by study and surgical specialty. Re-exposure appeared particularly important, with several cohorts reporting much higher reaction rates in patients exposed repeatedly to cyanoacrylate adhesive.
Earlier systematic work also showed how difficult these reactions can be to manage clinically. Redness, itching, swelling and blistering around an incision can resemble surgical-site infection, potentially leading to diagnostic uncertainty and unnecessary antibiotics before clinicians recognize a delayed hypersensitivity reaction. Orthopedic procedures represented a large proportion of reported cases in FDA’s MAUDE database review, which makes Resivant’s choice of foot and ankle surgery for initial use particularly relevant.
Resivant says Cutiva PLUS has been formulated to reduce exposure to skin irritants and improve tolerability, but this should be treated as a design objective rather than a clinically proven superiority claim. First patient use without complications is encouraging but far too small to establish a lower dermatitis rate than established adhesives, particularly when hypersensitivity can appear days after surgery and may be uncommon enough to require hundreds or thousands of patients for reliable comparison.
Why does the mesh component matter?
Cutiva PLUS first places a 10-centimeter self-adhering polyester mesh over the approximated wound, after which the liquid adhesive is applied through the mesh. The mesh provides mechanical reinforcement and distributes closure forces across a broader surface area, while its repositionable design allows the clinician to adjust placement before the liquid adhesive fixes the system. Resivant’s applicator mixes the adhesive components during dispensing and uses a high-viscosity formulation intended to remain where it is placed rather than running across surrounding skin.
This architecture is particularly relevant for incisions exposed to tension. A liquid adhesive alone creates a polymer film across the wound, while a mesh can share mechanical load and potentially reduce localized stress on the adhesive layer. The first clinical cases involved foot and ankle procedures partly because these sites encounter significant movement and mechanical loading during recovery.
The company also says Cutiva PLUS forms a physical microbial barrier and can remain in place for approximately seven to 14 days. Resivant explicitly notes, however, that the microbial-barrier performance comes from in-vitro testing and that no clinical benefit has been established from that particular laboratory result. That qualification is useful because claims about preventing microbial penetration should not be converted into claims that the product reduces surgical-site infection unless clinical studies establish such an effect.
Why did first patient use occur almost two years after the initial FDA clearance?
Regulatory authorization is only one part of commercializing a new material technology. Resivant had to transfer the adhesive from development-scale processes into reproducible commercial manufacturing while maintaining chemistry, sterility, packaging integrity, shelf life and applicator performance at larger volumes. The company specifically linked the first patient cases to completion of that manufacturing-transfer work.
Materials-based medical devices can be particularly sensitive to scale-up because viscosity, polymerization behavior and chemical purity influence how the product performs during a procedure. An adhesive that behaves correctly in laboratory batches must still dispense consistently after sterilization, storage and transportation, and every production lot has to remain within validated specifications.
This explains why the first cases are commercially important even though they do not create a new regulatory status. Resivant has moved from possessing a cleared design to producing clinical-grade commercial material at scale, and additional sites can now generate the practical user experience required before a broader launch.
What evidence does Cutiva PLUS still need?
The most valuable evidence would compare the new system directly with established mesh-and-adhesive products or conventional wound closure across sufficiently large patient populations. Outcomes could include wound dehiscence, allergic dermatitis, infection, application time, patient discomfort, scar appearance and ease of removal, allowing hospitals to determine whether the new chemistry creates measurable clinical or operational value rather than simply another route to the same closure outcome.
Large datasets will be particularly important for the dermatitis proposition. Existing cyanoacrylate products are widely used because most patients tolerate them well, so demonstrating a significantly better skin-reaction profile requires enough exposures to detect relatively uncommon events reliably. A handful of successful cases cannot answer that question.
Resivant has nevertheless crossed a meaningful commercialization threshold. The company’s technology originated from polymer research at the University of Akron, gained FDA clearance, underwent manufacturing scale-up and has now been used in patients. The next phase will determine whether changing the chemistry underneath a familiar surgical glue produces a sufficiently visible difference above the skin to persuade surgeons and hospitals to switch from products they already understand.