New York, June 15, 2020 – Privately-held company Guard Medical Inc. today announces FDA 510k clearance for its next generation Negative Pressure Wound Therapy (NPWT) dressing NPseal for the treatment of closed surgical incisions. Guard Medical’s simple, innovative and cost-effective NPWT NPseal is a wearable dressing with an integrated pump that establishes and maintains negative pressure with just a few pinches.
“Receiving FDA clearance for our NPseal is a significant milestone for Guard Medical and validates our platform technology that we will continue to develop for the treatment of a wide variety of surgical wounds,” stated Machiel van der Leest, CEO of Guard Medical. “NPseal’s ease-of-use and cost-efficiency makes, for the first time, prophylactic use of NPWT for all eligible closed surgical wounds feasible.”
NPWT has been shown to reduce Surgical Site Infections (SSI) in a large number of peer reviewed articles, but is in limited use due to its high cost and complexity. While being easy-to-use, NPseal delivers the same NPWT as current more expensive and complex NPWT devices.
Guard Medical Inc, a privately-held company, is developing easy-to-use and cost-effective solutions that enable prophylactic Negative Pressure Wound Therapy (NPWT) wound care of closed surgical incisions. Guard Medical’s simple NPWT technology originated with NewYork-Presbyterian and Weill Cornell Medicine in response to physicians’ identification of unmet needs related to Surgical Site Infections (SSI). Current investors include Bpifrance and Matignon Investissement et Gestion.
Guard Medical’s vision is to develop NPWT solutions for use on a wide range of surgical wound types and sizes with broad applications for infection prevention, scar mitigation and enhanced cosmesis.