Guard Medical Announces FDA 510k Clearance for Additional Sizes of Its Novel NPseal, the First All-in-One NPWT Surgical Dressing

Privately-held company Guard Medical Inc. today announces FDA 510k clearance for additional sizes (10 and 15cm) of its next generation Negative Pressure Wound Therapy (NPWT) dressing NPseal^TM for the treatment of closed surgical incisions. NPseal^TM is an easy-to-use and cost-effective NPWT surgical dressing with an integrated pump that establishes and maintains negative pressure with just a few pinches.

“We’re excited to expand our NPseal^TM portfolio, now with the 5, 10 and 15 cm sizes. NPseal^TM can now be used on a large percentage of closed surgical incisions across multiple specialties. Receiving FDA clearance for the larger sizes is another significant milestone towards becoming the NPWT dressing of choice for the treatment of surgical incisions,” stated Machiel van der Leest, CEO of Guard Medical. “NPseal^TM ease-of-use and cost effectiveness makes, for the first time, prophylactic use of NPWT for all eligible closed surgical incisions possible.”

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^TM delivers the same NPWT as current more expensive and complex NPWT devices.

Guard Medical Inc. (www.guard-medical.com), a privately-held company, is developing easy-to-use and cost-effective solutions that enables 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 physician’s 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.

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