Michael Barbella, Managing Editor04.19.22
The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Guard Medical Inc. for additional sizes (10 and 15cm) of its next-generation Negative Pressure Wound Therapy (NPWT) dressing NPseal, used to treat closed surgical incisions. NPseal is an 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 portfolio, now with the 5, 10 and 15 cm sizes. NPseal 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 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 delivers the same NPWT as current more expensive and complex NPWT devices.
Guard Medical Inc., a privately-held company, develops easy-to-use and cost-effective solutions that enables prophylactic negative pressure wound therapy 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.
“We’re excited to expand our NPseal portfolio, now with the 5, 10 and 15 cm sizes. NPseal 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 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 delivers the same NPWT as current more expensive and complex NPWT devices.
Guard Medical Inc., a privately-held company, develops easy-to-use and cost-effective solutions that enables prophylactic negative pressure wound therapy 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.