Privately held company Guard Medical has announced the US Food and Drug Administration (FDA) 510(k) clearance for additional large sizes of its negative pressure wound therapy (NPWT) dressing, NPseal.
The clearance covers surgical wounds up to 25cm, potentially unlocking the orthopaedic market for the company.
Recognised for its ease of use, affordability, and cost-effectiveness, NPseal features an integrated pump that establishes and maintains negative pressure with minimal effort. Guard Medical announced in February 2022 the completion of the NPseal post-market study at Keck Medical Center of USC.
Englewood Orthopedic Associates senior partner and chief of orthopaedic surgery Asit Shah commented on the development: "Following the successful clinical results of NPseal with my hip replacement patients, the additional large sizes will expand the use of NPseal to all our patients including knee replacement patients. I look forward to dressing my patients' wounds for success with NPseal."
Guard Medical CEO Machiel van der Leest expressed enthusiasm about the expansion: "We're excited to expand our portfolio with the NPseal 20 and NPseal 25. FDA clearance for the additional large sizes allows NPseal to become the dressing of choice for the treatment of closed surgical incisions in orthopaedic, cesarean, and cardiothoracic procedures.
"We believe that NPseal uniquely fits in the ever-increasing outpatient trend requiring higher patient mobility and self-care."
The company aims to address the limitations of conventional disposable NPWT devices, which have been restricted in their widespread use due to high costs and complexity.
NPseal dressings are designed to broaden the application of NPWT while propelling conversion from the advanced wound dressing and standard dressing markets.
Guard Medical's NPWT technology originated with New York-Presbyterian and Weill Cornell Medicine, responding to the need for better solutions to prevent surgical site infections (SSI).
The company's current investors include Bpifrance and Matignon Investissement et Gestion, with a vision to develop NPWT solutions applicable across various surgical wound types and sizes, aiming for broad applications in infection prevention, scar mitigation, and enhanced cosmesis.
