Aatru Medical Begins Study of Negative Pressure Surgical Incision System

Aatru Medical LLC has enrolled the first 14 patients in its multi-center New Zealand-based clinical study of the U.S. Food and Drug Administration-approved NPSIMS Negative Pressure Surgical Incision Management System. The full Study enrollment will include plastic surgery, spinal surgery and cardiothoracic surgery closed incisions.

Principal Investigator Jon A Mathy, M.D., FACS FRACS, a plastic surgeon, said, “These devices were easy to use and totally silent in operation. This new system has an innovative adhesive silicone gasket which facilitates seal, including around joints.”
 
The NPSIMS contains no electrical or magnetic components and uses a solid-state chemical reaction to apply negative pressure to closed incisions. The first-in-human open label clinical study will enroll up to 30 patients and is being led out of Middlemore Hospital, coordinated by Middlemore Clinical Trials, Auckland, New Zealand.
 
An interim analysis after recruitment of the first five participants following elective plastic surgical procedures has showed that all patients were discharged with a single NPSIMS device that maintained negative pressure and managed wound exudate for a total of seven days. Follow up was for 30 days. There were no adverse events. The quality of wound healing and scarring are also being assessed.
 
Several post-operative wound complications are common following surgical procedures. Negative pressure wound therapy (NPWT) is well recognized for the management of open wounds, and in the last several years has been applied to closed surgical incisions. Compared with standard postoperative dressings, NPWT significantly reduces the rate of wound infection and seroma. The global market opportunity for NPWT in the closed surgical incision market is approximately $14 billion annually with low single-digit market penetration to date.
 
Aatru Medical is a privately held company focused on disrupting the surgical incision market with iNPSIMSTM, a simple, disposable, single-use, patented, lowcost NPWT device, uniquely designed to require no electromechanical pump, battery or canister.