CLEVELAND--(BUSINESS WIRE)--Aatru Medical, LLC ("Aatru") today announced the successful completion of the first 14 patients in their multi-center New Zealand-based clinical study of the FDA-approved NPSIMS™ Negative Pressure Surgical Incision Management System. The full Study enrollment will include plastic surgery, spinal surgery and cardiothoracic surgery closed incisions.
The NPSIMS™, which contains no electrical or magnetic components, utilizes a novel solid-state chemical reaction to apply negative pressure to closed incisions. The first-in-human open label clinical study, which is fully GCP compliant and registered on www.clinicaltrials.gov (NCT04488666), will enroll up to 30 patients and is being led out of Middlemore Hospital, coordinated by Middlemore Clinical Trials, Auckland, New Zealand.
Principal Investigator Plastic Surgeon Jon A Mathy, MD FACS FRACS, 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.”
An interim analysis after recruitment of the first 5 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 7 days. Follow up was for 30 days. There were no adverse events. The quality of wound healing and scarring are also being assessed.
About NPWT for closed surgical incisions:
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 $14B annually with low single-digit market penetration to date.
About Aatru Medical:
Aatru is a privately held medical device technology company focused on disrupting the surgical incision market with its FDA-cleared NPSIMSTM, a simple, disposable, single-use, patented, low-cost NPWT device, uniquely designed to require no electromechanical pump, battery or canister.
Introductory videos of the NPSIMS product can be found on the Aatru Medical, LLC website: www.aatru.com.