Cleveland--(BUSINESS WIRE)--Aatru Medical, LLC ("Aatru") today announced that they have successfully completed the first batch of 14 patients' FDA approval of NPSIMS™ in a multicenter clinical study in New Zealand Negative pressure surgical incision management system. The complete study registration will include plastic surgery, spinal surgery, and cardiothoracic surgery to close the incision.
NPSIMS™ does not contain electrical or magnetic components and uses a new type of solid-state chemical reaction to apply negative pressure to the closed incision. The first open-label human clinical study fully complies with GCP standards and is registered on www.clinicaltrials.gov (NCT04488666). Up to 30 patients will be recruited and will be managed by Middlemore Hospital and coordinated by Middlemore Clinical Trials in Auckland, New Zealand.
Principal Investigator Plastic Surgeon Jon A Mathy FACS FRACS, MD, said: "These devices are easy to use and completely silent to operate. This new system has an innovative adhesive silicone gasket that facilitates sealing, including around the joints."
An interim analysis after recruiting the first 5 participants after elective plastic surgery showed that all patients were discharged with an NPSIMS™ device that maintained negative pressure and controlled wound exudate for 7 days. Follow up for 30 days. There were no adverse events. The quality of wound healing and scarring is also being evaluated.
Regarding NPWT with closed surgical incisions:
After surgery, several postoperative wound complications are common. Negative pressure wound therapy (NPWT) is widely recognized in the management of open wounds and has been used to close surgical incisions in the past few years. Compared with standard postoperative dressings, NPWT significantly reduces the incidence of wound infection and seroma. The global market opportunity of NPWT in the closed surgical incision market is approximately US$14B per year, and the market penetration rate so far is low.
Aatru is a private medical device technology company focused on disrupting the surgical incision market through its FDA-approved NPSIMSTM. NPSIMSTM is a simple, disposable, disposable, patented and low-cost NPWT device. Its unique design does not require electromechanical pumps, Battery or canister.
The introduction video of NPSIMS products can be found on the Aatru Medical, LLC website: www.aatru.com.
Tom Lash Aatru Medical, LLC Chief Operating Officer 216-303-6063 tlash@aatru.com
Aatru Medical announced the clinical research and analysis of its FDA-approved NPSIMS negative pressure surgical incision management system in New Zealand.
Tom Lash Aatru Medical, LLC Chief Operating Officer 216-303-6063 tlash@aatru.com