GENERIC MEDICAL DEVICES RECEIVES CLEARANCE FOR UNIVERSAL SURGICAL MESH

GENERIC MEDICAL DEVICES, INC. (GMD), ANNOUNCES THAT THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) has cleared the GMD Universal Surgical Mesh for market. This marks the company's second 510(k) clearance by the FDA for a medical device that will be sold as a generic alternative to existing, standard-of-care surgical products. The availability of the Surgical Mesh will provide hospitals, ambulatory surgical centers, and independent practitioners a low-cost opportunity to administer highquality healthcare.

The GMD Universal Surgical Mesh is a Class II, non-active implantable medical device intended to support tissue growth in open or laparoscopic procedures, which are common for hernia repair. Clearance of the GMD Universal Surgical Mesh is based on the device being substantially equivalent – having the same or equivalent materials, design specifications, technological characteristics, operation, intended use and performance – to pre-amendment devices and a product currently on the market.

The procedure for patients undergoing laparoscopic or open surgical hernia repair involves the implantation of a surgical mesh over the hernia defect to provide a platform for where tissue ingrowth can occur, healing the defect. The GMD Universal Surgical Mesh will be used for this purpose to repair hernia or other defects that require the addition of a reinforcing or bridging material to achieve the desired surgical outcome.

GMD is the first company to implement the generic model. Leveraging expired patents on standard-of-care surgical devices that have undergone few, if any, changes since first being introduced to the market, GMD is bringing high-quality, substantially equivalent alternatives to market at lower prices. Devices chosen by GMD all have existing 510(k) classification, reimbursement by Medicare and third-party payers, established product safety, efficacy and outcomes, and a trained surgeon/physician base.