MEMPHIS, Tenn., May 18, 2005 (PRIMEZONE) -- Greystone Medical Group announced today that it has received U.S. Food and Drug Administration (FDA) clearance to market and sell Epi-Max(r), a wound care product created for the treatment of diabetic skin ulcers and other conditions. The FDA cleared Epi-Max(r) as a combination product, one of the few advanced wound care products that contains both a drug and a device.
The explosion in the number of new diabetes cases in the U.S. in the last decade has created the need for effective treatment of diabetic skin ulcers. Approximately fifteen percent of diabetic patients will eventually develop an ulcer; and of those that do develop ulcers, one in four will have a foot amputated.
"FDA clearance of Epi-Max(r) is extremely important, as the U.S. is the battleground for diabetes," said Greg Pilant, chairman and chief executive officer of Greystone Medical Group, Inc. "There is an unmet need for additional treatment options in the patient population suffering with diabetic ulcers."
Epi-Max(r) is a sterilized wound dressing impregnated with Greystone Medical Group's patented Poly Hydrated Ionogens (PHI) composition. Epi-Max(r) is designed to be the U.S. version of Greystone's DerMax(r) product, which has been approved as a medical device in Europe.
"Our experience in Europe has been very positive with regard to the safety and effectiveness of our products in treating chronic wounds of a wide range of etiologies," said Barry Willemsteijn, Marketing Manager of Greystone's European subsidiary, Dermagenics, B.V.
Epi-Max(r)'s impact is expected to be profound, providing an additional treatment option for patients with chronic wounds.
Greystone has operations in the U.S. and Europe, where numerous clinical trials and studies are underway evaluating the effectiveness of its PHI platform technology on several other medical conditions. The Company currently manufactures and sells advanced wound care products for treating and closing chronic wounds associated with systemic conditions -- including diabetes, burns, and pressure ulcers -- in Europe.
Greystone Medical Group, Inc. maintains its headquarters and manufacturing facilities in Memphis, Tennessee and its European headquarters, through its subsidiary Dermagenics, B.V., in Kaatsheuvel, The Netherlands. More information is available at www.greystonemedical.com.