The FDA has approved Greystone Medical‘s device for diabetic skin ulcers, the Epi-Max.
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® 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® is a sterilized wound dressing impregnated with Greystone Medical Group’s patented Poly Hydrated Ionogens (PHI) composition. Epi-Max® is designed to be the U.S. version of Greystone’s DerMax® product, which has been approved as a medical device in Europe.
The device is intended to keep the affected area moist, which promotes healing. It’s a different tack than that of EpiFLO we profiled two months ago. EpiFLO, which improves site oxygenation, was given a more general approval from the FDA, for more kinds of chronic skin breakdown. The makers of Epi-Max, however, also use it for general purposes in Europe under the name DerMax.
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