Breakthrough Device Designation received from the FDA
Tuesday, June 18, 2019
Accelerated regulatory pathway for first internal use product
GAITHERSBURG, Md., June 18, 2019 /PRNewswire/ -- gel-e Inc., announces Breakthrough Status Designation from the U.S. Food and Drug Administration (FDA) for its first internal-use flowable device.
gel-e is developing a line of advanced hemostatic and wound treatment products that address unmet needs from the operating room to the backyard. Following previous clearances for topical and external use of its platform technology (see http://www.gel-e.co/news.html), the Company is now expanding its label to include use for internal and surgical applications. The first product, now on an accelerated path as a Breakthrough Device, is an expanding injectable hemostat, Life Foam™. Life Foam can rapidly provide temporary control of bleeding from non-compressible abdominal wounds that are not amenable to tourniquet application in trauma and battlefield conditions. As the tradename suggests, this product is designed to save the lives of those injured in battle, or that are the victims of traumatic accidents or even terrorist attacks.
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