Wound-care startup Gel-e said today that it has won FDA breakthrough status designation for its first internal-use flowable device.
The College Park, Md.-based company’s first product, Life Foam, is an expanding, injectable hemostat designed to rapidly provide temporary control of bleeding from non-compressible abdominal wounds that are not suited to tourniquet application in trauma and battlefield conditions.
The FDA previously cleared Gel-e’s platform technology for topical and external use.