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.
“Receiving Breakthrough Device Designation is an important milestone in accelerating the development and clinical implementation of Life Foam, which holds so much potential to save lives on the battlefield and in treating traumatic injuries,” chief scientific officer Dr. Matthew Dowling said in a press release. “We look forward to collaborating with the FDA to hasten the clinical development of Life Foam so that it can be used to treat a condition which is otherwise is often deadly or disabling.”