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BC3 Technologies gets FDA clearance for wound spray
//March 23, 2023
BC3 Technologies, a Baltimore-based medical device company, announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance for its SEAL Hemostatic Wound Spray, an aerosolized chitosan for the rapid management of serious arterial bleeding.
When sprayed on a bleeding wound, SEAL quickly forms a strong barrier that helps stop bleeding within seconds and without pain.
SEAL can be used by first responders, in surgical environments or in battlefield combat. In its pivotal study, SEAL was therapeutically equivalent to other chitosan-based products indicated for hemorrhage.
Use of SEAL resulted in 50% less blood loss than other chitosan-based dressings or granules, the company said. Its proprietary aerosol delivery system – unique in the class – helps to stop the bleeding rapidly and effectively and it reduces the risk of wound infections by preventing the growth of harmful bacteria.
With FDA marketing clearance, SEAL is now available by prescription and will soon be available for over-the-counter use, the company said.
BC3 Technologies plans to make available a veterinarian version of SEAL later this year.
