BC3 Technologies receives FDA approval for SEAL Hemostatic Wound Spray

Written on: April 13, 2023 by SprayTM

BC3 Technologies, a privately held medical device company, has received clearance from the U.S. Food & Drug Administration (FDA) for its SEAL Hemostatic Wound Spray. The chitosan-based aerosol spray is the first of its kind on the market for rapidly managing serious arterial bleeding, according to the company.

When sprayed on a bleeding wound, SEAL quickly forms a strong barrier that helps stop bleeding within seconds, without pain, and reducing the risk of wound infections by preventing the growth of harmful bacteria. SEAL can be used by first responders, in surgical environments or in battlefield combat.

“This clearance by the FDA puts SEAL wound spray in the hands of paramedics, police officers, doctors, military personnel and other front-line emergency responders who deal with hemorrhage-related trauma every day,” said Wayne Grube, CEO of BC3 Technologies.

Unlike bandage or granule-based chitosan products, SEAL can be applied under windy and wet conditions and in low light. The compact, portable product has undergone preliminary efficacy studies with several organizations, including the U.S. Army Institute of Surgical Research, said the company. Due to its novel spray design, SEAL can be applied directly to 3D wound architectures and can be forced into openings such as gunshot wounds.

SEAL aerosol containers come in two sizes: a three-second can for stab and bullet wounds and a 10-second can for wounds larger than four inches or for appendages that have been severed. With FDA marketing clearance, SEAL is now available by prescription and will soon be available for over-the-counter use, said the company. Additionally, BC3 Technologies plans to make a veterinarian version of SEAL Hemostatic Wound Spray available later this year.

For more information on SEAL Hemostatic Wound Spray, visit www.bc3tech.com