BC3 Technologies, a privately held medical device company, has received US Food and Drug Administration (FDA) 510(k) clearance for its SEAL Hemostatic Wound Spray - an aerosolised 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, according to BC3 Technologies.
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.
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, according to the company.
SEAL has undergone preliminary efficacy studies with several organisations, including the US Army Institute of Surgical Research.
It is the only chitosan-based aerosol spray product available for treating wounds. Due to its novel spray design, SEAL can be applied directly to complex 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. The product is manufactured in Baltimore, MD.
“We recognised a critical need to change the way wounds and significant bleeding are treated in emergency and trauma situations,” said Wayne Grube, CEO, BC3 Technologies.
“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. Among other traumas, we believe SEAL has significant potential in combating serious injury and death from gunshot wounds with the terrible rise of gun violence in the United States today.”
With FDA marketing clearance, SEAL is now available by prescription and will soon be available for over-the-counter use.
Every year, 40% of critically wounded people with arterial bleeding die in transit to the hospital. Bleeding wounds, including gunshot wounds, that cannot be treated with standard hemostatic methods, such as applying pressure with bandages, remain a leading cause of potentially preventable deaths. Arterial bleeding also increases the chances of spreading blood borne diseases.
Unlike bandage or granule-based chitosan products, SEAL can be applied under windy and wet conditions and in low-light, said the company. The product is compact, easy to carry, and can be administered by first responders, patients, professional medical staff, or caregivers.
BC3 Technologies plans to make available a veterinarian version of SEAL later this year.
Arterial bleeding management spray receives FDA clearance
