t has received FDA breakthrough designation to accelerate its development. It uses natural biopolymers that are abundant and inexpensive.
Trauma from accidents is the third leading cause of death in the US after only heart disease and cancer. Approximately 85% of all hemorrhage-related deaths result from non-compressible internal bleeding, a condition that results from intracavitary (e.g. abdominal) bleeding that is not accessible to direct pressure and cannot be controlled by traditional methods, such as gauze or a tourniquet.
Wound care markets are worth a projected $7 billion combined. These also include films to treat chronic wounds and venous leg ulcers and high-performance first aid kits.
Breakthrough products are a medical device must provide more effective treatment of a life-threatening or irreversibly debilitating condition, and
(i) have no approved or cleared alternatives, or
(ii) offer significant advantages over existing alternatives, or
(iii) be in the best interest of patients.