
Cresilon, a Brooklyn-based biotechnology company focused on hemostatic medical device technologies, announced the U.S. commercial launch of TRAUMAGEL, a hemostatic gel that controls bleeding when applied to a wound at the point of care.
TRAUMAGEL, which received FDA 510(k) clearance for temporary external use for controlling moderate to severe bleeding, is now available for widespread use by EMTs, paramedics, first responders, emergency departments, and trauma healthcare providers. TRAUMAGEL is supplied in a 30 mL sterile prefilled syringe, requires no preparation, is easy to apply and remove, stops bleeding, and provides immediate hemorrhage control.
Prior to its nationwide launch, Cresilon initiated a strategic rollout of TRAUMAGEL with regional EMS agencies, fire departments, academic medical centers, and Level I trauma centers in select markets, including Boston, New Orleans, Denver, and Columbus, Ohio. The innovative hemostatic gel has been successfully used in the field and applied to a wide variety of moderate to severe bleeds, such as extremity injuries, head lacerations, and penetrating wounds. Results of initial use cases have been positive and will be reported in future case studies.
The company said TRAUMAGEL, which uses Cresilon's proprietary hydrogel technology, is the first gel in a syringe for traumatic hemorrhage and the only flowable hemostatic cleared for temporary external use to control moderate to severe bleeding.
TRAUMAGEL is now available nationwide and is being manufactured at Cresilon's facility in Brooklyn, New York.