By Puyaan Singh
(Reuters) – The U.S. Food and Drug Administration (FDA) has approved Cresilon’s gel for rapid hemostasis, the private company said on Thursday, potentially giving paramedics and combat medics a tool they can use to prevent deaths from blood loss.
Unlike the product previously approved for minor cuts and scratches, the new gel, called Traumagel, can be used for life-threatening injuries, CEO and co-founder Joe Landolina told Reuters.
“This (trauma gel) is for stab wounds, gunshot wounds, car accidents – basically anywhere where this product stands between a patient and death.”
Current treatments, which use gauze and other chemical agents, take more than five minutes to work, including applying pressure to the wound, according to Landolina, whereas Traumagel takes just a few seconds.
Traumagel is an algae-derived gel that comes in a prefilled syringe and does not require manual pressure to be applied to the wound to form a blood clot, the company says.
FDA approval for the gel, which is expected to hit the market in late 2024, is based on preclinical data comparing it to a standard product.
Landolina, who invented the plant-based hemostatic gel technology at the age of 17, said: “91% of battlefield deaths are related to what is known as preventable bleeding. This means that countless lives could be saved if only there was a better hemostatic product.”
The company plans to price the gel “competitively” compared to other treatments, Landolina said, but declined to provide further details.
Cresilon also sells a gel to stop bleeding in animals during surgery.
(Reporting by Puyaan Singh in Bengaluru; Editing by Shilpi Majumdar and Shinjini Ganguli)
