The Food and Drug Administration has approved a medical device that blends seamlessly with modern medical equipment. Star Trek On Thursday, the FDA approved Cresilon’s Trauma Gel as an emergency treatment for moderate to severe bleeding. The gel is expected to be available on store shelves later this year.
The product uses algae-derived hydrogel technology developed by the Brooklyn-based company. It is Cresilon’s second gel-based treatment approved, following a hemostatic gel that received FDA approval in June 2023. While that gel was approved to seal small cuts and wounds, the trauma gel is intended to treat bleeding from more serious injuries, such as gunshot wounds, stab wounds and car accidents.
The FDA approved Traumagel based on preclinical data showing it is as effective as standard wound treatments currently in use, but the company claims its product offers several advantages over existing treatments, including working within just seconds. The gel is also easy to apply with a pre-filled syringe that doesn’t require pressure to be applied to the wound, and it’s said to be usable to treat any type of bleeding.
“The ability to quickly stop bleeding and stop life-threatening bleeding at the point of care can mean the difference between life and death for people suffering from traumatic injuries,” said Cresilon’s CEO, co-founder and inventor. Joe Landolina said in a company statement:“The FDA approval of Traumagel marks a milestone for Cresilon and marks another step in our mission to save lives and transform the standard of care in wound care. Our proprietary hemostatic gel technology is revolutionary and unlike any other hemostatic agent currently in use.”
The company plans to begin selling the gel in the second half of 2024 and will sell the product to the U.S. military, government health agencies, emergency medical systems and other medical professionals who regularly treat trauma patients. The company is also working with the U.S. Department of Defense to develop new products for potential in-field and pre-hospital treatments to help manage life-threatening brain hemorrhages and traumatic brain injuries. Early results are promising, the company says.
Scientists elsewhere are working on their own gel-based technologies to improve medical care: Some have developed gel-infused bandages to speed healing, while others are using the gel as male contraception or to help treat conditions such as Parkinson’s disease and back pain.
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