Revolutionary hemostatic gel technology for the treatment of penetrating traumatic brain injuries – Intensive Care

Image: TRAUMAGEL has received FDA 510(k) clearance (Photo courtesy of Cresilon)

Severe blood loss from incidents such as gunshot wounds or significant injury-related bleeding can be fatal within minutes. Up to 60% of bleeding-related deaths occur within the first three hours after injury. Penetrating traumatic brain injuries (TBI), caused by incidents such as gunshot wounds or shrapnel, represent the most serious category of head injuries and frequently result in death, permanent disability, neurodegenerative disease, and long-term health complications. A revolutionary hemostatic gel technology has now shown promise for treating penetrating TBI.

TRAUMAGEL from Cresilon Inc. (Brooklyn, NY, USA), utilizing its proprietary hydrogel technology, is the first hemostatic device of its kind approved by the FDA for temporary external use in moderate to severe bleeding wounds. This breakthrough hemostatic gel combines sophisticated plant-based polymers that immediately form a mechanical barrier upon contact with a wound. Packaged in a prefilled syringe, Cresilon's plant-based gel is intended to be a fast, effective and easy-to-use way to stop severe bleeding immediately at the site of injury without the need for prior preparation or specific storage conditions.

Cresilon has now announced the successful completion of the first phase of a preclinical study in collaboration with the Walter Reed Army Institute of Research (WRAIR) evaluating the efficacy and safety of its hemostatic hydrogel in a penetrating TBI model. Initial results from the study suggest that Cresilon's hemostatic gel is effective in controlling bleeding and is neuroprotective when applied to penetrating brain injuries. The first phase of this study, which examined factors such as intracranial pressure, cerebral perfusion pressure and hemoglobin levels compared to a control group, showed promising results. The safety profile was consistent between the experimental and control groups of the study. Encouraged by these findings, WRAIR plans to conduct further research using Cresilon's innovative hemostatic hydrogel technology.

“We are honored to partner with WRAIR to investigate our innovative hemostatic gel technology as a potential solution to a critical unmet medical need for both military personnel and civilians,” said Joe Landolina, CEO and co-founder of Cresilon. “We look forward to continuing our partnership with WRAIR and the next phases of this study, which could potentially lead to on-site, on-site treatment that can not only save lives, but also minimize brain damage in the event of a penetrating head injury.”

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Cresilon Inc.