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Revolutionary Hemostatic Gel Technology Treats Penetrating Traumatic Brain Injury

By HospiMedica International staff writers
Posted on 19 Aug 2024
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Image: TRAUMAGEL has received FDA 510(k) clearance (Photo courtesy of Cresilon)
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 hemorrhages can be fatal within minutes, with up to 60% of hemorrhage-related deaths occurring within the first three hours post-injury. Penetrating traumatic brain injury (TBI), resulting from incidents like gunshots or shrapnel, represents the most severe category of head trauma, often leading to death, permanent disability, neurodegenerative diseases, and long-term health complications. Now, a revolutionary hemostatic gel technology has shown promise for the treatment of penetrating TBI.

Cresilon Inc.’s (Brooklyn, NY, USA) TRAUMAGEL, which utilizes its proprietary hydrogel technology, is the first hemostatic device of its kind to be granted FDA approval for temporary external application on moderate to severe bleeding wounds. This groundbreaking hemostatic gel combines refined plant polymers that instantly form a mechanical barrier upon contact with a wound. Packaged in a pre-filled syringe, Cresilon's plant-based gel is designed to be a quick, effective, and easy-to-use option for stopping severe bleeding promptly at the point of injury, without the need for prior preparation or specific storage conditions.

Cresilon has now announced the successful completion of the initial phase of a preclinical study, in collaboration with the Walter Reed Army Institute of Research (WRAIR), which assessed the effectiveness and safety of its hemostatic hydrogel in a penetrating TBI model. Early results from the study indicate that Cresilon’s hemostatic gel effectively controls bleeding and offers neuroprotection when applied to penetrating brain injuries. The initial phase of this study, which evaluated factors like intracranial pressure, cerebral perfusion pressure, and hemoglobin levels in comparison to a control group, showed promising outcomes. The safety profile was consistent between the experimental and control groups of the study. Encouraged by these findings, WRAIR plans to conduct additional research utilizing Cresilon’s innovative hemostatic hydrogel technology.

“We are honored to be collaborating with WRAIR in studying our innovative hemostatic gel technology as a potential solution to address a critical unmet medical need for both military service members and civilians,” said Cresilon CEO and Co-Founder Joe Landolina. “We look forward to continuing our partnership with the WRAIR and the next phases of this study, which could potentially yield a field and prehospital treatment that may not only save lives, but also minimize brain damage when a penetrating head injury occurs.”

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