Hemostatic Gel Shows Promise for Treating Traumatic Brain Injury

The study could improve treatment for both military service members and civilians.

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Cresilon announced the successful completion of the first phase of a preclinical study conducted with the Walter Reed Army Institute of Research (WRAIR), the largest research institute in the U.S. Department of Defense (DOD). The preclinical study was performed under a Cooperative Research and Development Agreement (CRADA) between WRAIR and Cresilon in a joint effort to advance the treatment of traumatic brain injury (TBI) for both military service members and civilians.

The study was designed to evaluate the safety and efficacy of Cresilon's proprietary hemostatic hydrogel in a model of penetrating TBI. Preliminary findings from the preclinical study demonstrated promising results in the ability of Cresilon's plant-based hemostatic gel to control bleeding when applied to a wound and to provide neuroprotection following a penetrating TBI.

The first phase of this preclinical study evaluating intracranial pressure, cerebral perfusion pressure, and hemoglobin content, against a control was successful. There was no difference in safety between the test and control arms of the study.

Penetrating TBI (such as from a gunshot or shrapnel) is the most severe form of traumatic head injury and can lead to death, permanent disability, neurodegenerative diseases, and long-term health issues. Since the DOD began tracking and reporting the number of service members diagnosed with TBI, a total of 492,167 service members sustained one or more TBIs, 5,766 of which were classified as penetrating TBI.

Based on the results from this first phase of the study, WRAIR will pursue further studies utilizing Cresilon's proprietary hemostatic hydrogel. The revolutionary hemostatic gel is the first-ever technology to blend refined plant polymers to instantaneously create a mechanical barrier when applied to wounds. Cresilon's plant-based hemostatic gel is supplied in a pre-filled syringe and designed to provide a fast, effective, and easy-to-use solution to rapidly stop and control severe bleeding at the point of care – without preparation or special storage conditions.

In addition to the WRAIR study progressing to the next phases, Cresilon recently submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for TRAUMAGEL, which is intended to be used in moderate to severe external bleeding. Last year, the company received FDA 510(k) clearance for Cresilon Hemostatic Gel (CHG), which is intended for use in the local management of bleeding wounds such as minor cuts, lacerations, and abrasions. CHG marked the company's first FDA clearance as Cresilon is pursuing broader indications and aims to bring its revolutionary hemostatic gel technology to the trauma and emergency markets this year.

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