Cresilon's Revolutionary Hemostatic Gel Technology Shows Promising Results for Treatment of Penetrating Traumatic Brain Injury in Study Performed with Walter Reed Army Institute of Research

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Jul 09, 2024, 08:00 ET

Findings from preclinical study demonstrate potential for a field and prehospital treatment following a penetrating TBI

NEW YORK, July 9, 2024 /PRNewswire/ -- Cresilon Inc. ("Cresilon"), a Brooklyn-based biotechnology company focused on hemostatic medical device technologies, today 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.

"TBIs significantly impact the health, preparedness, and resilience of military personnel," said Dr. Anke Scultetus, WRAIR. "The results of this study with Cresilon are encouraging as we work to deliver solutions for medical personnel and our injured service members."

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.

"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."

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.

For more information about Cresilon, which was recently named to Fast Company's annual list of the World's Most Innovative Companies, ranking No. 1 in the medical devices category, visit www.cresilon.com.

About Cresilon
Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company's proprietary hydrogel technology. The company's plant-based technology has revolutionized the current standard by stopping bleeding in seconds. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about Cresilon at www.cresilon.com.

About the Walter Reed Army Institute of Research
WRAIR provides unique research capabilities and innovative medical solutions to enable readiness and protect the Warfighter. Focus areas include infectious disease, combat casualty care, military psychiatry, and neuroscience, among others. WRAIR is part of the U.S. Army Medical Research and Development Command, under the U.S. Army Medical Command. For more information, visit https://wrair.health.mil/.

SOURCE Cresilon