Initial testing promising for hemostatic hydrogel to treat TBI
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A Brooklyn-based biotech firm has announced successful completion of the first phase of a preclinical study conducted with the Walter Reed Army Institute of Research involving a proprietary hemostatic hydrogel to treat traumatic brain injury.
According to a release from Cresilon Inc., the study was performed under a research and development agreement with Walter Reed for the benefit of military service members and civilians.
The study evaluated the safety and efficacy of Traumagel in a model of penetrating TBI.
“Preliminary findings from the preclinical study alongside the Walter Reed Army Institute of Research demonstrated promising results in the ability of our plant-based hemostatic gel to not only control bleeding when applied to a wound, but also provide neuroprotection following a penetrating traumatic brain injury,” Cresilon CEO and co-founder Joe Landolina told Healio in an email.
The first phase of the study, which evaluated intracranial pressure, cerebral perfusion pressure, and hemoglobin content against a control, showed no measurable difference in safety between test and control arms, according to the release.
The plant-based hemostatic substance is supplied in a pre-filled syringe and its administration addresses severe bleeding at the point of injury.
According to statistics cited in the release, since the U.S. Department of Defense began tracking and reporting TBI, a total of 492,167 service members have sustained one or more such injuries, 5,766 of which were classified as penetrating.
Based on these initial results, Walter Reed plans to pursue further studies utilizing Cresilon’s proprietary hemostatic hydrogel, according to the release. Cresilon recently submitted a 510(k) application to the FDA for Traumagel.
“Our goal is to address the needs of the U.S. military, government health agencies, EMS systems and medical professionals who routinely encounter bleeding injuries and need a solution to quickly and effectively stop and control severe bleeding,” Landolina told Healio.