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/.
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SOURCE Cresilon