U.S. Army Medical Research and Development Command Funds
FORCE Study to Evaluate Advanced Hemorrhage Control Technology on
the Battlefield - Prytime Medical
SAN
ANTONIO, Nov. 1, 2024 /PRNewswire/ -- The U.S. Army
Medical Research and Development Command has announced a new study
that will assess the efficacy of the new 2+ hour pREBOA-PRO™
catheter in treating casualties in extremely far forward austere
combat environments. The FORCE (Field Observation of REBOA in
Combat Environments) study, officially titled A Study of Partial
REBOA Use on the Battlefield: Enabling Transport of Combat
Casualties with Non-compressible Torso Hemorrhage (NCTH),
focuses on the urgent need to manage severe hemorrhage on the
battlefield. The study utilizes the
pREBOA-PRO™ catheter with the goal of providing
longer partial aortic occlusion time to enable triage, treatment
and transport for the critically injured. The study commenced
September 2024. This effort was
awarded through MTEC solicitation MTEC-24-01-MPAI and is funded by
the DOD Combat Casualty Research Program (CCCRP) in accordance with
the Congressional direction to establish military medical
partnerships with the Ukraine
specified in NDAA 2023 and 2024. To date, the CCCRP has funded
research projects within Ukraine
related to traumatic brain injury, hemorrhage control, traumatic
stress, rehabilitation, wound management, severe sepsis, and trauma
registry development. The DOD CCRP seeks to develop requirements
driven knowledge and material solutions for the care of combat
related traumatic injury during current and future conflicts.
Non-compressible torso hemorrhage (NCTH) is the leading cause of
preventable death among military trauma patients. In the current
conflict in Ukraine, evacuation
delays are common and require much longer hemorrhage control and
resuscitation support than in previous conflicts. The pREBOA-PRO™
catheter, a third-generation device approved by the U.S. Food and
Drug Administration and the European Union Medical Device
Regulation – Regulation (EU) 2017/745 (EU MDR), has been in combat
use in Ukraine for over 18 months.
By extending the safe usage of resuscitative endovascular balloon
occlusion of the aorta, or REBOA, beyond 30 minutes, the
pREBOA-PRO™ catheter enables forward medical teams to
hemodynamically stabilize critically injured soldiers outside of
the hospital, improving their chances of survival during extended
transport. This new catheter provides a critical solution by
allowing over two hours of hemorrhage control and resuscitation
support through a capability known as partial occlusion of the
aorta. Its patented technology has become pivotal for casualty
management on the modern battlefield.
Based on 18 months of successful use of the pREBOA-PRO™ in
combat, the FORCE study will formalize the detailed collection of
observational data on the use of the new 2+ hour partial REBOA
pREBOA-PRO™ catheter in extremely austere and far forward combat
environments. The key objectives of the study are to determine the
utility of central aortic pressure monitoring and 2+ hour extended
aortic occlusion on the battlefield.
REBOA has a long-standing history of military research &
funding. Most recently, Prytime was selected by the U.S. Army
Medical Research and Development Command to receive $6.2 million from the U.S. Department of Defense,
awarded through the Medical Technology Enterprise Consortium for a
multi-center observational study of NCTH patients being treated
with the pREBOA-PRO for partial occlusion as standard of care. This
effort is titled the Partial REBOA Outcomes Multi-Center
Prospective (PROMPT) study scheduled to be completed November 30, 2025.
"No one should bleed to death: that is our company's mission,"
said Dr. Jessica Raley, the
Principal Investigator for the FORCE and PROMPT studies. "We're
passionate about finding new ways for civilian and combat wounded
patients to reach definitive care, and we're grateful for the
opportunity to document the latest REBOA combat casualty management
strategies and share them with the world."
ABOUT PRYTIME MEDICAL DEVICES, INC.
Prytime Medical Devices, Inc. is an innovative medical device
company that designs, develops, and commercializes minimally
invasive solutions for hemorrhage control. The underlying
intellectual property for REBOA was conceived based on lessons
learned in war. Our latest innovations, the industry-leading
ER-REBOA™ PLUS, and the innovative partial REBOA
pREBOA-PRO™ catheter, enable torso hemorrhage
control with more controlled resuscitation in a much wider range of
clinical scenarios. The pREBOA-PRO™ catheter is the
first and only FDA-cleared REBOA catheter designed specifically for
True Partial REBOA™. More information can be found at
http://www.PrytimeMedical.com.
ABOUT THE U.S. ARMY MEDICAL RESEARCH AND DEVELOPMENT
COMMAND
The U.S. Army Medical Research and Development Command is the
Army's medical materiel developer, with responsibility for medical
research, development, and acquisition. USAMRDC produces medical
solutions for the battlefield with a focus on various areas of
biomedical research, including military infectious diseases, combat
casualty care, military operational medicine, medical chemical and
biological defense. https://mrdc.amedd.army.mil/
ABOUT MTEC
The Medical Technology Enterprise Consortium is a 501(c)(3)
biomedical technology consortium that is internationally dispersed,
collaborating with multiple government agencies under a 10-year
renewable Other Transaction Agreement with the U.S. Army Medical
Research and Development Command. The consortium focuses on the
development of medical solutions that protect, treat, and optimize
the health and performance of U.S. military personnel and
civilians. To find out more about MTEC, visit mtec-sc.org.
Disclaimer: The views and conclusions contained herein
are those of the authors and should not be interpreted as
representing the official policies or endorsements, either
expressed or implied, of the U.S. Government.
Contact Information:
For more information about this study, please contact:
[Jessica Raley] [Principal
Investigator for the FORCE study] [Prytime Medical] [210-340-0116]
[jraley@prytimemedical.com]
Press Contact: [Nicole
Calvert] [Marketing Manager for Prytime Medical]
[210-340-0116] [ncalvert@prytimemedical.com]
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SOURCE Prytime Medical