Company follows recent 510(k) clearance and $5MM investment round with a $14.3MM contract win to advance the science behind the REBOA technique and perform clinical trials
San Antonio, TX – Nov 10, 2015 – Pryor Medical Devices (The REBOA CompanyTM), today announced it has been awarded a $14.3MM contract from the U.S. military to advance the science behind REBOA (Resuscitative Endovascular Balloon Occlusion of the Aorta), and to perform an advanced clinical trial to develop data for FDA consideration of fluoroscopy free use of REBOA.
The military is particularly interested in the REBOA technique being used on-label for fluoroscopy-free catheter placement in deployed and far forward environments, which if done today would be considered off-label.
“We are honored to be selected for this important research effort,” said David A. Spencer, CEO of Pryor Medical Devices. “The military is working hard to make sure in future conflicts, no wounded warrior ever bleeds to death from potentially survivable wounds. The REBOA technique shows great promise in preventing potentially survivable death in both military and civilian settings. This contract will support research efforts to advance the science of the REBOA technique in general, while also funding a clinical trial of great promise for possible fluoroscopy free use.”
This work is being performed for the Naval Health Research Center and the U.S. Army Contracting Command, Aberdeen Proving Ground, Natick Contracting Division, under contract #W911QY-15-C-0099.
Military working to eliminate the #1 source of potentially survivable death in combat Following extensive data analysis from over 10 years of war, the military has identified Non-Compressible Torso Hemorrhage (NCTH) as the #1 cause of potentially survivable death in combat. NCTH is defined as hemorrhage arising from trauma to the torso vessels, pulmonary parenchyma, solid abdominal organs and/or disruption of the bony pelvis resulting in hypotension or shock. It is often called ‘truncal hemorrhage’ for brevity. NCTH is also a leading cause of potentially survivable death in car crashes and other civilian related trauma. The military is actively pursuing a range of technologies to eliminate potentially survivable death by truncal hemorrhage.
About REBOA (Resuscitative Endovascular Balloon Occlusion of the Aorta)
REBOA is a minimally invasive vascular technique that uses a balloon to temporarily occlude large vessels. Based on lessons learned during war, the REBOA technique shows tremendous promise in providing a minimally invasive solution in cases of trauma such as Non-Compressible Torso Hemorrhage (NCTH), which the military has identified as the number one cause of potentially survivable death in combat.
About Pryor Medical Devices – The REBOA Company™
Pryor Medical Devices, Inc. (The REBOA CompanyTM) is an innovative medical device company that researches, develops and commercializes minimally invasive solutions for trauma. Our flagship product is the ER-REBOATM Catheter, a 7 Fr compatible balloon catheter indicated for temporary occlusion of large vessels and pressure monitoring. The underlying intellectual property for the ER-REBOA catheter was conceived by experienced military vascular and trauma surgeons based on lessons learned in war. The company recently received regulatory clearance to market the ER-REBOA catheter for sale in the U.S.
Any opinions, findings and conclusions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the Naval Health Research Center and/or the U.S. Army Contracting Command, Aberdeen Proving Ground, Natick Contracting Division.