The partnership includes researching the effectiveness of Daxor’s BVA-100 diagnostic test on quantifying circulatory blood volume in the context of traumatic injury on the battlefield.
The collaboration will encompass multiple projects with the ultimate objective of saving the lives of American soldiers and translating the results to civilian care. Target indications include hemorrhage, burn, trauma, sepsis, and acute respiratory distress syndrome.
Outsourcing-Pharma (OSP) recently spoke with Michael Feldschuh (MF), Daxor CEO and president, about Daxor’s work, potential benefits for both civilians and soldiers, COVID-19 implications and notable partnerships.
OSP: Could you please tell us about Daxor Corp.—who you are, what you do, key services/capabilities, and what sets you apart?
MF: Daxor Corp. is an innovative medical instrumentation and biotechnology company based in New York City. We have been the industry leader in precision blood volume measurement since developing our BVA-100TM blood volume analyzer over two decades ago; BVA-100 is a simple one hour blood test that provides 98% accurate measures of total blood volume, red blood cell volume, plasma volume, and albumin transudation – all measures that are unmatched by any other available technology or test.
BVA-100 takes the guesswork out of diagnosing and treating volume abnormalities in many of the largest and most deadly diseases in the US, including COVID-19, heart failure, sepsis, and surgical blood loss. This ends the frequent bedside debates over volume status giving clinicians the information they need to make optimal treatment decisions.
Studies have shown access to the BVA-100 test reduces mortality by more than 80% in hospitalized heart failure (P<0.001) and in surgical ICU care by 66% (P<0.03) and reduces costs by making care more efficient. Daxor provides education and resources to ensure easy onboarding with ongoing support to derive maximum value from the Daxor system.
The BVA-100 test is FDA-cleared and reimbursed by Medicare and private insurance. To date over 45,000 tests have been performed to evaluate blood volume at many of the largest hospitals and academic medical centers in the country, including Duke, Vanderbilt, the Mayo Clinic, the VA, NYU, and Geisinger.
Our mission is to partner with clinicians to incorporate BVA technology into standard clinical practice and improve the quality of life for patients.
OSP: Please tell us about the BVA-100 diagnostic test—how it works, and what applications it might have (including traumatic battlefield injuries, and others).
MF: Maintaining tissue perfusion by optimizing blood volume is the key to survivability for many conditions; in fact, severe blood loss is the leading cause of preventable mortality for both military and civilian trauma patients. Tests currently used to guide ICU and battlefield resuscitation and transfusion often misdiagnose the severity of blood loss, leading to delayed and imprecise treatment.
The US Army and US Air Force have joined civilian hospitals in recognizing the BVA-100’s unique ability to address this crucial need by providing direct, precise quantification of patient volume status.
The BVA-100 is the only FDA-cleared test clinically available that uses the gold standard indicator dilution technique – all others rely on surrogate measures that have been shown to be far less accurate. A small amount of tagged albumin, a naturally occurring blood protein, is injected into the patient followed by several small blood draws.
The BVA-100 analyzer measures the amount of tracer in each sample and automatically calculates the patient blood volume and albumin transudation rate, a unique metric that provides insights into capillary leak, relevant for treatment of COVID-19, sepsis, hemorrhagic shock and other conditions.
The development of a blood volume analyzer designed specifically for battlefield conditions has been a multiyear process. In 2018, Daxor was awarded a Phase I contract by the U.S. Army under the Defense Department’s Small Business Innovative Research (SBIR) program.
Since then, Daxor has been awarded a follow-on Phase II contract from the U.S. Army and an additional U.S Air Force SBIR to further innovate BVA testing. In the future, Daxor plans to offer a portable, rapid analyzer that will deliver gold standard accuracy in even the most challenging military and civilian environments.
OSP: How did Daxor come to partner with the Uniformed Services University of the Health Sciences, and the Henry M. Jackson Foundation for the Advancement of Military Medicine?
MF: To further the mission of improving medical care to the injured warfighter, Daxor has entered into a Cooperative Research and Development Agreement (CRADA) with the Uniformed Services University of the Health Sciences (USU), a medical school and research center affiliated with the U.S. Army, Air Force, Navy, and Public Health Serve as well as Walter Reade Medical Center, and The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) on behalf of USU’s Battlefield Shock and Organ Support Research Program (BSOS).
The collaboration was a natural extension of USU researchers recognizing BVA-100’s unique capabilities and potential for improving care in many dangerous conditions caused by combat injury. We are very excited to be working with the expert clinicians and researchers, many among the foremost in the world, who will help us improve our technology so it can reach those soldiers and civilians who need it most in even the toughest conditions.
OSP: Can you tell us anything about the other projects the partners might be tackling in this collaboration?
MF: Daxor’s research and development collaboration with USU has already begun, and will continue with a wide range of projects focused on burn, hemorrhage, sepsis, acute respiratory distress syndrome (ARDS), and other conditions. These conditions are some of the hardest to treat and most lethal – both on the battlefield and for ICU patients here at home. USU, HJF, and Daxor are committed to the shared objective of innovating improvements in care for the most critically injured patients in the most settings possible.
OSP: Do you have any past projects that might be related to or applicable to this?
MF: BVA-100 is currently used in ICUs to treat civilian hemorrhage, trauma, sepsis, and ARDS patients. The Queen’s Medical Center (QMC), Hawaii’s first and only Level 1 Trauma Center, published a study demonstrating that BVA provided a 66% mortality benefit when treating surgical ICU patients, many with conditions that impact injured soldiers, such as hemorrhage, trauma, septic shock and ARDS. BVA continues to be used extensively in the QMC surgical ICU, a practice that is helping to inform Daxor’s research and development projects with the U.S. Army, U.S. Air Force, and USU.
Daxor also has a longstanding research relationship with Oregon Health and Sciences University where we are working toward translating even more of the BVA-100’s unique capabilities into improvements for both civilian and military patient care.
OSP: Can you provide any insight on how often research originating with the military benefits civilians, and vice versa?
MF: All branches of the U.S. military are heavily focused on delivering the best possible care to service members at home and abroad. Their teams of medical experts are leading the development and evaluation of innovative technologies and practices suited for specialized military needs.
Often this work translates to improved care for civilians; for example, the Military Burn Research Program (MBRP) has been among the most impactful organizations focused on burn care and research since its foundation in 2011. Further, the military’s research and development of early whole blood transfusion in the case of acute injury is a practice that has impacted civilian trauma and other care globally.
In the case of Daxor, our next generation technology will meet the rigorous logistical and usage needs of the military and will also bring the benefits of precision BVA testing to many more civilian patients. This may include applications as diverse as offering rapid testing in the hospital Emergency Department to inform life-saving blood transfusions, at the bedside to provide essential fluid monitoring of severely ill patients, and as part of the Strategic National Stockpile to save lives in the case of a public health emergency.