#USA #Jerusalem #BARDA #Rafa Laboratories #TXA Injection

Rafa Laboratories Receives $186 Million from BARDA

In a groundbreaking announcement, Rafa Laboratories, a prominent player in medical countermeasures for Chemical, Biological, Radiological, and Nuclear hazards, has secured a landmark development contract valued up to $186 million from the Biomedical Advanced Research and Development Authority (BARDA). This funding is designated for the advanced development of an innovative intramuscular (IM) formulation of tranexamic acid (TXA), a potentially life-saving therapy for uncontrolled bleeding in emergency scenarios.

This new collaboration marks Rafa's second significant contract with BARDA, reinforcing the urgent global need for a treatment that can be rapidly deployed to address hemorrhage in critical prehospital settings. Acknowledging the dire statistics, uncontrolled bleeding is a leading cause of preventable death following trauma, whether it arises from accidents, mass-casualty events, or battlefield injuries. The need for a solution that can be easily administered by caregivers to multiple casualties is paramount.

The Importance of Timing in Trauma Care

Clinical studies involving thousands of patients have shown that administering TXA promptly after a traumatic injury can considerably reduce mortality rates. Roy Shay, the Vice President of Biodefense at Rafa Laboratories, highlighted the significance of the initial minutes after a hemorrhagic injury, stating, "The clock starts ticking the moment a patient sustains a hemorrhagic injury, and the few minutes before reaching a hospital are the most critical ones."

Currently, TXA is delivered intravenously, a method that can be challenging and time-consuming, particularly in high-pressure scenarios such as mass-casualty situations. The introduction of an intramuscular injection of TXA is poised to be transformative, simplifying the administration process and allowing for rapid intervention, especially when used alongside an autoinjector. Shay further noted, "The IM route offers a fast, reliable, and user-friendly alternative for the existing IV administration, which can be extremely difficult in patients experiencing severe shock."

Comprehensive Development Strategy

As part of this initiative, Rafa Laboratories will undertake an integrated product development approach that includes formulation development, manufacturing scale-up, preclinical trials, and a streamlined pathway for obtaining FDA approval. Iddo Leshem, CEO of Rafa Laboratories, expressed the company's commitment, noting, "Over the past four decades, Rafa has built a reputation for developing highly dependable medical countermeasures targeting acute, life-threatening conditions. The IM TXA development contract marks a strategic expansion of Rafa's presence in acute trauma care."

Founded in 1937 and based in Jerusalem, Rafa Laboratories has been at the forefront of biodefense and emergency medical solutions. With experience supplying medical countermeasure autoinjectors to the U.S. federal government, NATO allies, and military forces, the company’s portfolio includes FDA-approved autoinjectors, such as its Midazolam and Atropine products. Expertise in the complete value chain showcases Rafa's capacity to address emerging threats with innovative solutions.

Looking Ahead

The project is partially funded by federal appropriations from the U.S. Department of Health and Human Services under contract number 75A50125C00018. By fostering partnerships like the one with BARDA, Rafa Laboratories aims to expedite the delivery of this vital, life-saving treatment to countless patients worldwide. This ambitious project not only enhances the company’s offerings but also directly contributes to saving lives in critical situations, reaffirming Rafa's unwavering commitment to medical excellence and emergency preparedness.