JERUSALEM, March 20, 2024 /PRNewswire/ — Rafa Laboratories, LTD., a leading manufacturer of Emergency Medical Solutions, and the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response at the U.S. Department of Health and Human Services, aim to enhance the national preparedness for nerve agent emergencies by developing a new design for Rafa’s pediatric atropine autoinjectors. Nerve agents like sarin and VX, as well as certain insecticide organophosphates, pose severe health risks, requiring rapid and effective medical countermeasure response, especially in multi-casualty scenarios.
Atropine – the primary antidote for nerve agent and insecticide poisoning, is usually administered via autoinjectors. Consequently, these medical devices play a crucial role in emergency preparedness and response, as they enable health care professionals and even non-health care professionals to rapidly administer lifesaving treatment.
Rafa Laboratories already manufactures adult atropine autoinjectors, FDA-approved in July 2018, and pediatric atropine autoinjectors authorized for use under FDA Emergency Use Authorization (EUA) in January 2018.
Rafa’s atropine autoinjectors are widely utilized in military settings, due to their high reliability and robustness properties. The current device is designed to align with the military practice of pinning a used autoinjector onto clothing using the bent needle. The new design for the pediatric atropine autoinjector, which is intended for civilian use, will incorporate a new needle shield mechanism feature.
BARDA’s Support for Innovation: Ensuring Safety and Efficacy
To meet FDA approval requirements for the enhanced pediatric atropine autoinjector, BARDA will provide comprehensive support to Rafa Laboratories. This includes funding support for advanced development activities, human factor studies, and all regulatory, quality assurance, management, and administrative activities associated with the development of the product. The new autoinjector will offer two dosage strengths based on the patient’s weight, catering to diverse pediatric populations.
A Promising Future: Beyond Pediatric Atropine Autoinjectors
Rafa’s newly-designed pediatric autoinjector platform is poised not only to meet the needs of pediatric patients but also to potentially pave the way for needle-protected adult atropine and adult midazolam (for the treatment of Status Epilepticus) autoinjectors, while maintaining an exceptionally high reliability rate of 99.999% successful activation, as required by the FDA for emergency use autoinjectors. These additional developments are included under two options under the contract with BARDA.
The collaboration between BARDA and Rafa Laboratories reflects a shared commitment to developing and improving medical countermeasures to meet emerging global challenges. The newly-designed autoinjector is set to enhance national preparedness, ensuring that civilians will receive life-saving medical treatment promptly and safely in times of crisis.
This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; BARDA, under contract number 75A50123C00055.
About Rafa Laboratories LTDFounded in 1937 and headquartered in Jerusalem, Israel, Rafa Laboratories is a global leader in medical emergency solutions. For over 30 years, Rafa has been supplying medical countermeasure autoinjectors to government entities, military forces, and civilian stockpiles worldwide. The company excels across the entire value chain, commencing from an extensive R&D pipeline addressing emerging threats, through cGMP-compliant manufacturing, to obtaining regulatory approvals for its products from the US-FDA and European health authorities. Rafa’s controlling shareholder, FIMI Opportunity Funds, is Israel’s leading private equity fund. With a 25-year history, FIMI manages assets of $7 billion and has an impressive track record of nearly 100 investments, demonstrating outstanding performance both locally and globally.
For more information, please contact:
Roy Shay, VP, Emergency Solutions
Rafa Laboratories
roys@rafa.co.il
