{"id":38980,"date":"2025-11-19T14:04:22","date_gmt":"2025-11-19T07:04:22","guid":{"rendered":"https:\/\/thaipropertynews.com\/feeds\/?p=38980"},"modified":"2025-11-19T14:04:22","modified_gmt":"2025-11-19T07:04:22","slug":"rafa-laboratories-awarded-up-to-186-million-by-barda-to-develop-a-life-saving-intramuscular-txa-injection-for-prehospital-care-2","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=38980","title":{"rendered":"Rafa Laboratories Awarded up to $186 Million by BARDA to Develop a Life-Saving Intramuscular TXA Injection for Prehospital Care"},"content":{"rendered":"

JERUSALEM<\/span><\/span>, Nov. 19, 2025<\/span><\/span> \/PRNewswire\/ — Rafa Laboratories, a global leader in Chemical, Biological, Radiological, and Nuclear hazards medical countermeasures and Biodefense, today announced it has been awarded with a landmark development contract by the Biomedical Advanced Research and Development Authority (BARDA)<\/b>, part of Administration for Strategic Preparedness and Response\u00a0 at the U.S. Department of Health and Human Services (HHS), for the advanced development of a novel intramuscular (IM) formulation of tranexamic acid (TXA)<\/b>\u2014a potentially life-saving therapy for uncontrolled bleeding. The contract is valued at up to $186 million<\/span><\/b>, including all option periods.<\/p>\n

This pivotal collaboration, which represents Rafa’s second major contract with BARDA, addresses an urgent global need: a rapidly deployable, easy-to-administer treatment for hemorrhage in the critical prehospital setting.<\/p>\n

\u00a0Addressing the Critical Window to Save Lives<\/b><\/p>\n

Uncontrolled bleeding is the\u00a0leading cause of preventable death following trauma<\/b>, whether caused by accidents, mass-casualty events or in the battlefield. Caregivers need a tool which can be easily administered to a large number of casualties in a short period of time. TXA is an antifibrinolytic agent commonly used off label around the world to treat trauma bleeding in the pre-hospital and hospital space.<\/p>\n

Landmark clinical studies performed in tens of thousands of individuals have demonstrated that TXA can significantly reduce mortality rates if administered quickly enough following trauma hemorrhagic injury.<\/p>\n

“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,” said Roy Shay<\/span>, Vice President of Biodefense at Rafa Laboratories<\/b>. “Currently, TXA is typically administered intravenously (IV), which is challenging, time-consuming and requires training. \u00a0The need for trained individuals even greater in high-stress, or mass-casualty situations. Developing a new intramuscular TXA injection is a potential game-changer as it simplifies the administration process<\/b>, especially if administered with an autoinjector.<\/p>\n

As planned under the potential scope of this project, Rafa shall also develop a TXA autoinjector which will enable \u00a0professional as well as nonprofessional care givers to deliver this essential treatment instantly<\/b>\u2014dramatically increasing survival chances worldwide.”<\/p>\n

“The IM route offers a fast, reliable, and user-friendly alternative<\/b> for the existing IV administration, which can be extremely difficult in patients experiencing severe shock”.<\/p>\n

BARDA and Rafa are Collaborating on a Comprehensive Development Approach<\/b><\/p>\n

Rafa Laboratoriesis adopting a robust and integrated product development approach, <\/b>which is planned to include formulation development, manufacturing scale-up, pre\/clinical trials and a streamlined regulatory pathway designed to secure U.S. Food and Drug Administration (FDA) approval.<\/p>\n

“Over the past four decades, Rafa has built a reputation for developing highly dependable medical countermeasures targeting acute, life-threatening conditions, mainly CBRN and pain management.” said Iddo Leshem<\/span>, Chief Executive Officer of Rafa Laboratories<\/b>. “The IM TXA development contract marks a strategic expansion of Rafa’s presence in acute trauma care. We are deeply committed to partnering with BARDA to accelerate the delivery of this urgently needed, life-saving solution to hundreds of thousands of patients across the globe”.<\/p>\n

About\u00a0Rafa Laboratories<\/b><\/p>\n

Founded in 1937 and headquartered in\u00a0Jerusalem, Israel<\/span><\/b>, Rafa Laboratories<\/b> is a global leader in biodefense and emergency medical solutions. For more than 40 years, Rafa has supplied medical countermeasure autoinjectors to the U.S. federal government<\/b>, NATO allies<\/b>, military forces<\/b>, and civilian stockpiles<\/b> worldwide, including its Midazolam 10 mg autoinjector (US-FDA approved under NDA #216359 since 2022) and Atropine autoinjector (US-FDA approved under NDA #212319 for 2 mg since 2018 and EUA # for 0.5 & 1 mg since 2017). The company’s expertise spans the entire value chain \u2014 from a robust R&D pipeline addressing emerging threats, to cGMP-compliant manufacturing<\/b> and successful regulatory approvals from the U.S. FDA<\/b> and European health authorities<\/b>.<\/p>\n

Rafa’s controlling shareholder, FIMI Opportunity Funds<\/b>, is Israel’s<\/span> leading private equity fund. With over 25 years of experience, FIMI manages assets of $7 billion<\/span><\/b> and has completed nearly 100 investments globally.<\/p>\n

This project has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number \u00a075A50125C00018.<\/p>\n

Media Contact:<\/b>
Roy Shay<\/span><\/b>
VP, Biodefense<\/b>
Rafa Laboratories
roys@rafa.co.il<\/a>\u00a0<\/b><\/p>\n

\u00a0<\/p>","protected":false},"excerpt":{"rendered":"

<\/p>\n

JERUSALEM<\/span><\/span>, Nov. 19, 2025<\/span><\/span> \/PRNewswire\/ — Rafa Laboratories, a global leader in Chemical, Biological, Radiological, and Nuclear hazards medical countermeasures and Biodefense, today announced it has been awarded with a landmark development contract by the Biomedical Advanced Research and Development Authority (BARDA)<\/b>, part of Administration for Strategic Preparedness and Response\u00a0 at the U.S. Department of Health and Human Services (HHS), for the advanced development of a novel intramuscular (IM) formulation of tranexamic acid (TXA)<\/b>\u2014a potentially life-saving therapy for uncontrolled bleeding. The contract is valued at up to $186 million<\/span><\/b>, including all option periods.<\/p>\n

This pivotal collaboration, which represents Rafa’s second major contract with BARDA, addresses an urgent global need: a rapidly deployable, easy-to-administer treatment for hemorrhage in the critical prehospital setting.<\/p>\n

\u00a0Addressing the Critical Window to Save Lives<\/b><\/p>\n

Uncontrolled bleeding is the\u00a0leading cause of preventable death following trauma<\/b>, whether caused by accidents, mass-casualty events or in the battlefield. Caregivers need a tool which can be easily administered to a large number of casualties in a short period of time. TXA is an antifibrinolytic agent commonly used off label around the world to treat trauma bleeding in the pre-hospital and hospital space.<\/p>\n

Landmark clinical studies performed in tens of thousands of individuals have demonstrated that TXA can significantly reduce mortality rates if administered quickly enough following trauma hemorrhagic injury.<\/p>\n

“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,” said Roy Shay<\/span>, Vice President of Biodefense at Rafa Laboratories<\/b>. “Currently, TXA is typically administered intravenously (IV), which is challenging, time-consuming and requires training. \u00a0The need for trained individuals even greater in high-stress, or mass-casualty situations. Developing a new intramuscular TXA injection is a potential game-changer as it simplifies the administration process<\/b>, especially if administered with an autoinjector.<\/p>\n

As planned under the potential scope of this project, Rafa shall also develop a TXA autoinjector which will enable \u00a0professional as well as nonprofessional care givers to deliver this essential treatment instantly<\/b>\u2014dramatically increasing survival chances worldwide.”<\/p>\n

“The IM route offers a fast, reliable, and user-friendly alternative<\/b> for the existing IV administration, which can be extremely difficult in patients experiencing severe shock”.<\/p>\n

BARDA and Rafa are Collaborating on a Comprehensive Development Approach<\/b><\/p>\n

Rafa Laboratoriesis adopting a robust and integrated product development approach, <\/b>which is planned to include formulation development, manufacturing scale-up, pre\/clinical trials and a streamlined regulatory pathway designed to secure U.S. Food and Drug Administration (FDA) approval.<\/p>\n

“Over the past four decades, Rafa has built a reputation for developing highly dependable medical countermeasures targeting acute, life-threatening conditions, mainly CBRN and pain management.” said Iddo Leshem<\/span>, Chief Executive Officer of Rafa Laboratories<\/b>. “The IM TXA development contract marks a strategic expansion of Rafa’s presence in acute trauma care. We are deeply committed to partnering with BARDA to accelerate the delivery of this urgently needed, life-saving solution to hundreds of thousands of patients across the globe”.<\/p>\n

About\u00a0Rafa Laboratories<\/b><\/p>\n

Founded in 1937 and headquartered in\u00a0Jerusalem, Israel<\/span><\/b>, Rafa Laboratories<\/b> is a global leader in biodefense and emergency medical solutions. For more than 40 years, Rafa has supplied medical countermeasure autoinjectors to the U.S. federal government<\/b>, NATO allies<\/b>, military forces<\/b>, and civilian stockpiles<\/b> worldwide, including its Midazolam 10 mg autoinjector (US-FDA approved under NDA #216359 since 2022) and Atropine autoinjector (US-FDA approved under NDA #212319 for 2 mg since 2018 and EUA # for 0.5 & 1 mg since 2017). The company’s expertise spans the entire value chain \u2014 from a robust R&D pipeline addressing emerging threats, to cGMP-compliant manufacturing<\/b> and successful regulatory approvals from the U.S. FDA<\/b> and European health authorities<\/b>.<\/p>\n

Rafa’s controlling shareholder, FIMI Opportunity Funds<\/b>, is Israel’s<\/span> leading private equity fund. With over 25 years of experience, FIMI manages assets of $7 billion<\/span><\/b> and has completed nearly 100 investments globally.<\/p>\n

This project has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number \u00a075A50125C00018.<\/p>\n

Media Contact:<\/b>
Roy Shay<\/span><\/b>
VP, Biodefense<\/b>
Rafa Laboratories
roys@rafa.co.il<\/a>\u00a0<\/b><\/p>\n

\u00a0<\/p>\n

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