Device for Intramuscular Administration of TXA in patients with TBI

Innovation Overview and Health Problem Revive s innovation is a compact, intramuscular (IM) auto-injector specifically designed for the rapid delivery of Tranexamic Acid (TXA) in emergency prehospital settings. Our innovation directly addresses the underutilization of TXA in traumatic brain injury (TBI) patients at risk of life-threatening hemorrhage or secondary brain injury, particularly due to the resource-intensive nature of the current intravenous (IV) administration method.[1] Against NICE guidelines, Currently, only 9% of major trauma patients who could benefit from TXA receive it in the critical prehospital phase.[2,3] This gap was streamlined by the CRASH-3 trial (NIHR), which showed that early TXA administration can reduce deaths from TBI by up to 20%.[4] In response, NICE updated its guidelines to recommend that TXA be administered within two hours of injury, and underscored need for rapid, accessible solutions in non-clinical settings.[5] Annually, the estimated 70,000 (5% of 1.4 million) head injuries with a Glasgow Coma Scale (GCS) score of 12 or less should be administered TXA, representing a 200% requirement increase.[6] Revive aims to drastically reduce the time and resources required to administer TXA by using a simple, easy-to-operate auto-injector, allowing first responders to deliver the drug in less than a minute compared to the 16-18 minutes currently required for IV setup and infusion.[7] Given that every 15-minute delay in TXA administration decreases its efficacy by 10%, our device promises to improve survival rates and reduce secondary complications such as hematoma expansion, increased intracranial pressure and hypoxia in TBI and trauma patients.[8] These complications can have irreversible consequences like an increased risk of death or the potential development of dementia.[9] Stage of Development and Evidence Generated The development of our TXA auto-injector (10mL drug volume) builds upon our proven technology from the development of the Revive Adrenaline auto-injector (0.5-2mL drug volume) for anaphylaxis. This previous product has reached TRL-5 and meets the ISO 11608 standards for needle-based injection systems. We are leveraging the intellectual property, delivery mechanism, and usability features for the TXA auto-injector. Fig1. Revive (0.5-2mL) Our Proof of Concept (PoC) for the TXA auto-injector must demonstrate the ability to deliver precise doses of 10mL TXA via IM injection, achieving therapeutic levels within 5 minutes of administration.[10] Intramuscular TXA administration has been shown to be safe and effective.[10] Additional scientific evidence is being generated through ongoing collaboration with clinicians and TBI experts, and we are closely following the findings of the CRASH-4 trial, which explores the feasibility of IM TXA administration in emergency settings. Early results show that intramuscular TXA achieves therapeutic levels quickly and is well tolerated in patients with mild TBI.[11] PPI activities have directly influenced several key aspects of the device s design, including: Miniaturization, ensuring portability Ease of use, requiring minimal training Visual and tactile indicators, ensuring the device can be used even in low-visibility or high-pressure situations. Clear instructions on the device packaging, reducing the likelihood of user error in critical moments. We will conduct further PPI sessions to ensure that our TXA auto-injector can be used without specialized training.