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MACH32 Inc


MACH32 is a seed-stage Canadian medical device company addressing pre-hospital emergency bleeding. Traumatic injury is responsible for 9% of deaths worldwide annually; too many patients bleed to death before reaching the hospital. A generic anti-fibrinolytic agent (Tranexamic Acid; TXA) is clinically proven to reduce mortality due to bleeding following injury, but is vastly under-utilized in the pre-hospital environment because it is difficult to deliver and requires setting up an IV. Setting up an IV takes both time and skill. MACH32's lead product, IMSAFE solves the delivery problem for TXA. IMSAFE is a novel high-volume intramuscular autoinjector that allows for fast and easy delivery of TXA with minimal medical training. The intended users of IMSAFE are military medics, emergency medical services (EMS), and first responders such as fire fighters and police officer. Senior UK Ministry of Defence physicians have stated "My aspiration is to have every deployed soldier, sailor, and airman carry a TXA autoinjector and for them to be rolled out across the UK NHS PHEC (ambulance) services too. The total addressable market in the United States alone is ~$4 Billion; as traumatic injury results in > 9 millions EMS calls annually. MACH32 has developed functional working prototypes that have been tested with a Canadian military partner; PCT patent applications have been filed. Research and development collaboration are in progress with Canadian and US militaries. A pre-IND meeting submission to the FDA is in progress. MACH32 is currently seeking seed-stage capital to establish a manufacturing line for IMSAFE and complete pre-clinical testing required for regulatory approval. MACH32 is seeking strategic pharmaceutical partnerships to commercialize IMSAFE.