Cooling The Brain: New Therapies For Stroke
Therapeutic hypothermia has shown promise as a neuroprotective treatment for a variety of applications, including cardiac arrest and neonatal hypoxic brain injury. Now companies with temperature management technologies are conducting clinical trials and developing new cooling devices with an eye toward cooling the brain in patients who experience an acute ischemic stroke – an indication with an estimated worldwide market potential of $3 billion annually.
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For therapeutic hypothermia device companies, the clinical trials that came before have been inconclusive, but they have provided insights to incorporate into the development of next-generation technologies. START-UP interviews two hypothermia device companies with novel approaches: Thermocure and ThermopeutiX.
Despite market headwinds, the endovascular treatment of acute ischemic stroke remains a growing and highly under-penetrated market opportunity valued at more than $1 billion worldwide. Although advances in neurothrombectomy devices, access catheters, imaging, and neuroprotective therapies have the potential to help expand the treatable population, positive Level I clinical evidence is needed to drive adoption and market growth.
CoAxia Inc. did not have the funds to continue after its de novo petition for the NeuroFlo catheter was rejected by FDA for acute ischemic stroke. But Zoll still sees opportunity for the device; now that it owns the technology, the firm plans to design a new pivotal trial to take before the agency.