Development of Mi-Helper: A Thermodynamic Neuromodulation Device for Migraine Relief

ABSTACT Migraine is a severely disabling neurologic condition and the second most disabling disorder worldwide, affecting over a billion people. The prevalence of migraine in the U.S. is increasing, with 15% of the population suffering from either episodic or chronic migraine. The global economic burden of migraine is staggering, at approximately $20 billion in the U.S. and $56 billion worldwide per year. Migraine is one of the most common reasons for emergency room visits. Despite first-line treatment recommendations, many migraine patients are still prescribed opioid pain medications, particularly in emergency departments (EDs). There is an enormous unmet need for an effective and affordable non-drug abortive therapy for acute migraine to significantly improve quality of life and substantially reduce the cost burden to our healthcare system and society. CoolTech has developed the Mi-Helper device - a novel approach to migraine treatment that is simple, safe, and drug free, using nothing but clean, dry air. Mi-Helper induces thermodynamic neuromodulation by a low flow of dry, ambient air across the nasal turbinates. This approach targets the sphenopalatine ganglion (SPG), a nerve bundle behind the upper airway that is associated with migraine symptoms. Evidence has shown that SPG inhibition, including the use of intranasal lidocaine, can reduce the pain and duration of migraines. However, the location of the SPG makes it hard to access to apply anesthetics and requires a skilled physician to administer. Neuromodulation by way of transnasal cooling is an approach that provides fast, convenient, drug-free symptom relief. We have demonstrated proof of concept of this technique’s capacity for pain and symptom reduction in multiple in-clinic, feasibility studies and in a decentralized, double-blinded, randomized controlled study in which the sham was confirmed, blinding was effective and a range of doses were tested to determine the most effective dose that was statistically significant compared to the control. Upon commercialization, Mi-Helper will offer a fast, low-cost, non-invasive treatment designed for on-demand use in an at-home setting at the earliest sign of onset. In this Direct to Phase II SBIR, CoolTech will conduct a double-blind, decentralized, randomized, sham- controlled clinical trial to demonstrate the safety and confirm the optimal dose of Mi-Helper as an acute treatment for episodic migraine, as well as optimize the usability of Mi-Helper for the target population. Additionally, CoolTech will implement design enhancements to improve the Mi-Helper device, focusing on reusability of key components, which will enhance usability, affordability, and functionality. These improvements aim to increase the benefits to migraine patients and strengthen the Mi-Helper's competitive position in the market.