ShiraTronics, a medical device company developing neurostimulation therapy for chronic migraine patients, has successfully closed a $66 million Series B financing round. The funding round was led by Norwest Venture Partners, with participation from new investors Seroba, OSF Ventures, the Global BioAccess Fund, and an undisclosed strategic investor. Returning investors U.S. Venture Partners, Amzak Health, Treo Ventures, and Aperture Venture Partners also participated in the round.
This substantial investment comes at a crucial time, as chronic migraine affects approximately 5 to 6 million people in the United States, with about 3 million of these patients considered treatment-resistant. The condition, characterized by 15 or more headache days per month, has proven challenging to treat effectively and disproportionately affects women. According to the Migraine Research Foundation, migraine is three times more common in women than in men, with 18% of women experiencing migraines compared to 6% of men. This gender disparity is particularly pronounced during reproductive years, likely due to hormonal influences.
A study by the National Headache Foundation revealed that over 50% of chronic migraine patients report dissatisfaction with current therapies due to lack of symptom improvement, while about 75% have stopped or avoid systemic drugs due to side effects. These statistics underscore the urgent need for innovative treatment options, especially for women who bear a higher burden of the disease. ShiraTronics aims to address this need with its Migraine Therapy System.
ShiraTronics CEO Rob Binney highlighted the potential impact of their technology: “Today, about 3 million patients in the U.S. suffer from chronic migraine attacks that are resistant to conventional therapies. Our recent pilot study, which evaluated the preliminary safety and efficacy of the ShiraTronics Migraine Therapy System, shows immense promise in improving patient quality of life and reducing the severity, duration and frequency of migraine headaches for these patients.”
The ShiraTronics Migraine Therapy System represents a novel approach to migraine treatment. The minimally invasive device, implanted beneath the skin in the head, delivers electrical pulses to nerves associated with migraine pain. By targeting these specific nerves, the system aims to interrupt pain signals, potentially offering relief to patients who have found little success with other treatments. Adding to its appeal, patients can control the therapy using a dedicated application, allowing for round-the-clock management of their condition.
Given the higher prevalence of migraines in women, this personalized approach could be particularly beneficial. Women often report that their migraines are influenced by menstrual cycles, pregnancy, and menopause, making a flexible, patient-controlled treatment option especially valuable.
The promise of this technology has not gone unnoticed by regulatory bodies. In 2021, ShiraTronics received Breakthrough Device designation from the FDA’s Center of Devices and Radiological Health (CDRH) division, a recognition that has helped pave the way for accelerated development and review. Furthermore, a recent pilot study of the ShiraTronics system reported encouraging results, including improvements in quality-of-life scores, reductions in headache days per month, and decreased severity of migraine attacks.
With the new funding in hand, ShiraTronics is poised to take its next significant step: supporting its FDA-approved pivotal trial, the RELIEV-CM2 Clinical Study. This multi-center, blinded, randomized, sham-controlled clinical trial will rigorously evaluate the safety and effectiveness of the Migraine Therapy System in patients with treatment-resistant chronic migraine, potentially bringing the company closer to market approval.
Dr. Zack Scott, General Partner at Norwest Venture Partners, which led the funding round, commented: “ShiraTronics is offering new hope to the millions of people with chronic migraine who cannot get relief from existing therapies. The company’s breakthrough therapeutic neuromodulation system is purpose-built to tackle this debilitating condition.”
