Implantable Neuromodulation System Shows Early Promise in Improving Patient Quality of Life by Reducing Monthly Headache Days and Severity of Migraine Attacks
MINNEAPOLIS, Oct. 9, 2024 /PRNewswire/ — ShiraTronics, a clinical-stage medical device company developing neurostimulation therapies for chronic migraine patients, today announced the closing of a $66 million Series B financing. The round was led by new investor Norwest Venture Partners, with participation from additional 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 latest round of funding will support ShiraTronics’ recently launched U.S. Food and Drug Administration (FDA)-approved pivotal trial, the RELIEV-CM2 Clinical Study, a multi-center, blinded, randomized, sham-controlled clinical trial. The trial is designed to evaluate the safety and effectiveness of the company’s Migraine Therapy System in patients who have failed current medical therapies and have treatment-resistant chronic migraine. The financing also will support the company as it seeks premarket approval from the FDA and fund the initial commercial launch of its innovative therapy for chronic migraine patients.
"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," said ShiraTronics CEO Rob Binney. "We are deeply grateful for the support of our distinguished new and existing investors, and are laser-focused on delivering this breakthrough therapy to those in need."
Current Treatment Options Are Limited for Chronic Migraine Suffers
Migraine is a neurological disease with no cure. About 2% of the world’s population suffer from migraine, severe headaches accompanied by a complex set of debilitating symptoms including pulsating head pain, nausea, and sensitivity to light and sound. In the U.S., 5 to 6 million people have chronic migraine, a condition characterized by 15 or more headache days a month with at least eight of those days marked by typical migraine symptoms. Of these chronic migraine patients, approximately 3 million are treatment resistant. For these individuals, existing therapy options fail to deliver consistent and lasting relief, often leaving them to rely on a dark room and isolation as their best therapy.
There is an urgent need for better treatment options. A recent study by the National Headache Foundation found that more than 50% of chronic migraine patients are dissatisfied with their current therapies due to lack of symptom improvement and about 75% have stopped, or avoid, systemic drugs due to side effects. Additionally, many approved medications show limited efficacy, reducing headache days by just two per month on average, compared to placebo controls.
"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," said Dr. Zack Scott, general partner, Norwest Venture Partners. "ShiraTronics fits perfectly with our mission to partner with medical device companies that have a winning combination: a proven team that brings impressive clinical and commercial experience, and cutting-edge technology that has a real potential to lower costs, enhance outcomes and drastically improve quality of life for patients."
ShiraTronics’ Pioneering Neuromodulation System
With its drug-free neuromodulation system, ShiraTronics is addressing the debilitating symptoms of chronic migraine with a potential new solution for patients who have exhausted all other treatment options. The ShiraTronics Migraine Therapy System is a minimally invasive device that is implanted just beneath the skin in the head where it delivers small electrical pulses to targeted nerves associated with migraine pain. The therapy aims to interrupt and calm pain signals in the head, potentially relieving and preventing chronic migraine symptoms. Patients can personalize and control their therapy using a dedicated application, allowing for continuous, 24-hour management of their disease.
Shiratronics received Breakthrough Device designation from the Center of Devices and Radiological Health (CDRH) division of the FDA in 2021. In a recent pilot study, the ShiraTronics Migraine Therapy System demonstrated improvement in quality-of-life scores, substantial reductions in headache days per month and decreased severity of migraine attacks.
"Since Lynn Elliott and I co-founded ShiraTronics, it has been exciting to see the product development and clinical progress made by the ShiraTronics team under Rob’s leadership. I am looking forward to the next steps in the ShiraTronics journey to bring this novel therapy to serve millions of chronic migraine patients globally," said Co-founder and Chairman of the Board Mudit K. Jain, Ph.D.
About ShiraTronics
ShiraTronics is a pioneering medical device company dedicated to developing state-of-the-art neurostimulation solutions aimed at improving the quality of life for patients living with chronic migraine. The ShiraTronics Migraine Therapy System demonstrated encouraging reductions in headache days and decreased severity of migraine attacks, as well as improvement in quality-of-life scores in its first-in-human pilot study. The company is currently enrolling its pivotal trial for FDA premarket approval, the RELIEV-CM2 Clinical Study. Based in Minneapolis, ShiraTronics is the first spinoff company from medical accelerator NuXcel and is backed by investors including Norwest Venture Partners, U.S. Venture Partners, Amzak Health, Treo Ventures, Aperture Venture Partners, Seroba., OSF Ventures, the Global BioAccess Fund and others. For more information, visit shiratronics.com.
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