ShiraTronics, a clinical-stage medical device company developing neurostimulation therapies for chronic migraine patients, announced the closing of a $66 million Series B financing. The funding 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 joined the round.
This latest funding round 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. And 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 funding will also support the company as it seeks premarket approval from the FDA and funds the initial commercial launch of its innovative therapy for chronic migraine patients.
Migraine is a neurological disease without a cure. Around 2% of the world’s population suffer from migraine and 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, about 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, and a recent study by the National Headache Foundation found that over 50% of chronic migraine patients are dissatisfied with their current therapies due to a lack of symptom improvement, and about 75% have stopped, or avoid, systemic drugs due to side effects. Plus, compared to placebo controls, many approved medications show limited efficacy, reducing headache days by just two per month on average.
With a 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. And 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.
This therapy aims to interrupt and calm pain signals in the head, potentially relieving and preventing chronic migraine symptoms. And patients can personalize and control their therapy using a dedicated application, allowing for continuous, 24-hour management of their disease.
Shiratronics has received Breakthrough Device designation from the Center of Devices and Radiological Health (CDRH) division of the FDA in 2021. And 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.
KEY QUOTES:
“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. 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.”
-ShiraTronics CEO Rob Binney
“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. 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.”
-Dr. Zack Scott, general partner, Norwest Venture Partners
“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.”
-Co-founder and Chairman of the Board Mudit K. Jain, Ph.D.
