ShiraTronics closed a $66 million Series B financing to support its recently launched 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.
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.
