After putting forward preliminary clinical data earlier this year from its neuromodulation implant for reducing chronic migraines, ShiraTronics has raised $66 million in venture capital financing to complete a new pivotal trial and take its device through to the FDA.
The Minneapolis-based company’s drug-free therapy system is designed for patients who have not seen relief with pharmaceutical treatments, with severe headaches occurring at least 15 days each month. The device is implanted under the skin in the head and delivers small electrical pulses to the occipital and supraorbital nerves to help interrupt migraine pain signals.
This past July, ShiraTronics presented poster findings (PDF) from a pilot study of about 10 patients in Australia, at a conference hosted by the American Society of Pain and Neuroscience.
After 12 weeks of treatment, the participants reported significant reductions in the number of migraine days per month—from an average of 19 at the start of the study down to about seven—as well as improvements in quality of life, according to the company.
ShiraTronics reported the first human implantation of its system, which includes bilateral pulse generators aimed at nerves on the right and left sides of the head, in December 2023. The approach previously received a breakthrough designation from the FDA in 2021.
“Today, about 3 million patients in the U.S. suffer from chronic migraine attacks that are resistant to conventional therapies,” CEO Rob Binney said in a statement. “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.”
The company’s series B round was led by Norwest Venture Partners and was joined by Seroba, OSF Ventures and the Global BioAccess Fund, alongside previous backers U.S. Venture Partners, Amzak Health, Treo Ventures and Aperture Venture Partners.
ShiraTronics is currently enrolling participants for a randomized, sham-controlled trial at centers in the U.S. and Australia. It will include the use of a trial system to gauge tolerability, with temporarily implanted electrical leads, before a procedure that places a permanent device. The company said its neuromodulation therapy can be delivered 24 hours a day, seven days a week, with weekly charging sessions.