Minneapolis-based ShiraTronics designed its minimally invasive implantable neuromodulation system to address the symptoms of migraines. The fully implantable, programmable device goes just beneath the skin in the head. It delivers precise electrical pulses tailored to disrupt migraine pain signals. ShiraTronics designed it to offer a new and potentially more effective treatment option.
The device won FDA breakthrough device designation in 2021. ShiraTronics completed enrollment for its RELIEV-CM pilot study for the device in February.
ShiraTronics said its latest funding will support its recently launched FDA-approved pivotal trial, the RELIEV-CM2 clinical study. It aims to evaluate the safety and effectiveness of its Migraine Therapy System in patients who failed current medical therapies and have treatment-resistant chronic migraine.
Funding could also support the company as it progresses toward premarket approval from the FDA and an initial commercial launch.
New investor Norwest Venture Partners led the Series B. Additional new investors Seroba, OSF Ventures, the Global BioAccess Fund and an undisclosed strategic investor also participated. Existing investors .S. Venture Partners, Amzak Health, Treo Ventures and Aperture Venture Partners joined in, too.
“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.”