US-based neurostimulation company ShiraTronics has announced that it has raised $66m in Series B funding to advance a pivotal implantable device designed to stave off migraines.
ShiraTronic’s Migraine Therapy System is a small implantable device that sits beneath the skin delivering mild electrical pulses to targeted nerves associated with migraine pain with the aim of disrupting pain signals in the head to relieve or prevent migraines. It also comes with a dedicated app that allows the user to manage their own therapy.
The company said that the $66m in funding will be used to move ahead with a multi-centre, blinded, randomised, sham-controlled clinical trial dubbed the RELIEV-CM2 Clinical Study. This trial, previously approved by the US Food and Drug Administration (FDA), will seek to evaluate the safety and efficacy of the company's Migraine Therapy System in patients who have failed current medical therapies and live with treatment-resistant chronic migraines.
The funding round was primarily led by new investor Norwest Venture Partners, with Seroba., OSF Ventures, the Global BioAccess Fund and an undisclosed strategic investor contributing to the pot of $66m.
ShiraTronics CEO Rob Binney said: “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.”
Neurostimulation devices have risen in strength despite some regulatory setbacks. Globally, by the end of this year, the neurostimulation market is set to be valued at approximately $6.4bn according to GlobalData’s Medical Device Database. At the same time, the US market for neurostimulation is estimated to reach $7bn by the end of 2030.
At present there is no cure for migraines, with the condition thought to affect approximately 2% of the global population according to research published in the Journal of Headache Pain. Typically, migraines can be accompanied by a range of symptoms including nausea and audio-visual oversensitivity.
Zack Scott, general partner at Norwest Venture Partners, said: “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."
Previously, the company was able to share results from its RELIEV-CM Australian pilot study at the American Society of Pain and Neuroscience (ASPN) conference, detailing a reduction in migraine pain and instance.
Elsewhere in the field of neurostimulation devices, the Australian government has pulled a number of spinal cord stimulation devices from shelves amid serious concerns over the devices’ efficacy and safety.
