Salvia BioElectronics Wins Breakthrough Device Status in Chronic Migraine

Wim Pollet, MD

The FDA has granted a breakthrough device designation to Salvia BioElectronics for its implantable neurostimulation system in the treatment of patients with chronic migraine, the company has announced.¹

Although neurostimulation has shown its effectiveness for those with chronic migraine, there are no approved devices commercially available, the company noted, adding that it was founded with the intent to provide aid to those suffering from chronic migraine by developing thin and conforming bioelectronic foils that uniquely adapt to the anatomy of the head.

"The FDA breakthrough device designation of our neurostimulation system reflects the recognition of the large unmet medical need of patients suffering from refractory chronic migraine, and the potential of Salvia's bioelectronic foil technology to address this,” Wim Pollet, MD, chief medical officer, Salvia BioElectronics, said in a statement. “We look forward to working closely with the FDA to expedite the review process to accelerate the development of our therapy."

Salvia, a Dutch company founded in 2017, noted that it has been developing an innovative neurostimulation solution for this patient population based on a novel device concept that offers unique benefits to both the patients it would treat and their physicians. In September 2020, the company announced that it had raised €26 million (roughly $31 million) for the development of this device.²

At that time, Hubert Martens, PhD, MSc, chief executive officer, Salvia BioElectronics, said in a statement that the company is "building a team of highly talented people that are passionate to develop a therapy that can change the lives of people suffering from chronic migraine. We are delighted to welcome our new investors, and I would like to thank our existing investors for their continued support. This strong syndicate of highly renowned medical technology investors validates our approach and the funding enables us to complete our therapy development towards market entry."

This FDA designation adds to the recent push of device development in migraine care. In 2020, a number of other migraine treatment devices have made progress in some form or another, continuing a trend of nonpharmacologic advances somewhat paralleling the pharmacologic approvals.

In June, Cefaly Technology, the makers of the FDA-approved Cefaly migraine treatment device, have announced a partnership with Azova’s Collaborative Clinical Care Platform to expand access to the Cefaly Dual migraine device, which was approved for preventive use in March 2014 and for abortive use in September 2017.³ Then, in August, a newly published clinical update suggested that the combination of the safety and tolerability of electroCore’s non-invasive vagus nerve stimulation (nVNS) device, gammaCore, along with the identified clinical and mechanistic evidence, support its use as a first-line treatment for patients with cluster headache as both an acute and preventive therapy. The literature review ultimately suggested that the device is effective for acute migraine treatment and practical for migraine prevention. The reviewing group identified 4 core areas providing mechanistic explanations for the device’s efficacy: Effects on autonomic nervous system functions; inhibition of cortical spreading depression; neurotransmitter regulation; and nociceptive modulation.⁴

Additionally, just last month, Theranica Biotherapeutics announced that its Nerivio medical device was granted clearance from the FDA for an expansion on its treatment indication to include the acute treatment of chronic migraine in patients aged 18 years and older. The new indication clears the device to use in the acute treatment of migraine with or without aura in individuals aged 18 years or older, regardless of episodic or chronic migraine classification. The FDA’s decision was made based on the results of 2 clinical studies in chronic migraine.⁵

REFERENCES
1. Salvia BioElectronics receives FDA Breakthrough Device Designation for innovative neurostimulation solution. News release. Salvia BioElectronics. November 3, 2020. Accessed November 3, 2020. https://www.prnewswire.com/news-releases/salvia-bioelectronics-receives-fda-breakthrough-device-designation-for-innovative-neurostimulation-solution-301165575.html
2. Salvia BioElectronics raises EUR 26M (USD 31M) to develop innovative neurostimulation therapy for chronic migraine. News release. Salvia BioElectronics. September 22, 2020. Accessed November 3, 2020. https://www.prnewswire.com/news-releases/salvia-bioelectronics-raises-eur-26m-usd-31m-to-develop-innovative-neurostimulation-therapy-for-chronic-migraine-301134866.html
3. CEFALY Technology Partners with AZOVA Telemedicine Platform for Virtual Migraine Treatment Prescriptions [press release]. New York, NY: Cefaly; Published June 8, 2020. Accessed June 12, 2020. prnewswire.com/news-releases/cefaly-technology-partners-with-azova-telemedicine-platform-for-virtual-migraine-treatment-prescriptions-301071741.html
4. electroCore Announces Non-Invasive Vagus Nerve Stimulation Clinical Update Publication in Cephalalgia. News release. electroCore. July 28, 2020. Accessed August 11, 2020. https://www.globenewswire.com/news-release/2020/07/28/2068686/0/en/electroCore-Announces-Non-Invasive-Vagus-Nerve-Stimulation-Clinical-Update-Publication-in-Cephalalgia.html
5. Nerivio receives clearance of expanded indication to cover chronic migraine patients. News release. Theranica Biotherapeutics. October 26, 2020. Accessed October 26, 2020. https://www.prnewswire.com/news-releases/nerivio-receives-clearance-of-expanded-indication-to-cover-chronic-migraine-patients-301159445.html