Salvia gets FDA breakthrough device status for implantable neurostimulation system
Salvia BioElectronics has secured breakthrough device status from the US Food and Drug Administration (FDA) for its implantable neurostimulation system to treat chronic migraine.
The company is involved in the development of an advanced neurostimulation solution for chronic migraine based on a novel device concept that will benefit both patients and physicians.
People with migraine undergo episodes of throbbing, pulsating pain, sometimes accompanied by nausea, vomiting, and sensitivity to light, which can last from few hours to few hours.
Salvia’s thin bioelectronic foils designed to adapt to anatomy of head
Salvia is focusing on the development of thin and conforming bioelectronic foils that adapt to the anatomy of the head and efficiently treat patients suffering from chronic migraine.
The breakthrough device designation facilitates Salvia to frequently interact with the FDA regulatory experts when preparing its FDA submissions followed by prioritised reviews.
According to the company, neurostimulation has been demonstrated to be effective for patients with chronic migraine, and currently, there are no commercially approved devices.
Salvia BioElectronics chief medical officer Wim Pollet said: “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.
“We look forward to working closely with the FDA to expedite the review process to accelerate the development of our therapy.”
Salvia BioElectronics was established in 2017 with an aim of developing a bioelectronics therapy for people suffering from chronic migraine.
In February this year, BioElectronics secured 510(k) from the FDA for its drug-free ActiPatch medical device.
BioElectronics said that the FDA has granted the marketing approval for ActiPatch device, as an over-the-counter adjunctive treatment of musculoskeletal pain.
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