After winning breakthrough device designation, SetPoint Medical has been accepted into the US Food and Drug Administration’s (FDA) total product life cycle advisory programme (TAP) for its neuroimmune modulation platform for patients with relapsing-remitting multiple sclerosis (RRMS).
The TAP is a new initiative by the FDA to supply US patients with high-quality and safe medical devices by harnessing early communication between the FDA and device sponsors, providing faster development and patient access to medical devices.
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The device initially gained breakthrough device designation for rheumatoid arthritis treatment in 2020 and recently secured a second designation from the FDA. Joining the TAP now means improved collaboration and support, offering advantages like early risk management and quicker premarket interactions.
SetPoint’s neurostimulation device activates the body’s anti-inflammatory and immune-restorative pathways by precisely stimulating the vagus nerve. The device is implanted in an outpatient procedure, delivering therapy automatically once a day, aiming to trigger the inflammatory reflex.
According to a report on GlobalData’s Medical Intelligence Center, the implantable vagus nerve stimulators market is expected to grow from $679m in 2022 to $1.27bn by 2033. Existing implantable devices may be underutilised, as they are costly, invasive, and often only used once all other treatment options have been exhausted, according to GlobalData medical analyst Ashley Clarke.
The device is currently being tested in the RESET-RA study (NCT04539964), enrolling 250 patients with rheumatoid arthritis. Half of these patients will receive the therapy, with the other half receiving a non-active version. The primary endpoint of the trial is improvement in tender and swollen joints between the two groups according to the American College of Rheumatology (ACR) 20 response following 12 weeks of treatment.
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By GlobalDataSetPoint Medical’s regulatory affairs vice president Alexis Dineen said: “Ultimately, this program highlights the FDA’s commitment to spur development and widespread access of safe and effective treatment options to the people that need them most.”
SetPoint joins Onward Medical’s brain-computer interface (BCI) technology on the TAP scheme, as well as one other unnamed BCI company.
