Healthcare company SetPoint Medical has filed a premarket approval (PMA) application with the US Food and Drug Administration (FDA) for its SetPoint System, a new device intended for the treatment of rheumatoid arthritis (RA).
The application seeks approval for the neuroimmune modulation device for adults with moderate-to-severe RA. It targets those who do not respond or cannot tolerate biologic or targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs).
The PMA submission is backed by positive results from the RESET-RA clinical study, which was announced in July this year. The study showed that the SetPoint System could serve as a safe and effective treatment alternative for RA patients who do not respond to or cannot tolerate current therapies.
SetPoint Medical regulatory affairs vice president Alexis Dineen said: “We remain steadfast in our goal to address the unmet medical needs in RA treatment and look forward to continuing to work cooperatively with the FDA during the upcoming PMA review process.
“I am incredibly appreciative of all the SetPoint employees, RESET-RA study investigators and participants who have helped us get one step closer to offering this new treatment category to RA patients.”
The SetPoint System features an implantable, rechargeable neurostimulation device that stimulates the vagus nerve electrically. This stimulation activates innate anti-inflammatory pathways, potentially treating autoimmune conditions like RA while preserving immune surveillance.
The device is implanted during an outpatient procedure and programmed to stimulate the vagus nerve daily on a preset schedule, thereby improving therapy adherence and persistence.
The SetPoint System has received breakthrough device designation from the FDA for treating adult RA patients who are incomplete responders or intolerant to one or more biologic or targeted synthetic DMARDs.
In March 2024, SetPoint Medical’s neuroimmune modulation platform was also granted breakthrough device designation and accepted into the Total Product Life Cycle (TPLC) Advisory Program (TAP) for the treatment of relapsing-remitting multiple sclerosis (RRMS).
SetPoint Medical, based in California, is a privately held clinical-stage company focused on developing solutions for chronic autoimmune diseases. Its platform technology aims to provide treatment alternatives for RA, multiple sclerosis, inflammatory bowel disease, and other chronic autoimmune conditions.
In October 2024, the healthcare firm secured FDA investigational device exemption (IDE) approval to trial its proprietary neuroimmune modulation platform in people living with relapsing-remitting multiple sclerosis (RRMS).
