Valencia, California-based SetPoint Medical announced today that they have formally lodged an application for premarket approval (PMA) with the FDA for their neuroimmune modulation device. The company is pioneering this technology as a potential novel treatment option for individuals suffering from moderate-to-severe rheumatoid arthritis (RA), specifically targeting those who have seen insufficient results or cannot tolerate conventional biologic or synthetic DMARDs.
SetPoint’s innovative rechargeable neurostimulation device is engineered to administer daily electrical stimulation to the vagus nerve. This process is intended to activate the body’s own anti-inflammatory and immune-restorative mechanisms, thereby offering potential therapeutic benefits without carrying the immunosuppressive risks traditionally linked to pharmacological treatments. Once implanted during an outpatient procedure, the device is designed to autonomously deliver therapy according to a preset schedule, ensuring patient compliance.
This groundbreaking device by SetPoint Medical has already been recognized with FDA breakthrough device designation. Furthermore, earlier this year, the FDA integrated the technology into its Total Product Life Cycle Advisory Program (TAP) pilot project.
The company buttressed their PMA submission with data acquired from their extensive RESET-RA study.
“Our commitment to addressing unmet medical needs in RA treatment persists, and we eagerly anticipate collaborating closely with the FDA in the upcoming PMA review phase,” stated Alexis Dineen, VP of regulatory affairs for SetPoint Medical. “I immensely appreciate the dedication of every SetPoint employee, researchers, and participants of the RESET-RA study, whose efforts have significantly advanced us towards presenting a pioneering treatment alternative to RA patients.”