SetPoint System Receives FDA Approval for Rheumatoid Arthritis, First Patient Implanted

NEW HYDE PARK, N.Y. – SetPoint Medical, in collaboration with Northwell Health, has announced the U.S. Food and Drug Administration (FDA) approval of its SetPoint® System for the treatment of moderate-to-severe rheumatoid arthritis (RA). The FDA granted approval on July 30, paving the way for a novel bioelectronic medicine approach, with Northwell Health performing the nation's first patient implant on August 22 at North Shore University Hospital. This marks a significant advancement for patients who have not responded adequately to or cannot tolerate existing RA therapies.

The SetPoint System introduces a neuroimmune modulation therapy designed to alleviate painful RA symptoms by modulating the body's immune response through vagus nerve stimulation. This device-based alternative aims to reduce inflammation without the immune-compromising risks associated with some traditional pharmaceutical treatments. The first patient will receive post-surgical follow-up care before the device is activated.

This FDA approval culminates nearly three decades of pioneering research led by Kevin J. Tracey, MD, president and CEO of Northwell’s Feinstein Institutes for Medical Research. Dr. Tracey's work has focused on the intricate connections between the brain, immune system, and inflammation, and the therapeutic potential of modulating these pathways via the vagus nerve. Northwell Health emphasized its commitment to innovation, with CEO-Elect John D’Angelo stating, "Bioelectronic medicine represents a profound shift in the future of healthcare."

The development has garnered attention from prominent figures such as author and podcaster Tim Ferriss, who recently highlighted the "FDA approval for SetPoint’s RA implant" on his popular podcast. Ferriss, known for his interest in health and technology, underscored the potential of such bioelectronic advancements. SetPoint Medical plans to evaluate its platform technology for other autoimmune conditions, including multiple sclerosis and Crohn’s disease, signaling a broader application for this emerging field.