SetPoint Medical Announces Positive Results from Landmark RESET-RA Study on Neuroimmune Modulation for Rheumatoid Arthritis Treatment

SetPoint Medical, a clinical-stage healthcare company focused on treating chronic autoimmune diseases, has announced positive results from the RESET-RA clinical study, which evaluates the SetPoint System as a potential treatment for moderate-to-severe rheumatoid arthritis (RA). This innovative system is designed for adults who do not respond adequately to biologic or targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs) or cannot tolerate them.

The RESET-RA study achieved its primary goal, showing a significantly greater proportion of participants in the treatment group reaching an ACR20 response compared to the control group after 12 weeks. The ACR20 response is a standard measure set by the American College of Rheumatology to assess the effectiveness of RA treatments. Importantly, no safety concerns were reported during the initial 12 weeks or in long-term follow-up. Adverse event rates were low for both the implant procedure and the stimulation therapy, making the overall treatment both effective and well-tolerated.

Dr. David Chernoff, Chief Medical Officer of SetPoint Medical, emphasized the need for new treatment options due to the challenges and unmet medical needs in managing RA. Many patients do not respond adequately to current treatments or cannot tolerate them, and these treatments come with serious immunosuppressive risks, leading to safety concerns and lower patient satisfaction and adherence.

RA affects over 1.5 million Americans, causing pain, bone erosion, joint deformity, reduced function, and long-term disability. There is no cure, and existing therapies often result in poor patient satisfaction and low persistence rates. Most patients stop their medication within two years due to lack of efficacy or side effects.

The SetPoint System offers a new approach by using an implantable, rechargeable neurostimulation device to stimulate the vagus nerve once daily. This activation promotes anti-inflammatory and immune-restorative pathways, potentially treating autoimmune conditions like RA without the immunosuppressive risks associated with drugs. The device is implanted during an outpatient procedure and is programmed to deliver therapy on a preset schedule, improving compliance and persistence.

Murthy V. Simhambhatla, CEO of SetPoint Medical, expressed enthusiasm about the RESET-RA study results, highlighting the SetPoint System's potential to provide a safe and effective alternative to current RA therapies. The company plans to present these findings at upcoming medical meetings and submit the data to the FDA for premarket approval.

The RESET-RA study is a multicenter, randomized, sham-controlled, double-blind trial involving 242 patients across 41 U.S. sites. Following the primary endpoint completion at 12 weeks, the study continues to evaluate the long-term safety and effectiveness of the device in an open-label extension.

The SetPoint System has received Breakthrough Device Designation from the FDA for patients with moderate-to-severe RA who do not respond to or tolerate biological DMARDs or targeted synthetic DMARDs like JAK inhibitors. Additionally, SetPoint's neuroimmune modulation platform has been granted Breakthrough Device Designation and accepted into the Total Product Life Cycle (TPLC) Advisory Program for treating relapsing-remitting multiple sclerosis (RRMS), based on evidence suggesting the device can reduce demyelination and promote remyelination.

SetPoint Medical, a private clinical-stage company, aims to treat chronic autoimmune diseases by developing a platform that stimulates the vagus nerve to activate a neuroimmune pathway, producing a systemic immune-restorative effect. This technology offers a potentially safer and more cost-effective treatment alternative for diseases such as rheumatoid arthritis, multiple sclerosis, and inflammatory bowel disease compared to traditional drug therapies.