Participated · Series D · Aug 2017

SetPoint Medical is a commercial-stage medical technology company headquartered in Valencia, Calif., focused on therapies for chronic autoimmune diseases. Its FDA‑approved SetPoint System is the first neuroimmune modulation therapy for adults with moderate-to-severe rheumatoid arthritis, providing a device-based alternative for patients who do not respond to or cannot tolerate biologic or targeted drug therapies. The company’s proprietary integrated neurostimulation platform is designed to activate innate anti-inflammatory pathways in the vagus nerve to reduce inflammation and restore immunologic setpoint. Proceeds from the recent financing will support commercialization of the SetPoint System in select U.S. markets this year and broader national expansion in 2026, and will also fund advancement of the company’s pipeline in other autoimmune conditions. SetPoint plans to evaluate its platform for additional indications including multiple sclerosis and Crohn’s disease. In conjunction with the fundraise the company expanded its leadership team and board to support commercialization and market access efforts. SetPoint Medical is a privately held clinical-stage healthcare company focused on treating chronic autoimmune diseases. The company is developing a novel platform that stimulates the vagus nerve to activate the inflammatory reflex and produce a systemic immune-restorative effect. The SetPoint system is a miniaturized stimulation device placed on the vagus nerve through a small incision on the left side of the neck in an outpatient procedure and delivers stimulation on a preset schedule. The platform is being developed as an alternative for patients with rheumatoid arthritis who have an incomplete response to or are intolerant of biologic drugs, and is also intended for inflammatory bowel disease and other chronic autoimmune conditions. SetPoint is advancing the RESET-RA study and preparing U.S. FDA regulatory submissions and early commercialization for the RA indication. Financially, the company recently announced an $80 million equity financing and expanded a senior secured term loan facility of up to $65 million with Runway Growth Capital to support development and early commercial activities. SetPoint Medical develops a bioelectronic medicine platform designed to stimulate the vagus nerve and activate the body’s inflammatory reflex to produce a systemic immune‑restorative effect for chronic autoimmune diseases. The company is pursuing electrical‑pulse therapies as a potentially safer, lower‑cost alternative to drugs and biologics for conditions including rheumatoid arthritis and inflammatory bowel disease. SetPoint is clinical‑stage and is advancing its technology through the RESET‑RA study, which will evaluate safety and efficacy in patients with moderate‑to‑severe RA. The $35 million financing announced will support the ongoing RESET‑RA trial and other development activities. SetPoint is privately held, was founded in 2007, and is based in Valencia, California. The articles do not disclose revenue or user metrics. SetPoint Medical is a privately held, clinical‑stage bioelectronic medicine company developing a platform that stimulates the vagus nerve to activate the inflammatory reflex and reduce systemic inflammation. The company is initially focused on a less immunosuppressive therapeutic option for patients with rheumatoid arthritis (RA) and is also developing applications for inflammatory bowel disease and other chronic autoimmune conditions. SetPoint’s investigational device is intended to offer an alternative to biologic and targeted drug therapies with potentially lower risk and cost. The company has received Breakthrough Device designation from the U.S. FDA for use in RA patients who are incomplete responders to, or intolerant of, multiple biologic drugs. Proceeds from the financing will support the RESET‑RA multicenter, double‑blind, randomized, sham‑controlled pivotal trial that will enroll up to 250 patients at 40 U.S. sites to evaluate safety and effectiveness. SetPoint converts neurostimulation of the vagus nerve into a systemic immune‑restorative effect and is positioning its platform toward regulatory‑pathway clinical validation. SetPoint Medical is developing a proprietary bioelectronic medicine platform that uses a small implanted device to activate the body’s Inflammatory Reflex and produce a systemic anti-inflammatory effect. The company’s core product is an implanted stimulator that targets the vagus nerve as an alternative to drug therapies for chronic inflammatory diseases. SetPoint has published positive results from a first‑in‑human proof‑of‑concept trial in rheumatoid arthritis in PNAS and presented positive data at the American College of Rheumatology meeting. The company positions its approach as potentially lower risk and lower cost compared with current biologic treatments. SetPoint plans to use the new financing to advance clinical development and enable its next clinical trial in rheumatoid arthritis. It is a privately held company focused on commercializing bioelectronic medicines for debilitating inflammatory diseases.