Participated · Series D · Aug 2025

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.

Led · Series D · Jun 2023

Conformal Medical develops the CLAAS AcuFORM LAAO system, a foam-based device designed to conform to a broad range of left atrial appendage anatomies using only two sizes. The company aims to make LAAO a same-day, single-operator procedure and to enable ICE-guided closure that could eliminate the need for transesophageal echocardiography and general anesthesia. Conformal has treated over 100 patients with the AcuFORM System and reports impressive deliverability and safety performance to date. Its CONFORM Pivotal Trial is a prospective, randomized, multicenter study planning to randomize approximately 1,600 patients and is now more than 30% enrolled. The company is completing the CONFORM and GLACE clinical trials to support FDA pre-market approval and to validate its one-size strategy. Proceeds from the recent financing will fund enrollment of the CONFORM trial and key pre-commercialization initiatives for the CLAAS AcuFORM system. Conformal Medical develops the CLAAS System, a proprietary left atrial appendage occlusion (LAAO) implant designed to seal the LAA in patients with non‑valvular atrial fibrillation to reduce stroke risk without anticoagulants. The CLAAS device aims to make LAAO a same‑day, single‑operator procedure by enabling off‑axis positioning and providing a more uniform seal. The implant may eliminate the need for procedural transesophageal echocardiogram and general anesthesia, simplifying the procedure for physicians. The company is advancing the CLAAS System through the CONFORM pivotal clinical trial to evaluate safety and efficacy versus other commercially available LAAO devices and to support U.S. FDA pre‑market approval. Conformal intends to use the new capital to complete the clinical trial and demonstrate the device’s safety profile and clinical utility. Founded in 2016 and led by CEO James Reinstein, the company is based in Nashua, New Hampshire. Conformal Medical is an early-stage medical device company developing the Conformal Left Atrial Appendage Seal for LAA occlusion to prevent stroke in patients with non-valvular atrial fibrillation. The device is designed to adapt to the unique shape of each patient's left atrial appendage, be simpler to place, require less imaging, and eliminate the need for general anesthesia. Conformal's proprietary sealing technology aims to remove the need for long-term anticoagulants by sealing the LAA where clots form. The company says pre-clinical studies have borne out improved delivery and sealing versus first-generation devices. Conformal plans to use its recent financing to validate the technology in human trials. The company was founded in 2016 and is based in Nashua, NH.