Loading organizations...
§ Private Profile · Valencia, CA, USA
SetPoint Medical is a technology company.
SetPoint Medical develops an implantable bioelectronic medical device to treat chronic autoimmune diseases. Their SetPoint System precisely modulates neuroimmune pathways by stimulating the vagus nerve. This aims to reduce inflammation and restore immunologic balance, offering a novel device-based therapeutic option for conditions such as rheumatoid arthritis.
Founded in 2007 by H. Shaw Warren, Jim Broderick, and Dr. Kevin J. Tracey, the company’s inception arose from Dr. Tracey’s extensive research. His pioneering work revealed how the brain modulates inflammation via the vagus nerve, providing the foundational scientific insight for SetPoint Medical’s bioelectronic treatment paradigm.
The SetPoint System targets adult patients with moderately to severely active rheumatoid arthritis unresponsive to conventional therapies. SetPoint Medical envisions expanding bioelectronic medicine to a wider array of autoimmune and inflammatory disorders. They aim to establish their device as a crucial, patient-friendly method for long-term disease management.
SetPoint Medical has raised $491.0M across 11 funding rounds.
SetPoint Medical has raised $491.0M in total across 11 funding rounds.
SetPoint Medical has raised $491.0M in total across 11 funding rounds.
SetPoint Medical's investors include Kevin Reilly, Josh Makower, Action Potential Venture Capital, Morgenthaler Ventures, New Enterprise Associates (NEA), Norwest Venture Partners, Runway Growth Capital, Shangbay Capital, Abbott, Ascendum Capital, Boston Scientific, Catalio Capital Management.
SetPoint Medical has raised $491.0M across 11 funding rounds. Most recently, it raised $120.0M Series D in August 2025.
SetPoint Medical is a commercial-stage medical technology company developing implantable neurostimulation devices to treat chronic autoimmune diseases by modulating the vagus nerve.[1][2][3] Its flagship SetPoint System is an FDA-approved (July 2025), first-of-its-kind neuroimmune modulation therapy for adults with moderate-to-severe rheumatoid arthritis (RA) who inadequately respond to or cannot tolerate biologic or targeted synthetic drugs.[2][4][5] The device—a small, rechargeable implant placed on the left vagus nerve—delivers precise one-minute daily electrical pulses to activate anti-inflammatory pathways, reducing proinflammatory cytokines by 30-70% and restoring immunologic balance, with therapy lasting up to 10 years on a single charge cycle.[2][4][5][6] It serves RA patients (over 1.5 million in the U.S.) and rheumatology providers, offering a non-drug alternative with potentially lower risk, cost, and immunosuppression than ongoing therapies.[1][2][4] Growth momentum includes FDA Breakthrough Device Designation, CMS Transitional Pass-Through Payment approval, and U.S. launch plans in targeted cities by late 2025, expanding nationwide in early 2026, alongside evaluations for multiple sclerosis and Crohn's disease.[2][4]
Founded in 2007, SetPoint Medical emerged from over 20 years of research identifying specific vagus nerve fibers and stimulation parameters to trigger anti-inflammatory responses without broad immunosuppression.[3][5][6] The company's mission integrates scientific discovery, precision engineering, and commercialization to address unmet needs in autoimmune diseases like RA, multiple sclerosis, and inflammatory bowel disease.[1][3] Key leadership includes CEO Murthy V. Simhambhatla, Ph.D., who leads commercialization efforts post-FDA approval, alongside executives like David Chernoff, MD, and a board featuring investors from New Enterprise Associates, Norwest Venture Partners, and others.[2][3] Pivotal moments include the landmark RESET-RA clinical trial proving safety and efficacy, FDA approval in July 2025 via the Breakthrough Devices Program, and CMS reimbursement approval, enabling commercial rollout.[2][4][5]
SetPoint rides the neuromodulation wave in medtech, shifting autoimmune treatment from lifelong drugs to precise, restorative devices amid rising biologic failures (many RA patients inadequately managed).[1][2][6] Timing aligns with maturing vagus nerve research, FDA's Breakthrough pathway for innovative devices, and payer pressures for cost-effective alternatives to expensive DMARDs.[2][4] Market forces favoring it include the $50B+ RA therapeutics market, growing demand for non-pharmacologic options amid drug side effects and resistance, and expansion potential to MS and Crohn's.[1][2] SetPoint influences the ecosystem by pioneering neuroimmune modulation, potentially redefining care standards, enabling provider adoption via familiar implantation techniques, and spurring competitor innovation in bioelectronic medicine.[3][5][6]
SetPoint is poised for rapid U.S. scaling post-2025 launch, with CMS coverage ensuring reimbursement and early 2026 nationwide expansion.[2][4] Upcoming trials for MS and Crohn's could broaden its platform, tapping adjacent autoimmune markets while leveraging RA momentum.[2] Trends like AI-optimized stimulation, outpatient procedures, and payer prioritization of durable devices will amplify growth, evolving SetPoint from RA pioneer to multi-indication leader in neuroimmune therapies—transforming chronic disease management as its vagus nerve platform proves drug alternatives at scale.[2][3][6]