SetPoint Medical

SetPoint Medical is a clinical-stage healthcare company developing a novel neuroimmune modulation platform to treat chronic, inflammation-mediated autoimmune diseases. The company's core technology involves a miniaturized stimulation device surgically placed on the vagus nerve through a small incision on the left side of the neck in an outpatient procedure. Once implanted, the device delivers precise vagus nerve stimulation on a preset schedule, activating anti-inflammatory and immune-restorative pathways to treat conditions like rheumatoid arthritis (RA), inflammatory bowel disease (IBD), and multiple sclerosis (MS).

SetPoint Medical's initial focus is on rheumatoid arthritis, a debilitating autoimmune condition affecting over 1.5 million Americans and costing nearly USD 30 billion annually to manage with existing immunosuppressive therapies and biologics. The company believes its approach could offer a potentially less immunosuppressive treatment option. SetPoint Medical is currently evaluating its RA treatment in the RESET-RA pivotal trial, a multicenter, double-blind, randomized, sham-controlled study. As of January 2023, the first patient was enrolled in Stage two of the trial.

The FDA granted SetPoint Medical's device Breakthrough Device Designation for RA patients who have an incomplete response or intolerance to multiple biologic drugs. In March 2024, the company also received Breakthrough Device Designation from the FDA for using its platform to treat relapsing-remitting multiple sclerosis (RRMS), an autoimmune disorder affecting nearly 1 million Americans. SetPoint Medical is the first to initiate a clinical trial evaluating this neuroimmune modulation approach for RRMS.

Key customers and partnerships

SetPoint Medical secured an USD 80 million preferred stock financing in January 2023, co-led by new investors Norwest Venture Partners and Viking Global Investors, along with participation from Gilmartin Capital and existing investors. The financing will support the RESET-RA trial completion, FDA submissions, and early RA indication commercialization. As part of the financing, Dr. Zack Scott from Norwest joined SetPoint Medical's board of directors.

In March 2024, SetPoint Medical was accepted into the FDA's Total Product lifecycle (TPLC) Advisory Program Pilot to expedite the development and patient access of its neuroimmune modulation platform for RRMS treatment. This program facilitates earlier interactions with providers, payors, patients, and strategic advice from the FDA's Center for Devices and Radiological Health.