SetPoint Medical Accepted into FDA Total Product Life Cycle Advisory Program for Development of its Neuroimmune Modulation Platform for the Treatment of Multiple Sclerosis

Acceptance into the TAP Pilot will help expedite regulatory and patient access pathways for a first-of-its-kind therapeutic approach for people with relapsing-remitting multiple sclerosis (RRMS)

TAP Pilot acceptance follows Breakthrough Device Designation announcement for the treatment of RRMS

SetPoint Medical, a clinical-stage healthcare company dedicated to patients with chronic autoimmune diseases, announced that it has been accepted into the Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot from the U.S. Food and Drug Administration (FDA) for the development of its novel neuroimmune modulation platform for people living with relapsing-remitting multiple sclerosis (RRMS).

The FDA’s Center for Devices and Radiological Health (CDRH) launched the TAP Pilot to help expedite development and patient access to safe and effective high-quality medical devices upon FDA approval. In October 2023, the FDA expanded the program to include neurological and physical medicine devices. To help accelerate development of SetPoint’s device, the TAP Pilot will allow the company to have earlier and more frequent interactions with providers, payors and patients, as well as proactive, strategic advice from the CDRH.

“We’re excited to be included in the TAP Pilot as the program will help streamline collaboration with the FDA - from initiating the first-of-its-kind clinical trial evaluating this approach for people living with RRMS, to accelerating access to this breakthrough therapy upon approval,” said Alexis Dineen, Vice President of Regulatory Affairs at SetPoint Medical. “Ultimately, this program highlights the FDA's commitment to spur development and widespread access of safe and effective treatment options to the people that need them most.”

The TAP Pilot acceptance follows the recent announcement that the FDA granted Breakthrough Device Designation to SetPoint's device for the treatment of RRMS, based on evidence demonstrating that the device has the potential to reduce demyelination and promote remyelination.

In addition, SetPoint has also received Breakthrough Device Designation for the treatment of adults with moderate-to-severe rheumatoid arthritis (RA), and is studying the safety and effectiveness of this application in a pivotal clinical trial, the RESET-RA study.

SetPoint's integrated neurostimulation device uses precise vagus nerve stimulation to activate innate anti-inflammatory and immune-restorative pathways to treat autoimmune conditions. After placement during an outpatient procedure, the device is programmed to automatically deliver therapy on a preset schedule by stimulating the vagus nerve once daily to activate the inflammatory reflex for a systemic immune-restorative effect.

About SetPoint Medical

SetPoint Medical is a privately held clinical-stage healthcare company dedicated to treating patients with chronic autoimmune diseases. The company is developing a novel platform designed to stimulate the vagus nerve to activate the inflammatory reflex to produce a systemic immune-restorative effect. SetPoint Medical’s platform technology is designed to offer patients and providers a treatment alternative for rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease and other chronic autoimmune conditions with potentially less risk and cost than drug therapy. For more information, visit www.setpointmedical.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240321236439/en/