SetPoint Medical
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).
TAP Pilot
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.
Alexis Dineen, Vice President of Regulatory Affairs at SetPoint Medical
“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. 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.