SetPoint nerve stimulator for RRMS accepted to FDA TAP program
Pilot program to help accelerate patient access to innovative devices
The U.S. Food and Drug Administration (FDA) has accepted SetPoint Medical, which is developing a nerve stimulator for people with relapsing-remitting multiple sclerosis (RRMS), into a pilot program designed to promote the development of new medical devices, the company said.
The Total Product Life Cycle Advisory Program (TAP) provides for earlier and more frequent communication between the FDA and medical device sponsors in an effort to speed patient access to innovative devices. The FDA’s Center for Devices and Radiological Health launched the program in January 2023, and expanded it in October to include neurological and physical medicine devices.
“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,” Alexis Dineen, SetPoint’s vice president of regulatory affairs, said in a press release.
SetPoint’s nerve stimulator also has received FDA breakthrough device designation for RRMS. The FDA said its decision to grant breakthrough device status — a designation intended to accelerate development of devices intended to treat or diagnose serious diseases more effectively than standard approaches — was based on evidence showing the device may slow myelin damage and promote its repair, an unmet need in multiple sclerosis (MS) and other demyelinating conditions.
Battery-operated nerve stimulator implanted in neck
SetPoint’s device is an implantable nerve stimulator, about the size of an oral capsule, designed to electrically stimulate the vagus nerve. The vagus nerve runs from the brain to multiple organs to control involuntary body functions such as digestion, heart rate, and breathing.
The vagus nerve also can detect and respond to inflammatory signals, activating the inflammatory reflex pathway to reduce excessive inflammation and restore immune balance. SetPoint says it has identified the precise nerve fibers involved in this pathway and the specific stimulation parameters needed to activate it.
The device is implanted in the neck’s region of the vagus nerve through a small incision done in an outpatient setting. It runs on a battery that can be recharged using a wireless charger, and its electrical pulses can be precisely adjusted using an iPad application.
Proof-of-concept studies have demonstrated the device is generally safe and can effectively reduce immune responses in people with rheumatoid arthritis and inflammatory bowel diseases, according to the company.
SetPoint is studying the device’s safety and efficacy in a pilot Phase 3 clinical trial (NCT04539964), which may support its approval for people with rheumatoid arthritis.
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