SetPoint nerve stimulator for RRMS accepted to FDA TAP program

Pilot program to help accelerate patient access to innovative devices

by Andrea Lobo, PhD | March 26, 2024

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 companies with earlier and more frequent communications with 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.

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