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Thursday, May 23, 2024

Setpoint Gets Breakthrough FDA Rulings

Valencia-based Setpoint Medical Corp., which has a medical device platform to treat patients with chronic autoimmune diseases, has recently received two decisions from the Food and Drug Administration that are aimed at fast-tracking medical device approvals.

On March 13, SetPoint announced that it had received “breakthrough device designation from the FDA for the use of its novel neuroimmune modulation platform for people living with a type of multiple sclerosis in which the patient goes into remission and then relapses.

Breakthrough-device designation facilitates interactive communication and priority regulatory review with the agency, as well as support reimbursement and patient access upon the agency’s approval of SetPoint’s technology.

Nearly 1 million people in the United States are living with multiple sclerosis, an autoimmune disorder that damages the protective layer that surrounds and insulates nerve fibers. This disrupts signals to and from the brain, leading to debilitating symptoms such as difficulty walking, sensory disturbance, pain, cognitive difficulty and fatigue. There is no cure for the disease.

SetPoint’s medical-device technology stimulates one of the body’s nerve networks to activate anti-inflammatory and immune-restorative pathways.

“This significant milestone highlights the platform potential of SetPoint’s device and therapeutic approach for the treatment of multiple chronic conditions,” Murthy Simhambhatla, SetPoint’s chief executive, said in the announcement.

On a related front, a week later SetPoint announced that this same medical-device platform to treat MS had been accepted into a separate program at the FDA to expedite development and patient access to safe and effective medical devices that have received agency approval.

“We’re excited to be included in the TAP Pilot, as the program will help streamline collaboration with the FDA,” Alexis Dineen, vice president of regulatory affairs for SetPoint, said in the announcement.

James Brock
James Brock
James Brock has worked in newsrooms around the world, including in New York, Paris, Abu Dhabi, Dubai, Houston, and Los Angeles. He began his career with a Newhouse News daily, where he served on the news desk and the editorial page. He was the copy chief for The New York Sun, and founded and edited the personal finance section for Abu Dhabi-based The National, among other positions. He has interviewed Anthony Bourdain, Tom Ford, Mark Cuban, and many other individuals, and has written and edited thousands of stories and articles.

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