SetPoint Medical

TAP provides early and frequent strategic engagement from the FDA, patients, providers and payers. It facilitates rapid development and widespread access to medical devices. Acceptance requires breakthrough device designation, which SetPoint Medical garnered last week.

With acceptance into TAP, SetPoint can progress the development of its novel neuroimmune modulation platform. Valencia, California–based SetPoint designed its nerve modulation technology for people with relapsing-remitting multiple sclerosis (RRMS).

SetPoint designed its device to use precise vagus nerve stimulation. It activates anti-inflammatory and immune-restorative pathways to treat inflammation-mediated autoimmune conditions.

The SetPoint platform features a miniaturized stimulation device placed on the vagus nerve. Onc…

Valencia, California–based SetPoint designed its nerve modulation technology for people with relapsing-remitting multiple sclerosis (RRMS). Breakthrough designation enables more communication and priority regulatory review with the FDA. Plus, it supports reimbursement and patient access upon approval.

This isn’t the first breakthrough nod for SetPoint’s technology. It picked up the designation in 2020 to treat rheumatoid arthritis (RA). The company continues evaluating the investigational platform in a pivotal clinical trial for the treatment of RA.

However, the latest breakthrough nod helps the company explore the technology for yet another condition. SetPoint’s platform features a miniaturized stimulation device placed on the vagus nerve. Once placed through a small inc…