SetPoint Medical announced today that received FDA breakthrough device designation for its novel neuroimmune modulation platform.
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.
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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 incision on the left side of the neck in an outpatient procedure, the device automatically delivers therapy on a preset schedule.
SetPoint designed its device to use precise vagus nerve stimulation. It activates anti-inflammatory and immune-restorative pathways to treat inflammation-mediated autoimmune conditions.
“This significant milestone highlights the platform potential of SetPoint’s device and therapeutic approach for the treatment of multiple chronic conditions,” said Murthy V. Simhambhatla, Ph.D., Chief Executive Officer of SetPoint Medical. “As next steps, we look forward to working collaboratively with the FDA to initiate the first-of-its-kind clinical trial to investigate our device for people living with RRMS.”
