The breakthrough device status for the investigational platform technology was given by the US regulator based on data which showed that SetPoint Medical’s therapeutic approach can possibly lessen demyelination and boost remyelination
SetPoint Medical secures FDA breakthrough device designation in MS for its neuroimmune modulation platform. (Credit: Robina Weermeijer on Unsplash)
SetPoint Medical has received breakthrough device designation from the US Food and Drug Administration (FDA) for its neuroimmune modulation platform to treat relapsing-remitting multiple sclerosis (RRMS).
The investigational platform technology is said to precisely stimulate the vagus nerve to activate innate anti-inflammatory and immune-restorative pathways for the treatment of inflammation-mediated autoimmune diseases.
During an outpatient surgery, SetPoint Medical’s integrated and miniaturised neurostimulation device is put on the vagus nerve via a small incision on the left side of the neck.
Using a preprogrammed schedule, the device is set up to automatically administer therapy by stimulating the vagus nerve once a day. This triggers the inflammatory response for a systemic immune-restorative impact.
The breakthrough status was granted based on data which showed that SetPoint Medical’s therapeutic approach can possibly lessen demyelination and boost remyelination.
The designation is expected to facilitate patient access and reimbursement upon approval and before that, priority regulatory review and interactive engagement with the FDA.
SetPoint Medical CEO Murthy Simhambhatla said: “This significant milestone highlights the platform potential of SetPoint’s device and therapeutic approach for the treatment of multiple chronic conditions.
“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.”
In 2020, the FDA issued breakthrough device designation to SetPoint Medical’s platform technology for the treatment of rheumatoid arthritis (RA).
The healthcare company is presently assessing its experimental platform technology in the RESET-RA study in humans.
RESET-RA is a multicentre, double-blind, randomised, sham-controlled clinical trial that will evaluate the technology in the treatment of moderate-to-severe RA.
Using the device, SetPoint Medical aims to offer a potentially safer and more cost-effective therapeutic alternative to medication therapy for patients and providers dealing with conditions such as RA, multiple sclerosis, inflammatory bowel disease, and other chronic autoimmune disorders.
Last year, the firm raised $80m in preferred stock financing to support the development of its neuroimmune modulation platform.