FDA Grants Breakthrough Device Designation for Neuroimmune Modulation Platform To Treat MS
The platform is a first-of-its-kind therapeutic approach to promote remyelination among individuals with relapsing/remitting multiple sclerosis.
A novel neuroimmune modulation platform (SetPoint Medical) for individuals experiencing relapsing-remitting multiple sclerosis (RRMS) has received breakthrough device designation (BDD) from the FDA. BDD aims to allow interactive communication with the FDA, an FDA priority review, as well as aid the reimbursement process following the approval of the platform. The platform is a first-of-its-kind therapeutic approach to promote remyelination (repair) among individuals with RRMS.1
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“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, PhD, Chief Executive Officer of SetPoint Medical, in a press release. “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.”1
Multiple sclerosis (MS) is an autoimmune disorder that causes harm to the protective layer that surrounds and insulate nerve fibers, impacting approximately 1 million US individuals. Symptoms of MS can include visual impairment, difficulty walking, sensory disturbance, pain, cognitive difficulty, and fatigue.1 Possible causes of the disorder include autoimmune disorders, infectious viruses, environmental factors, and genetic factors.2 However, the study authors noted that there is not a present cure and no approved treatments to address the underlying cause of MS.1
“Great strides have been made over the past decade to develop drugs that can attenuate disease activity and slow the rate of development of new lesions in MS,” said Shiv Saidha, MBBCh, professor of neurology at Johns Hopkins University, in a press release. “However, these drugs do not completely stop the development of new lesions, nor do they promote [remyelination] of existing lesions and damaged tissue. There is an urgent unmet medical need for therapies that can promote protection and functional restoration of damaged axons through remyelination in patients, and SetPoint's therapeutic approach could offer new hope to people living with this chronic debilitating condition.”1
To use the neuroimmune modulation platform, individuals must undergo an outpatient procedure that makes a small incision on the left side of the neck, allowing the integrated neurostimulation device to be placed on the vagus nerve. The study authors noted that the device is then programed to automatically transport therapy that can be preset on a schedule. The therapy is designed to stimulate the vagus nerve once daily to trigger an inflammatory reflex for a system immune restorative effect, according to study authors.1
The BDD was based on positive results showing that the treatment could decrease demyelination and increase remyelination, according to study authors.
“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,” said Simhambhatla, in the press release.1
