A novel neuroimmune modulation platform (SetPoint Medical) for individuals experiencing relapsing-remitting multiple sclerosis (RRMS) has received breakthrough device designation (BDD) from the FDA.
The platform is a first-of-its-kind therapeutic approach to promote remyelination (repair) among individuals with RRMS.
“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.”
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.
The BDD was based on positive results showing that the treatment could decrease demyelination and increase remyelination, according to study authors.
https://www.pharmacytimes.com/view/f...rm-to-treat-ms
The platform is a first-of-its-kind therapeutic approach to promote remyelination (repair) among individuals with RRMS.
“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.”
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.
The BDD was based on positive results showing that the treatment could decrease demyelination and increase remyelination, according to study authors.
https://www.pharmacytimes.com/view/f...rm-to-treat-ms
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