Neurostimulator to repair myelin in RRMS
Posted: Fri Apr 05, 2024 6:19 am
The U.S. Food and Drug Administration has designated SetPoint Medical’s neurostimulator a breakthrough device for the treatment of relapsing-remitting multiple sclerosis (RRMS).
This designation is intended to accelerate the development of devices intending to more effectively treat or diagnose life-threatening or chronically debilitating diseases than standard approaches.
It was supported by evidence showing that SetPoint’s nerve stimulator platform may slow myelin damage and promote its repair, an unmeet need in multiple sclerosis (MS) and other demyelinating conditions. The company now is planing to work with the regulatory agency to open a clinical trial of the therapeutic device in RRMS patients.
https://multiplesclerosisnewstoday.com/ ... WToJ2giAHz
This designation is intended to accelerate the development of devices intending to more effectively treat or diagnose life-threatening or chronically debilitating diseases than standard approaches.
It was supported by evidence showing that SetPoint’s nerve stimulator platform may slow myelin damage and promote its repair, an unmeet need in multiple sclerosis (MS) and other demyelinating conditions. The company now is planing to work with the regulatory agency to open a clinical trial of the therapeutic device in RRMS patients.
https://multiplesclerosisnewstoday.com/ ... WToJ2giAHz