SetPoint Medical Reports the US FDA’s IDE Approval to Initiate Neuroimmune Modulation Platform’s Evaluation for Relapsing-Remitting Multiple Sclerosis
Shots:
- The US FDA has granted IDE approval for conducting clinical evaluation of neuroimmune modulation platform vs sham in patients (n=60) with relapsing-remitting multiple sclerosis (RRMS) across the US in 2025
- The system is an implantable, rechargeable neurostimulation device that stimulates the vagus nerve (QD) to induce anti-inflammatory & immune-restorative pathways. It was designated as a breakthrough device & accepted into the TPLC Advisory Program (TAP) Pilot in Mar 2024 for RRMS
- The company also assessed the platform in RESET-RA trial. Its topline data showed a safe & effective treatment for mod. to sev. rheumatoid arthritis (RA) in patients who didn’t respond or are intolerant to biologic or synthetic DMARDs
Ref: SetPoint Medical | Image: SetPoint Medical
Related News:- SetPoint Medical’s Neuroimmune Modulation Platform Obtains the US FDA’s Breakthrough Device Designation to Treat Multiple Sclerosis
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
