Breakthrough Device Designation for SetPoint MS Neurostim

Image credit: Colin Behrens via Pixabay

SetPoint Medical has received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its novel neuroimmune modulation technology for people living with relapsing-remitting multiple sclerosis (RRMS).

The FDA nod follows evidence published by SetPoint Medical showing the potential of the integrated neurostimulation device to reduce demyelination of the central nervous system as is caused in patients with RRMS, and to promote remyelination.

The same device received Breakthrough Device Designation from the FDA in 2020 for the treatment of rheumatoid arthritis.

Placed on the vagus nerve through a small incision in a patient’s neck, the device is then scheduled to provide daily stimulation to the nerve and activate the inflammatory reflex.

“This significant milestone highlights the platform potential of SetPoint’s device and therapeutic approach for the treatment of multiple chronic conditions,” said SetPont Medical CEO, Dr Murthy Simhambhatla.

“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.”

Refer to the full release from SetPoint Medical for more information.