SetPoint Medical is looking to shake up the way rheumatoid arthritis (RA) is treated. The Valencia, CA-based company has completed enrollment for a pilot IDE that will evaluate its bioelectronic device to treat patients with drug refractory RA.
“[Enrollment completion] is coming on the back of two studies we did in Europe previously,” Murthy Simhambhatla, PhD, CEO of SetPoint Medical, told MD+DI. "These studies were not done with our device, but with an off-the shelf device we programmed with our pulse parameters. One was in RA the other in Crohn’s Disease. We saw good signals from both of those studies.”
Simhambhatla said that SetPoint’s device has a much smaller footprint than the technology that was appropriated for the two Europe studies. The company’s device is one inch long and bases its platform on the Inflammatory Reflex, a mechanism discovered by SetPoint cofounder Kevin Tracy. The Inflammatory Reflex regulates the immune system by way of the central nervous system. By activating the Inflammatory Reflex with targeted electrical pulses to the vagus nerve, the body produces a systemic anti-inflammatory response.
The pilot IDE study will include 14 subjects who had failed or were intolerant to multiple, mechanistically different, biological therapies. Initial feedback from neurosurgeons performing the implantation has been positive.
“We expect to get a data readout in the first quarter of ,” he said.