FDA has awarded SetPoint Medical breakthrough device designation for a bioelectronic technology that stimulates the vagus nerve to treat rheumatoid arthritis (RA).

The breakthrough device designation comes roughly five months after the Valencia, CA-based company won an IDE for the bioelectronic device from FDA to start a pivotal trial.

The breakthrough device designation is beneficial because it not only gives the company expedited review from FDA, but it could also help secure reimbursement from the Centers of Medicare and Medicaid Services, said Murthy Simhambhatla, SetPoint’s president and CEO.

“CMS issued a proposed rule in August of 2020 that tied early reimbursement immediately after FDA approval for a period of four years to provide reimbursement for medical devices with breakthrough designations,” Simhambhatla told MD+DI. “Now this is a proposed rule that will have to go through public comment before its finalized, but it clearly offers a tailwind to support the advancement and more importantly the access of novel medical devices for patients.”

Potential approval of the device is a few years out.

“[Approval] is probably four years away because you have to run your trial and file your PMA,” Simhambhatla said. “There’s a PMA review process timeline associated with that. So, when you add all of those up, you’re talking four years or so to get to the finish line.”

SetPoint Says What Stays in Vagus

SetPoint’s device is about the size of a coffee bean. The foundation of the technology is based on impacting the Inflammatory Reflex, a mechanism discovered by SetPoint co-founder Kevin Tracy, said David Chernoff, MD, SetPoint’s CMO.  

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.

“When you purposely stimulate the vagus with a device – and we have a unique one, then you activate a neural reflex that connects the brain to the immune system,” Chernoff told MD+DI. “The vagus nerve is the longest of the 12 cranial nerves and after it exits the brain stem it has touchpoints throughout the body so it can communicate and detect inflammation in the body.”

Simhambhatla added, “the advantage of the approach that we’ve chosen of directly stimulating the vagus nerve instead of stimulating a peripheral nerve to deal with each disease state separately, is the same device in the same location of implantation can be used to treat patients with multiple autoimmune diseases. Now RA is the beginning. We’re very focused as a startup company in getting RA to the finish line.”

The device has the potential to treat other disease states.

SetPoint has a positive proof-of-concept study it ran in Europe on Crohn’s Disease. The company has also been doing pre-clinical research in multiple sclerosis.

“The early results are quite exciting,” Simhambhatla said. “It’s going to be at least another year of work in multiple sclerosis for us to determine if we’re ready at some point to start a human clinical study.”