Is it possible to treat rheumatoid arthritis (RA) and other inflammatory diseases as effectively as a drug without the side effects and at a lower cost? SetPoint Medical thinks so. They announced positive results in 2012 at the American College of Rheumatology Annual Meeting from the first-ever human study using an implanted neuromodulation device to treat RA. The device is currently in ongoing clinical trials.
The implant, which is surgically attached to the vagus nerve in the neck, sends mild shocks to the nerve to trigger the body’s inflammatory reflex, which then reduces swelling and inflammation. The results of the study were exciting because they were similar to those typically seen in larger studies with RA drugs: two of the eight patients achieved DAS remission, and six had a positive ACR 20 response. These results suggest that it’s possible to actually regulate the inflammatory process to improve RA symptoms via electrical stimulation – something previously not thought possible.
If you’re thinking this technology sounds familiar, you’re right. Thousands of people with epilepsy and heart disease have had their vagus nerve stimulated; however, this is the first time the nerve has been stimulated in humans specifically for RA. Once the implant is activated, electrical impulses from the implant tell immune cells in the spleen and the gastrointestinal tract to reduce their production of cytokines, which are involved in inflammation in the body. Patients and physicians will be able to recharge the device’s batteries and update its software through an iPad app and a collar that transmits wirelessly through the skin.
SetPoint’s device is much smaller than the devices in use today. It’s also projected to cost less versus RA drugs currently in use. According to SetPoint, the device will cost about as much as 18 months of an RA drug. Designed to last 10 years, it will give patients a decade of treatment for the cost of just one year to 18 months of drug treatment, SetPoint says.
Yet much work needs to be done. Scientists are still trying to make the hardware smaller for more advanced clinical trials – about the size of a jellybean. The end goal is to have something that can both monitor the patient and provide bioelectronic therapy based on patient need. Safety is also a concern, as these types of devices could potentially be hacked.
Still there are many who are optimistic about this type of therapy. SetPoint has raised $46 million in seed funding since its start and last year received $27 million from GSK, Boston Scientific and Covidien. Given that SetPoint’s chief technology officer is Mike Faltys, a medical engineer who played a key role in designing the modern cochlear implant, they may be onto something.