SetPoint Medical Partners With Sagentia on Neuromodulation Device

SetPoint Medical is partnering with Sagentia to develop the programming interface for a neuromodulation device. The device is intended to provide patients with a lower risk and lower cost alternative to immunosuppressive drugs for the treatment of chronic inflammatory diseases.

Valencia, Calif.-based SetPoint Medical is a biomedical technology company developing neuromodulation therapies for patients with inflammatory autoimmune diseases, such as rheumatoid arthritis and Crohn’s disease. SetPoint’s approach—positioned as an alternative to drugs—uses vagus nerve stimulation to activate the inflammatory reflex, which produces a potent systemic anti-inflammatory effect.

The company received $27 million in financing in August, and was named by Fierce Medical Devices as one of its “2013 Fierce 15 Device & Diagnostic Companies.”

The therapy consists of three core components: an implanted MicroRegulator, a charger unit that charges the MicroRegulator and an “RxPad” iPad prescription application that sets the dose and frequency of the therapy. The implantable MicroRegulator stimulates the vagus nerve, activating the body’s natural inflammatory reflex to produce a potent systemic anti-inflammatory effect and resulting in dampened inflammation and improved clinical signs and symptoms. 

Sagentia, a product development firm based in Cambridge in the United Kingdom, was brought into the project to develop the iPad app, and to advise on the radiofrequency and Bluetooth low-energy interfaces within the system. Sagentia will develop the app according to the applicable medical device standards in line with the recent guidelines released by the U.S. Food and Drug Administration. Sagentia provides services across the product development lifecycle, from new concept generation and technology validation, through prototyping and full product development, to transfer to manufacture and sustainability.

“We at SetPoint Medical are excited to have the bright minds of the people at Sagentia join us in the development of this revolutionary therapy designed to improve the lives of people with inflammatory diseases,” said Anthony Arnold, CEO at SetPoint Medical. “Together we intend to develop a convenient and novel iOS programming interface that will help facilitate the adoption of this exciting new therapy.”

According to officials at SetPoint Medical, the company’s technology has the potential to deliver ground-breaking benefits across the healthcare system. For patients, the implanted device has a target to last up to 10 years, replacing the need for routine injections or pills and reducing the risks associated with current treatments. For physicians, the device should offer a new and less-expensive treatment option for patients suffering from chronic inflammatory diseases, such as rheumatoid arthritis. For payors, the new proposed approach could decrease costs by up to 75 percent.

“SetPoint Medical is truly becoming a front-runner in the emerging field of neuromodulation,” said David Pettigrew, medical sector manager at Sagentia. “With this new device there is the potential to revolutionize the treatment of chronic inflammatory disease by bringing a real new alternative to traditional drug-based therapy. We see the medically regulated iPad app as a key enabler of this product and the Sagentia team is proud to contribute our experience in wireless systems engineering and medically regulated app development to the project.”

The current development program is due to continue through 2014, followed by clinical trials in late 2014 or early 2015.