Sagentia, a global technology and product development company, has been hired by SetPoint Medical to work on the development of the programming interface for a neuromodulation device. The device aims to provide patients with a lower risk and lower cost alternative to immunosuppressive drugs for the treatment of chronic inflammatory diseases.
SetPoint Medical, a Californian-based biomedical technology company that received $27m in financing in August this year and was named by Fierce Medical Devices as one of its ‘2013 Fierce 15 Device & Diagnostic Companies’, is developing a novel, proprietary bioelectronics medicine platform to treat a variety of inflammation-mediated autoimmune diseases as a safe and effective alternative to using drugs. The therapy consists of three core components: an implanted MicroRegulator, a charger unit that charges the MicroRegulator and an “RxPad” iPad prescription application which 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 has been brought into the project to develop the iPad App, and to advise on the RF 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 FDA.
Anthony Arnold, CEO at SetPoint Medical, comments: “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.Together we intend to develop a convenient and novel iOS programming interface that will help facilitate the adoption of this exciting new therapy.” Dr David Pettigrew, Medical Sector Manager at Sagentia, adds: “SetPoint Medical are truly becoming the front-runners in the emerging field of neuromodulation.With this new device there is the potential to revolutionise 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.” From a stakeholder perspective, the SetPoint Medical device 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 aims to 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%. The current development program is due to continue through 2014, followed by clinical trials in late 2014/early 2015.