SetPoint Medical Presents Positive Clinical Results for First Human Study of Implantable Neuromodulation Device for Rheumatoid Arthritis

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 SetPoint Medical Presents Positive Clinical Results for First Human Study of Implantable Neuromodulation Device for Rheumatoid Arthritis

– Validates Neuromodulation as an Approach to Treat Inflammatory and Autoimmune Diseases –
2012 ACR/ARHP Scientific Meeting

VALENCIA, Calif.--(BUSINESS WIRE)--SetPoint Medical, a biomedical technology company developing neuromodulation therapies for inflammatory diseases, presented positive results from a first-in-human study using a neuromodulation device to treat rheumatoid arthritis (RA) yesterday at the American College of Rheumatology annual meeting in Washington, D.C.

"In contrast to immunosuppressive drugs, the neuromodulation therapy in this study used an implantable pulse generator to stimulate the vagus nerve, activating the body's natural Inflammatory Reflex to produce a systemic anti-inflammatory effect," said Dr. Kevin Tracey, President of Feinstein Institute for Medical Research, discoverer of the inflammatory reflex, and co-author of the ACR presentation. "The results of this study show promising clinical efficacy, and confirm a decade of foundational scientific research done by our laboratory and others."

"This study validates neuromodulation as a breakthrough approach to treating RA and other autoimmune and inflammatory diseases," said Anthony Arnold, chief executive officer of SetPoint Medical. "We look forward to developing safe and effective alternative therapies for a range of inflammatory diseases such as Crohn's disease, ulcerative colitis, psoriasis, and for the inflammation that worsens diabetes and heart disease. This approach could offer patients 10 years of treatment for the cost of about 18 months of biologic therapy and would be an exciting new alternative for physicians to treat their patients."

In this open label pilot study, eight patients with active rheumatoid arthritis despite treatment with the RA agent methotrexate, who would otherwise have been candidates for a TNF inhibitor, instead received the neuromodulation implant on the vagus nerve in their neck. The treatment was well tolerated, with one patient reporting hoarseness after implantation, a known side effect with this type of device. Improvement in RA was assessed at the six-week primary endpoint using standard measures of efficacy including the Disease Activity Score (DAS), and the American College of Rheumatology (ACR) 20 response rate.

At the primary end point, two of the eight patients in the study achieved DAS remission, and six of the eight had a positive ACR 20 response, results similar to those typically achieved in larger studies with drugs currently used to treat RA.

SetPoint is developing a novel platform to treat a variety of inflammation-mediated autoimmune diseases. The company is planning larger clinical studies in several diseases scheduled to begin in 2013.

About SetPoint Medical

SetPoint Medical is a privately held biomedical technology company dedicated to treating patients with debilitating inflammatory diseases using proprietary implantable neuromodulation devices.

SetPoint is developing safe and effective neuromodulation therapies for patients with inflammatory autoimmune diseases, such as Crohn's Disease and rheumatoid arthritis. SetPoint's novel platform consists of an implantable miniature neuromodulation device, wireless charger and iPad prescription pad application. The system uses vagus nerve stimulation to activate the body's natural Inflammatory Reflex, which produces a potent systemic anti-inflammatory effect. The company has just completed a first-in-human open-label proof-of-concept trial in rheumatoid arthritis. The results confirm extensive preclinical studies, and show clinical efficacy comparable to leading immunosuppressive drugs. SetPoint's approach is intended to offer patients and providers a better alternative approach for the treatment of RA and other chronic inflammatory diseases with less risk and cost than drug therapy. SetPoint is headquartered in Valencia, Ca., and investors in the company include Morgenthaler Ventures, Foundation Medicine and Topspin Partners. For more information, visit www.setpointmedical.com.