|How SetPoint's neuromodulation device works--Courtesy of SetPoint (click to enlarge)|
SetPoint Medical is starting a clinical trial to treat Crohn's disease patients with its implantable neuromodulation device. The startup previously reported a positive pilot study of the device to treat rheumatoid arthritis. Stimulation of the vagus nerve is expected to activate the body's natural reflexes to produce a systemic anti-inflammatory effect, thereby improving the symptoms of inflammatory diseases.
The startup is backed by a heavyweight group of investors that contains a few strategic backers. They include Morgenthaler Ventures, Foundation Medical Partners, Topspin Partners, Covidien Ventures, Action Potential Venture Capital Limited, the GlaxoSmithKline ($GSK) strategic venture capital fund for bioelectronic medicines and technologies, and Boston Scientific ($BSX). Last year, SetPoint raised $27 million in a financing and was named one of FierceMedicalDevices' 2013 Fierce 15 companies.
The proof-of-concept Crohn's trial will be conducted at five European centers in patients with moderately-to-severely active Crohn's despite treatment with a tumor necrosis factor antagonist drug.
"Despite recent advances in therapy for Crohn's, most patients do not achieve full disease control, and many who are adequately controlled seek alternatives to standard drug treatments," Dr. Geert D'Haens, professor of gastroenterology at The Academic Medical Center at the University of Amsterdam and coordinating investigator for the study, said in a statement. "SetPoint's approach has shown encouraging results in patients with rheumatoid arthritis, and we look forward to evaluating its potential in Crohn's patients in this important new study."
SetPoint's platform includes an implantable, miniature neuromodulation device, a wireless charger and an iPad software application.
The startup presented proof-of-concept data for its system to treat RA in late 2012. Of the 8 patients in the study, two had complete remission based on the Disease Activity Score. And 6 of the 8 patients had a positive response as measured by the American College of Rheumatology Response Rate.
The company said that these results are comparable to those for RA therapeutics, but it expects its technology to be less risky and expensive than existing drugs.
- here is the release
Special Report: FierceMedicalDevices' 2013 Fierce 15 - SetPoint Medical