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SetPoint Medical Announces Data Supporting Continued Clinical Development of its Bioelectronic Device for Treatment of Rheumatoid Arthritis (RA)Successful proof-of-concept study demonstrates positive long-term 24-month safety and efficacy data Results to be Presented in Two Poster Presentations Today during the American College of Rheumatology (ACR) / Association of Rheumatology Health Professionals (ARHP) Annual Meeting VALENCIA, Calif., Oct. 23, 2018 (GLOBE NEWSWIRE) -- SetPoint Medical, a clinical-stage bioelectronic medicine company developing therapy for chronic autoimmune diseases, today announced long-term, 24-month follow up data from its proof-of-concept study that support the continued clinical development of its proprietary bioelectronic device to treat patients with rheumatoid arthritis (RA). Results will be presented today in two poster presentations during the American College of Rheumatology (ACR) / Association of Rheumatology Health Professionals (ARHP) 2018 Annual Meeting, taking place October 19-23 in Chicago, IL. Results for the completed proof-of-concept study in Europe supported the initiation of a U.S. Food and Drug Administration (FDA) pilot Investigational Device Exemption (IDE) study evaluating SetPoint’s proprietary miniaturized microregulator, for which the company recently announced completion of enrollment. Murthy Simhambhatla, President and Chief Executive Officer of SetPoint Medical, said, “It’s exciting to see the development of our unique bioelectronic medicine solution progressing as a fundamentally different treatment option for rheumatoid arthritis. Current autoimmune disease treatments slow disease progression but have significant negative side effects, leave many patients with significantly diminished quality of life, have substantial compliance challenges and are extremely costly. Our alternative approach has the potential to improve upon each of these limitations and we look forward to having our recent clinical advancements presented by leading experts at this year’s ACR/ARHP Annual Meeting.” A First-in-Man Bioelectronic Therapy for Biologic-Refractory Rheumatoid Arthritis
Vagus Nerve Stimulation in Patients with Rheumatoid Arthritis: 24 Month Safety and Efficacy
The poster reports 24-month follow-up long-term safety and efficacy results from the proof-of-concept EU study evaluating a VNS device to treat RA, as outlined in Poster #72161. All 17 enrolled subjects elected to continue VNS for the duration of the 24-month follow-up and showed significant reduction in RA symptoms and strong therapy adherence. At 24 months, 87% of the subjects reported clinically meaningful responses by standard EULAR criteria, demonstrating that bioelectronic medicine has the potential to substantially reduce both clinical RA disease activity and patient disability for two years, with no unexpected safety issues. These improvements were maintained in patients with and without concurrent use of biologic agents. These long-term data, initially presented in June 2018, further support SetPoint’s ongoing U.S. prospective double-blinded and controlled pilot IDE study in RA patients. About SetPoint Medical Media Contact: |