Latest news with #SetPointMedical
Yahoo
4 days ago
- Health
- Yahoo
FDA approves SetPoint's neuroimmune modulation device for RA treatment
The US Food and Drug Administration (FDA) has approved SetPoint Medical's implantable neuroimmune modulation device, SetPoint System, to treat moderate-to-severe rheumatoid arthritis (RA) in adults. The system is designed for individuals who are inadequately managed by or intolerant to current RA therapies such as biological and targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs). The system is said to activate the body's natural anti-inflammatory and immune-restorative pathways by delivering electrical stimulation to the vagus nerve once a day. The neurostimulation therapy can potentially provide an alternative treatment without immune-compromising risks. The FDA approval was based on the outcomes of the RESET-RA study, a 242-patient double-blind, randomised, sham-controlled trial, which showed the system's efficacy and safety in this patient group. Patients tolerated the device placement procedure and the stimulation therapy well, with a low incidence of related serious adverse events at 1.7%. SetPoint Medical CEO Murthy Simhambhatla said: 'The approval of the SetPoint System, the first-in-class neuroimmune modulation platform, represents a transformative milestone in the management of autoimmune diseases. 'We are committed to improving the health of people living with RA, and look forward to working with providers and payers to make our innovative therapy accessible to their patients. We plan to introduce the SetPoint System in targeted US cities this year, followed by expansion across the country starting in early 2026.' SetPoint Medical is also exploring the use of its neuroimmune modulation platform for other autoimmune diseases such as multiple sclerosis (MS) and Crohn's disease. In March 2024, the company's neuroimmune modulation device secured a breakthrough device designation to treat relapsing-remitting MS. "FDA approves SetPoint's neuroimmune modulation device for RA treatment" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Medscape
31-07-2025
- Health
- Medscape
FDA Approves First Vagus Nerve Stimulation Device for RA
The FDA has approved a medical device that stimulates the vagus nerve for the treatment of moderate-to-severe rheumatoid arthritis (RA) in patients who have not responded to — or cannot tolerate — biologic or targeted synthetic disease-modifying antirheumatic drugs (DMARDs). The device, developed by SetPoint Medical in Valencia, California, is the first treatment of its kind approved for RA. The company is also planning trials for multiple sclerosis and Crohn's disease. Implanted into the neck, the Setpoint System is a multivitamin-sized device that stimulates the vagus nerve for 1 minute every day and 'is designed to activate innate anti-inflammatory pathways in the vagus nerve to reduce inflammation and restore immunologic setpoint,' according to a press release from SetPoint Medical on July 31. The device's approval was based on a randomized, double-blinded, and sham-controlled clinical study of 242 patients with RA. At 3 months, 35.2% of patients in the treatment group achieved 20% improvement in American College of Rheumatology response criteria (ACR20), compared with 24.2% in the sham group, according to trial results presented at the 2024 ACR annual meeting held in Washington, DC. ACR response rates and disease activity metrics improved over 12 months of follow-up, John Tesser, MD, a principal investigator of the trial, said in a statement. At 1 year, '75% of patients in the study were free of biologic or targeted synthetic DMARDs,' he said. Commercialization of the device will begin in certain US cities this year, with a larger expansion across the US planned in early 2026. SetPoint could not provide specifics on which cities are selected for this phased roll out due to confidentiality requirements.
Business Wire
31-07-2025
- Health
- Business Wire
SetPoint Medical Receives FDA Approval for Novel Neuroimmune Modulation Therapy for Rheumatoid Arthritis
VALENCIA, Calif.--(BUSINESS WIRE)-- SetPoint Medical, a company dedicated to developing therapies for people living with chronic autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved the company's SetPoint System, a breakthrough innovation for people with rheumatoid arthritis (RA). The SetPoint System is a first-of-its-kind neuroimmune modulation device for the treatment of adults living with moderate-to-severe RA who are not adequately managed by—or cannot tolerate—existing advanced RA therapies, such as biological and targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs). 'The approval of the SetPoint System, the first-in-class neuroimmune modulation platform, represents a transformative milestone in the management of autoimmune diseases,' said Murthy V. Simhambhatla, Ph.D., CEO of SetPoint Medical. 'We are committed to improving the health of people living with RA, and look forward to working with providers and payers to make our innovative therapy accessible to their patients. We plan to introduce the SetPoint System in targeted U.S. cities this year, followed by expansion across the country starting in early 2026.' A Novel Therapy, Backed by Robust Clinical Research More than 1.5 million Americans are living with RA, a chronic autoimmune disease in which the immune system mistakenly attacks healthy tissue, leading to joint pain, bone erosion, deformity, reduced mobility, and long-term disability. There is no cure for RA, and current treatment options are often limited by poor patient adherence and dissatisfaction. Only 25% of RA patients are satisfied with their therapy, 1 and up to 50% discontinue their prescribed therapies within two years, largely due to inadequate or diminishing outcomes or intolerance to adverse effects. 2,3 The SetPoint System is an implantable, integrated neurostimulation device designed to deliver electrical stimulation to the vagus nerve, once daily, to activate the body's innate anti-inflammatory and immune-restorative pathways. This groundbreaking therapy has the potential to transform the care for RA sufferers by offering a treatment option without immune-compromising risks. FDA approval is supported by the results of the 242-patient randomized, double-blind, sham-controlled, RESET-RA study, that demonstrated the SetPoint System's safety and efficacy in patients with moderately to severely active RA who had an incomplete response or intolerance to one or more biologic or targeted synthetic DMARDS. 'This is a landmark study in the treatment and care of rheumatoid arthritis,' said John Tesser, MD, FACP, FACR, MACR, a leading rheumatologist and national rheumatology principal investigator of the RESET-RA study. 'The study met its primary efficacy endpoint of ACR20 at three months, with improvements observed in ACR response rates and disease activity metrics through 12 months of follow-up. 75% of patients in the study were free of biologic or targeted synthetic DMARDs at 12 months.' The device placement procedure and stimulation therapy were well-tolerated, with a low rate of related serious adverse events (1.7%), and no observations of malignancies, major cardiac events, or serious infections related to the SetPoint Therapy. 'The approval of the SetPoint System highlights the potential of neuroimmune modulation as a novel approach for autoimmune disease, by harnessing the body's neural pathways to combat inflammation,' said Mark Richardson, MD, PhD, Director of Functional Neurosurgery at Massachusetts General Hospital and Professor of Neurosciences at Harvard Medical School, and national surgical principal investigator in the RESET-RA study. 'After implantation during a minimally invasive outpatient procedure, the SetPoint device is programmed to automatically administer therapy on a predetermined schedule for up to 10 years, simplifying care for people living with RA.' The SetPoint System received Breakthrough Device Designation from the FDA, a program designed for technologies that offer potentially more effective treatment or diagnosis for debilitating diseases. The company is also planning to evaluate its platform for treatment of additional autoimmune indications, including multiple sclerosis and Crohn's disease. About SetPoint Medical SetPoint Medical is a commercial-stage medical technology company dedicated to improving care for people living with chronic autoimmune diseases. The company's FDA-approved SetPoint System is the first neuroimmune modulation therapy available for people living with rheumatoid arthritis (RA), offering a novel, device-based alternative for those who do not respond to or cannot tolerate biologic or targeted drug therapies. SetPoint's proprietary integrated neurostimulation platform is designed to activate innate anti-inflammatory pathways in the vagus nerve to reduce inflammation and restore immunologic setpoint. With a vision to redefine the care of autoimmune conditions, SetPoint is also planning to evaluate its platform technology for other conditions including multiple sclerosis and Crohn's disease. Learn more at 1 Radawski C, Genovese MC, Hauber B, et. al. Patient Perceptions of Unmet Medical Need in Rheumatoid Arthritis: A Cross-Sectional Survey in the USA. Rheumatol Ther. 2019 Sep;6(3):461-471. 2 Strand V, Miller P, Williams SA et al. Discontinuation of Biologic Therapy in Rheumatoid Arthritis: Analysis from the Corrona RA Registry. Rheumatol Ther 4, 489–502 (2017). 3 Pombo-Suarez M, Sanchez-Piedra C, Gómez-Reino J, et. al. After JAK inhibitor failure: to cycle or to switch, that is the question - data from the JAK-pot collaboration of registries. Ann Rheum Dis. 2023 Feb;82(2):175-181.
Yahoo
04-06-2025
- Business
- Yahoo
SetPoint Medical Appoints Tyler Binney to Its Board of Directors
VALENCIA, Calif., June 04, 2025--(BUSINESS WIRE)--SetPoint Medical, a clinical-stage healthcare company dedicated to people living with chronic autoimmune diseases, today announced the appointment of Tyler Binney to its Board of Directors. With a career built around scaling disruptive MedTech platforms, Binney brings over two decades of commercial leadership experience that will be instrumental to SetPoint's mission to deliver a new treatment alternative to patients with autoimmune conditions, including rheumatoid arthritis (RA). "Tyler has a strong track record of building successful commercial organizations and delivering sustained growth in new markets," said Murthy V. Simhambhatla, Ph.D., Chief Executive Officer of SetPoint Medical. "His experience bringing novel, category-creating technologies to market will be an incredible asset to our team as we work to provide patients with access to our innovative neuroimmune modulation platform." With over 20 years of proven leadership experience in the medical device industry, Mr. Binney most recently served as President and Chief Executive Officer of Relievant Medical Systems, which Boston Scientific acquired in November 2023 for an upfront payment of $850 million, plus performance-based earnouts. Previously, he served as President and General Manager of the Interventional Urology Business Unit at Teleflex, and as Vice President of Sales at NeoTract, where he led the successful commercialization of the UroLift® System, contributing to its $1.1 billion acquisition by Teleflex. "What SetPoint is doing in the field of neuroimmune modulation is truly groundbreaking," said Tyler Binney. "This team is on the verge of transforming the treatment of chronic autoimmune conditions, and I look forward to contributing my experience as they accelerate their strategy to commercialize this platform technology." About SetPoint Medical SetPoint Medical is a privately held clinical-stage healthcare company dedicated to treating people living with chronic autoimmune diseases. The company is developing a novel platform designed to stimulate the vagus nerve to activate neuroimmune pathways to produce a systemic anti-inflammatory and immune-restorative effect. SetPoint Medical's platform technology is designed to offer patients and providers a treatment alternative for rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease and other chronic autoimmune conditions with potentially less risk and cost than drug therapy. For more information, visit View source version on Contacts Emma YangHealth+Commercemedia@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
04-06-2025
- Business
- Business Wire
SetPoint Medical Appoints Tyler Binney to Its Board of Directors
VALENCIA, Calif.--(BUSINESS WIRE)-- SetPoint Medical, a clinical-stage healthcare company dedicated to people living with chronic autoimmune diseases, today announced the appointment of Tyler Binney to its Board of Directors. With a career built around scaling disruptive MedTech platforms, Binney brings over two decades of commercial leadership experience that will be instrumental to SetPoint's mission to deliver a new treatment alternative to patients with autoimmune conditions, including rheumatoid arthritis (RA). 'Tyler has a strong track record of building successful commercial organizations and delivering sustained growth in new markets,' said Murthy V. Simhambhatla, Ph.D., Chief Executive Officer of SetPoint Medical. 'His experience bringing novel, category-creating technologies to market will be an incredible asset to our team as we work to provide patients with access to our innovative neuroimmune modulation platform.' With over 20 years of proven leadership experience in the medical device industry, Mr. Binney most recently served as President and Chief Executive Officer of Relievant Medical Systems, which Boston Scientific acquired in November 2023 for an upfront payment of $850 million, plus performance-based earnouts. Previously, he served as President and General Manager of the Interventional Urology Business Unit at Teleflex, and as Vice President of Sales at NeoTract, where he led the successful commercialization of the UroLift® System, contributing to its $1.1 billion acquisition by Teleflex. 'What SetPoint is doing in the field of neuroimmune modulation is truly groundbreaking,' said Tyler Binney. 'This team is on the verge of transforming the treatment of chronic autoimmune conditions, and I look forward to contributing my experience as they accelerate their strategy to commercialize this platform technology.' About SetPoint Medical SetPoint Medical is a privately held clinical-stage healthcare company dedicated to treating people living with chronic autoimmune diseases. The company is developing a novel platform designed to stimulate the vagus nerve to activate neuroimmune pathways to produce a systemic anti-inflammatory and immune-restorative effect. SetPoint Medical's platform technology is designed to offer patients and providers a treatment alternative for rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease and other chronic autoimmune conditions with potentially less risk and cost than drug therapy. For more information, visit
