Latest news with #SetPoint
Time of India
a day ago
- Health
- Time of India
How a one-minute jolt from the SetPoint implant offers new hope for autoimmune disease patients
The US Food and Drug Administration (FDA) recently approved a medical device that could bring new hope to patients suffering from rheumatoid arthritis (RA), a chronic autoimmune condition often difficult to treat with conventional medications. Unlike standard therapies, the device harnesses the brain and nervous system to suppress the uncontrolled inflammation responsible for the disease. The SetPoint System is a small, inch-long implant surgically placed in the neck, wrapping around the vagus nerve, which is thought to be the longest nerve in the body. It delivers one minute of electrical stimulation per day, which research suggests can 'reset' the immune system and reduce crippling inflammation. Unlike most RA drugs that suppress the immune system and increase infection risk, this device works by re-educating the body's immune response. Finance Value and Valuation Masterclass - Batch 4 By CA Himanshu Jain View Program Artificial Intelligence AI For Business Professionals Batch 2 By Ansh Mehra View Program Finance Value and Valuation Masterclass - Batch 3 By CA Himanshu Jain View Program Artificial Intelligence AI For Business Professionals By Vaibhav Sisinity View Program Finance Value and Valuation Masterclass - Batch 2 By CA Himanshu Jain View Program Finance Value and Valuation Masterclass Batch-1 By CA Himanshu Jain View Program Described on a recent episode of the American College of Rheumatology podcast as a 'true paradigm shift' in RA treatment, the SetPoint implant moves away from decades of reliance on pharmaceuticals, from gold salts to biologics. The FDA had granted it breakthrough designation last year to accelerate development and approval. The device represents an early example of bioelectronic medicine, which aims to control inflammation—a key factor in conditions including diabetes, heart disease, and cancer. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like This Could Be the Best Time to Trade Gold in 5 Years IC Markets Learn More Clinical trials are already exploring vagus nerve stimulation for inflammatory bowel disease in children, lupus, multiple sclerosis, and Crohn's disease. In a yearlong randomized controlled trial involving 242 patients with a sham-treatment group, over half of participants using the implant alone achieved remission or experienced disease improvement. Joint pain and swelling decreased by 60% and 63%, respectively. However, the device's long-term safety and effectiveness outside clinical trials remain unknown, and the FDA requires post-marketing monitoring. Experts warn that surgery for implants can carry a risk of serious infections resistant to antibiotics. For Dawn Steiner, a 58-year-old speech pathologist and clinical trial participant, the implant has been transformative. Diagnosed with RA 15 years ago, she tried eight biologic drugs with limited success. 'Before the implant, the doctor would ask where I was in terms of pain on a scale of one to 10, and I would say I was living a six or seven,' she said. 'Now I'm about a two.' Live Events The SetPoint device stems from decades of research led by Dr. Kevin J. Tracey, neurosurgeon and president of the Feinstein Institutes for Medical Research at Northwell Health. Tracey co-founded SetPoint Medical and now serves as an adviser. He describes the vagus nerve as an 'on-off switch' for an overactive immune system. 'The brain can turn off inflammation as long as the vagus nerve is intact,' he said. 'It's like a brake system in your car.' Dr. David Chernoff, chief medical officer of SetPoint Medical, explained, 'Drugs find a pathway that contributes to damaging joints in RA patients and try to block it. What we're doing is completely different. We're re-educating the immune system through the brain to behave differently.' He added, 'we're not blocking the ability to fight off infection.' Tracey noted that some inflammation is necessary for healing wounds, fighting infections, and tissue repair. The device's price has not been disclosed, but a spokeswoman said it is designed to last 10 years and could cost less than a year of certain RA medications. Dr. Lou Bridges, chief of rheumatology at the Hospital for Special Surgery and NewYork-Presbyterian/Weill Cornell Medical Center, expressed cautious optimism. 'It's still early days. The proof will be in the pudding,' he said. 'I'm hoping they are correct, and this is a revolutionary new way to treat RA without drugs and without side effects. But I've heard this story before.' [With TOI inputs]
Time of India
2 days ago
- Health
- Time of India
How a one-minute jolt can offer hope to those with auto-immune disease
The US Food and Drug Administration (FDA) approved a medical device recently that offers new hope to patients incapacitated by rheumatoid arthritis (RA), a chronic condition often resistant to treatment and usually managed with medications. The device represents a radical departure from standard care, tapping the power of the brain and nervous system to tamp down the uncontrolled inflammation that leads to the debilitating autoimmune disease. The SetPoint System is an inch-long device surgically implanted into the neck, where it sits in a pod wrapped around the vagus nerve, which some scientists believe is the longest nerve in the body. The device electrically stimulates the nerve for one minute each day. The stimulation can turn off crippling inflammation and 'reset' the immune system, research has shown. Most drugs used to treat rheumatoid arthritis suppress the immune system, leaving patients vulnerable to serious infections. On a recent episode of the American College of Rheumatology podcast, the SetPoint implant was described as a 'true paradigm shift' in treatment of the disease, which until now has relied almost entirely on an evolving set of pharmaceutical interventions, from gold salts to biologics. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like No annual fees for life UnionBank Credit Card Apply Now Undo The FDA designated the implant as a breakthrough last year to expedite its development and approval. It represents an early test of the promise of so-called bioelectronic medicine to modulate inflammation, which plays a key role in diseases including diabetes, heart disease and cancer. Clinical trials are already underway testing vagus nerve stimulation to manage inflammatory bowel disease in children, lupus and other conditions. Trials for patients with multiple sclerosis and Crohn's disease are also planned. In a yearlong randomised controlled trial of 242 patients that included a sham-treatment arm, over half of the participants using the SetPoint implant alone achieved remission or saw their disease recede. Measures of joint pain and swelling fell by 60% and 63% respectively. The device's long-term effectiveness and safety outside a clinical trial are not yet known. The FDA required post-marketing monitoring of patients and adverse events as part of the approval. Surgery involving implants can lead to serious infections resistant to antibiotics, experts noted. For Dawn Steiner, 58, a speech pathologist, who participated in the clinical trial, the implant has been a game changer. She was diagnosed with rheumatoid arthritis 15 years ago and has tried eight different biologic agents since then. 'Before the implant, the doctor would ask where I was in terms of pain on a scale of one to 10, and I would say I was living a six or seven,' she said. 'Now I'm about a two.' The SetPoint device is the product of decades of research spearheaded by Dr Kevin J Tracey, a neurosurgeon who is president and chief executive of the Feinstein Institutes for Medical Research at Northwell Health. Tracey co-founded SetPoint Medical, but now serves as an adviser. He describes the vagus nerve, which originates in the brain and travels to virtually all the organs of the body, as an 'on-off switch' for an overactive immune system. 'The brain can turn off inflammation as long as the vagus nerve is intact,' he said. 'It's like a brake system in your car.' Dr David Chernoff, chief medical officer of SetPoint Medical, said, 'Drugs find a pathway that contributes to damaging joints in RA patients and try to block it. What we're doing is completely different. We're re-educating the immune system through the brain to behave differently,' he added. As a result, he said, 'we're not blocking the ability to fight off infection.' The body needs some level of inflammation, Tracey said, to help heal wounds, fight infections and promote tissue repair. The price has not been disclosed, but a spokeswoman said it was designed to last for 10 years and would be less expensive than a year's worth of some rheumatoid arthritis drugs, which can be quite costly. One key question is whether the implant's effectiveness will wane over time, said Dr Lou Bridges, chief of the division of rheumatology at the Hospital for Special Surgery and NewYork-Presbyterian/Weill Cornell Medical Center. 'It's still early days. The proof will be in the pudding,' he said. 'I'm hoping they are correct, and this is a revolutionary new way to treat RA without drugs and without side effects. But I've heard this story before. ' nyt news service By: Dr David Chernoff, CMO, SetPoint Medical
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
