Amsterdam, Manhasset, NY and Valencia, CA – July 4, 2016 – Clinical trial data published in the Proceedings of the National Academy of Sciences (PNAS) demonstrates stimulating the vagus nerve along with an implantable bioelectronic device significantly improved measures of health problem activity in patients along with rheumatoid arthritis (RA). RA is a chronic inflammatory health problem that affects 1.3 million people in the United States and costs tens of billions of dollars annually to treat. The findings, announced by the Academic Medical Center/University of Amsterdam, the Feinstein Institute for Medical Research and SetPoint Medical, appear online in PNAS Early Edition and will certainly appear in an upcoming print issue.
The publication, titled “Vagus nerve stimulation inhibits cytokine production and attenuates health problem severity in rheumatoid arthritis,” highlights a human study made to reduce symptoms of RA, cytokine levels and inflammation by stimulating the vagus nerve along with a small implanted device.
“This is the initial study to evaluate whether stimulating the inflammatory reflex directly along with an implanted electronic device can easily handle RA in humans,” said Professor Paul-Peter Tak, MD, PhD, FMedSci, the worldwide principal investigator and lead author of the paper at the Division of Clinical Immunology & Rheumatology of the Academic Medical Center/University of Amsterdam. “We have actually previously revealed that targeting the inflammatory reflex might reduce inflammation in pet models and in vitro models of RA. The direct correlation between vagus nerve stimulation and the suppression of several essential cytokines adore TNF too as low RA signs and symptoms demonstrates proof of mechanism, which may be relevant for various other immune-mediated inflammatory diseases as well.”
“Our findings suggest a brand-new approach to fighting diseases along with bioelectronic medicines, which usage electrical pulses to handle diseases currently treated along with potent and relatively expensive drugs,” said Anthony Arnold, Chief Executive Officer of SetPoint Medical. “These outcomes support our ongoing improvement of bioelectronic medicines made to enhance the lives of people suffering from chronic inflammatory diseases and provide healthcare providers brand-new and potentially safer treatment replacements at a considerably reduced total cost for the healthcare system.”
“This is a genuine breakthrough in our ability to tips people suffering from inflammatory diseases,” said co-author Kevin J. Tracey, MD, president and CEO of the Feinstein Institute for Medical Research, discoverer of the inflammatory reflex and co-founder of SetPoint Medical. “While we’ve previously studied pet models of inflammation, until now we had no proof that electrical stimulation of the vagus nerve can easily indeed inhibit cytokine production and reduce health problem severity in humans. I believe this study will certainly adjustment the method we see modern medicine, assisting us already know that our nerves can, along with a little help, make the drugs that we should tips our physique heal itself.”
While focused on rheumatoid arthritis, the trial’s outcomes might have actually implications for patients suffering from various other inflammatory diseases, including Crohn’s, Parkinson’s, Alzheimer’s and others.
Study Methodology and Results
In the study, a stimulation device was implanted on the vagus nerve throughout a surgical procedure, after that activated and deactivated based on a set book to measure response over 84 days, along with primary endpoints measured at day 42 using DAS28-CRP, a standard health problem activity composite score for RA that involves counts of tender and swollen joints, patient’s and physician’s assessment of health problem activity and serum C-reactive healthy protein (CRP) levels.
Of 17 patients along with energetic RA in the study, several patients that had failed to respond to multiple therapies, including biologicals along with various mechanisms of action, demonstrated robust responses. The findings indicate that energetic electrical stimulation of the vagus nerve inhibits TNF production in RA patients and significantly attenuates RA health problem severity.
Several patients reported considerable improvements, including some that had previously failed to respond to any sort of various other form of pharmaceutical treatment. In addition, no major edge edge effects were reported.
The emerging field of bioelectronic medicine aims to target disorders traditionally treated along with drugs and rather uses advanced neuromodulation machines that might supply considerable advantages. SetPoint is producing a novel proprietary bioelectronic medicine platform to handle a number of immune-mediated inflammatory diseases, using an implanted device to stimulate the vagus nerve.
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About Academic Medical Focus at the University of Amsterdam
The Academic Medical Focus (AMC) is one of the foremost research institutions of the Netherlands too as one of the largest hospitals. The AMC complex houses the university hospital and the medical faculty of the University of Amsterdam, too the Netherlands Institute Neurosciences and, the medical department of the Royal Tropical Institute. In the coming years, a national Neuroimaging Focus will certainly arise alongside the AMC. Likewise a lot of biotech companies — partly AMC spin-offs — are located on the premises. This concentration of expertise makes the AMC a breeding ground for fruitful scientific collaboration. The AMC houses every one of medical specializations that are recognized in the Netherlands, and every one of types of top clinical patient care. http://www. amc. nl
About The Feinstein Institute for Medical Research
The Feinstein Institute for Medical Research is the research arm of Northwell Health, the largest healthcare provider in brand-new York. Residence to 50 research laboratories and to clinical research throughout dozens of hospitals and outpatient facilities, the 2,000 researchers and staff of the Feinstein are making breakthroughs in molecular medicine, genetics, oncology, brain research, mental health, autoimmunity, and bioelectronic medicine – a brand-new field of science that has actually the potential to revolutionize medicine. For a lot more guide Concerning exactly how we empower imagination and pioneer discovery, visit FeinsteinInstitute.org.
About SetPoint Medical
SetPoint Medical is a privately held biomedical technology business dedicated to treating patients along with debilitating inflammatory diseases using bioelectronic therapy. SetPoint’s approach is intended to supply patients and providers an alternative for the treatment of RA and various other chronic inflammatory diseases along with much less risk and cost compared to drug therapy. SetPoint’s therapy is being evaluated in an open-label clinical study for Crohn’s Disease.
SetPoint is producing a novel bioelectronic medicine platform consisting of an implantable miniature neuromodulation device and iPad prescription pad application. The implantable device stimulates the vagus nerve to activate the body’s natural inflammatory reflex, which is intended to develop a potent systemic anti-inflammatory effect. The business has actually published positive outcomes from a first-in-human open-label proof-of-idea trial in rheumatoid arthritis in Proceedings of the National Academy of Sciences (PNAS) and presented positive outcomes at the American College of Rheumatology. Current investors in the business contain Morgenthaler Ventures, Flare Capital Partners, Topspin Partners, Medtronic, GlaxoSmithKline’s Action Potential Venture Capital Limited and Boston Scientific. For a lot more information, visit http://www. setpointmedical. com.
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