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News Article | May 24, 2017

The News story ‘How Trump’s science cuts could hurt his supporters’ (Nature 545, 273–274; 2017) misstated the number of advanced manufacturing institutes funded by the US government — there are 14, not 9. The graphic also gave the funding amounts in US$ instead of millions of US$. The News Feature ‘The electric cure’ (Nature 545, 20–22; 2017) erroneously stated that Kevin Tracey initiated the first trial for vagus nerve stimulation in humans. In fact, the trial was started by SetPoint Medical. And Paul-Peter Tak, who ran the trial, first joined GlaxoSmithKline in 2011, not 2016.

News Article | April 21, 2017

The Food and Drug Administration approved on April 18 a handheld vagus nerve stimulation device for treating episodic cluster headaches. These “suicide headaches,” however, are only one among different chronic conditions that experts seek to address through the use of vagus nerve stimulation, which consists of sending a low electric pulse through the vagus nerve situated in the neck. In fact, a new report stated that increasing innovation in the field has led to greater knowledge of these VNS devices. For instance, patients that have resistance toward anti-epileptic drugs are being treated using the devices, while surgeons increasingly focus on minimizing the potential side effects of using the tools. GammaCore, the patient-administered handheld device for stimulating the vagus nerve, was developed by New Jersey-based neuroscience and technology firm ElectroCore. It transmits a mild electrical stimulation to the nerve through the skin, leading to pain reduction. “It does not have the side effects or dose limitations of commonly prescribed treatments or the need for invasive implantation procedures, which can be inconvenient, costly, and high-risk,” assured Dr. Stephen Silberstein, director of Jefferson University’s Headache Center in a statement. Long available in Europe, the device is applied to the neck during a headache. But while the FDA release was based on two trials, it is important to note that using the device could lead to mild, transient side effects. It should also be avoided by patients with active implantable medical devices; those with hypotension, hypertension, tachycardia (rapid heartbeat), or bradychardia (slow heartbeat); and children and pregnant women. Adjunctive vagus nerve stimulation, too, was shown to improve antidepressant effects among patients with treatment-resistant depression. “APA [American Psychiatric Association] recommends VNS as a treatment option for patients who have not responded to at least four adequate trials of depression treatments, including electroconvulsive therapy,” wrote Dr. Scott Aaronson and his colleagues. Patients who underwent VNS demonstrated improved clinical outcomes than those who received the usual treatment, including a significantly greater f-year cumulative response rate or 67.6 percent versus 40.9 percent. VNS therapy is used to help people overcome drug addiction, with the process consisting of helping the patient’s addicted brain adopt new behaviors and replace the ones linked to the need for drug intake. "When a subject is addicted to a drug, extinction is a method to help them relearn behaviors - so they are able to take different actions," said lead author and assistant professor Sven Kroener. The treatment aims to reinforce positive behavior as opposed to the drug-related one, placing the two types of behaviors in direct contradiction. When applied correctly, it could also decrease the relapse rates in drug-addicted individuals. Last year, a study found that rheumatoid arthritis patients who received VNS displayed “robust” responses. Researchers from the Feinstein Institute, SetPoint Medical, and the University of Amsterdam conducted a trial to see if a direct inflammatory reflex stimulation can minimize rheumatoid arthritis symptoms. Prior studies done on animals already showed great promise and success rates. Here, the team recruited 17 patients whose vagus nerve was surgically given a stimulation device, and then measured their response and progress for 42 days. Many of the patients whose previous rheumatoid arthritis treatments failed exhibited significant developments, according to the study. © 2017 Tech Times, All rights reserved. Do not reproduce without permission.

News Article | June 15, 2017

VALENCIA, Calif.--(BUSINESS WIRE)--SetPoint Medical, a clinical-stage biomedical technology company developing a bioelectronic therapy for chronic inflammatory diseases, announced today the appointment of David Chernoff, MD as Chief Medical Officer. Dr. Chernoff is a molecular diagnostics and biopharmaceutical industry veteran who has played pivotal roles in moving early stage R&D programs successfully through clinical development and product commercialization and evaluating a broad range of in-licensing opportunities. He will oversee all clinical development activities for SetPoint as the company continues to advance its bioelectronic medicine platform, reporting to Anthony Arnold, Chief Executive Officer of SetPoint Medical. “The depth and breadth of David’s expertise in advancing and commercializing a wide range of products make him an ideal fit for SetPoint,” said Anthony Arnold, Chief Executive Officer of SetPoint Medical. “With his combination of senior clinical leadership experience and key commercial perspective, David is uniquely qualified to lead our clinical team as we prepare for the next phase of clinical development using our new proprietary bioelectronic medicine therapy.” SetPoint is developing a novel proprietary bioelectronic medicine platform to treat a variety of inflammation-mediated autoimmune diseases, using an implanted device to stimulate the vagus nerve, activating the body’s natural Inflammatory Reflex to produce a systemic anti-inflammatory effect. The emerging field of bioelectronic medicine aims to address unmet patient needs by delivering digital doses to modulate physiological circuits to treat diseases historically treated with drugs in a more highly targeted fashion. “This is a tremendous opportunity to create an entirely new category of therapeutics designed to treat autoimmune diseases using the rapidly advancing technology of bioelectronic medicine,” said Dr. Chernoff. “SetPoint’s unique approach clearly establishes a novel path to meet the unmet needs of patients with chronic inflammatory diseases, and I look forward to becoming part of the SetPoint team poised to advance bioelectronic therapies and position the company for continued growth.” Prior to joining SetPoint, Dr. Chernoff has served as a translational medicine consultant to more than 40 biotechnology, pharmaceutical and medical device companies and has held chief medical officer posts with a number of companies, including Crescendo Bioscience, Adamas Pharma, XDX, CardioDX, Tethys Biosciences and Aquinox Pharma. Dr. Chernoff was Vice President of Corporate Technology at Elan Pharmaceuticals and Medical Director at Chiron Diagnostics, where he played a pivotal role in the development of viral load assays for HIV, HCV, HBV and CMV. He was a principal with life sciences management consulting firm Keelin Reeds Ventures and entrepreneur in residence and operating partner at TPG Biotech VC Fund. He received a Bachelor of Science degree in molecular biology from Yale University and an MD from New York University and completed his medical training and research in internal medicine, rheumatology and infectious disease at the University of California San Francisco Medical Center. He also served as Chief Resident in Internal Medicine at San Francisco General Hospital and Assistant Chief of Medicine at UCSF Medical Center. SetPoint Medical is a privately held biomedical technology company dedicated to treating patients with debilitating inflammatory diseases using bioelectronic therapy. SetPoint’s approach is intended to offer patients and providers an alternative for the treatment of rheumatoid arthritis (RA) and other chronic inflammatory diseases with less risk and cost than drug therapy. SetPoint is developing a novel bioelectronic medicine platform that stimulates the vagus nerve to activate the body’s natural Inflammatory Reflex, which is intended to produce a potent systemic anti-inflammatory effect. The company has published positive results from a first-in-human open-label proof-of-concept trial in rheumatoid arthritis in Proceedings of the National Academy of Sciences (PNAS) and presented positive results at the American College of Rheumatology meeting. Current investors in the company include Morgenthaler Ventures, NEA, Topspin Partners, Medtronic, GlaxoSmithKline’s Action Potential Venture Capital Limited and Boston Scientific. For more information, visit

News Article | November 13, 2015

With outposts in nearly every organ and a direct line into the brain stem, the vagus nerve is the nervous system’s superhighway. About 80 percent of its nerve fibers — or four of its five “lanes” — drive information from the body to the brain. Its fifth lane runs in the opposite direction, shuttling signals from the brain throughout the body. Doctors have long exploited the nerve’s influence on the brain to combat epilepsy and depression. Electrical stimulation of the vagus through a surgically implanted device has already been approved by the U.S. Food and Drug Administration as a therapy for patients who don’t get relief from existing treatments. Now, researchers are taking a closer look at the nerve to see if stimulating its fibers can improve treatments for rheumatoid arthritis, heart failure, diabetes and even intractable hiccups. In one recent study, vagus stimulation made damaged hearts beat more regularly and pump blood more efficiently. Researchers are now testing new tools to replace implants with external zappers that stimulate the nerve through the skin. But there’s a lot left to learn. While studies continue to explore its broad potential, much about the vagus remains a mystery. In some cases, it’s not yet clear exactly how the nerve exerts its influence. And researchers are still figuring out where and how to best apply electricity. “The vagus has far-reaching effects,” says electrophysiologist Douglas Zipes of Indiana University in Indianapolis. “We’re only beginning to understand them.” Anchored in the brain stem, the vagus travels through the neck and into the chest, splitting into the left vagus and the right vagus. Each of these roads is composed of tens of thousands of nerve fibers that branch into the heart, lungs, stomach, pancreas and nearly every other organ in the abdomen. This broad meandering earned the nerve its name — vagus means “wandering” in Latin — and enables its diverse influence. The nerve plays a role in a vast range of the body’s functions. It controls heart rate and blood pressure as well as digestion, inflammation and immunity. It’s even responsible for sweating and the gag reflex. “The vagus is a huge communicator between the brain and the rest of the body,” says cardiologist Brian Olshansky of the University of Iowa in Iowa City. “There really isn’t any other nerve like that.” The FDA approved the first surgically implanted vagus nerve stimulator for epilepsy in 1997. Data from 15 years of vagus nerve stimulation in 59 patients at one hospital suggest that the implant is a safe, effective approach for combating epilepsy in some people, researchers in Spain reported in Clinical Neurology and Neurosurgery in October. Twenty of the patients experienced at least 50 percent fewer seizures; two of those had a 90 percent drop in seizures. The most common side effects were hoarseness, neck pain and coughing. In other research, those effects often subsided when stimulation was stopped. Early on, researchers studying the effects of vagus stimulation on epilepsy noticed that patients experienced a benefit unrelated to seizure reduction: Their moods improved. Subsequent studies in adults without epilepsy found similar effects. In 2005, the FDA approved vagus nerve stimulation to treat drug-resistant depression. The vagus nerve detects inflammation or infection in the body and relays signals from the brain stem along its southbound fibers. This signal prompts other nerves to release norepinephrine, which makes immune T cells in the spleen release the chemical acetylcholine to depress inflammation via macrophages. Although many details about how stimulation affects the brain remain unclear, studies suggest that vagus stimulation increases levels of the neurotransmitter norepinephrine, which carries messages between nerve cells in parts of the brain implicated in mood disorders. Some antidepressant drugs work by boosting levels of norepinephrine. Silencing norepinephrine-producing brain cells in rats erased the antidepressant effect of vagus nerve stimulation, scientists reported in the Journal of Psychiatric Research in September. Vagus stimulation for epilepsy and depression attempts to target the nerve fibers that shuttle information from body to brain. But its fifth lane, which carries signals from brain to body, is a major conductor of messages controlling the body’s involuntary functions, including heart rhythms and gut activity. The nerve’s southbound fibers can also be a valuable target for stimulation. Around 15 years ago, scientists determined that the brain-to-body lane of the vagus plays a crucial role in controlling inflammation. While testing the effects of an anti-inflammatory drug in rats, neurosurgeon Kevin Tracey and his colleagues found that a tiny amount of the drug in the rats’ brains blocked the production of an inflammatory molecule in the liver and spleen. The researchers began cutting nerves one at a time to find the ones responsible for transmitting the anti-inflammatory signal from brain to body. “When we cut the vagus nerve, which runs from the brain stem down to the spleen, the effect was gone,” says Tracey, president and CEO of the Feinstein Institute for Medical Research in Manhasset, N.Y. Later research indicated that stimulating undamaged vagus fibers also had anti-inflammatory effects in animals. Vagus stimulation prompts release of acetylcholine, Tracey and colleagues reported in 2000. Acetylcholine, a neurotransmitter like norepinephrine, can prevent inflammation. In 2011, rheumatologist Paul-Peter Tak, of the University of Amsterdam, and his colleagues implanted vagus nerve stimulators into four men and four women who had rheumatoid arthritis, an autoimmune inflammatory condition that causes swollen, tender joints. After 42 days of vagus stimulation — one to four minutes per day — six of the eight arthritis patients experienced at least a 20 percent improvement in their pain and swelling. Two of the six had complete remission, the researchers reported at an American College of Rheumatology conference in 2012. “From a scientific perspective, it’s an extremely exciting result,” says Tak, who is also a senior vice president at GlaxoSmithKline pharmaceuticals based in Stevenage, England. Despite advances in treatments over the last two decades, rheumatoid arthritis patients need better options, he says. In 2014, Tak and his colleagues reported that vagus stimulation reduced inflammation and joint damage in rats with arthritis. After a week of once-daily, minute-long stimulation sessions, swelling in the rats’ ankles shrank by more than 50 percent, the scientists reported in PLOS ONE. If these results hold up in future studies, Tak hopes to see the procedure tested in a range of other chronic inflammatory illnesses, including inflammatory bowel disorders such as Crohn’s disease. Studies in animals have shown promise in this area: In 2011, researchers reported in Autonomic Neuroscience: Basic and Clinical that vagus stimulation prevented weight loss in rats with inflamed colons. Treating inflammatory conditions with vagus stimulation is fundamentally different from treating epilepsy or depression, Tak says. More research with patients will be necessary to develop the technique. “We are entering a completely unknown area, because it’s such a new approach,” he says. There could be financial hurdles as well, he says. But GlaxoSmithKline, which Tak joined after initiating the arthritis study, has purchased shares of SetPoint Medical, a company in Valencia, Calif., that produces implantable vagus nerve stimulators, Tak says. As he and others put stimulation to the test for inflammation, some scientists are attempting to see if manipulating the nerve can help heal the heart. The vagus nerve has profound control over heart rate and blood pressure. Patients with heart failure, in which the heart fails to pump enough blood through the body, tend to have less active vagus nerves. Trying to correct the problem with electrical stimulation makes sense, says Michael Lauer, director of the cardiovascular sciences division at the National Heart, Lung and Blood Institute in Bethesda, Md. “It’s a great idea.” Yet so far, results from studies on the effects of vagus stimulation on heart failure have been inconsistent. In 2011, researchers reported in the European Heart Journal that repeated vagus nerve stimulation improved quality of life and the heart’s blood-pumping efficiency in heart failure patients. A vagus stimulation trial of heart failure patients in India published in the Journal of Cardiac Failure in 2014 echoed these results. After six months of therapy, the patients’ left ventricles pumped an average of 4.5 percent more blood per beat. Last August, however, researchers reported that a six-month clinical trial of vagus stimulation failed to improve heart function in heart failure patients in Europe. This study had the most participants — 87 — but used the lowest average level of electrical stimulation. “All the results thus far are preliminary. The studies that have been finished to date are relatively small,” Lauer says. “But there certainly are promising findings that [suggest] we may be barking up the right tree.” Another group of scientists is testing more intense vagus stimulation for patients with heart failure. The trial, called INOVATE-HF, is funded by the Israeli medical device company BioControl Medical and uses a higher level of electrical current than the European study that showed no measurable improvements. “If you try to lower blood pressure and you take a quarter of a pill instead of one pill, blood pressure won’t change,” says cardiologist Peter Schwartz of the IRCCS Istituto Auxologico Italiano in Milan. It’s equally important to use the right dose of vagus stimulation, he says. The new trial is also much larger than earlier studies, with more than 700 patients enrolled internationally. Results are expected by the end of 2016. Vagus manipulation isn’t limited to heart failure research. It’s also being tried in atrial fibrillation, in which the heart flutters erratically. “When it flutters, it doesn’t really push blood very efficiently,” says clinical electrophysiologist Benjamin Scherlag of the University of Oklahoma in Oklahoma City. Atrial fibrillation is common in people over age 60, Scherlag says, and can ultimately lead to blood clots and strokes. Treatments include drugs that alter heart rhythm or thin the blood, but they don’t work for all patients and some have nasty side effects, Scherlag says. In the lab, scientists can use high-intensity vagus stimulation to alter heart rhythm and induce atrial fibrillation in animals. But milder stimulation that alters heart rate only slightly, if at all, can actually quell atrial fibrillation, animal studies and one human study show. Vagus stimulation for atrial fibrillation is still in its infancy, and clinical applications haven’t been adequately tested, says Indiana’s Zipes. “Nevertheless, the concept bears looking into.” In patients with atrial fibrillation (AF), stimulating the vagus through the right ear (blue) decreased the length of heart fluttering episodes. With no stimulation (red), episodes did not shorten. At intensities so low they didn’t cause any perceptible change in heart rate, vagus stimulation controlled atrial fibrillation in dogs, Scherlag and colleagues reported in 2011. In 20 people receiving surgery for atrial fibrillation, low-level vagus stimulation reduced the duration of heart fluttering episodes from an average of 16.7 minutes to an average of 10.4 minutes, Scherlag and his colleagues reported in the Journal of the American College of Cardiology in March. In their study, Scherlag and his colleagues didn’t implant a nerve stimulator. In fact, they didn’t directly contact the nerve at all. They accessed tendrils of the vagus through the skin of their patients’ ears. Other researchers are also testing devices that stimulate the nerve without surgery. “Vagal nerve stimulation is very nice, but in order to get to the vagus nerve … you have to cut down surgically,” Scherlag says. “This is not the kind of thing you want to do, except under extreme situations.” But in the ear, tiny fingers of the vagus’s fibers run close to the surface of the skin, primarily under the small flap of flesh, the tragus, that covers the ear’s opening. Studies have explored using stimulation of those fibers through the skin of the ear to treat heart failure, epilepsy and depression, as well as memory loss, headaches and even diabetes — a reflection of the nerve’s control over a variety of hormones in addition to acetylcholine and norepinephrine. Stimulating the vagus nerve through the ear of diabetic rats lowered and controlled blood sugar concentrations, researchers from China and Boston reported in PLOS ONE in April. The stimulation prompted the rats’ bodies to release the hormone melatonin, which controls other hormones that regulate blood sugar. Ear-based vagus stimulation appeared to improve memory slightly in 30 older adults in the Netherlands. After stimulation, study subjects were better able to recall whether they had been shown a particular face before, says study coauthor Heidi Jacobs, a clinical neuroscientist at Maastricht University in the Netherlands. The researchers, who reported the work in the May Neurobiology of Aging, plan to investigate whether these effects last over time and exactly how the stimulation affects the brain, Jacobs says. The ear isn’t the only nonsurgical target. The company electroCore, based in Basking Ridge, N.J., manufactures a small, handheld device that can stimulate the vagus when placed on the throat. The company initially tested the devices to reduce asthma symptoms — relying on the nerve’s anti-inflammatory action. But during testing, patients reported that their headaches were disappearing, says J.P. Errico, CEO of electroCore. Now, the company is investigating the use of an electroCore device to treat chronic cluster headaches, severe headache attacks that can come and go for over a year. People suffering from an average of 67.3 cluster headaches each month experienced around four fewer attacks per week on average when using the device along with standard treatments like drugs, researchers reported in Cephalalgia in September. Several researchers have reservations about skin-deep stimulation. “The advantages of the handheld devices are that there’s no surgery required,” says Feinstein Institute’s Tracey, who is a founder and consultant for implant maker SetPoint Medical. But patient compliance becomes an issue. “Patient compliance with anything, whether it’s swallowing a pill or holding a device, is notoriously difficult,” he says. If a stimulator is implanted, a patient can forget about it, Tak agrees. He and Tracey both predict that implants will soon become smaller and safer. Even for depression and epilepsy, Tak says, researchers still need to figure out the best ways of stimulating the vagus — exactly where to place a device, and how much of a shock to deliver. The nerve’s multitasking, two-way nature makes it a challenge to fully understand and control. It’s hard to know exactly what you’re zapping when you stimulate the vagus nerve, says physiologist Gareth Ackland of University College London. He compares vagus stimulation to flipping on a light switch in one room of a house and discovering that this endows other rooms in the house with magical powers. “I’m not sure which room it’s going to happen in, I’m not sure for how long and I’m not sure if, after a while, it’s going to work or not,” he says. The intensity of electrical current, duration of stimulation and each patient’s health status could all affect the results of a vagus stimulation trial, Ackland says. And it’s possible that a widespread effect, such as suppressing inflammation caused by the immune system, could even be harmful to some patients. Ackland says that he and his colleagues agree that the vagus nerve is important. And he’s not ready to discount vagus stimulation as a potential therapy for conditions such as heart failure. But he warns that there’s a good deal of biology left to understand. “There’s an awful lot of basic science and basic clinical research that is needed before launching into a variety of potential interventions,” he says. For Tracey, it’s about way more than the vagus. “Nobody should overpromise that the vagus nerve is the secret to everything,” he says. But with a better map of the body’s nerves and their functions, the lessons learned by studying the vagus could inform future therapies that use nerve stimulation, he says. If researchers can understand and manipulate a particular circuit in a nerve that controls a specific molecule — for example, a protein involved in pain or even cell division — they could zero in on crucial targets. “The promise,” he says, “is for tremendous precision.” This article appears in the November 28, 2015, issue of Science News with the headline, "Waking the Vagus."

News Article | November 16, 2016

— The report provides comprehensive information on the pipeline products with comparative analysis of the products at various stages of development. The report reviews major players involved in the pipeline product development. It also provides information about clinical trials in progress, which includes trial phase, trial status, trial start and end dates, and, the number of trials for the key Vagus Nerve Stimulators pipeline products. This report is prepared using data sourced from in-house databases, secondary and primary research by team of industry experts. Scope - Extensive coverage of the Vagus Nerve Stimulators under development - The report reviews details of major pipeline products which includes, product description, licensing and collaboration details and other developmental activities - The report reviews the major players involved in the development of Vagus Nerve Stimulators and list all their pipeline projects - The coverage of pipeline products based on various stages of development ranging from Early Development to Approved / Issued stage - The report provides key clinical trial data of ongoing trials specific to pipeline products - Recent developments in the segment / industry The report enables you to - - Formulate significant competitor information, analysis, and insights to improve R&D strategies - Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage - Identify and understand important and diverse types of Vagus Nerve Stimulators under development - Develop market-entry and market expansion strategies - Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline - In-depth analysis of the product’s current stage of development, territory and estimated launch date Table of Contents 1 Table of Contents 2 1.1 List of Tables 4 1.2 List of Figures 6 2 Introduction 7 2.1 Vagus Nerve Stimulators Overview 7 3 Products under Development 8 3.1 Vagus Nerve Stimulators - Pipeline Products by Stage of Development 8 3.2 Vagus Nerve Stimulators - Pipeline Products by Territory 9 3.3 Vagus Nerve Stimulators - Pipeline Products by Regulatory Path 10 3.4 Vagus Nerve Stimulators - Pipeline Products by Estimated Approval Date 11 3.5 Vagus Nerve Stimulators - Ongoing Clinical Trials 12 4 Vagus Nerve Stimulators - Pipeline Products under Development by Companies 13 4.1 Vagus Nerve Stimulators Companies - Pipeline Products by Stage of Development 13 4.2 Vagus Nerve Stimulators - Pipeline Products by Stage of Development 14 5 Vagus Nerve Stimulators Companies and Product Overview 15 5.1 BioControl Medical Company Overview 15 5.1.1 BioControl Medical Pipeline Products & Ongoing Clinical Trials Overview 15 5.2 Boston Scientific Corporation Company Overview 17 5.2.1 Boston Scientific Corporation Pipeline Products & Ongoing Clinical Trials Overview 17 5.3 CerboMed GmbH Company Overview 21 5.3.1 CerboMed GmbH Pipeline Products & Ongoing Clinical Trials Overview 21 5.4 Cerebral RX Ltd. Company Overview 22 5.4.1 Cerebral RX Ltd. Pipeline Products & Ongoing Clinical Trials Overview 22 5.5 Cyberonics, Inc. Company Overview 23 5.5.1 Cyberonics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 23 5.6 DuoCure Ltd. Company Overview 27 5.6.1 DuoCure Ltd. Pipeline Products & Ongoing Clinical Trials Overview 27 5.7 ElectroCore, LLC Company Overview 28 5.7.1 ElectroCore, LLC Pipeline Products & Ongoing Clinical Trials Overview 28 5.8 LivaNova PLC Company Overview 34 5.8.1 LivaNova PLC Pipeline Products & Ongoing Clinical Trials Overview 34 5.9 Medical University of South Carolina Company Overview 40 5.9.1 Medical University of South Carolina Pipeline Products & Ongoing Clinical Trials Overview 40 5.10 MicroTransponder Inc. Company Overview 42 5.10.1 MicroTransponder Inc. Pipeline Products & Ongoing Clinical Trials Overview 42 5.11 Neurostream Technologies G.P. (Inactive) Company Overview 49 5.11.1 Neurostream Technologies G.P. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 49 5.12 Purdue University Company Overview 51 5.12.1 Purdue University Pipeline Products & Ongoing Clinical Trials Overview 51 5.13 Setpoint Medical Corp Company Overview 52 5.13.1 Setpoint Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 52 5.14 Trifectas Medical Corp. Company Overview 56 5.14.1 Trifectas Medical Corp. Pipeline Products & Ongoing Clinical Trials Overview 56 6 Vagus Nerve Stimulators- Recent Developments 57 6.1 Oct 26, 2016: Boston Scientific Announces Results For Third Quarter 2016 57 6.2 Oct 19, 2016: SetPoint Medical Presents Positive Clinical Results in Crohn’s Disease 58 For more information, please visit

News Article | July 7, 2016

Zika Virus - What You Should Know Ticked Off! Here's What You Need To Know About Lyme Disease A new study has found that rheumatoid arthritis patients who received vagus nerve stimulation showed "robust" responses. The treatment involved an implantation of a device designed to stimulate the vagus nerve. The experiment was conducted at the Feinstein Institute for Medical Research. In this autoimmune disease, the immune system attacks the joints. While the actual cause of rheumatoid arthritis remains unknown, treatments are designed to stop the resulting inflammations, which then relieves the symptoms, reduces long-term difficulties and prevents severe injury. A team of researchers from the Feinstein Institute, SetPoint Medical and the University of Amsterdam conducted a study to see if a direct inflammatory reflex stimulation can reduce rheumatoid arthritis symptoms. Prior studies of the method conducted on animals already showed success rates. The findings of the recent experiment showed that the method could also work in humans. Moreover, the treatment concept can be effective in treating other forms of inflammatory diseases. Feinstein Institute president and CEO Kevin Tracey said that the study is a "real breakthrough" in the ability to help patients with inflammatory diseases. Tracey added that until the study, there was no evidence that electrically stimulating the vagus nerve can prevent the production of cytokine and reduce the disease's severity in human patients. The findings can change the way the scientific and medical communities see modern medicine and deepen our understanding of what the nerves can do. For instance, with a little help, the nerves can make the "drugs" needed to help the body repair itself. For the study, the research team enrolled 17 patients whose vagus nerve was surgically given a stimulation device. Working on a schedule, the implanted device activated and deactivated the vagus nerve for a total of 84 days. The rate of response and progress were measured for 42 days. The patient's response to the stimulation device was measured using the standard DAS28-CRP scoring system, which includes measurements for swollen and tender joints, levels of serum C-reactive protein (CRP) as well as the evaluations made by both patients and physicians. The research team noted there were no dangerous side effects documented in any patient. Moreover, many of the patients whose previous treatments failed showed significant developments. "Our findings suggest a new approach to fighting diseases with bioelectronic medicines," said SetPoint Medical chief executive officer Anthony Arnold. The new method makes use of electrical pulses to treat medical conditions that are currently using strong and costly drugs. The findings were published in the journal Proceedings of the National Academy of Sciences. © 2017 Tech Times, All rights reserved. Do not reproduce without permission.

Zitnik R.J.,SetPoint Medical
Cleveland Clinic Journal of Medicine | Year: 2011

Implantable medical devices are finding increasing use in the treatment of diseases traditionally targeted with drugs. It is well established that the cholinergic antiinflammatory pathway serves as a physiological regulator of inflammatory responses, but stimulation of this pathway therapeutically by electrical stimulation of the vagus nerve can also diminish excessive or dysregulated states of inflammation. Recent data from a wide variety of animal models, as well as evidence of reduced vagal tone in rheumatoid arthritis and other inflammatory diseases, support the rationale for, and feasibility of, developing implantable vagal nerve stimulation devices to treat chronic inflammation in humans.

Olofsson P.S.,Feinstein Institute for Medical Research | Rosas-Ballina M.,University of Basel | Levine Y.A.,SetPoint Medical | Tracey K.J.,Feinstein Institute for Medical Research
Immunological Reviews | Year: 2012

Neural reflex circuits regulate cytokine release to prevent potentially damaging inflammation and maintain homeostasis. In the inflammatory reflex, sensory input elicited by infection or injury travels through the afferent vagus nerve to integrative regions in the brainstem, and efferent nerves carry outbound signals that terminate in the spleen and other tissues. Neurotransmitters from peripheral autonomic nerves subsequently promote acetylcholine-release from a subset of CD4 + T cells that relay the neural signal to other immune cells, e.g. through activation of α7 nicotinic acetylcholine receptors on macrophages. Here, we review recent progress in the understanding of the inflammatory reflex and discuss potential therapeutic implications of current findings in this evolving field. © 2012 John Wiley & Sons A/S.

Described herein are methods and systems for applying extremely low duty-cycle stimulation sufficient to treat chronic inflammation. In particular, described herein are single supra-threshold pulses of electrical stimulation sufficient to result in a long-lasting (e.g., >4 hours, greater than 12 hours, greater than 24 hours, greater than 48 hours) inhibition of pro-inflammatory cytokines and/or effects of chronic inflammation. These methods and devices are particularly of interest in treatment of inflammatory bowel disease (IBD).

SetPoint Medical | Date: 2014-04-10

Devices, systems and methods for the treatment of chronic inflammatory disorders that include an implantable microstimulator and an external charger/controller wherein the controller is configured to operate using closed-loop feedback.

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