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 | July 31, 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 Terry Bevirt as Vice President of Clinical Affairs. Ms. Bevirt brings more than 20 years of leadership experience in clinical research operations for pharmaceutical and biotechnology companies that range from large multinationals to startups. At SetPoint, Ms. Bevirt will oversee clinical programs as the company advances its bioelectronic medicine approach for inflammatory diseases including rheumatoid arthritis and Crohn’s disease. She will report to Anthony Arnold, Chief Executive Officer of SetPoint Medical. “SetPoint is pleased to welcome Terry, whose senior leadership expertise and successful history running pivotal clinical trials will be crucial to us as we conduct clinical trials with our new proprietary bioelectronic medicine device,” said Anthony Arnold, Chief Executive Officer of SetPoint Medical. “Terry will work closely with our new Chief Medical Officer and other team leaders that make up a capable clinical team and ideally position SetPoint to develop and execute our clinical strategy through commercialization.” 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 targeted fashion. Prior to joining SetPoint, Ms. Bevirt was Senior Director, Head of Clinical Operations at Armagen, where she managed operational strategy, study design feasibility, and the successful execution of clinical trials. Prior, she served as Therapeutic Area Planning and Operations Director at Amgen, where she provided strategic leadership and direction for study operations staff of 25, and she earlier held several other key clinical positions. Prior to Amgen, she held positions with Pharmacia, Affiliated Research Centers and Abbott Laboratories. She holds a B.S. in Medical Technology from the University of Wisconsin at Milwaukee and is a Certified Clinical Research Associate. About SetPoint Medical 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 treatment for 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 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 www.setpointmedical.com.
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 | 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 www.setpointmedical.com.
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 http://www.wiseguyreports.com
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.
SetPoint Medical | Date: 2012-05-09
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.