NEW YORK, NY, USA, November 8, 2019 /EINPresswire.com/ — Evoke Neuroscience, a medical device company developing and commercializing technologies...
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The eVox system is a Class II medical device that has received Section 510(K) clearance from the FDA. It is intended for the acquisition, display, and storage, of electrical activity of a patient’s brain including electroencephalograph (EEG) and event-related potentials (ERP) obtained by placing two or more electrodes on the head to aid in diagnosis.
Evoke Neuroscience has been recognized as one of America’s fastest growing private companies. Market leader in brain assessment and training, Evoke has been honored by Inc. magazine’s prestigious Inc 500|5000 list for two consecutive years.
Evoke Neuroscience recognized as key innovator in advancing transformative technology for mental wellbeing. Focused on improving human health, starting with the brain, Evoke was featured in the TransTech200 list that highlights pivotal innovators, scientists, and entrepreneurs who are expanding the known limits of human thriving.
Evoke Neuroscience is an FDA Registered Establishment and is compliant with all FDA standards, meaning that all of our business policies, procedures, and products align with the FDA and are subject to FDA audits. In addition, our facility goes through a rigorous and ongoing auditing process and is certified by BSI (ISO 13485).
Evoke Neuroscience neurotechnology patent strength ranked #72 in the world.
Finally, you have the tool you need to objectively assess patients with memory loss and cognitive impairment. The eVox System facilitates the collection of data that may be helpful to physicians in early detection of cognitive diseases, potentially leading to early intervention and positive outcomes. The eVox System includes a portable workstation with a 24-channel amplifier, software, testing and therapy supplies.
Stress is a significant contributor to many diseases, including depression, anxiety, weight gain, and sleep difficulties. Reducing stress can be an important part of a treatment plan. The Evoke WAVEBAND is an innovative tool to help patients maintain or improve their overall wellness in the comfort of their own home. WAVEBAND is an app-powered heart rate variability (HRV) training tool to optimize overall health, fitness, and energy levels. WAVEBAND includes a lightweight armband that attaches easily to the wrist, WAVEBAND sensor, and charging station. It pairs with the Evoke HRV training Mindja app and helps patients synchronize their brain and heart functions in order to improve physical and mental performance and enhance resilience to everyday stressors.
Introducing our latest R&D project, the Evoke WAVE, the complete brain monitoring and training system. Evoke Neuroscience puts rock-solid neuroscience technologies at your fingertips to help relax your mind, increase your focus, and improve your cognitive fitness.
Dr. David Hagedorn is experienced in clinical health psychology and neuropsychology and serves as an international neuroscience and biofeedback research consultant and instructor.
Dr. Hagedorn has master’s degrees in both Applied Behavior Analysis and Clinical Psychology, with a graduate specialty in Gerontology. He also has a doctoral degree in Clinical Psychology, with an additional Health Psychology Doctoral Certificate and postdoctoral training in neuropsychology. Dr. Hagedorn is Board Certified by the Biofeedback Certification International Alliance as an electroencephalography biofeedback practitioner. He is a recognized leader in the clinical neuroscience field with expertise in EEG and ERP acquisition, QEEG analysis, and brain computer interface (BCI) and portable peripheral biofeedback methods.
Eileen Sukumaran is a seasoned operations executive with 18 years of specialized experience in the FDA regulated medical device industry.
Ms. Sukumaran is experienced working with start-ups in developing operational strategies, identifying regulatory risks and executing infrastructure frameworks.
Prior to joining Evoke Neuroscience, Ms. Sukumaran served as Director of Operations for Nephros Inc, a publicly-traded medical device company. She worked to transition the company from R&D to a commercial manufacturer bringing multiple FDA cleared products and military-grade products to market. She also served as operation project director for the Chairman's Office, Department of Surgery at Columbia University Medical Center (NYPH). Ms. Sukumaran is a graduate of Hunter College with a Bachelor of Arts degree in Political Science and Philosophy.
Dr. James Thompson holds both a master’s degree and a doctorate degree in Kinesiology (specializing in sports-related brain injury) and Psychophysiology from Pennsylvania State University. He also holds a Bachelor of Science degree in Human Kinetics (Athletic Training and Rehabilitation). He is a Certified Kinesiologist with the Canadian Kinesiology Association, board certified in Neurofeedback, and is an Associate Fellow of the Biofeedback Certification International Alliance.
Dr. Thompson has worked with many high-level athletic programs to improve neuro-safety and cognitive performance. These programs include Penn State ‘Nittany Lions football, hockey and rugby programs; the Bermuda National Junior Sailing Team; the Japanese Youth Curling Team; Canadian Junior Alpine skiers; and the Canadian Provincial Sailing teams. He also provided EEG consultation services to champion football clubs AC Milan and Chelsea Football Club.
Dr. Thompson has been an invited speaker at international conferences in the United States, Canada, Mexico, and Europe. He has also published articles and book chapters in the areas of EEG, traumatic brain injury, sports-related concussions, and peak performance and biofeedback.
Dr. Nicole Hagedorn is a graduate of the United States Military Academy at West Point where she earned the title of Commissioned Officer in the U.S. Army. She is also a graduate of the Michigan State University College of Osteopathic Medicine.
Dr. Hagedorn holds a certificate from the American Board of Osteopathic Obstetricians and Gynecologists (FACOOG) and has been in medical practice since 1998. She also holds advanced certifications from the American Board of Anti-Aging & Regenerative Medicine (ABAARM) and the American College of Anti-Aging Sports Medicine Professionals (ACASP). She is an expert in scientific bio-identical hormone applications and functional integrative medicine.
Marinela Gombosev is President and CEO of Evoke Neuroscience, a medical diagnostic technology company that has twice been ranked in the Inc. 500|5000 fastest growing private companies. Evoke develops diagnostic technology that aids physicians in diagnosis of memory loss, Alzheimer's, dementia and other cognitive disorders. Marinela Gombosev has nearly 15 years of leadership experience scaling operations, product development and execution of marketing strategies in regulated industries. Previously, Ms. Gombosev was at BIT Group where she led cross-functional teams on a product development effort of a Class II medical diagnostic device in preparation for global commercial launch.
Marinela earned a Master of Business Administration from Pepperdine University and a Bachelor of Science in Electrical Engineering from the University of California, Irvine, where she was named Engineer of the Year at the Henry Samueli School of Engineering.
In 2013, Ms. Gombosev was honored as one of the leading business people in OC METRO magazine's "Hot 25" list of influential leaders and innovators. Ms. Gombosev has been inducted into the University of California, Irvine School of Engineering Hall of Fame for her professional achievements and service to the community.
John Armstrong has 25 years of experience in various sales and marketing roles. Prior to joining Evoke Neuroscience, Mr. Armstrong served as Senior Vice President of Commercial Operations at Bentlin Products. He also served as Senior National Sales Director/Head of Sales at Accera, Inc., where he was responsible for leading the sales, training, and sales operations teams in the Alzheimer’s disease franchise. Mr. Armstrong has also worked at Bristol-Myers Squibb in a variety of sales leadership, sales, sales training, and marketing roles that focused on selling pharmaceutical products to doctors, hospitals, and clinics. Mr. Armstrong is a graduate of the University of Florida with a Bachelor of Arts degree in Political Science, and served in the United States Navy as a Cryptologist for four years.
Dr. Michael A. Repucci received a Ph.D. in neuroscience in 2004 from the Weill Graduate School of Medical Science at Cornell University for work on the nonlinear dynamics in the visual system. He has worked in the field of EEG data analysis since 1999, In his graduate work, he received extensive training in experimental and computational techniques, and significant experience in software design and development. In his subsequent work in several research laboratories and as an independent scientific consultant, he gained further experience in software development and statistical analysis, from work in finance on trading strategies to lead developer on the Spike Train Analysis Toolkit. He has created tools for scientific research with languages including C/C++/C#, Java, Matlab, and Python. In his recent work, he leveraged this strong background in neuroscience, computational methods, and software development to guide the design and implementation of novel brain-computer interface technologies at Neuromatters, and now leads the software development of the flagship QEEG and neurofeedback platform, the eVox System, at Evoke Neuroscience.
Gordon Smith has been a leader of technology organizations for over two decades. His experience includes technology staff and infrastructure management, software design and development, systems analysis, and project management. Mr. Smith is experienced in delivering intellectual property and infrastructure for startups, growing firms, and multinational corporations. Mr. Smith has worked at and performed consulting services for Goldman Sachs, Merrill Lynch, The New York Stock Exchange, and Towers Watson. He was also a member of the board of directors of Members Alliance Insurance.
Dr. Felipe Fregni is the Director of the Laboratory of Neuromodulation at Spaulding Rehabilitation Hospital and Associate Professor of Neurology and Physical Medicine and Rehabilitation at Harvard Medical School. His research is focused on understanding neuroplastic changes associated with conditions such as chronic pain, Parkinson’s disease, and stroke, using non-invasive brain stimulation as an investigative tool for such aims.
Dr. John Polich is dedicated to developing event-related brain potentials (ERPs) and other neuroelectric measures for the assessment of human cognition. His current research focuses on assessing the acute and chronic effects of drug use, neurologic disorders, and basic information processes studies on frontal lobe function.
Dr. Pamela Hyde is a Board Certified by the American Board of Osteopathic Obstetricians and Gynecologists (FACOOG) as well as Anti-Aging and Regenerative Medicine holding the distinction of Advanced Fellow. With a BS from the University of Maryland in Nutrition Research, Dr. Hyde continues the pursuit of health and wellness and is enrolled in the University of South Florida Master’s Degree in Medical Sciences with a Concentration in Metabolic & Nutritional Medicine. After her Active Duty Military commitment, Dr. Hyde moved to southwest Oklahoma in January 2001; and continues as an Active Reservist in the U.S. Air Force. Dr. Hyde has always had a passion for the underserved and has severed on humanitarian missions to Nicaragua and Afghanistan. She is active in the community giving seminars on Healthy lifestyle, Disease Prevention, Stress Reduction, and Hormone Replacement.
Dr. David Haase is board certified in Family Medicine and Integrative Holistic Medicine and is an IFM Certified Functional Medicine Practitioner. Dr. Haase is a recognized expert in the field of non-invasive brain assessment and advanced neuro-performance. He created the QEEG and neurofeedback section of the first US Medical School sponsored Brain Health certification program. He teaches physicians internationally about how the brain is the center of Quality of Life, and a better understanding of the brain is the key to improve patient outcomes.
Dr. Dirk de Ridder is the Neurological Foundation Chair of Neurosurgery at the University of Otago in New Zealand. In his clinical capacity, Dr. Ridder is responsible for skull base surgery, and microvascular decompression surgery. His research interests are centered on a Darwinian predictive brain model with Bayesian updating to adapt to an ever changing environment. This model is the basis to understand common pathophysiological mechanisms clustering groups of pathologies, such as thalamocortical dysrhythmias (pain, tinnitus, epilepsy, depression, Parkinson's disease, schizophrenia) or obsessive compulsive spectrum disorder (such as addiction, OCD, or eating disorders).
Evoke Neuroscience was honored by The Silicon Review as one of the 50 most valuable brands of the year for its commitment to introduce trusted technology into everyday patient care. Thanks to Evoke, physicians across the country have integrated into their medical practice the most advanced and easiest to use medical neuroscience system, developed by doctors for doctors.
Peter E. Raymond has spent the last two decades solving problems, by combining emerging technology with design and innovative, yet robust business models. His award-winning work in health care has spanned the globe, and he was selected to develop the Bill and Melinda Gates Foundation's global communications strategy as Warren Buffet's gift was endowed.
Raymond has developed the world's first clinically accurate NYHA biometric heart failure simulation for Astra Zeneca to educate cardiologists, and help them diagnose and intervene earlier in heart failure patients. For several years, he was profiled by Apple, for this groundbreaking medical invention and he has also developed immersive simulations for MS, bipolar, and Alzheimer's.
In late 2016, in recognition of his extensive work across Cognitive AI, IoT, and business leadership, IBM conferred upon Raymond the Platinum Entrepreneur Award, their highest level of the IBM "Global Entrepreneurship Program".
He was a Senior Fellow at Thomas Jefferson University School of Population Health, working on population health behaviors, encoding the physical exam to AI, clinician empathy, developing biometrically enabled medical devices, and immersive disease simulation for continuing medical education.
A serial entrepreneur, Raymond has founded and sold multiple ventures, including a biometric sports training company for Olympic and professional athletes, a vehicle data analytics platform to Nissan in 2012, and most recently, exiting his last startup, HCS, to Wall Street investors.
Dr. Morgan Ingemanson holds a doctorate degree in Anatomy and Neurobiology and has specialty training in functional neuroimaging. She has led clinical trials focused on neural repair after central nervous system injury in humans, utilizing tools including anatomical brain imaging, functional MRI, dense-array EEG, and transcranial magnetic stimulation (TMS). In her doctoral work at University of California, Irvine, a major emphasis was placed on translating new drugs and devices to reduce disability after CNS injury, and on individualizing therapy for each patient’s needs. At Evoke Neuroscience, Dr. Ingemanson is the leading expert in computational EEG/ERP neuroimaging biomarkers and is the Principal Investigator for ongoing Research & Development efforts.
Dane has served as the Company’s Chief Commercial Officer since December of 2019. Dane is a seasoned senior sales and marketing executive with over 25 years of experience in the medical device industry. Dane has held senior management positions in a variety of medical device firms, including LabCorp, Alsius/ZOll, GE Healthcare, Philips and has spent over a decade growing sales at industry leader KCI/Acelity. He was VP of Sales & Marketing at Spiracur, commercializing a disruptive disposable Negative Pressure Wound Therapy device, which was sold to KCI/Acelity in December of 2015.
Dane’s innovative leadership style has facilitated the development of high performing sales, clinical, service and marketing teams throughout his career. These teams have ranged in size from 10 individuals to 100+ and the associated revenue growth has ranged from $5M to $250M plus. Dane also brings with him strategic planning and Marketing development experience in to the Hospital, Physician, Managed Care, Clinical Trials, Skilled Nursing, and Home Health markets.
In addition to Dane’s Chief Commercial Officer position at Evoke Neuroscience, Dane actively serves as an Expert in Residence at the University of California Irvine Applied Innovation Program, where he assists teams with the commercialization of their products/ideas.