Neurovalens Ltd.

DUBLIN--( BUSINESS WIRE )--The "Neurostimulation: Technologies and Global Markets" report has been added to ResearchAndMarkets.com's offering. This report provides a comprehensive study of the global market for neurostimulation technologies and devices. It provides a detailed description of the different types of neurostimulation technologies and devices (invasive and noninvasive) and their current and historical market revenues. The human nervous system works as the chief commander of the human body. The medical science community has long believed that it has huge potential in treatment of human body disorders. Neurostimulation technology involves the alteration or modulation of nerves. Neurostimulation devices deliver electrical current or magnetic impulses directly to nerves in order to modify their activity. Over the past 25 to 30 years, neurostimulation has emerged as one of the most dynamic fields of therapy, and has been actively investigated for treatment of a range of clinical conditions including chronic pain, movement disorders (Parkinson's disease, tremor, dystonia and others), epilepsy, psychiatric disorders, functional restoration, cardiovascular disorders, gastrointestinal disorders and genitourinary disorders. It is also said to consist of "drug-free solutions." Currently, the potential of neurostimulation technology is actively being explored for other clinical conditions including obesity, tinnitus and central nerve system disorders. Given the vast size of the potential treatment population and the many ongoing scientific discoveries and technological advances in neurostimulation technologies, the market for neurostimulation devices market is poised for significant growth. Other factors expected to aid in the market boom include many countries' growing elderly populations and increasing trends toward the use of nondrug therapies, greater expectations for quality of life, and improved patient attitudes toward receiving medical attention. Neurostimulation technologies represent a cutting-edge field in neuroscience and medical science, aiming to modulate the activity of the nervous system to treat a wide range of neurological and neuropsychiatric disorders. These innovative techniques involve the application of electrical, magnetic or optogenetic stimuli to specific areas of the brain or nervous system, offering the potential to alleviate symptoms, restore lost function and enhance cognitive capabilities. Neurostimulation is based on the concept of neuromodulation, where electrical signals are applied to neurons to alter their activity and influence neural networks. Neurons communicate through electrical impulses, and by selectively stimulating or inhibiting specific neural populations, neuroscientists and clinicians can modulate brain function. This report also covers in detail the therapeutic applications of neurostimulation technologies and devices, including chronic pain, Parkinson's disease, epilepsy, urinary and fecal incontinence, obstructive sleep apnea, essential tremor, obsessive compulsive disorder, major depressive disorder/clinical depression and others. An in-depth analysis of the global market for neurostimulation technologies and devices includes historical data and market projections by device type, therapeutic application and region. Report Includes Estimation of the market size and analyses of market trends, with data from 2020 to 2022, estimates for 2023 and projection of CAGR through 2028 Description of Dorsal Root Ganglion (DRG) neurostimulator system and discussion on approved indications of stimulation therapy for various diseases Detailed description of various types of stimulation such as spinal cord stimulation, transcutaneous electrical nerve stimulation, deep brain stimulation, sacral nerve stimulation, Vagus nerve stimulation, hypoglossal nerve stimulation, and transcranial magnetic stimulation; and discussion on their mode of action and advantages Information on recent therapy improvements and new indications for use, and discussion on alternatives to traditional stimulation therapies Coverage of ongoing scientific discoveries and technological advances in neurostimulation technologies and insights into marketed and pipeline (R&D) products, product recalls and reimbursement policies Market share analysis of neurostimulation devices by application, type and region, and evaluation of market size and forecast, and detailed analysis of drivers, challenges and opportunities affecting market growth Market share analysis of the key companies of the industry and coverage of events like mergers & acquisitions, joint ventures, collaborations or partnerships, and other key market strategies Comprehensive company profiles of major players Axonics Inc Boston Scientific Corp Medtronic PLC Synapse Biomedical Inc Xavant Technology Key Attributes: Report Attribute Details No. of Pages 160 Forecast Period 2023 - 2028 Estimated Market Value (USD) in 2023 $8.2 Billion Forecasted Market Value (USD) by 2028 $11.7 Billion Compound Annual Growth Rate 7.4% Regions Covered Global Key Topics Covered: Chapter 1 Introduction Chapter 2 Summary and Highlights Chapter 3 Market and Technology Background Overview of Neurostimulation Types of Neurostimulation Technologies Spinal Cord Stimulation Deep Brain Stimulation Sacral Nerve Stimulation (Sns) Vagus Nerve Stimulation Hypoglossal Nerve Stimulation Transcutaneous Electrical Nerve Stimulation Transcranial Magnetic Stimulation (Tms) Other Neurostimulation Technologies Therapeutic Applications for Neurostimulation Chronic Pain Management Neurological Disorders Urinary and Fecal Incontinence Obstructive Sleep Apnea Chronic Migraine and Headache Cardiovascular Diseases Gastrointestinal Disorders Obesity Psychiatric Disorders Technological Developments Mri Compatibility Rechargeable and Non-Rechargeable Devices Chapter 4 Market Dynamics Market Trends Drivers Market Restraints Chapter 5 Market Breakdown by Technology/Device Type Global Market for Neurostimulation Devices by Type Spinal Cord Stimulation (Scs) Devices Transcutaneous Electrical Nerve Stimulation (Tens) Devices Deep Brain Stimulation (Dbs) Devices Sacral Nerve Stimulation (Sns) Devices Vagus Nerve Stimulation (Vns) Devices Hypoglossal Nerve Stimulation (Hgns) Devices Market Size and Forecast Transcranial Magnetic Stimulation (Tms) Devices Other Types of Neurostimulation Devices Chapter 6 Market Breakdown by Therapeutic Application Global Market for Neurostimulation Devices by Therapeutic Application Chronic Pain Urinary and Fecal Incontinence Parkinson's Disease Epilepsy Obstructive Sleep Apnea (Osa) Essential Tremor Major Depressive Disorder (Mdd)/Clinical Depression Obsessive Compulsive Disorder (Ocd) Other Therapeutic Applications Chapter 7 Market Breakdown by Region Global Market for Neurostimulation Devices by Region North America Europe Asia-Pacific Rest of the World Chapter 8 Regulatory Structure Regulatory Framework U.S. European Union Japan Chapter 9 Key Products and Technologies on the Market Recent Therapeutic Improvements and New Indications Spinal Cord Stimulation Deep Brain Stimulation Sacral Nerve Stimulation (Sns) Axonics Medtronic Vagus Nerve Stimulation Hypoglossal Nerve Stimulation Transcutaneous Electrical Nerve Stimulation Transcranial Magnetic Stimulation Other Types of Stimulation New Indications and Neurostimulation Therapies Chapter 10 Emerging Technologies and Developments Emerging Technologies and Developments Closed-Loop Neurostimulation Non-Invasive Brain Stimulation Techniques High-Frequency Stimulation Magnetic Resonance-Guided Focused Ultrasound Optogenetics Bioelectronic Medicine Wireless and Remote-Controlled Devices Chapter 11 Recent M&A M&A in the Neurostimulation Technologies Industry Chapter 12 Competitive Landscape Company Market Shares by Product Segment Spinal Cord Stimulation Devices Deep Brain Stimulation Devices Sacral Nerve Stimulation Devices Vagus Nerve Stimulation Devices Hypoglossal Nerve Stimulation Devices Transcranial Magnetic Stimulation Devices Transcutaneous Electrical Nerve Stimulation Devices Recent Industry Activities Chapter 13 Company Profiles Abbott Laboratories Aleva Neurotherapeutics Sa Avery Biomedical Devices Inc. Axonics Inc. Bioinduction Ltd. Bioventus LLC Biowave Corp. Boston Scientific Corp. Brainsway Ltd. Cochlear Americas Cvrx Inc. Electrocore Inc. Inspire Medical Systems Inc. Integer Holdings Corp. Laborie Inc. Livanova plc Mag & More GmbH Magstim Inc. Medtronic plc Nalu Medical Inc. Neuromed Consulting Inc. Neurometrix Inc. Neuronetics Inc. Neuropace Inc. Neurosigma Inc. Neurovalens Ltd. Nevro Corp. Nexstim plc Nyxoah Sa Soterix Medical Inc. Synapse Biomedical Inc. Xavant Technology (Pty) Ltd. Zoll Medical Corp. For more information about this report visit https://www.researchandmarkets.com/r/7hblrg About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

The Modius Sleep device is a headset that delivers small electrical pulses through an electrode placed behind the ear, with an aim of stimulating the areas of the brain’s hypothalamus associated with the sleep-wake cycle and the circadian rhythm. People suffering from chronic insomnia now have a new, drug-free option to treat the condition in the U.S. The FDA doled out a clearance to Neurovalens’ Modius Sleep device, which relies on neuromodulation technology to target the neurological processes that cause insomnia. With the regulatory nod, the Northern Ireland-based company will now be able to focus on growing its stateside presence, CEO Jason McKeown, Ph.D., said in a company announcement. “Most other products on the market measure symptoms of insomnia, but Modius Sleep is a non-invasive device that actually treats the underlying issue, improving the lives of our patients,” McKeown continued. “We believe that the low-risk, non-invasive therapeutic intervention offered by Neurovalens technology will be truly transformative for a range of serious medical conditions and, having carried out extensive clinical trials in the U.S. and Northern Ireland, we’re really excited to be moving to this next stage.” The Modius Sleep device is a headset that delivers small electrical pulses through an electrode placed behind the ear, with an aim of stimulating the areas of the brain’s hypothalamus associated with the sleep-wake cycle and the circadian rhythm. According to Neurovalens, users should wear the headset for a 30-minute session before bed, during which they’re free to watch TV, read or do other activities as they wind down for the night. The device’s neurostimulation is meant to improve both the quality and duration of sleep. In a pilot study (PDF) of the technology in 2020, 20 adults were tasked with using the neurostimulation headset every night before bed for two weeks. By the end of the study period, they reported significant decreases in their Insomnia Severity Index (ISI) scores, as well as an improvement in how well-rested they felt throughout the day. Specifically, the participants kicked off the study with an average baseline ISI score of 15.7, indicating “moderate insomnia” on the 28-point scale, and after two weeks their average score had dropped to 8.15, well below the threshold for a clinical diagnosis of insomnia. Meanwhile, when asked to rate their restfulness on a scale of zero to four, the participants’ scores improved from an average of 1.6 before the study started to 2.67 after undergoing the two weeks of regular Modius Sleep treatment. Neurovalens’ FDA submission was supported by the results of a “robust” pivotal clinical trial conducted in the U.K., Ireland and Hong Kong, the results of which haven’t yet been published. Next up on the company’s agenda is a plan to work with insurance providers to secure reimbursement for U.S. users of the Modius sleep device. In the meantime, Neurovalens is also in the process of adapting its neurostimulation technology to a variety of other indications, including Type 2 diabetes, obesity, anxiety and post-traumatic stress disorder, the last of which is on deck to be studied in a now-recruiting clinical trial.

慢性疾病通常源于脑干或下丘脑功能障碍。例如，下丘脑功能失调会引起胰岛素抵抗，从而导致2型糖尿病和肥胖症，而下丘脑昼夜节律调节的功能障碍会导致失眠。虽然药物可以影响下丘脑的神经元，但它们也会导致其他区域类似受体的交叉激活，从而产生副作用，增加心理健康问题或心血管疾病。相较于药物治疗，通过直接对相应的神经元施加电刺激，可以获得更好的治疗效果，并显著减少副作用的产生。Neurovalens就是这样一家公司，基于神经科学研究，研发非侵入性的神经刺激医疗设备。其研发的基于颅神经刺激技术的设备，可以对脑干神经元进行非侵入性激活，为肥胖症、失眠症、2型糖尿病和焦虑症等提供无药物的创新治疗方案。   创始人充当“小白鼠”，验证神经刺激的减肥作用Neurovalens于2015年建立，总部位于贝尔法斯特（Belfast），其创始人是Jason McKeown和Paul McGeoch。Jason是贝尔法斯特女王大学的硕士研究员，他从小对计算机有着浓厚的兴趣，但在十几岁的时候他突然意识到，计算机领域的发展是大势所趋，而他并不想走上这样一条必然的发展道路。他决定开始学医，转向探索人类最先进的计算机——大脑和神经系统。Paul是一位神经科学家，拥有阿伯丁大学的医学学位和博士学位，发表过约20篇关于神经科学的学术论文。   左图为Jason McKeown，右图为Paul McGeoch 图源：Neurovalens官网第一款产品设计的灵感来源于Paul的实验研究，Paul发现对大脑进行电刺激可以降低体重。Paul将研究结果分享给正在爱丁堡神经外科工作的Jason，他们一拍即合，迅速基于神经刺激初步设计出了产品原型。Jason将设备用在自己身上进行测试。随着时间的推移，他注意到自己的食欲显著下降，饱腹感增加。一年后，他成功地减少了44%的身体脂肪，增加了2公斤的肌肉质量。经过数次验证测试，确定神经刺激有鲜为人知的减肥作用。在欧洲区域发展基金（European Regional Development Fund）的投资项目资助下，Jason和Paul联系专业团队着手开发设备，Modius SLIM于2017年正式推出。进入市场的Modius SLIM被提炼成一种高科技的头戴式耳机，如今已在80多个国家和地区销售，帮助世界各地成千上万的人减肥。   基于前庭刺激，“耳机”也能治疗肥胖和失眠● 健康减肥设备Modius SLIMModius SLIM是Neurovalens开发的第一款设备，是一种非侵入性头戴式耳机。用户打开蓝牙连接设备和APP，将电极垫放置在耳朵后面骨骼皮肤表面的位置，通过激活前庭神经产生低电平脉冲，从耳后皮肤表面向下丘脑发送信号，可以减少体内脂肪、改变新陈代谢率和降低食欲，最终达到协助减肥的目的。                                Modius SLIM不属于医疗设备，而是一种通用的健康设备。用户在坐姿状态下每天佩戴一小时，每周至少五次，当然仅仅只依靠设备是无法完成减肥目标的，更多的还是要结合健康的饮食和合理的运动，Modius SLIM的目的只是促进减肥效果最大化。通常，用户可以在一周左右明显感受到对碳水化合物和含糖食物的食欲下降。● 睡眠质量改善设备Modius SLEEP发表在《Current Biology》上的研究表明，持续的摇晃有助于同步大脑丘脑皮层网络的神经活动，让大脑进入非快速眼动睡眠的特殊振荡状态，而摇晃对睡眠的影响与前庭神经系统的节律性刺激有关。Modius SLEEP就是一款由神经科学驱动的新型耳机，通过电脉冲刺激前庭神经，影响下丘脑和脑干区域，改变人体的昼夜节律和睡眠模式。在无镇静剂和安眠药等药物协助下，仅在睡前佩戴30分钟耳机就可减少入睡时间、延长睡眠时间，达到改善睡眠质量的目的。一些用户在使用SLEEP设备两晚左右就能改善睡眠状况，而由于外界干扰的存在，也有部分用户需要更长的适应时间。Modius SLEEP设备  图源：Neurovalens官网Modius SLEEP和Modius SLIM两种设备存在技术相似性，都是通过刺激前庭神经间接影响下丘脑。从某种意义上来说，由于这两种设备刺激的是大脑的相同区域，在功能上会存在重合。例如，SLIM设备可能产生改善睡眠的“副作用”，部分用户在使用SLEEP设备后也会产生食欲下降的现象。但它们电刺激的频率是不同的，SLEEP经过专门优化，针对性的刺激大脑睡眠中心的关键睡眠神经元，其设置适用于睡眠管理，一般来说不会影响用户的体重；而SLIM的设置则适用于体重管理。启动新试点计划，开发调节神经系统的系列设备Neurovalens正在开发Modius系列的其他设备，包括Modius Spero和Modius Stress，以及新系列设备Vestal DM。Modius Spero是一种治疗创伤后应激障碍（PTSD）的非侵入性设备，将电极放置在双耳后面皮肤上，通过电脉冲刺激与PTSD相关的大脑区域，可以减缓PTSD患者的症状。Modius Stress是一款治疗焦虑症的设备，主要通过刺激大脑蓝斑（LC）和下丘脑室旁核（PVN），调节自主神经系统对应激反应的副交感神经和交感神经通路。目前，Neurovalens正在与加州大学圣地亚哥分校（UCSD）、阿尔斯特大学（UU）合作，分别展开这两款设备的临床试验，以评估Modius Spero设备降低PTSD症状严重程度的能力，以及Modius Stress设备前庭电刺激的疗效。新系列设备Vestal DM的试点研究是与都柏林大学学院（UCD）合作开展的，其工作原理是将低水平的电脉冲发送到大脑区域，以检测和调节血糖水平，可预防2型糖尿病（T2DM）和肥胖症。目前糖尿病患者的治疗方式有注射胰岛素、服用药物和脑深部刺激（DBS），增加细胞对胰岛素的敏感性，但是药物治疗会带来副作用，DBS侵入性太强且手术费用高昂，Vestal DM则可为糖尿病患者提供一种非侵入性的低风险治疗方案。非侵入性神经调控技术正在提高疾病治疗覆盖率神经调控是一种利用刺激定向改变神经活动，从而调节神经组织功能的技术。从作用形式上分为侵入性与非侵入性两种。侵入性的神经调控涉及手术治疗，需要在大脑颅骨内部植入电极，通过电流刺激以改善大脑损伤的程度。而非侵入性神经调控无创、便利、依从性更好，有潜力拓展更大的市场。临床上，非侵入性神经刺激可为三类疾病提供治疗方案：神经退行性疾病、脑损伤相关疾病和精神心理疾病。目前全球已有许多企业在此领域进行了深入探索，如美国的Cognito开发的CogTx-001可治疗神经退行性疾病，Nexalin Technology开发的Nexalin ADI，已被美国FDA批准用于临床治疗焦虑、抑郁、失眠等。非侵入性神经刺激主要包括迷走神经刺激、颅神经刺激等，目前国内布局非侵入性脑刺激赛道的企业也越来越多，如针对颅神经刺激的康哲药业，专注于耳部迷走神经刺激的智联脑控，对迷走神经、骶神经以及脊髓神经刺激均有涉猎的品驰医疗，这些企业都在这个领域进行了深入探索，具有丰富的行业经验。近期推荐声明：动脉网所刊载内容之知识产权为动脉网及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。动脉网，未来医疗服务平台