share_log

Tivic Health Announces Successful Completion of Non-Invasive Vagus Nerve Stimulation Study (VNS); Demonstrates Clinically Effective Biological Changes in the Autonomic, Cardiac, and Central Nervous Systems

Tivic Health Announces Successful Completion of Non-Invasive Vagus Nerve Stimulation Study (VNS); Demonstrates Clinically Effective Biological Changes in the Autonomic, Cardiac, and Central Nervous Systems

Tivic Health 宣布成功完成无创迷走神经刺激研究 (VNS);证明自主神经、心脏和中枢神经系统具有临床有效的生物学变化
Tivic Health Systems ·  05/01 00:00

SAN FRANCISCO – May 8, 2024 Tivic Health Systems, Inc. ("Tivic Health", Nasdaq: TIVC), a health tech company that develops and commercializes bioelectronic medicine, announced today the final results of their pilot research study with The Feinstein Institutes for Medical Research at Northwell Health. Through this collaboration, Tivic Health has confirmed the effectiveness of its patent-pending non-invasive cervical vagus nerve stimulation (ncVNS) approach, which induces responses in the autonomic, cardiac, and central nervous systems and can be expected to have clinical utility in several major disease areas.

旧金山 — 2024 年 5 月 8 日 Tivic 健康系统公司 (“Tivic Health”,纳斯达克股票代码:TIVC)是一家开发和商业化生物电子医学的健康科技公司,今天公布了其试点研究的最终结果 诺斯韦尔健康中心的费恩斯坦医学研究所。 通过此次合作,Tivic Health证实了其正在申请专利的非侵入性宫颈迷走神经刺激(ncVN)方法的有效性,该方法可诱发自主权、心脏和中枢神经系统的反应,并有望在多个主要疾病领域具有临床用途。

Study Design:

研究设计:

Tivic Health conducted a 20-person clinical trial in collaboration with Theodoros Zanos, Ph.D., Associate Professor in the Institute of Bioelectronic Medicine and Head of the Neural and Data Science Lab at the Feinstein Institutes.

Tivic Health与生物电子医学研究所副教授、费恩斯坦研究所神经与数据科学实验室负责人西奥多罗斯·扎诺斯博士合作进行了一项由20人组成的临床试验。

Physiological measurements were taken before, during, and after ncVNS treatment to assess the impact on the autonomic nervous system, cardiac function, and brain activity. The trial validated Tivic Health's novel and proprietary approach to ncVNS using objective measures of the autonomic nervous system, cardiac function, and brain activity.

在 ncVNS 治疗之前、期间和之后进行了生理测量,以评估对自主神经系统、心脏功能和大脑活动的影响。该试验使用自主神经系统、心脏功能和大脑活动的客观测量结果验证了Tivic Health针对NCVN的新型专有方法。

Results:

结果:

  • Compared to baseline measurement, Tivic Health's ncVNS intervention resulted in a 97% increase in the root mean square of successive differences (RMSSD) measure of heart rate variability, which is a widely accepted proxy for vagus nerve activity.
  • Measurements of brain activity using EEG demonstrated that Tivic Health's ncVNS intervention increased frontal theta power by 24% and reduced gamma power in several brain regions, including a 66% reduction in frontal gamma power. These changes in brain activity are consistent with reduced arousal and anxiety.
  • During ncVNS stimulation, subjects had sustained pupil constriction, a 9.5% reduction in pupil diameter, an outcome associated with activation of the parasympathetic nervous system.
  • 与基线测量相比,Tivic Health的ncVNS干预使心率变异性的连续差异均方根(RMSSD)增加了97%,这是迷走神经活动的广泛接受的指标。
  • 使用脑电图对大脑活动进行测量表明,Tivic Health的ncVNS干预使额叶theta功率提高了24%,并降低了多个大脑区域的伽玛功率,包括额叶伽玛功率降低了66%。大脑活动的这些变化与觉醒和焦虑的减少是一致的。
  • 在刺激ncVNs期间,受试者出现持续的瞳孔收缩,瞳孔直径缩小了9.5%,这一结果与副交感神经系统的激活有关。

Previous studies of non-invasive VNS devices have reported mixed results regarding autonomic nervous system changes. The magnitude of our ncVNS data imply potential for greater clinical effects and enhanced reproducibility. While these results were in healthy subjects, the data suggest our ncVNS approach may have clinical utility in several patient populations including those with epilepsy, post-traumatic stress disorder, and ischemic stroke, among others.

先前对非侵入性VNS设备的研究报告称,自主神经系统变化的结果好坏参半。我们的 ncVNS 数据的规模意味着有可能获得更大的临床效果和更高的可重复性。虽然这些结果是针对健康受试者的,但数据表明,我们的ncVNS方法可能在包括癫痫、创伤后应激障碍和缺血性中风等患者群体在内的多种患者群体中具有临床用途。

"We are strongly encouraged by the magnitude of the treatment effects from our ncVNS approach, particularly in the context of current state of the art," says Blake Gurfein, Ph.D., Chief Scientific Officer of Tivic Health. "This study provided important validation of our approach and will help steer our design of new products leveraging ncVNS."

Tivic Health首席科学官布莱克·古尔芬博士说:“我们的ncVNs方法所产生的巨大治疗效果令我们深受鼓舞,尤其是在当前最先进的背景下。”“这项研究为我们的方法提供了重要的验证,将有助于指导我们利用NCVN设计新产品。”

"Our mission is to improve vibrancy of life through advancement of bioelectronic medicine," added Jennifer Ernst, CEO of Tivic Health. "We are energized about these results and look forward to unlocking valuable new market segments with this program that can benefit both patients and investors."

Tivic Health首席执行官詹妮弗·恩斯特补充说:“我们的使命是通过生物电子医学的进步来改善生活活力。”“我们对这些结果充满活力,并期待通过该计划开启有价值的新细分市场,使患者和投资者都受益。”

Background:

背景:

VNS is a growing market that is part of the $8.3B neurostimulation market, which has a projected CAGR of 12.2% from 2023 through 2032, according to Global Market Insights. The vagus nerve is the longest autonomic nerve in the body. The vagus nerve regulates many organ systems associated with chronic disease and thus modulating activity in this nerve pathway is of significant interest in the medical industry. VNS is currently indicated for treatment-resistant epilepsy and depression, cluster headache, migraine headache, and stroke rehabilitation, and it is being studied for other neurological, cardiac, and immune conditions. However, many of the applications of VNS rely on surgical implants.

VNS是一个不断增长的市场,是83亿美元神经刺激市场的一部分,根据全球市场洞察,预计从2023年到2032年,该市场的复合年增长率为12.2%。迷走神经是人体中最长的自主神经。迷走神经调节许多与慢性病相关的器官系统,因此调节这种神经通路的活性引起了医疗行业的极大兴趣。VNS 目前适用于耐药性癫痫和抑郁症、丛集性头痛、偏头痛和中风康复,并且正在研究其他神经、心脏和免疫疾病。但是,VNS的许多应用都依赖于手术植入物。

Tivic Health, with collaborators such as The Feinstein Institute for Bioelectronic Medicine, hopes to lead the way to meaningful improvement in how VNS devices can more precisely target and modulate vagus nerve activity to achieve intended biological and clinical outcomes, in particular with non-invasive or minimally invasive devices.

Tivic Health希望与费恩斯坦生物电子医学研究所等合作方引领有意义的改进,使VNS设备能够更精确地靶向和调节迷走神经活动以实现预期的生物和临床结果,特别是使用非侵入性或微创设备。

Previously the company has announced:

该公司此前曾宣布:

  • January 2024: Tivic Health Announces Enrollment Complete for Study of Novel Non- Invasive Bioelectronic Approach to Vagus Nerve Stimulation
  • August 2023: Tivic Health Funded Study Begins Enrollment for Novel Non-Invasive Bioelectronic Approach to Vagus Nerve Stimulation
  • April 2023: Tivic Expands Bioeletronic Portfolio: Files Patent Application for New Approach to Non-Invasive Vagus Nerve Stimulation
  • 2024 年 1 月:Tivic Health 宣布迷走神经刺激的新型非侵入性生物电子方法研究的注册工作已完成
  • 2023 年 8 月:Tivic Health 资助的研究开始招募新型非侵入性生物电子刺激迷走神经的方法
  • 2023 年 4 月:Tivic 扩大生物电子产品组合:提交非侵入性迷走神经刺激新方法的专利申请

About Tivic Health

关于 Tivic Heal

Tivic Health is a commercial health tech company advancing the field of bioelectronic medicine. Tivic Health's patented technology platform leverages stimulation on the trigeminal, sympathetic, and vagus nerve structures. Tivic Health's non-invasive and targeted approach to the treatment of inflammatory chronic health conditions gives consumers and providers drug-free therapeutic solutions with high safety profiles, low risk, and broad applications. Tivic Health's first commercial product ClearUP is an FDA approved, award-winning, handheld bioelectronic sinus device. ClearUP is clinically proven, doctor-recommended, and is available through online retailers and commercial distributors. For more information visit http://tivichealth.com @TivicHealth

Tivic Health是一家商业健康科技公司,致力于推动生物电子医学领域的发展。Tivic Health 的专利技术平台利用对三叉神经、交感神经和迷走神经结构的刺激。Tivic Health的非侵入性和有针对性的慢性炎症性疾病治疗方法为消费者和提供商提供了安全性高、风险低和应用广泛的无药物治疗解决方案。Tivic Health的首款商用产品ClearUp是美国食品药品管理局批准的、屡获殊荣的手持式生物电子鼻窦设备。ClearUp 经临床验证,经医生推荐,可通过在线零售商和商业分销商购买。欲了解更多信息,请访问 http://tivichealth.com @TivicHealth

Forward-Looking Statements

前瞻性陈述

This press release may contain "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Tivic Health Systems, Inc.'s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: statements regarding the future development of ncVNS treatment, the Tivic Health's ability to commercialize products arising out of the ncVNS treatment and the Tivic Health's plans to seek regulatory approval for such clinical products and Tivic Health's continued focus on developing ncVNS treatment, including in the epilepsy, post-traumatic stress disorder, and/or ischemic stroke space; expected clinical utility including which patient populations may be pursued; market and other conditions; supply chain constraints; macroeconomic factors, including inflation; and unexpected costs, charges or expenses that reduce Tivic Health's capital resources. Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Tivic Health's actual results to differ from those contained in the forward-looking statements, see Tivic Health's filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 29, 2024, under the heading "Risk Factors"; as well as the company's subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and Tivic Health Systems, Inc. undertakes no duty to update such information except as required by applicable law.

本新闻稿可能包含受重大风险和不确定性影响的 “前瞻性陈述”。本新闻稿中包含的所有陈述,除历史事实陈述外,均为前瞻性陈述。本新闻稿中包含的前瞻性陈述可以通过使用 “预期”、“相信”、“考虑”、“可以”、“估计”、“期望”、“打算”、“寻求”、“可能”、“可能”、“计划”、“潜力”、“预测”、“项目”、“目标”、“目标”、“应该”、“将” 或尽管并非所有前瞻性陈述都包含这些词语,但对这些词语或其他类似表达方式持否定态度。前瞻性陈述基于 Tivic Health Systems, Inc.的当前预期,并受难以预测的固有不确定性、风险和假设的影响。此外,某些前瞻性陈述基于对未来事件的假设,这些假设可能并不准确。 由于各种因素,实际结果可能与任何前瞻性陈述中包含的结果存在重大差异,包括但不限于:关于ncVNS治疗未来发展的陈述、Tivic Health将由NCVNS治疗产生的产品商业化的能力以及Tivic Health寻求监管部门批准此类临床产品的计划,以及Tivic Health继续专注于开发ncVNS治疗方法,包括癫痫、创伤后应激障碍和/或ISVIC Health的治疗方法化学性中风空间;预期临床公用事业包括可以追踪的患者群体;市场和其他条件;供应链限制;宏观经济因素,包括通货膨胀;以及减少Tivic Health资本资源的意外成本、收费或开支。鉴于这些风险和不确定性,提醒您不要过分依赖此类前瞻性陈述。有关其他风险和不确定性以及其他重要因素的讨论,其中任何一个都可能导致Tivic Health的实际业绩与前瞻性陈述中包含的有所不同,请参阅Tivic Health向美国证券交易委员会提交的截至2023年12月31日止年度的10-K表年度报告,标题为 “风险因素”;以及该公司随后向美国证券交易委员会提交的文件。本新闻稿中包含的前瞻性陈述自该日起作出,除非适用法律要求,否则Tivic Health Systems, Inc.没有义务更新此类信息。

Media Contact:

媒体联系人:

Morgan Luke

摩根·卢克

Investor Contact:

投资者联系人:

Hanover International, Inc.

汉诺威国际有限公司

声明:本内容仅用作提供资讯及教育之目的,不构成对任何特定投资或投资策略的推荐或认可。 更多信息
    抢沙发