Tivic Health Announces Completion of Enrollment for Study of Novel Non-Invasive Bioelectronic Approach to Vagus Nerve Stimulation
Tivic Health Announces Completion of Enrollment for Study of Novel Non-Invasive Bioelectronic Approach to Vagus Nerve Stimulation
SAN FRANCISCO – February 21, 2024– Tivic Health Systems, Inc. ("Tivic", Nasdaq: TIVC), a health tech company that develops and commercializes bioelectronic medicine, announced today that enrollment in its pilot clinical study of a proprietary approach to non-invasive vagus nerve stimulation (VNS) has been completed.
旧金山 — 2024 年 2 月 21 日— Tivic 健康系统公司 (“Tivic”,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,今天宣布,其非侵入性迷走神经刺激(VNS)专有方法的试点临床研究的注册已经完成。
VNS is a growing market that is part of the $8.3B global neurostimulation market, which has a projected CAGR of 12.2%, according to Global Market Insights. Implanted VNS is currently used in the treatment of various neurologic and psychiatric disorders and is being tested in systemic inflammatory diseases. Tivic is testing a proprietary approach to more precisely influence vagus nerve signals, while enhancing effectiveness and safety with a non-invasive treatment.
VNS是一个不断增长的市场,是83亿美元的全球神经刺激市场的一部分,根据全球市场洞察,该市场的复合年增长率预计为12.2%。植入式 VNS 目前用于治疗各种神经系统和精神疾病,并正在全身性炎症性疾病中进行测试。Tivic正在测试一种专有方法,该方法可以更精确地影响迷走神经信号,同时通过非侵入性治疗提高有效性和安全性。
The pilot study utilized a new neurostimulation approach with 20 individuals during which the data collection and analysis were performed by researchers at The Feinstein Institutes for Medical Research. This work aims to provide more precise targeting strategies for VNS and more control over the types of physiologic effects that result from stimulation.
该试点研究使用了一种新的神经刺激方法,涉及20人,在此期间,费恩斯坦医学研究所的研究人员进行了数据收集和分析。这项工作旨在为VNS提供更精确的靶向策略,并更好地控制刺激产生的生理效应的类型。
"With study enrollment completed less than six months from initiation, we are looking forward to receiving and analyzing the final study results. This is one of the studies underway to expand Tivic's non-invasive bioelectronic portfolio to new clinical uses beyond our existing product line," said Jennifer Ernst, CEO at Tivic.
“由于研究注册在开始不到六个月的时间内就完成了,我们期待收到和分析最终的研究结果。这是正在进行的研究之一,旨在将Tivic的非侵入性生物电子产品组合扩展到我们现有产品线之外的新临床用途。” Tivic首席执行官詹妮弗·恩斯特说。
Previously, the company has announced:
此前,该公司曾宣布:
- April 2023: Tivic, The Feinstein Institutes for Medical Research Announce Pilot Study to Test Novel Non-Invasive Bioelectronic Approach to Vagus Nerve Stimulation
- April 2023: Tivic Expands Bioelectronic Portfolio: Files Patent Application for New Approach to Non-Invasive Vagus Nerve Stimulation
- April 2023: Tivic Health Expands Clinical Study of Post-Operative Pain in Nasal and Sinus Surgeries
- August 2023: Tivic Health Funded Study Begins Enrollment for Novel Non-Invasive Bioelectronic Approach to Vagus Nerve Stimulation
- 2023 年 4 月:费恩斯坦医学研究所 Tivic 宣布了一项试点研究,以测试迷走神经刺激的新型非侵入性生物电子方法
- 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
- 2023 年 4 月:Tivic Health 扩大了对鼻腔和鼻窦手术中术后疼痛的临床研究
- 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
About Tivic
关于 Tivic
Tivic is a commercial health tech company advancing the field of bioelectronic medicine. Tivic's patented technology platform leverages stimulation on the trigeminal, sympathetic, and vagus nerve structures. Tivic'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'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是一家推进生物电子医学领域的商业健康科技公司。Tivic 的专利技术平台利用对三叉神经结构、交感神经和迷走神经结构的刺激。Tivic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 的首款商用产品 ClearUp 是一款获得 FDA 批准、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: final results of the study, once commenced; market and other conditions; supply chain constraints; macroeconomic factors, including inflation; and unexpected costs, charges or expenses that reduce Tivic'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's actual results to differ from those contained in the forward-looking statements, see Tivic's filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 31, 2023, 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,包括但不限于:研究开始后的最终结果,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; 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资本资源的意外成本、费用或支出。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的实际业绩与前瞻性陈述中包含的业绩有所不同,请参阅Tivic向美国证券交易委员会提交的截至2022年12月31日的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。
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