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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 宣佈成功完成無創迷走神經刺激研究 (VNS);證明自主神經、心臟和中樞神經系統具有臨床有效的生物學變化
Tivic Health Systems ·  05/01 12:00

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.

舊金山 — 2024 年 5 月 8 日 Tivic 健康系統公司 (“Tivic Health”,納斯達克股票代碼:TIVC)是一家開發和商業化生物電子醫學的健康科技公司,今天公佈了其試點研究的最終結果 諾斯韋爾健康中心的費恩斯坦醫學研究所。 通過此次合作,Tivic Health證實了其正在申請專利的非侵入性宮頸迷走神經刺激(ncVN)方法的有效性,該方法可誘發自主權、心臟和中樞神經系統的反應,並有望在多個主要疾病領域具有臨床用途。

Study Design:

研究設計:

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與生物電子醫學研究所副教授、費恩斯坦研究所神經與數據科學實驗室負責人西奧多羅斯·扎諾斯博士合作進行了一項由20人組成的臨床試驗。

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 治療之前、期間和之後進行了生理測量,以評估對自主神經系統、心臟功能和大腦活動的影響。該試驗使用自主神經系統、心臟功能和大腦活動的客觀測量結果驗證了Tivic Health針對NCVN的新型專有方法。

Results:

結果:

  • 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.
  • 與基線測量相比,Tivic Health的ncVNS干預使心率變異性的連續差異均方根(RMSSD)增加了97%,這是迷走神經活動的廣泛接受的指標。
  • 使用腦電圖對大腦活動進行測量表明,Tivic Health的ncVNS干預使額葉theta功率提高了24%,並降低了多個大腦區域的伽瑪功率,包括額葉伽瑪功率降低了66%。大腦活動的這些變化與覺醒和焦慮的減少是一致的。
  • 在刺激ncVNs期間,受試者出現持續的瞳孔收縮,瞳孔直徑縮小了9.5%,這一結果與副交感神經系統的激活有關。

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.

先前對非侵入性VNS設備的研究報告稱,自主神經系統變化的結果好壞參半。我們的 ncVNS 數據的規模意味着有可能獲得更大的臨床效果和更高的可重複性。雖然這些結果是針對健康受試者的,但數據表明,我們的ncVNS方法可能在包括癲癇、創傷後應激障礙和缺血性中風等患者群體在內的多種患者群體中具有臨床用途。

"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首席科學官布萊克·古爾芬博士說:“我們的ncVNs方法所產生的巨大治療效果令我們深受鼓舞,尤其是在當前最先進的背景下。”“這項研究爲我們的方法提供了重要的驗證,將有助於指導我們利用NCVN設計新產品。”

"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首席執行官詹妮弗·恩斯特補充說:“我們的使命是通過生物電子醫學的進步來改善生活活力。”“我們對這些結果充滿活力,並期待通過該計劃開啓有價值的新細分市場,使患者和投資者都受益。”

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是一個不斷增長的市場,是83億美元神經刺激市場的一部分,根據全球市場洞察,預計從2023年到2032年,該市場的複合年增長率爲12.2%。迷走神經是人體中最長的自主神經。迷走神經調節許多與慢性病相關的器官系統,因此調節這種神經通路的活性引起了醫療行業的極大興趣。VNS 目前適用於耐藥性癲癇和抑鬱症、叢集性頭痛、偏頭痛和中風康復,並且正在研究其他神經、心臟和免疫疾病。但是,VNS的許多應用都依賴於手術植入物。

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希望與費恩斯坦生物電子醫學研究所等合作方引領有意義的改進,使VNS設備能夠更精確地靶向和調節迷走神經活動以實現預期的生物和臨床結果,特別是使用非侵入性或微創設備。

Previously the company has announced:

該公司此前曾宣佈:

  • 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 宣佈迷走神經刺激的新型非侵入性生物電子方法研究的註冊工作已完成
  • 2023 年 8 月:Tivic Health 資助的研究開始招募新型非侵入性生物電子刺激迷走神經的方法
  • 2023 年 4 月:Tivic 擴大生物電子產品組合:提交非侵入性迷走神經刺激新方法的專利申請

About Tivic Health

關於 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是一家商業健康科技公司,致力於推動生物電子醫學領域的發展。Tivic Health 的專利技術平台利用對三叉神經、交感神經和迷走神經結構的刺激。Tivic Health的非侵入性和有針對性的慢性炎症性疾病治療方法爲消費者和提供商提供了安全性高、風險低和應用廣泛的無藥物治療解決方案。Tivic Health的首款商用產品ClearUp是美國食品藥品管理局批准的、屢獲殊榮的手持式生物電子鼻竇設備。ClearUp 經臨床驗證,經醫生推薦,可通過在線零售商和商業分銷商購買。欲了解更多信息,請訪問 http://tivichealth.com @TivicHealth

Forward-Looking Statements

前瞻性陳述

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.

本新聞稿可能包含受重大風險和不確定性影響的 “前瞻性陳述”。本新聞稿中包含的所有陳述,除歷史事實陳述外,均爲前瞻性陳述。本新聞稿中包含的前瞻性陳述可以通過使用 “預期”、“相信”、“考慮”、“可以”、“估計”、“期望”、“打算”、“尋求”、“可能”、“可能”、“計劃”、“潛力”、“預測”、“項目”、“目標”、“目標”、“應該”、“將” 或儘管並非所有前瞻性陳述都包含這些詞語,但對這些詞語或其他類似表達方式持否定態度。前瞻性陳述基於 Tivic Health Systems, Inc.的當前預期,並受難以預測的固有不確定性、風險和假設的影響。此外,某些前瞻性陳述基於對未來事件的假設,這些假設可能並不準確。 由於各種因素,實際結果可能與任何前瞻性陳述中包含的結果存在重大差異,包括但不限於:關於ncVNS治療未來發展的陳述、Tivic Health將由NCVNS治療產生的產品商業化的能力以及Tivic Health尋求監管部門批准此類臨床產品的計劃,以及Tivic Health繼續專注於開發ncVNS治療方法,包括癲癇、創傷後應激障礙和/或ISVIC Health的治療方法化學性中風空間;預期臨床公用事業包括可以追蹤的患者群體;市場和其他條件;供應鏈限制;宏觀經濟因素,包括通貨膨脹;以及減少Tivic Health資本資源的意外成本、收費或開支。鑑於這些風險和不確定性,提醒您不要過分依賴此類前瞻性陳述。有關其他風險和不確定性以及其他重要因素的討論,其中任何一個都可能導致Tivic Health的實際業績與前瞻性陳述中包含的有所不同,請參閱Tivic Health向美國證券交易委員會提交的截至2023年12月31日止年度的10-K表年度報告,標題爲 “風險因素”;以及該公司隨後向美國證券交易委員會提交的文件。本新聞稿中包含的前瞻性陳述自該日起作出,除非適用法律要求,否則Tivic Health Systems, Inc.沒有義務更新此類信息。

Media Contact:

媒體聯繫人:

Morgan Luke

摩根·盧克

Investor Contact:

投資者聯繫人:

Hanover International, Inc.

漢諾威國際有限公司

譯文內容由第三人軟體翻譯。


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