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.
舊金山 — 2024 年 2 月 21 日— Tivic 健康系統公司 (“Tivic”,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,今天宣佈,其非侵入性迷走神經刺激(VNS)專有方法的試點臨床研究的註冊已經完成。
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是一個不斷增長的市場,是83億美元的全球神經刺激市場的一部分,根據全球市場洞察,該市場的複合年增長率預計爲12.2%。植入式 VNS 目前用於治療各種神經系統和精神疾病,並正在全身性炎症性疾病中進行測試。Tivic正在測試一種專有方法,該方法可以更精確地影響迷走神經信號,同時通過非侵入性治療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.
該試點研究使用了一種新的神經刺激方法,涉及20人,在此期間,費恩斯坦醫學研究所的研究人員進行了數據收集和分析。這項工作旨在爲VNS提供更精確的靶向策略,並更好地控制刺激產生的生理效應的類型。
"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.
“由於研究註冊在開始不到六個月的時間內就完成了,我們期待收到和分析最終的研究結果。這是正在進行的研究之一,旨在將Tivic的非侵入性生物電子產品組合擴展到我們現有產品線之外的新臨床用途。” Tivic首席執行官詹妮弗·恩斯特說。
Previously, the company has announced:
此前,該公司曾宣佈:
- 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:費恩斯坦醫學研究所 Tivic 宣佈了一項試點研究,以測試迷走神經刺激的新型非侵入性生物電子方法
- 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
- 2023 年 4 月:Tivic Health 擴大了對鼻腔和鼻竇手術中術後疼痛的臨床研究
- 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
About Tivic
關於 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是一家推進生物電子醫學領域的商業健康科技公司。Tivic 的專利技術平台利用對三叉神經結構、交感神經和迷走神經結構的刺激。Tivic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 的首款商用產品 ClearUp 是一款獲得 FDA 批准、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: 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,包括但不限於:研究開始後的最終結果,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; 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資本資源的意外成本、費用或支出。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的實際業績與前瞻性陳述中包含的業績有所不同,請參閱Tivic向美國證券交易委員會提交的截至2022年12月31日的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。
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