– Conavi Medical's Novasight Hybrid System is the first technology to combine both IVUS and OCT to enable simultaneous and co-registered imaging of coronary arteries –
– Company showcasing its Novasight technology this week at TCT 2024 –
TORONTO, Oct. 28, 2024 (GLOBE NEWSWIRE) -- Conavi Medical Corp. (TSXV: CNVI) ("Conavi Medical"), a commercial stage company focused on designing, manufacturing, and marketing imaging technologies to guide common minimally invasive cardiovascular procedures, is pleased to announce that the peer-reviewed Journal of the American College of Cardiology: Cardiovascular Interventions has published an article by Tufaro et al. which provides an overview of recent developments in hybrid intracoronary imaging and discusses its potential value in different clinical and research areas, such as percutaneous coronary intervention ("PCI") guidance, vulnerable plaque detection, and the assessment of focal and systemic therapies targeting atherosclerosis.
An abstract of the article can be accessed here.
Quoting directly from the full article:
"Several studies have shown that specific morphologic features observed on intravascular imaging post-PCI are associated with a high risk of stent failure. Stent underexpansion constitutes the most common cause of stent failure; large edge dissection and plaque at the edge of the stent have been associated with stent edge–related events, whereas tissue or thrombus protrusion in stented segments was found to be a predictor of restenosis and stent thrombosis. Finally, the presence of uncovered or malapposed struts has been associated with an increased risk of stent thrombosis in large registries of patients who had [optical coherence tomography ("OCT")] imaging at the time of the event, but prospective OCT imaging studies have provided conflicting results; therefore, the role of these features on stent failure remains elusive
Combined [intravascular ultrasound ("IVUS")] OCT imaging has theoretical advantages over standalone imaging in assessing post-PCI results; IVUS can minimize the risk of stent underexpansion and assess [plaque burden] at the edge of the stent, whereas OCT can detect more accurately edge dissections, the presence of lipid at the reference segments, malappositions, and tissue protrusion. This hypothesis is supported by a recent prospective observational study of 17 patients who underwent elective PCI using the Novasight Hybrid IVUS OCT system [Conavi Medical]. IVUS OCT imaging was performed successfully in 10 patients post–stent implantation. Compared to IVUS, OCT more often identified the presence of incomplete strut apposition (8.0% vs 0.8%; P < 0.001) and tissue protrusion (50.6% vs 15.9%; P < 0.001), but IVUS detected stent underexpansion more often than OCT (28.7% vs 23.1%; P 1⁄4 0.039). These promising findings are expected to provide the substrate for the conduction of larger studies that will allow us to draw safe conclusions about the superiority of IVUS OCT over standalone intravascular imaging."
Christos V. Bourantas, MD, PhD, a Consultant Cardiologist at Barts Heart Centre and Professor of Cardiology (Hon) at Queen Mary University London, and one of the authors of the JACC: Cardiovascular Interventions article, commented, "There is a large and growing body of evidence that the use of OCT or IVUS to guide PCI procedures has substantially improved patient event-free survival, enhancing both the long-term safety and effectiveness of the procedure. However, each imaging modality has unique advantages and limitations. Conavi Medical's Novasight Hybrid System offers an elegant solution, providing simultaneous and complementary data with which to better inform patient care."
"The publication of this article comes at an opportune time as we showcase our Novasight Hybrid System at the Cardiovascular Research Foundation's annual Transcatheter Cardiovascular Therapeutics (TCT) conference taking place now in Washington, DC," said Tom Looby, Conavi Medical's CEO. "We would like to take this opportunity to thank Drs. Tufaro and Bourantas, as well as their esteemed colleagues who have contributed to the growing awareness and adoption of hybrid imaging in the care of coronary patients, and look forward to continuing to build on that positive momentum as we progress."
About JACC: Cardiovascular Interventions
JACC: Cardiovascular Interventions encompasses the entire field of interventional cardiovascular medicine, including coronary, structural, peripheral and cerebrovascular interventions. Submissions of original research papers, state-of-the-art reviews, research letters, editorials and viewpoints from cardiology, vascular surgery, neurology, radiology, hematology, vascular biology, materials science, outcomes research and related fields are encouraged. In general, papers on electrophysiology, cardiac surgery or other interventional specialties are not recruited. In 2023, the journal had an impact factor of 11.7.
About Conavi Medical
Conavi Medical is focused on designing, manufacturing, and marketing imaging technologies to guide common minimally invasive cardiovascular procedures. Its patented Novasight Hybrid System is the first system to combine both intravascular ultrasound (IVUS) and optical coherence tomography (OCT) to enable simultaneous and co-registered imaging of coronary arteries. The Novasight Hybrid System has 510(k) clearance from the U.S. Food and Drug Administration; and regulatory approval for clinical use from Health Canada, China's National Medical Products Administration, and Japan's Ministry of Health, Labor and Welfare. For more information, visit .
Cautionary Statement Regarding Forward-Looking Information
This news release contains "forward-looking statements" within the meaning of applicable Canadian and U.S. securities laws, which reflect the current expectations of management of Conavi's future growth, results of operations, performance and business prospects and opportunities. Forward-looking statements are frequently, but not always, identified by words such as "may", "would", "could", "will", "anticipate", "believe", "plan", "expect", "intend", "estimate", "potential for" and similar expressions, although these words may not be present in all forward-looking statements. Forward-looking statements that appear in this release may include, without limitation, references to Conavi's plans for the commercialization of its Novasight Hybrid System.
These forward-looking statements reflect management's current beliefs with respect to future events, and are based on information currently available to management that, while considered reasonable by management as of the date on which the statements are made, are inherently subject to significant business, economic and competitive uncertainties and contingencies which could result in actions, events, conditions, results, performance or achievements to be materially different from those projected in the forward-looking statements. Forward-looking statements involve significant risks, uncertainties and assumptions and many factors could cause Conavi's actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements. Such factors and assumptions include, but are not limited to, Conavi's ability to retain key personnel; its ability to execute on its business plans and strategies; and other factors listed in the "Risk Factors" sections of the joint information circular of Conavi dated August 30, 2024 (which may be viewed at ). Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance, or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements.
Although the forward-looking statements contained in the news release are based upon what management currently believes to be reasonable assumptions and Conavi has attempted to identify important factors that could cause actual actions, events, conditions, results, performance or achievements to differ materially from those described in forward-looking statements, Conavi cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements. Except as required by law, Conavi expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. Accordingly, investors should not place undue reliance on forward-looking statements. All the forward-looking statements are expressly qualified by the foregoing cautionary statements.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.
Contacts
Stephen Kilmer
Investor Relations
(647) 872-4849
stephen.kilmer@conavi.com
Stefano Picone
Chief Financial Officer
(416) 483-0100
Conavi Medical的Novasight Hybrid System是第一個結合IVUS和OCT技術,實現冠狀動脈的同時成像和註冊成像的技術。
公司將在本週的TCt 2024展示其Novasight技術。
多倫多,2024年10月28日(全球新聞社)——致富金融(臨時代碼:CNVI)("Conavi Medical")的商業階段公司,專注於設計,製造和營銷影像技術,指導常見的微創心血管手術,很高興宣佈美國心臟病學院雜誌:心血管介入專輯已經刊登了Tufaro等人撰寫的一篇文章,概述了混合介入冠脈成像的最新發展,並討論了其在不同臨床和研究領域的潛在價值,如經皮冠狀動脈介入("PCI")指導,易損斑塊檢測,以及評估針對動脈粥樣硬化的局部和全身療法。
本文摘要可在此處查閱。
引用完整文章內容如下:
多項研究表明,洗淨術後血管內成像觀察到的特定形態特徵與支架失敗風險較高相關。 支架未膨脹是支架失敗最常見原因;大型邊緣撕裂和邊緣支架處的斑塊與支架邊緣相關事件有關,而支架段組織或栓子突出被發現是支架再狹窄和支架血栓形成的預測因素。 最後,在有大量在支架事件發生時進行[光學相干斷層掃描("OCT")]成像的患者的大型登記研究中,發現未遮蓋或者錯位支架支柱與支架血栓形成的風險增加有關,但遠景OCt成像研究結果存在衝突;因此,這些特徵對支架失敗的作用仍然難以捉摸
[血管內超聲("IVUS")OCt成像在評估洗淨術後結果方面具有理論上的優勢;IVUS可以減小支架未膨脹風險,評估支架邊緣的[斑塊負擔],而OCt可以更準確地檢測邊緣撕裂、參考段的脂質存在、錯位和組織突出。 這一假設得到17名接受使用Novasight混合IVUS OCt系統進行擇期PCI手術的患者最近一項前瞻性觀察性研究的支持 [Conavi Medical]。 在支架植入術後順利爲10名患者完成了IVUS OCt成像。 與IVUS相比,OCt更經常識別到支架支柱完全不貼合(8.0% vs 0.8%; P < 0.001)和組織突出(50.6% vs 15.9%; P < 0.001),但IVUS更常檢測到支架未膨脹,而不如OCt(28.7% vs 23.1%; P 1⁄4 0.039)。 這些有希望的發現有望爲進行更大規模的研究提供基礎,使我們能夠對IVUS OCt與獨立血管內成像的優越性做出安全結論。
克里斯托斯·V·布蘭塔斯(Christos V. Bourantas),Barts心臟中心心臟病顧問和倫敦瑪麗皇后大學心臟病學榮譽教授之一,也是JACC:心血管介入文章的作者之一,他評論說:"有大量且不斷增長的證據表明,使用OCt或IVUS指導PCI程序極大地提高了患者無事件存活率,增強了程序的長期安全性和有效性。 但是,每種成像模式都有獨特的優勢和侷限性。 Conavi Medical的NovaSight混合系統提供了一個優雅的解決方案,提供同時和互補的數據,以更好地爲患者護理提供信息。"
「這篇文章的發佈恰逢時機,當我們在華盛頓特區舉行的心血管研究基金會年度經導管介入心血管治療(TCT)大會上展示我們的Novasight Hybrid System時,Conavi Medical的首席執行官湯姆·魯比表示。"我們要藉此機會感謝Tu法羅和布蘭塔斯醫生,以及他們尊敬的同事們,他們對冠狀動脈患者護理中混合成像的增加意識和採用做出了貢獻,並期待繼續在積極的勢頭上建設,推進事業。」
關於JACC:心血管介入
JACC:心血管介入涵蓋整個介入性心血管醫學領域,包括冠心病、結構、外周和腦血管介入。鼓勵提交原始研究論文、最新評論、研究簡報、社論以及來自心臟病學、血管外科、神經學、放射學、血液學、血管生物學、材料科學、結局研究和相關領域的觀點。一般而言,心電生理學、心臟手術或其他介入專業的論文不會被招募。2023年,該雜誌的影響因子爲11.7。
關於康納維醫療
康納維醫療專注於設計、製造和營銷影像技術,以引導常見的微創心血管程序。其擁有專利的Novasight Hybrid System是第一個將血管內超聲(IVUS)和光學相干斷層掃描(OCT)結合起來,實現冠狀動脈的同時和共同成像的系統。Novasight Hybrid System已獲得美國食品和藥物管理局的510(k)清除;並獲得了加拿大衛生部、中國國家藥品監督管理局和日本厚生勞動省的臨床使用監管批准。欲了解更多信息,請訪問。
關於前瞻性信息的警告聲明
本新聞稿包含着"前瞻性聲明",涉及適用的加拿大和美國證券法規,反映了Conavi未來增長、運營結果、業務前景和機會管理層的當前期望。前瞻性聲明經常被,但並非總是,通過諸如"可能"、"會"、"能夠"、"將"、"預期"、"相信"、"計劃"、"期待"、"打算"、"估計"、"具有潛力"等表達識別,儘管這些詞可能不會出現在所有前瞻性聲明中。出現在本新聞稿中的前瞻性聲明可能包括但不限於對Conavi的Novasight Hybrid System商業化計劃的引用。
這些前瞻性聲明反映了管理層對未來事件的當前信念,並基於目前可獲得的信息,儘管管理層在做出上述聲明的日期認爲其合理,但本質上受到重大的商業、經濟和競爭性的不確定因素和意外事件的影響,可能導致行動、事件、狀況、結果、績效或成就與前瞻性聲明中所預測的大不相同。前瞻性聲明涉及重大風險、不確定性和假設,許多因素可能導致Conavi的實際結果、績效或成就與前瞻性聲明中可能體現或暗示的任何未來的結果、績效或成就大不相同。這些因素和假設包括但不限於Conavi保留關鍵人員的能力;其執行業務計劃和策略的能力;以及列在Conavi於2024年8月30日日期的聯合信息通知信中的"風險因素"部分的其他因素(可查看)。如果這些風險或不確定因素中的一個或多個實現,或前瞻性聲明下的假設被證明不正確,實際結果、績效或成就可能會大不同於本新聞稿中包含的前瞻性聲明所暗示或體現的結果、績效或成就。這些因素應該仔細考慮,潛在投資者不應過分依賴本新聞稿中包含的前瞻性聲明。
儘管新聞稿中的前瞻性聲明基於管理層目前認爲合理的假設,並且Conavi已嘗試確定可能導致實際行動、事件、條件、結果、表現或成就與前瞻性聲明描述不符的重要因素,但Conavi 不能保證未來投資者實際結果、表現或成就將與這些前瞻性聲明一致。除非法律要求,Conavi 明確否認有意或有義務更新或修訂任何前瞻性聲明,無論是基於新信息、未來事件或其他原因。因此,投資者不應過度依賴前瞻性聲明。所有前瞻性聲明均受上述警告性聲明的明確限制。
TSX Venture Exchange及其監管服務提供商(如TSX Venture Exchange政策中所定義)對本新聞稿的充分性或準確性不承擔責任。
聯繫方式
Stephen Kilmer
投資者關係
(647) 872-4849
stephen.kilmer@conavi.com
Stefano Picone
致富金融(臨時代碼) - 首席財務官
(416) 483-0100