– 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是第一个结合IVUS和OCT技术,实现冠状动脉的同时成像和注册成像的技术。
公司将在本周的TCt 2024展示其Novasight技术。
多伦多,2024年10月28日(全球新闻社)——致富金融(临时代码:CNVI)("Conavi Medical")的商业阶段公司,专注于设计,制造和营销影像技术,指导常见的微创心血管手术,很高兴宣布美国心脏病学院杂志:心血管介入专辑已经刊登了Tufaro等人撰写的一篇文章,概述了混合介入冠脉成像的最新发展,并讨论了其在不同临床和研究领域的潜在价值,如经皮冠状动脉介入("PCI")指导,易损斑块检测,以及评估针对动脉粥样硬化的局部和全身疗法。
本文摘要可在此处查阅。
引用完整文章内容如下:
多项研究表明,洗净术后血管内成像观察到的特定形态特征与支架失败风险较高相关。 支架未膨胀是支架失败最常见原因;大型边缘撕裂和边缘支架处的斑块与支架边缘相关事件有关,而支架段组织或栓子突出被发现是支架再狭窄和支架血栓形成的预测因素。 最后,在有大量在支架事件发生时进行[光学相干断层扫描("OCT")]成像的患者的大型登记研究中,发现未遮盖或者错位支架支柱与支架血栓形成的风险增加有关,但远景OCt成像研究结果存在冲突;因此,这些特征对支架失败的作用仍然难以捉摸
[血管内超声("IVUS")OCt成像在评估洗净术后结果方面具有理论上的优势;IVUS可以减小支架未膨胀风险,评估支架边缘的[斑块负担],而OCt可以更准确地检测边缘撕裂、参考段的脂质存在、错位和组织突出。 这一假设得到17名接受使用Novasight混合IVUS OCt系统进行择期PCI手术的患者最近一项前瞻性观察性研究的支持 [Conavi Medical]。 在支架植入术后顺利为10名患者完成了IVUS OCt成像。 与IVUS相比,OCt更经常识别到支架支柱完全不贴合(8.0% vs 0.8%; P < 0.001)和组织突出(50.6% vs 15.9%; P < 0.001),但IVUS更常检测到支架未膨胀,而不如OCt(28.7% vs 23.1%; P 1⁄4 0.039)。 这些有希望的发现有望为进行更大规模的研究提供基础,使我们能够对IVUS OCt与独立血管内成像的优越性做出安全结论。
克里斯托斯·V·布兰塔斯(Christos V. Bourantas),Barts心脏中心心脏病顾问和伦敦玛丽皇后大学心脏病学荣誉教授之一,也是JACC:心血管介入文章的作者之一,他评论说:"有大量且不断增长的证据表明,使用OCt或IVUS指导PCI程序极大地提高了患者无事件存活率,增强了程序的长期安全性和有效性。 但是,每种成像模式都有独特的优势和局限性。 Conavi Medical的NovaSight混合系统提供了一个优雅的解决方案,提供同时和互补的数据,以更好地为患者护理提供信息。"
“这篇文章的发布恰逢时机,当我们在华盛顿特区举行的心血管研究基金会年度经导管介入心血管治疗(TCT)大会上展示我们的Novasight Hybrid System时,Conavi Medical的首席执行官汤姆·鲁比表示。"我们要借此机会感谢Tu法罗和布兰塔斯医生,以及他们尊敬的同事们,他们对冠状动脉患者护理中混合成像的增加意识和采用做出了贡献,并期待继续在积极的势头上建设,推进事业。”
关于JACC:心血管介入
JACC:心血管介入涵盖整个介入性心血管医学领域,包括冠心病、结构、外周和脑血管介入。鼓励提交原始研究论文、最新评论、研究简报、社论以及来自心脏病学、血管外科、神经学、放射学、血液学、血管生物学、材料科学、结局研究和相关领域的观点。一般而言,心电生理学、心脏手术或其他介入专业的论文不会被招募。2023年,该杂志的影响因子为11.7。
关于康纳维医疗
康纳维医疗专注于设计、制造和营销影像技术,以引导常见的微创心血管程序。其拥有专利的Novasight Hybrid System是第一个将血管内超声(IVUS)和光学相干断层扫描(OCT)结合起来,实现冠状动脉的同时和共同成像的系统。Novasight Hybrid System已获得美国食品和药物管理局的510(k)清除;并获得了加拿大卫生部、中国国家药品监督管理局和日本厚生劳动省的临床使用监管批准。欲了解更多信息,请访问。
关于前瞻性信息的警告声明
本新闻稿包含着"前瞻性声明",涉及适用的加拿大和美国证券法规,反映了Conavi未来增长、运营结果、业务前景和机会管理层的当前期望。前瞻性声明经常被,但并非总是,通过诸如"可能"、"会"、"能够"、"将"、"预期"、"相信"、"计划"、"期待"、"打算"、"估计"、"具有潜力"等表达识别,尽管这些词可能不会出现在所有前瞻性声明中。出现在本新闻稿中的前瞻性声明可能包括但不限于对Conavi的Novasight Hybrid System商业化计划的引用。
这些前瞻性声明反映了管理层对未来事件的当前信念,并基于目前可获得的信息,尽管管理层在做出上述声明的日期认为其合理,但本质上受到重大的商业、经济和竞争性的不确定因素和意外事件的影响,可能导致行动、事件、状况、结果、绩效或成就与前瞻性声明中所预测的大不相同。前瞻性声明涉及重大风险、不确定性和假设,许多因素可能导致Conavi的实际结果、绩效或成就与前瞻性声明中可能体现或暗示的任何未来的结果、绩效或成就大不相同。这些因素和假设包括但不限于Conavi保留关键人员的能力;其执行业务计划和策略的能力;以及列在Conavi于2024年8月30日日期的联合信息通知信中的"风险因素"部分的其他因素(可查看)。如果这些风险或不确定因素中的一个或多个实现,或前瞻性声明下的假设被证明不正确,实际结果、绩效或成就可能会大不同于本新闻稿中包含的前瞻性声明所暗示或体现的结果、绩效或成就。这些因素应该仔细考虑,潜在投资者不应过分依赖本新闻稿中包含的前瞻性声明。
尽管新闻稿中的前瞻性声明基于管理层目前认为合理的假设,并且Conavi已尝试确定可能导致实际行动、事件、条件、结果、表现或成就与前瞻性声明描述不符的重要因素,但Conavi 不能保证未来投资者实际结果、表现或成就将与这些前瞻性声明一致。除非法律要求,Conavi 明确否认有意或有义务更新或修订任何前瞻性声明,无论是基于新信息、未来事件或其他原因。因此,投资者不应过度依赖前瞻性声明。所有前瞻性声明均受上述警告性声明的明确限制。
TSX Venture Exchange及其监管服务提供商(如TSX Venture Exchange政策中所定义)对本新闻稿的充分性或准确性不承担责任。
联系方式
Stephen Kilmer
投资者关系
(647) 872-4849
stephen.kilmer@conavi.com
Stefano Picone
首席财务官
(416) 483-0100