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Presentation at European Society of Cardiology Demonstrates VIVO Accuracy in Complex VT Patients

Presentation at European Society of Cardiology Demonstrates VIVO Accuracy in Complex VT Patients

在欧洲心脏病学会议上展示VIVO在复杂Vt患者中的准确性
Accesswire ·  09/05 09:00

FORT MILL, SC / ACCESSWIRE / September 5, 2024 / Catheter Precision, Inc. (NYSE American:VTAK) today announced that at the recently held European Society of Cardiology (ESC) Symposium, interim results demonstrating the use of VIVO in localizing the site of origin of ventricular tachycardia (VT) for patients with scar related re-entrant VT were presented. Additionally, the presentation showed the relationship to the relevant myocardial scar on cross-sectional imaging from the CT scan. The study, ongoing at the Warwick Medical School at the University Hospitals of Coventry and Warwickshire is ongoing with lead investigator Professor Tarv Dhanjal. The presentation was entitled "Accuracy of a non-invasive mapping system for the localization of re-entrant VT site of origin and its relationship to myocardial scar on cross-sectional imaging".

南卡罗来纳州Fort Mill - 2024年9月5日 - Catheter Precision, Inc. (纽交所美国公司:VTAK)今天宣布,在最近举行的欧洲心脏学学会(ESC)研讨会上,介绍了使用VIVO定位心室心动过速(VT)起源部位的中期结果,用于有瘢痕相关再入VT的患者。此外,该演示还展示了Ct扫描的横断面图像与相关心肌瘢痕之间的关系。该研究正在科文特里和沃里克郡大学医院的华威医学院进行,并由首席调查员塔夫·达尼亚尔教授负责。此次演示主题为“一种非侵入性映射系统定位再入性VT起源部位的准确性及其与心肌瘢痕之间的关系”。

The interim results were presented on twenty patients with structural heart disease and a mean ejection fraction of 35.5 and included patients with ischemic cardiomyopathy, dilated cardiomyopathy, and hypertrophic cardiomyopathy. The results showed a VIVO accuracy of 90% as compared to invasive mapping, performed with the Abbott Advisor HD Grid multipolar catheter. VIVO non-invasive mapping showed a significant match especially in the area of myocardial scar in these patients. At a mean follow up of seven months, procedural success has been noted in 90% of the patients.

该中期结果针对二十名结构性心脏病患者进行了介绍,平均射血分数为35.5%,包括缺血型心肌病、扩张型心肌病和肥厚型心肌病的患者。结果显示,与由Abbott Advisor HD Grid多极导管进行的侵入性映射相比,VIVO的准确性达到90%。VIVO的非侵入性映射在这些患者的心肌瘢痕区域尤其匹配。在平均七个月的随访中,手术成功率达到90%。

David Jenkins, CEO of Catheter Precision, commented, "These are significant results shown in very sick post heart attack patients with scarred heart muscle and structural heart disease. We look forward to the enrollment of additional patients and the conclusion of the study. We are hopeful that the results and continued research will bring about additional indications for use here in the US. As well, we are hopeful that the VIVO technology will be seen as a very useful tool in treating this expanded group of patients in need of state-of-the-art medical care."

Catheter Precision的首席执行官大卫·詹金斯评论道:“这些结果对于心脏病发作后心肌瘢痕和结构性心脏病的患者来说非常重要。我们期待能够招募更多患者并完成这项研究。我们希望这些结果和持续的研究能够为VIVO技术在美国带来更多使用适应症。同时,我们希望VIVO技术能够成为治疗这一扩大患者群体的非常有用的工具,他们需要最先进的医疗保健。”

About VIVO

有关VIVO Catheter Precision的VIVO(View Into Ventricular Onset)是一种无侵入性三维成像系统,使医生能够在手术前确定心室心律失常的起源,从而简化工作流程并缩短手术时间。VIVO已获得美国FDA的市场准入,以及符合CE标准。

Catheter Precision's VIVO (View Into Ventricular Onset), is a non-invasive 3D imaging system that enables physicians to identify the origin of ventricular arrhythmias pre-procedure, thereby streamlining workflow and reducing procedure time. VIVO has received marketing clearance from the U.S. FDA and has the CE Mark.

Catheter Precision的VIVO(视心室起源),是一种非侵入性的3D成像系统,可使医生在手术前确定室性心动过速的起点,从而简化工作流程,减少手术时间。VIVO已获得美国FDA的市场准入和CE标志。

VIVO is intended for acquisition, analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician.

VIVO用于心脏电生理数据和图表的采集、分析、显示和存储,供医生分析使用。

VIVO is intended to be used as a pre-procedure planning tool for patients with structurally normal hearts undergoing ablation treatment for idiopathic ventricular arrhythmias.

VIVO用于结构正常的患有特发性室性心律失常的患者进行消融治疗的术前规划工具。

About Catheter Precision

关于Catheter Precision

Catheter Precision is an innovative U.S.-based medical device company bringing new solutions to market to improve the treatment of cardiac arrhythmias. It is focused on developing groundbreaking technology for electrophysiology procedures by collaborating with physicians and continuously advancing its products.

Catheter Precision是一家创新的美国医疗器械公司,致力于推出新的市场解决方案,以改善心律失常的治疗。通过与医生合作并不断提高其产品,专注于开发电生理程序的突破性技术产品。

Cautionary Note Regarding Forward-Looking Statements

关于前瞻性声明的谨慎说明

Statements in this press release may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to substantial risk and uncertainties. Forward-looking statements can be identified by words such as "believe," "anticipate," "may," "might," "can," "could," "continue," "depends," "expect," "expand," "forecast," "intend," "predict," "plan," "rely," "should," "will," "may," "seek," or the negative of these terms and other similar expressions, although not all forward-looking statements contain these words. These forward-looking statements include, but are not limited to, statements regarding product evaluations at the hospital, and that the purchase order indicates that the hospital and its staff see the value and benefits that LockeT can bring and expectations regarding LockeT evaluations in the coming weeks. The Company's expectations and beliefs regarding these matters may not materialize. Actual outcomes and results may differ materially from those contemplated by these forward-looking statements as a result of uncertainties, risks and changes in circumstances, including but not limited to risks and uncertainties included under the caption "Risk Factors" in the Company's Form 10-K filed with the SEC and available at www.sec.gov. These risks and uncertainties include, but aren't limited to, that we do not have sufficient liquidity to fund our operations through May 2024 unless we are able to obtain additional financing or enter into a strategic transaction that would provide additional liquidity, we will not be able to reach profitability unless we are able to achieve our product expansion and growth goals, our research and development and commercialization efforts may depend on entering into agreements with corporate collaborators, we have entered into joint marketing agreements with respect to our products, and may enter into additional joint marketing agreements, that will reduce our revenues from product sales, royalty agreements with respect to our LockeT device will reduce any future profits from this product, if we experience significant disruptions in our information technology systems, our business may be adversely affected, litigation and other legal proceedings may adversely affect our business, if we make acquisitions or divestitures, we could encounter difficulties that harm our business, failure to attract and retain sufficient qualified personnel could also impede our growth, failure to maintain effective internal controls could cause our investors to lose confidence in us and adversely affect the market price of our common stock, we have determined that our internal controls and disclosure controls were not effective as of December 31, 2023 and March 31, 2024, and as a result, without effective remediation of the material weaknesses that we have identified, we may not be able to accurately report our financial results or prevent fraud, our revenues may depend on our customers' receipt of adequate reimbursement from private insurers and government sponsored healthcare programs, we may be unable to compete successfully with companies in our highly competitive industry, many of whom have substantially greater resources than we do, our future operating results depend upon our ability to obtain components in sufficient quantities on commercially reasonable terms or according to schedules, prices, quality and volumes that are acceptable to us, and suppliers may fail to deliver components, or we may be unable to manage these components effectively or obtain these components on such terms, if hospitals, physicians and patients do not accept our current and future products or if the market for indications for which any product candidate is approved is smaller than expected, we may be unable to generate significant revenue, if any, our medical device operations are subject to pervasive and continuing FDA regulatory requirements, our products may be subject to additional recalls, revocations or suspensions after receiving FDA or foreign approval or clearance, which could divert managerial and financial resources, harm our reputation, and adversely affect our business, changes in trade policies among the U.S. and other countries, in particular the imposition of new or higher tariffs, could place pressure on our average selling prices as our customers seek to offset the impact of increased tariffs on their own products, increased tariffs or the imposition of other barriers to international trade could have a material adverse effect on our revenues and operating results. The risks and uncertainties described above may be amplified by the COVID-19 pandemic, which has caused significant economic uncertainty, or other pandemics, supply chain disruptions from the Ukraine war or Israeli-Hamas conflict and otherwise, and ongoing volatility in the stock markets and the U.S. economy in general.

本新闻稿中的声明可能包含根据1995年美国《私人证券诉讼改革法案》的“前瞻性声明”,这些声明受到重大风险和不确定性的影响。前瞻性声明可以通过诸如“相信”、“预计”、“可能”、“也许”、“可以”、“能够”、“继续”、“依赖”、“期望”、“扩展”、“预测”、“打算”、“预测”、“计划”、“依赖”、“应该”、“将”、“可能”、“寻求”或这些术语的否定等其他类似表达来识别,尽管并不是所有的前瞻性声明都包含这些词。这些前瞻性声明包括但不限于与医院的产品评估有关的声明,并且购买订单表明医院及其员工看到Locket带来的价值和好处,并对未来几周Locket的评估有所期望。公司对这些事项的期望和信念可能未能实现。由于不确定性、风险和周围环境的变化,这些前瞻性声明可能与实际结果有实质性的差异,其中包括但不限于公司在其提交给美国证券交易委员会的Form 10-k中“风险因素”标题下载入并在www.sec.gov上提供的风险和不确定性。这些风险和不确定性包括但不限于,除非我们能够获得额外的融资或进行能够提供额外流动性的战略交易,否则我们没有足够的流动资金来资助我们的运营至2024年5月,否则我们将无法实现盈利,除非我们能够实现产品扩张和增长目标,我们的研发和商业化工作可能依赖于与合作公司达成协议,我们已经签署了关于我们产品的联合营销协议,并可能签署其他联合营销协议,这将减少我们来自产品销售的收入,有可能降低我们从Locket设备中获得的未来利润,如果我们的信息技术系统发生重大中断,我们的业务可能受到不利影响,诉讼和其他法律诉讼可能不利影响我们的业务,如果我们进行收购或出售,我们可能会遇到损害我们业务的困难,无法吸引和留住足够的合格人员也可能阻碍我们的增长,未能保持有效的内部控制可能会导致我们的投资者对我们失去信心并对我们的普通股市场价格产生不利影响,我们已经确定我们的内部控制和披露控制在2023年12月31日和2024年3月31日并没有有效,因此,如果我们确定的重要弱点不能得到有效纠正,我们可能无法准确报告我们的财务结果或防止欺诈,我们的收入可能依赖于我们的客户从私人保险公司和政府赞助的医疗保健计划中获得足够的赔偿,我们可能无法成功与我们行业中的公司竞争,其中许多公司的资源远远超过我们的资源,我们未来的运营结果取决于我们能否以商业上合理的条款或按照适合我们的时间表、价格、质量和数量来获取足够数量的元件,并且供应商可能未能交付元件,或者我们可能无法有效管理这些元件或根据这些条款获得这些元件,如果医院、医生和患者不接受我们现有和未来的产品,或者如果我们为任何产品候选人获得批准的适应症市场小于预期,我们可能无法产生重要的收入,即使有,我们的医疗器械业务仍然受到广泛和持续的FDA监管要求的影响,我们的产品在获得FDA或国外批准或许可之后可能会受到进一步的召回、撤销或中止,这可能会转移管理和财务资源,损害我们的声誉并对我们的业务产生不利影响,美国和其他国家之间的贸易政策变化,特别是新的或更高的关税的征收,可能会对我们的平均售价施加压力,因为我们的客户寻求抵消关税增加对其产品的影响,关税增加或对国际贸易设置其他壁垒可能对我们的收入和营业成果产生重大不利影响。所述风险和不确定因素上面可能会因为COVID-19大流行、乌克兰战争或以色列哈马斯冲突以及股市的持续波动及美国经济总体情况而进一步放大。

The forward-looking statements included in this communication are made only as of the date hereof. The Company assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

本次通信中包含的前瞻性声明仅作为此时此刻的陈述。该公司假设不会再更新这些前瞻性声明,除非法律上强制要求。

CONTACTS:

联系方式:

At the Company

公司联系人

David Jenkins
973-691-2000
IR@catheterprecision.com

David Jenkins
973-691-2000
IR@catheterprecision.com

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Contact Information

联系信息

Missiaen Huck
COO
mhuck@catheterprecision.com
973-691-2000

米西安·哈克
首席运营官
mhuck@catheterprecision.com
973-691-2000

SOURCE: Catheter Precision, Inc.

来源:Catheter Precision, Inc.


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