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Catheter Precision, Inc. (NYSE American: VTAK) Reports Q1 2024 Highlights and Operational Performance Report

Catheter Precision, Inc. (NYSE American: VTAK) Reports Q1 2024 Highlights and Operational Performance Report

Catheter Precision, Inc.(纽约证券交易所美国股票代码:VTAK)报告了2024年第一季度亮点和运营业绩报告
Accesswire ·  05/06 18:28

FORT MILL, SC / ACCESSWIRE / May 6, 2024 / Catheter Precision, Inc. (NYSE American:VTAK) a MedTech company pioneering products in the growing field of cardiac electrophysiology, including its VIVO and LockeT product(s), releases Q1 Financials, Operational Report for the quarter ending March 31, 2024.

南卡罗来纳州米尔堡/ACCESSWIRE/2024年5月6日/ Catheter Precision, Inc.(纽约证券交易所美国股票代码:VTAK)是一家医疗科技公司,该公司在不断增长的心脏电生理学领域开创性产品,包括其VIVO和Locket产品,发布了截至2024年3月31日的季度第一季度财务运营报告。

Operational highlights of the first quarter and early second quarter 2024 include the following:

2024年第一季度和第二季度初的运营亮点包括以下内容:

  • Submission of LockeT for CE Mark approval, which is expected in Q3 2024.
  • First published data on initial LockeT clinical study of over 100 patients presented at Western Atrial Fibrillation Symposium. Data included:
    • 100% immediate hemostasis.
    • Allows for same day discharge.
    • Effective at wound closure up to 27F which includes cardiac catheters and products such as left atrial appendage devices and leadless pacemakers.
    • Reduction in the need for multiple closure devices.
  • Attendance at the European Heart Rhythm Association (EHRA) conference
  • Attendance at Monaco USA Arrhythmia Conference (MUAC) at which positive interim study data related to VIVO was presented on the accuracy of VIVO when used for ventricular ablation on infarcted hearts by Professor Tarv Dhanjal from University Hospital of Coventry and Warwickshire.
  • First VIVO procedure in Spain at Hospital Universitario Virgen de las Nieves in Granda with Dr. Pablo J. Sanchez Millan.
  • First procedures at CHU de Rennes (University Hospital of Rennes) in Rennes, France. This hospital is one of the world's most prolific centers in terms of number of ventricular ablations performed each year.
  • Presentation of the first cases in Turkey by Professor Cem Karadeniz at the National Arrhythmia Congress Turkiye meeting.
  • Recruitment and onboarding of US sales and clinical support in new US regions to support the national launch of LockeT and continued expansion of VIVO.
  • Announced new Chief Commercial Officer, Marie-Claude Jaques, as of May 1, 2024.
  • 提交 Locket 以获得 CE 标志批准,预计将于 2024 年第三季度批准。
  • 首次公布了在西方心房颤动研讨会上发表的对100多名患者的Locket初步临床研究的数据。数据包括:
    • 100% 立即止血。
    • 允许当天出院。
    • 在高达 27F 的伤口闭合时有效,包括心脏导管和产品,例如左心房附属装置和无导线起搏器。
    • 减少了对多个封闭装置的需求。
  • 出席欧洲心律协会(EHRA)会议
  • 出席摩纳哥美国心律失常会议(MUAC),考文垂和沃里克郡大学医院的塔夫·丹贾尔教授在会上介绍了与VIVO相关的正面中期研究数据,说明了VIVO在对梗塞心脏进行心室消融时的准确性。
  • 西班牙在格兰达的圣母大学医院与巴勃罗·桑切斯·米兰博士一起进行了首次体外活体手术。
  • 在法国雷恩的CHU de Rennes(雷恩大学医院)进行了首次手术。就每年进行的心室消融术数量而言,该医院是世界上最多产的中心之一。
  • 杰姆·卡拉德尼兹教授在土耳其全国心律失常大会上介绍了土耳其的首批病例。
  • 在美国新地区招募和加入美国销售和临床支持,以支持Locket的全国发布和VIVO的持续扩张。
  • 宣布自2024年5月1日起新任首席商务官玛丽·克劳德·雅克斯。

2024 First Quarter Financial Results are as follows:

2024年第一季度财务业绩如下:

  • Total assets at March 31, 2024, were $28 million
  • Total cash on position at March 31, 2024 was $1.5 million, and $0.5 million at May 6, 2024
  • Total revenues for the three months ended March 31, 2024 were $82 thousand
  • Shareholders' equity as of March 31, 2024 was $18.5 million
  • Net loss for the quarter ended March 31, 2024 was ($2.7) million
  • All revenue as of March 31, 2024 resulted from the purchase of VIVO Positioning Patches (VIVO accessory product)
  • 截至2024年3月31日,总资产为2,800万美元
  • 截至2024年3月31日,头寸现金总额为150万美元,截至2024年5月6日为50万美元
  • 截至2024年3月31日的三个月,总收入为82,000美元
  • 截至2024年3月31日,股东权益为1,850万美元
  • 截至2024年3月31日的季度净亏损为(270万美元)
  • 截至 2024 年 3 月 31 日,所有收入均来自购买 VIVO 定位补丁(VIVO 配件产品)

David Jenkins, acting CEO, commented: "During the first quarter of 2024, we focused on acquiring additional talent for the US to support a formal LockeT launch, and expansion of our VIVO footprint in the US. With initial, positive, clinical data available to the public it is the right time to build upon our already great team and focus on our two unique and differentiated products in the EP market. We continue to seek financing solutions to provide sufficient liquidity to enable us to pursue our business objectives, including both public and private financings."

代理首席执行官大卫·詹金斯评论说:“在2024年第一季度,我们专注于为美国招聘更多人才,以支持Locket的正式推出以及扩大我们在美国的VIVO足迹。随着初步的积极临床数据向公众公开,现在是时候在我们已经很棒的团队基础上再接再厉,专注于我们在EP市场上两种独特的差异化产品上。我们将继续寻求融资解决方案,以提供足够的流动性,使我们能够实现业务目标,包括公共和私人融资。”

About VIVO
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.

关于 VIVO
Catheter Precision的VIVO(查看心室发作)是一种非侵入性的三维成像系统,使医生能够在术前识别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 已获得美国食品药品管理局的上市许可,并拥有 CE 标志。

About LockeT
Catheter Precision's LockeT is a suture retention device intended to assist in hemostasis after percutaneous venous punctures. LockeT is a Class 1 device registered with the FDA.

关于 LockET
Catheter Precision 的 Locket 是一种缝合固定装置,旨在帮助经皮静脉穿刺后的止血。Locket 是一款在 FDA 注册的 1 类设备。

About 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. Reincorporated as Ra Medical Systems, Inc. in Delaware in 2018, the Company changed its name to Catheter Precision, Inc. on August 17, 2023.

关于导管精度
Catheter Precision是一家总部位于美国的创新医疗器械公司,为市场带来了改善心律失常治疗的新解决方案。它专注于通过与医生合作并不断改进其产品,为电生理学手术开发开创性的技术。该公司于2018年在特拉华州重组为Ra Medical Systems, Inc.,并于2023年8月17日更名为Catheter Precision, Inc.

Cautionary Note Regarding Forward-Looking Statements

关于前瞻性陈述的警示说明

This communication contains forward-looking statement. 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 are subject to the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release include, but are not limited to, the following: our belief that it is the right time to build upon our already great team and focus on our two unique and differentiated products in the EP market, and our statement that we continue to seek financing solutions to provide sufficient liquidity to enable us to pursue our business objectives. 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.

本通讯包含前瞻性陈述。前瞻性陈述可以通过诸如 “相信”、“预测”、“可能”、“可能”、“可以”、“继续”、“取决于”、“期望”、“扩展”、“预测”、“打算”、“预测”、“计划”、“依靠”、“应该”、“可能”、“寻求” 等词语来识别,或者这些术语和其他类似表述的否定词,尽管并非所有前瞻性陈述都包含这些词语。这些前瞻性陈述受1995年《私人证券诉讼改革法》的安全港条款的约束。本新闻稿中包含的前瞻性陈述包括但不限于以下内容:我们认为现在是在我们已经很棒的团队基础上再接再厉,专注于我们在EP市场上两种独特的差异化产品的恰当时机;我们声明我们将继续寻求融资解决方案,以提供足够的流动性,使我们能够实现业务目标。公司对这些问题的期望和信念可能无法实现。由于不确定性、风险和情况变化,实际结果和业绩可能与这些前瞻性陈述所设想的结果和业绩存在重大差异,包括但不限于公司向美国证券交易委员会提交的10-K表中 “风险因素” 标题下包含的风险和不确定性,可在www.sec.gov上查阅。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达成提供额外流动性的战略交易,否则我们没有足够的流动性来为2024年5月的运营提供资金;除非我们能够实现产品扩张和增长目标,否则我们将无法实现盈利;我们的研发和商业化工作可能取决于与企业合作者的协议;我们已经与之签订了联合营销协议关于我们的产品,并可能签订额外的联合营销协议,这将减少我们的产品销售收入,与我们的Locket设备相关的特许权使用费协议将减少该产品的任何未来利润,如果我们的信息技术系统出现重大中断,我们的业务可能会受到不利影响,诉讼和其他法律诉讼可能会对我们的业务产生不利影响,如果我们进行收购或剥离,我们可能会遇到损害我们业务的困难,无法吸引和留住我们的业务足够的合格的人员也可能阻碍我们的增长,未能维持有效的内部控制可能导致我们的投资者对我们失去信心,并对普通股的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日没有生效,因此,如果不有效纠正我们已经发现的重大弱点,我们可能无法准确报告财务业绩或防止欺诈,我们的收入可能会取决于我们客户的收据如果私人保险公司和政府赞助的医疗保健计划提供充足的报销,我们可能无法在竞争激烈的行业中成功与公司竞争,其中许多公司的资源比我们多得多,我们未来的经营业绩取决于我们能否以商业上合理的条件或根据我们可接受的时间表、价格、质量和数量获得足够数量的组件,供应商可能无法交付组件,或者我们可能无法有效管理这些组件,或如果医院、医生和患者不接受我们当前和未来的产品,或者任何候选产品获得批准的适应症市场小于预期,我们可能无法创造可观的收入,如果有的话,我们的医疗器械业务受美国食品和药物管理局普遍持续的监管要求的约束,我们的产品在获得美国食品药品管理局或外国批准或许可后可能会被进一步召回、撤销或暂停,这可能会转移注意力管理和财政资源,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贸易政策的变化,特别是征收新的或更高的关税,可能会给我们的平均销售价格带来压力,因为我们的客户试图抵消提高关税、提高关税或实施其他国际贸易壁垒的影响,可能会对我们的收入和经营业绩产生重大不利影响。造成重大经济不确定性的 COVID-19 疫情或其他流行病、乌克兰战争或以色列-哈马斯冲突等造成的供应链中断,以及股市和整个美国经济的持续波动,可能会加剧上述风险和不确定性。

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.

本通讯中包含的前瞻性陈述仅自本文发布之日起作出。除非法律要求,否则公司不承担任何义务,也不打算更新这些前瞻性陈述。

CONTACTS:

联系人:

At the Company
David Jenkins
973-691-2000
IR@catheterprecision.com

在公司
大卫詹金斯
973-691-2000
IR@catheterprecision.com

SOURCE: Catheter Precision, Inc

来源:Catheter Precision, Inc


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