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Catheter Precision, Inc. Announces Receipt of First Purchase Order for VIVO From Distributor in Middle East

Catheter Precision, Inc. Announces Receipt of First Purchase Order for VIVO From Distributor in Middle East

导管精密公司宣布收到来自中东分销商的VIVO第一个采购订单。
Accesswire ·  06/20 08:00

FORT MILL, SC / ACCESSWIRE / June 20, 2024 / Catheter Precision, Inc. (the "Company") (NYSE American:VTAK), a US based innovative medical device company announced that it has received its first purchase order from Qatar. As previously announced, an initial evaluation of the VIVO product was completed earlier this year at Hamad Medical Corporation Heart Hospital in Doha.

美国创新医疗器械公司 Catheter Precision, Inc.(该公司)(纽交所:VTAK)近日宣布,公司已从卡塔尔收到第一个订单。正如之前所宣布的,今年早些时候,在多哈的Hamad Medical Corporation心脏医院完成了对VIVO产品的初步评估。

"VIVO is a tool that allows physicians to streamline ventricular ablation procedures potentially saving time and reducing patient complications", said Fatih Ayoglu, European Sales Manager. "We look forward to continuing this expansion strategy."

欧洲销售经理Fatih Ayoglu表示:“VIVO是一种工具,可使医生简化心室消融手术,潜在地节省时间并减少患者并发症。我们期待继续这种扩张战略。”

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.

本新闻发布中的声明可能包含1995年《私人证券诉讼改革法案》所规定的“前瞻性声明”,其受到重大风险和不确定性的影响。前瞻性声明可以通过单词“相信”、“期望”、“扩大”、“预测”、“计划”、“应该”、“愿意”、“寻求”、“将要”、“可能”、及其否定等类似的表达方式进行识别,尽管不是所有前瞻性声明都包含这些词语。这些前瞻性声明包括如下内容,但并不局限于:VIVO是一种工具,可使医生简化心室消融手术,潜在地节省时间并减少患者并发症,我们期待继续我们的扩张战略。它们还包括关于未来扩张战略成功的任何暗示性声明,经销商的订单将带来VIVO的广泛采用,当前订单将导致卡塔尔哈马德医疗公司或卡塔尔、中东或其他人员的未来订单。药企的希望和信心,这些言论可能不会成真。由于不确定性、风险和情况的变化,这些前瞻性声明的实际结果和成果可能与其设想的截然不同。风险包括但不限于不同的EP社区成员和其他医生和医院将不会发现VIVO的价值,或出于其他原因而更喜欢其他方法和/或产品,包括我们目前的竞争对手的产品以及我们尚未意识到的可能的新竞争对手的产品;客户和新分销商,包括尚未与我们签订长期采购合同的哈马德医疗公司,将来可能不会再次购买,我们与他们和/或其他分销商和/或卡塔尔和其他中东地区人员的业务关系可能会受到武装冲突、以及美国与其他国家之间的贸易政策变化和/或相关的地缘政治变化的影响而受到干扰;和我们企业的其他风险和不确定性,具体见公司10-K表中的“风险因素”部分以及其他SEC提交给www.sec.gov的文件。这些附加风险和不确定性可能会被COVID-19大流行病放大,该大流行病引发了重大的经济不确定性,以及其他大流行病,从乌克兰战争、以色列哈马斯冲突和其他中东和其他地区的持续冲突和不稳定性中的业务实施,以及股票市场和美国经济总体的持续波动。

About Catheter Precision

关于Catheter Precision

Catheter Precision is an innovative U.S.-based medical device company bringing new solutions to market to provide hospitals and physicians with the tools they need to push the standard of care. It is focused on developing groundbreaking technology by collaborating with physicians and continuously advancing its products.

Catheter Precision是一家医疗器械公司,致力于开发新的产品并将其推向市场,为医院和医生提供推动标准的工具。该公司专注于与医生合作开发前沿技术,并不断推进其产品。

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," "would," "forward," 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 that VIVO is a tool that allows physicians to streamline ventricular ablation procedures potentially saving time and reducing patient complications, and that we look forward to continuing our expansion strategy. They also include any implied statements regarding the future success of our expansion strategy, that purchase orders by distributors will lead to widespread adoption of VIVO, and that the current purchase order will lead to future orders from Hamad Medical Corporation or other persons in Qatar, the Middle East or elsewhere. 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 the risk that members of the EP community and other doctors and hospitals will fail to recognize VIVO's value or for other reasons will prefer other methodologies and/or products, including the products of our current competitors as well as possible new and emerging competing products of which we are not yet aware; the risk that customers and new distributors, including Hamad Medical Corporation, which has not entered into a long term purchasing contract with us, may not make additional purchases in the future, and that our business relationship with them and/or other distributors and/or persons in Qatar and elsewhere in the Middle East could be disrupted by the armed conflict in Israel and the Gaza strip and/or changes in U.S. international relations and/or related geopolitical changes; and other risks and uncertainties attendant to our business included under the caption "Risk Factors" in the Company's Form 10-K and other SEC filings available at www.sec.gov. These additional risks and uncertainties include, but aren't limited to, risks that our cash needs will continue to exceed our 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 and finished product 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 finished product, or we may be unable to manage these components or product procurement effectively or obtain these components or products 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 potential product liability risks as well as 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, disruptions to our ability to conduct business overseas, including to our supply chain, from the Ukraine war, the Israeli-Hamas armed conflict and other ongoing hostilities and instabilities in the Middle East and elsewhere, and ongoing volatility in the stock markets and the U.S. economy in general.

本文中的陈述可能包含《1995年私人证券诉讼改革法案》中的“前瞻性陈述”,而这些前瞻性陈述可能会受到重大的风险和不确定性的影响。 前瞻性陈述可通过单词“相信”、“预计”、“扩张”、“预测”、“计划”、“依赖”、“期待”、“增长”、“预期”、“想要”或类似的表达方式进行识别,尽管并非所有前瞻性陈述都包含这些词。 例如,本文中包括关于VIVO是一种工具,可使医生简化心室消融手术,潜在地节省时间并减少患者并发症,我们期待继续我们的扩张战略的陈述。 它们还包括任何关于未来扩张战略成功的暗示声明,分销商的订单将导致VIVO的广泛采用,当前订单将导致来自卡塔尔、中东或其他地区的哈马德医疗公司或个人的未来订单。本公司对这些事项的期望和信念可能不会实现。由于不确定性、风险和情况的变化,上述前瞻性陈述的实际结果和结果可能与上述内容所描绘的有本质的不同。这些变化的风险和防范措施包括,但不限于,关于我们业务风险因素的信息的详细描述,请参阅我们在SEC提交的有关 Form 10-K和其他文件中披露的内容。 我们的附加风险和不确定性包括,但不限于:我们的现金需求将继续超过我们的流动资金,除非我们能够实现我们的产品扩展和增长目标,否则我们将无法实现盈利,我们的研发和商业化努力可能依赖于与企业协作者签订协议,我们已经就产品签署了联合营销协议,并可能签署其他联合营销协议,这将减少我们从产品销售中的收入,与我们的LockeT设备有关的版税协议将会减少对该产品的任何未来利润,如果我们的信息技术系统遇到重大故障,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,无法招募和留住足够数量的合格人员也可能妨碍我们的增长,未能维护有效的内部控制可能导致我们的投资者失去信心,从而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截至2023年12月31日和2024年3月31日不起作用,因此,除了识别出的重大缺陷得到有效补救之外,我们可能无法准确报告我们的财务结果或防止欺诈行为,我们的收入可能取决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收到足够的报销,我们可能无法与我们高度竞争的行业中的公司成功竞争,其中许多公司的资源大大超过我们,我们未来的运营结果取决于我们能否按照合理商业条款或按照可接受我们的时间表、价格、质量和数量的调度获得元件和成品,供应商可能无法交付元件或成品,或者我们可能无法有效管理这些元件或产品采购或者在这些条款下获得这些元件或产品,如果医院、医生和患者不接受我们当前和未来的产品,或者任何已获批准的产品候选用于指示的市场小于预期,我们可能无法产生重要的收入,如果我们的医疗器械业务的运营不受到广泛和持续的FDA监管要求,我们的产品可能面临潜在的产品责任风险,以及在获得FDA或外国批准或认可后,可能会出现额外的召回、吊销或暂停,这可能会转移管理资源、损害我们的声誉并对我们的业务产生不利影响,美国和其他国家的贸易政策变化,特别是征收新的或更高的关税,可能会对我们的平均售价施加压力,因为我们的客户试图抵消其自己产品所受影响的增加关税的影响,增加的关税或其他国际贸易壁垒可能对我们的营业收入和营业结果产生重大不利影响。COVID-19大流行和其他大流行病、乌克兰战争、以色列哈马斯冲突和中东其他地区正在发生的持续冲突和不稳定因素,以及股票市场和美国经济总体的持续波动可能放大上述风险和不确定性。

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

SOURCE: Catheter Precision, Inc

SOURCE: Catheter Precision, Inc


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