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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

導管精密公司宣佈收到來自中東分銷商的VIVO第一個採購訂單。
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.

美國創新醫療器械公司 Catheter Precision, Inc.(該公司)(紐交所:VTAK)近日宣佈,公司已從卡塔爾收到第一個訂單。正如之前所宣佈的,今年早些時候,在多哈的Hamad Medical Corporation心臟醫院完成了對VIVO產品的初步評估。

"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."

歐洲銷售經理Fatih Ayoglu表示:“VIVO是一種工具,可使醫生簡化心室消融手術,潛在地節省時間並減少患者併發症。我們期待繼續這種擴張戰略。”

About VIVO

有關VIVO Catheter Precision的VIVO(View Into Ventricular Onset)是一種無侵入性三維成像系統,使醫生能夠在手術前確定心室心律失常的起源,從而簡化工作流程並縮短手術時間。VIVO已獲得美國FDA的市場準入,以及符合CE標準。

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.

本新聞發佈中的聲明可能包含1995年《私人證券訴訟改革法案》所規定的“前瞻性聲明”,其受到重大風險和不確定性的影響。前瞻性聲明可以通過單詞“相信”、“期望”、“擴大”、“預測”、“計劃”、“應該”、“願意”、“尋求”、“將要”、“可能”、及其否定等類似的表達方式進行識別,儘管不是所有前瞻性聲明都包含這些詞語。這些前瞻性聲明包括如下內容,但並不侷限於:VIVO是一種工具,可使醫生簡化心室消融手術,潛在地節省時間並減少患者併發症,我們期待繼續我們的擴張戰略。它們還包括關於未來擴張戰略成功的任何暗示性聲明,經銷商的訂單將帶來VIVO的廣泛採用,當前訂單將導致卡塔爾哈馬德醫療公司或卡塔爾、中東或其他人員的未來訂單。藥企的希望和信心,這些言論可能不會成真。由於不確定性、風險和情況的變化,這些前瞻性聲明的實際結果和成果可能與其設想的截然不同。風險包括但不限於不同的EP社區成員和其他醫生和醫院將不會發現VIVO的價值,或出於其他原因而更喜歡其他方法和/或產品,包括我們目前的競爭對手的產品以及我們尚未意識到的可能的新競爭對手的產品;客戶和新分銷商,包括尚未與我們簽訂長期採購合同的哈馬德醫療公司,將來可能不會再次購買,我們與他們和/或其他分銷商和/或卡塔爾和其他中東地區人員的業務關係可能會受到武裝衝突、以及美國與其他國家之間的貿易政策變化和/或相關的地緣政治變化的影響而受到干擾;和我們企業的其他風險和不確定性,具體見公司10-K表中的“風險因素”部分以及其他SEC提交給www.sec.gov的文件。這些附加風險和不確定性可能會被COVID-19大流行病放大,該大流行病引發了重大的經濟不確定性,以及其他大流行病,從烏克蘭戰爭、以色列哈馬斯衝突和其他中東和其他地區的持續衝突和不穩定性中的業務實施,以及股票市場和美國經濟總體的持續波動。

About Catheter Precision

關於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是一家醫療器械公司,致力於開發新的產品並將其推向市場,爲醫院和醫生提供推動標準的工具。該公司專注於與醫生合作開發前沿技術,並不斷推進其產品。

Cautionary Note Regarding Forward-Looking Statements

關於前瞻性聲明的謹慎說明

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.

本新聞稿中可能含有《1995年私人證券訴訟改革法案》中的"前瞻性陳述",這些陳述受到重大風險和不確定性的影響。 "前瞻性陳述" 可通過詞語 "相信"、"預期"、"可能"、"能夠"、"可以"、"繼續"、"依賴"、"期望"、"擴大"、"預測"、"打算"、"預測"、"計劃"、"信賴"、"應該"、"將"、"可能"、"尋求"、"會" 等來識別,或任何其他類似的表達方式,儘管並非所有前瞻性陳述都含有這些詞語。這些前瞻性陳述包括但不限於,聲稱 VIVO 是一種工具,允許醫生簡化室間隔消融手術,潛在地節省時間並減少患者併發症,以及我們期待繼續擴張策略的聲明。它們還包括任何關於我們擴張策略未來成功的暗示陳述,分銷商的採購訂單將導致VIVO的廣泛採用,以及當前採購訂單將導致哈馬德醫療公司或卡塔爾、中東或其他地區的其他人的未來訂單。公司對這些事項的期望和信念可能不會實現。由於不確定性、風險和情況變化,這些前瞻性陳述的實際結果和結果可能與之不同,其中包括但不限於:EP社區的成員和其他醫生和醫院將無法認識到VIVO的價值或由於其他原因會更喜歡其他方法和/或產品,包括我們現有競爭對手的產品以及我們尚未意識到的可能的新興競爭對手的產品;客戶和新分銷商,包括尚未與我們簽訂長期採購合同的哈馬德醫療公司,可能在未來不會進行額外的採購,他們和/或其他分銷商和/或卡塔爾和中東其他地區的人可能會受到以色列和加沙地帶的武裝衝突和/或美國國際關係和/或相關的地緣政治變化影響而造成干擾;以及我們的業務在"風險因素"中列出的公司10-k和其他SEC備案文件中所表述的其他風險和不確定性。這些額外的風險和不確定性包括但不限於:我們的現金需求將繼續超過我們的流動性,除非我們能夠達到我們的產品擴張和增長目標,否則我們將無法實現盈利;我們的研究和開發和商業化工作可能取決於與公司合作伙伴達成協議,我們已經簽署了與我們的產品相關的聯合營銷協議,並可能簽署其他聯合營銷協議,這將減少我們從產品銷售中的收入;與我們的Locket設備相關的版稅協議將減少我們未來從該產品中獲得的任何利潤;如果我們的信息技術系統出現重大故障,我們的業務可能會受到不利影響;訴訟和其他法律訴訟可能會對我們的業務產生不利影響;如果我們進行收購或剝離,我們可能會遭遇有害我們業務的困難;無法吸引和留住足夠數量的合格人員也可能阻礙我們的增長;沒有有效的內部控制可能會導致我們的投資者對我們失去信心,並不利於我們的普通股市場價格,我們已經確定,截至2023年12月31日和2024年3月31日,我們的內部控制和披露控制不具備有效性,因此,在未能有效糾正我們已經確定的重大弱點的情況下,我們可能無法準確報告我們的財務結果或防止欺詐;我們的營業收入可能取決於我們的客戶從私人保險機構和政府贊助的醫療保健計劃獲得足夠的補償,我們可能無法成功地與我們高度競爭的行業中的公司競爭,其中許多公司的資源要比我們多得多;我們未來的運營結果取決於我們在商業合理條款下獲得元件和成品的平衡數量或按照可接受的日程、價格、質量和量,供應商可能未能交付元件或成品,或我們可能無法有效地管理這些元件或產品採購,或按照這些條款獲得這些元件或產品;如果醫院、醫生和患者不接受我們現有和未來的產品或如果任何產品候選的指示市場比預期的小,我們可能無法產生重大的收入(如果有);我們的醫療器械業務必須服從廣泛的、持續的FDA監管要求,我們的產品可能面臨潛在的產品責任風險,以及在獲得FDA或外國批准或許可後,可能還會出現進一步的召回、吊銷或暫停,這些可能會轉移管理和財務資源,損害我們的聲譽,並對我們的業務產生不利影響;美國和其他國家貿易政策的變化,特別是新的或更高的關稅的徵收,可能會加大我們的平均售價所承受的壓力,因爲我們的客戶尋求抵消他們自己產品上關稅增加的影響,增加的關稅或其他國際貿易壁壘可能會對我們的營業收入和營業結果造成重大不利影響。上述風險和不確定性可能會受到COVID-19大流行或其他大流行病、從烏克蘭戰爭、以色列哈馬斯武裝衝突以及其他中東和其他地區的持續衝突和不穩定,以及股票市場的持續波動和美國經濟總體狀況的影響而增強。

CONTACTS:

聯繫方式:

At the Company

公司聯繫人

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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