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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

在歐洲心臟病學會議上展示VIVO在複雜Vt患者中的準確性
Accesswire ·  09/05 21:00

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".

南卡羅來納州Fort Mill - 2024年9月5日 - Catheter Precision, Inc. (紐交所美國公司:VTAK)今天宣佈,在最近舉行的歐洲心臟學學會(ESC)研討會上,介紹了使用VIVO定位心室心動過速(VT)起源部位的中期結果,用於有瘢痕相關再入VT的患者。此外,該演示還展示了Ct掃描的橫斷面圖像與相關心肌瘢痕之間的關係。該研究正在科文特里和沃裏克郡大學醫院的華威醫學院進行,並由首席調查員塔夫·達尼亞爾教授負責。此次演示主題爲「一種非侵入性映射系統定位再入性VT起源部位的準確性及其與心肌瘢痕之間的關係」。

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.

該中期結果針對二十名結構性心臟病患者進行了介紹,平均射血分數爲35.5%,包括缺血型心肌病、擴張型心肌病和肥厚型心肌病的患者。結果顯示,與由Abbott Advisor HD Grid多極導管進行的侵入性映射相比,VIVO的準確性達到90%。VIVO的非侵入性映射在這些患者的心肌瘢痕區域尤其匹配。在平均七個月的隨訪中,手術成功率達到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的首席執行官大衛·詹金斯評論道:「這些結果對於心臟病發作後心肌瘢痕和結構性心臟病的患者來說非常重要。我們期待能夠招募更多患者並完成這項研究。我們希望這些結果和持續的研究能夠爲VIVO技術在美國帶來更多使用適應症。同時,我們希望VIVO技術能夠成爲治療這一擴大患者群體的非常有用的工具,他們需要最先進的醫療保健。」

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.

Catheter Precision的VIVO(視心室起源),是一種非侵入性的3D成像系統,可使醫生在手術前確定室性心動過速的起點,從而簡化工作流程,減少手術時間。VIVO已獲得美國FDA的市場準入和CE標誌。

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

VIVO用於心臟電生理數據和圖表的採集、分析、顯示和存儲,供醫生分析使用。

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用於結構正常的患有特發性室性心律失常的患者進行消融治療的術前規劃工具。

About Catheter Precision

關於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是一家創新的美國醫療器械公司,致力於推出新的市場解決方案,以改善心律失常的治療。通過與醫生合作並不斷提高其產品,專注於開發電生理程序的突破性技術產品。

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," 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.

本新聞稿中的聲明可能包含根據1995年美國《私人證券訴訟改革法案》的「前瞻性聲明」,這些聲明受到重大風險和不確定性的影響。前瞻性聲明可以通過諸如「相信」、「預計」、「可能」、「也許」、「可以」、「能夠」、「繼續」、「依賴」、「期望」、「擴展」、「預測」、「打算」、「預測」、「計劃」、「依賴」、「應該」、「將」、「可能」、「尋求」或這些術語的否定等其他類似表達來識別,儘管並不是所有的前瞻性聲明都包含這些詞。這些前瞻性聲明包括但不限於與醫院的產品評估有關的聲明,並且購買訂單表明醫院及其員工看到Locket帶來的價值和好處,並對未來幾周Locket的評估有所期望。公司對這些事項的期望和信念可能未能實現。由於不確定性、風險和周圍環境的變化,這些前瞻性聲明可能與實際結果有實質性的差異,其中包括但不限於公司在其提交給美國證券交易委員會的Form 10-k中「風險因素」標題下載入並在www.sec.gov上提供的風險和不確定性。這些風險和不確定性包括但不限於,除非我們能夠獲得額外的融資或進行能夠提供額外流動性的戰略交易,否則我們沒有足夠的流動資金來資助我們的運營至2024年5月,否則我們將無法實現盈利,除非我們能夠實現產品擴張和增長目標,我們的研發和商業化工作可能依賴於與合作公司達成協議,我們已經簽署了關於我們產品的聯合營銷協議,並可能簽署其他聯合營銷協議,這將減少我們來自產品銷售的收入,有可能降低我們從Locket設備中獲得的未來利潤,如果我們的信息技術系統發生重大中斷,我們的業務可能受到不利影響,訴訟和其他法律訴訟可能不利影響我們的業務,如果我們進行收購或出售,我們可能會遇到損害我們業務的困難,無法吸引和留住足夠的合格人員也可能阻礙我們的增長,未能保持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對我們的普通股市場價格產生不利影響,我們已經確定我們的內部控制和披露控制在2023年12月31日和2024年3月31日並沒有有效,因此,如果我們確定的重要弱點不能得到有效糾正,我們可能無法準確報告我們的財務結果或防止欺詐,我們的收入可能依賴於我們的客戶從私人保險公司和政府贊助的醫療保健計劃中獲得足夠的賠償,我們可能無法成功與我們行業中的公司競爭,其中許多公司的資源遠遠超過我們的資源,我們未來的運營結果取決於我們能否以商業上合理的條款或按照適合我們的時間表、價格、質量和數量來獲取足夠數量的元件,並且供應商可能未能交付元件,或者我們可能無法有效管理這些元件或根據這些條款獲得這些元件,如果醫院、醫生和患者不接受我們現有和未來的產品,或者如果我們爲任何產品候選人獲得批准的適應症市場小於預期,我們可能無法產生重要的收入,即使有,我們的醫療器械業務仍然受到廣泛和持續的FDA監管要求的影響,我們的產品在獲得FDA或國外批准或許可之後可能會受到進一步的召回、撤銷或中止,這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,美國和其他國家之間的貿易政策變化,特別是新的或更高的關稅的徵收,可能會對我們的平均售價施加壓力,因爲我們的客戶尋求抵消關稅增加對其產品的影響,關稅增加或對國際貿易設置其他壁壘可能對我們的收入和營業成果產生重大不利影響。所述風險和不確定因素上面可能會因爲COVID-19大流行、烏克蘭戰爭或以色列哈馬斯衝突以及股市的持續波動及美國經濟總體情況而進一步放大。

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聲明僅作爲此時此刻的陳述。該公司假設不會再更新這些前瞻性聲明,除非法律上強制要求。

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

# # #

# # #

Contact Information

聯繫信息

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

米西安·哈克
首席運營官
mhuck@catheterprecision.com
973-691-2000

SOURCE: Catheter Precision, Inc.

來源:Catheter Precision, Inc.


譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
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