FORT MILL, SC / ACCESSWIRE / October 2, 2024 / Catheter Precision, Inc. (NYSE/American:VTAK), a company dedicated in the development and marketing of technologically advanced products for the cardiac electrophysiology market, today announced several updates for their VIVO non-invasive mapping system.
Over the last 60 days and through the month of October the company has participated in several industry meetings where VIVO has been or will be highlighted. During the recent European Society of Cardiology (ESC) meeting congress Professor Tarv Dhanjal from the University of Warwick Hospital in Coventry, UK, presented data of 20 patients from the "Accuracy of a non-invasive mapping system for the localisation of re-entrant VT site of origin and its relationship to myocardial scar on cross-sectional imaging" study. This study currently has 40 patients enrolled and is expected to enroll a total of 50 patients. It is anticipated that this final data to be available in 2025 and that the data will remain positive as enrollment and study conclusion comes to an end. Highlights of the most recent presentation include procedural success in 90% of patients at mean follow up of 7.3 ± 4.7 months in patients with scar related VT.
David Jenkins, Chief Executive Officer of Catheter Precision said, "This is an important study for electrophysiology. This study is focused on patients that have very sick hearts, with low ejection fraction and ischemic cardiomyopathy. This European study shows that VIVO is not only providing accurate results to the physician, but that it is providing better insight to the physician and may be resulting in better outcomes and improved quality of life for patients."
In addition to attending ESC, Catheter Precision will be attending the additional conferences to showcase VIVO during the month of October. These include:
International VT Symposium - October 11 - 12, New York City, NY
International Society of Cardiac Ablation Techniques (ISCAT) - October 16 - 18, Paris, France
Society of Cardiac Robotic Navigation (SCRN) - October 28 - 29, Lisbon, Portugal, where a presentation on European clinical data is scheduled
Catheter Precision continues to expand its commercial footprint for both US and international locations. As previously announced, a successful evaluation of five patients was completed in Doha, Qatar in March 2024. The hospital has now acquired and installed the VIVO system and has completed their first successful commercial procedures.
"Since starting in May, we have aggressively sought new VIVO sites in the US," said Marie-Claude Jacques, Chief Commercial Officer of Catheter Precision. "We are excited to say that more than 25 centers have confirmed interest and scheduled evaluations, with eight new centers scheduled to begin evaluations in the coming weeks".
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.
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.
Cautionary Note Regarding Forward-Looking Statements
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 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.
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.
CONTACTS:
At the Company
David Jenkins
973-691-2000
info@catheterprecision.com
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Contact Information
Missiaen Huck
COO
mhuck@catheterprecision.com
9736912000
SOURCE: Catheter Precision, Inc.
