FORT MILL, S.C., May 01, 2025 (GLOBE NEWSWIRE) — Catheter Precision, Inc. (VTAK – NYSE/American), a US based medical device company focused on developing technologically advanced products for the cardiac electrophysiology market announced that new clinical data about VIVO is available.
Catheter Precision previously announced that data was compiled and presented during three different abstract sessions on its VIVO product. VIVO is a non-invasive mapping system used to identify areas of ventricular arrhythmia prior to a procedure. Previously released data documents that VIVO is over 95% accurate and reduces procedure time by almost 30%. This new data comes from leading industry physicians including: Professor Sabine Ernst (UK), Professor Tarv Dhanjal (UK) and Dr. Dhanunjaya Lakkireddy (USA).
This new data highlights additional benefits of VIVO that include:
- When VIVO is used pre-procedurally, there are statistically significant differences in procedural outcomes.
- VIVO provides the ability to identify arrhythmia sources that could not otherwise be identified because the patient does not have frequent arrhythmias, or the patient has difficult anatomy.
- There was high accuracy in a new patient population (ischemic ventricular tachycardia) that also shows successful long-term outcomes.
The data from these abstracts is currently being written into a format that can be submitted to industry journals for more detailed publications.
CEO of Catheter Precision, David Jenkins, said, “New clinical data is the cornerstone of what we do. This new data demonstrates to physicians that not only does VIVO work as intended, but that using VIVO may improve outcomes for patients. Just as importantly, we continue to see evidence of meaningful reduction in procedure time, and in the VT cases we are seeing significantly less burden of VT during the procedure. We will continue to generate new data for publications and look forward to exploring next studies that confirm the data that was presented in these abstracts.”
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.
Caution Regarding Forward Looking Statements
This communication contains forward-looking statements. 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,” “promising,” “potential,” 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, express and implied statements regarding the following: That when VIVO is used pre-procedurally, there are statistically significant differences in procedural outcomes, that VIVO provides the ability to identify arrhythmia sources that could not otherwise be identified because the patient does not have frequent arrhythmias, or the patient has difficult anatomy, that there was high accuracy in a new patient population (ischemic ventricular tachycardia) that also shows successful long-term outcomes, that using VIVO may improve outcomes for patients, and that new studies may confirm the data that was presented in the abstracts discussed. 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 2024 Form 10-K filed with the SEC and available at www.sec.gov. These risks and uncertainties include, but aren’t limited to: that future studies may not confirm the recent data, and the recent data may not prove predictive of future performance.
In addition, our forward looking statements and our business are subject to the following additional uncertainties and risks: we do not have sufficient liquidity to fund our business unless we are able to obtain additional financing or enter into a strategic transaction that would provide additional liquidity during the next three to six months, 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 in the past entered into joint marketing agreements with respect to our products, and may again enter into additional joint marketing agreements in the future that could reduce our revenues from product sales, 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 March 31, 2024, June 30, 2024, September 30, 2024, and December 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 by the U.S. and/or its trading partners could increase our expenses, require us to increase prices, potentially lowering demand for our products, and/or reduce our revenues and operating results, and such increase , 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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