Presentation at European Society of Cardiology Demonstrates VIVO Accuracy in Complex VT Patients

Rhea-AI Summary

Catheter Precision, Inc. (NYSE American:VTAK) announced interim results from a study presented at the European Society of Cardiology (ESC) Symposium. The study, led by Professor Tarv Dhanjal at Warwick Medical School, demonstrated the accuracy of VIVO in localizing ventricular tachycardia (VT) origin in patients with scar-related re-entrant VT. Key findings include:

- 90% accuracy of VIVO compared to invasive mapping
- Significant match in myocardial scar areas
- 90% procedural success at 7-month follow-up
- Study included patients with various cardiomyopathies and mean ejection fraction of 35.5%

CEO David Jenkins highlighted the significance of these results for treating complex cardiac patients and expressed hope for expanded indications in the US.

Positive

• VIVO demonstrated 90% accuracy in localizing VT origin compared to invasive mapping
• 90% procedural success rate at 7-month follow-up
• Potential for expanded indications in the US market
• VIVO technology shows promise for treating complex cardiac patients

Negative

• None.

Medical Research Analyst

The interim results from the ESC Symposium demonstrate promising outcomes for Catheter Precision's VIVO technology. With a 90% accuracy rate in localizing ventricular tachycardia (VT) origins compared to invasive mapping, VIVO shows significant potential in complex cardiac cases. The study's focus on patients with structural heart disease and low ejection fractions (mean 35.5%) highlights VIVO's efficacy in challenging scenarios.

The 90% procedural success rate at seven-month follow-up is particularly noteworthy, suggesting VIVO's potential to improve long-term outcomes in VT treatment. However, it's important to note that these are interim results from a single-center study. Larger, multi-center trials will be necessary to confirm these findings and establish VIVO's place in clinical practice. The technology's ability to match invasive mapping results, especially in scarred myocardial areas, could significantly reduce procedural risks and improve patient care if validated in larger studies.

Financial Analyst

While the clinical results are promising, the financial implications for Catheter Precision (NYSE American:VTAK) remain uncertain. The VIVO technology's demonstrated accuracy in complex VT cases could potentially expand its market, particularly if additional indications are approved in the US. However, the study's small sample size (20 patients) and interim nature mean that significant market impact is likely still some time away.

Investors should monitor for the full study results and any subsequent regulatory developments. If VIVO gains expanded indications, it could drive revenue growth and market share in the electrophysiology sector. However, the path from clinical results to market success can be long and uncertain. The company's ability to capitalize on these results, secure regulatory approvals and effectively commercialize the technology will be important factors in translating this clinical promise into financial success.

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".

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.

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."

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.

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

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.

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 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.

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
IR@catheterprecision.com

# # #

Contact Information

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

SOURCE: Catheter Precision, Inc.

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FAQ

What was the accuracy rate of VIVO in the ESC study for localizing VT origin?

The study presented at the European Society of Cardiology Symposium showed that VIVO had a 90% accuracy rate in localizing the site of origin of ventricular tachycardia (VT) compared to invasive mapping.

What types of patients were included in the VTAK study on VIVO accuracy?

The study included patients with structural heart disease, including ischemic cardiomyopathy, dilated cardiomyopathy, and hypertrophic cardiomyopathy. The patients had a mean ejection fraction of 35.5%.

What was the procedural success rate for VTAK's VIVO system in the ESC study?

At a mean follow-up of seven months, the study reported a 90% procedural success rate for patients treated using the VIVO system.

Who led the study on VTAK's VIVO system presented at the European Society of Cardiology Symposium?

The study was led by Professor Tarv Dhanjal at the Warwick Medical School, University Hospitals of Coventry and Warwickshire.