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Catheter Precision Continues to Expand Clinical Data and Acceptance of VIVO

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Catheter Precision (NYSE/American:VTAK) has announced updates for their VIVO non-invasive mapping system. At the European Society of Cardiology (ESC) meeting, Prof. Tarv Dhanjal presented data from a 20-patient study, showing 90% procedural success at a mean follow-up of 7.3 ± 4.7 months in patients with scar-related VT. The full study, expected to enroll 50 patients, is anticipated to conclude in 2025.

Catheter Precision will showcase VIVO at several conferences in October, including the International VT Symposium, ISCAT, and SCRN. The company is expanding its commercial footprint, with over 25 centers confirming interest and eight new centers scheduled for evaluations. Additionally, following a successful evaluation in Doha, Qatar, the hospital has acquired and installed the VIVO system, completing its first commercial procedures.

Catheter Precision (NYSE/American: VTAK) ha annunciato aggiornamenti per il loro sistema di mappatura non invasivo VIVO. Durante il congresso della Società Europea di Cardiologia (ESC), il Prof. Tarv Dhanjal ha presentato dati da uno studio su 20 pazienti, mostrando un successo procedurale del 90% con un follow-up medio di 7,3 ± 4,7 mesi in pazienti con VT correlata a cicatrici. Si prevede che lo studio completo, che arruolerà 50 pazienti, si concluda nel 2025.

Catheter Precision presenterà VIVO in diverse conferenze a ottobre, inclusi il Simposio Internazionale sulle VT, ISCAT e SCRN. L'azienda sta espandendo la sua presenza commerciale, con oltre 25 centri che confermano il loro interesse e otto nuovi centri programmati per valutazioni. Inoltre, a seguito di una valutazione positiva a Doha, in Qatar, l'ospedale ha acquisito e installato il sistema VIVO, completando le sue prime procedure commerciali.

Catheter Precision (NYSE/American: VTAK) ha anunciado actualizaciones para su sistema de mapeo no invasivo VIVO. En la reunión de la Sociedad Europea de Cardiología (ESC), el Prof. Tarv Dhanjal presentó datos de un estudio con 20 pacientes, mostrando un 90% de éxito en los procedimientos con un seguimiento medio de 7.3 ± 4.7 meses en pacientes con TV relacionada con cicatrices. Se espera que el estudio completo, previsto para incluir 50 pacientes, concluya en 2025.

Catheter Precision mostrará VIVO en varias conferencias en octubre, incluyendo el Simposio Internacional de TV, ISCAT y SCRN. La empresa está ampliando su presencia comercial, con más de 25 centros confirmando interés y ocho nuevos centros programados para evaluaciones. Además, tras una evaluación exitosa en Doha, Catar, el hospital ha adquirido e instalado el sistema VIVO, completando sus primeros procedimientos comerciales.

카테터 프리시전 (NYSE/American: VTAK)은 비침습적 맵핑 시스템 VIVO에 대한 업데이트를 발표했습니다. 유럽 심장학회 (ESC) 회의에서 Tarv Dhanjal 교수는 20명의 환자에 대한 연구 데이터를 발표하며, 흉터 관련 VT 환자에서 평균 7.3 ± 4.7개월의 추적 관찰 기간 동안 90%의 절차 성공률을 보여주었습니다. 50명의 환자를 등록할 예정인 전체 연구는 2025년 완료될 것으로 예상됩니다.

카테터 프리시전은 10월에 국제 VT 심포지엄, ISCAT 및 SCRN과 같은 여러 회의에서 VIVO를 선보일 예정입니다. 이 회사는 25개 이상의 센터가 관심을 확정짓고, 8개의 새로운 센터가 평가를 위해 예정되어 있는 등 상업적 입지를 확대하고 있습니다. 또한 카타르 도하에서 성공적인 평가가 진행된 후, 해당 병원은 VIVO 시스템을 확보하고 설치하여 첫 상업적 절차를 완료했습니다.

Catheter Precision (NYSE/American: VTAK) a annoncé des mises à jour concernant son système de cartographie non invasif VIVO. Lors de la réunion de la Société Européenne de Cardiologie (ESC), le Prof. Tarv Dhanjal a présenté des données d'une étude sur 20 patients, montrant un taux de réussite procédural de 90% avec un suivi moyen de 7,3 ± 4,7 mois chez des patients ayant des TV liées aux cicatrices. L'étude complète, qui prévoit d'inclure 50 patients, devrait se terminer en 2025.

Catheter Precision présentera VIVO lors de plusieurs conférences en octobre, y compris le Symposium International sur la TV, ISCAT et SCRN. L'entreprise élargit son empreinte commerciale, avec plus de 25 centres confirmant leur intérêt et huit nouveaux centres prévus pour des évaluations. De plus, après une évaluation réussie à Doha, au Qatar, l'hôpital a acquis et installé le système VIVO, complétant ses premières procédures commerciales.

Catheter Precision (NYSE/American: VTAK) hat Updates für ihr nicht-invasives Mapping-System VIVO angekündigt. Auf dem Kongress der Europäischen Gesellschaft für Kardiologie (ESC) präsentierte Prof. Tarv Dhanjal Daten aus einer Studie mit 20 Patienten und zeigte einen 90%igen Verfahrenssuccess bei einer durchschnittlichen Nachbeobachtungszeit von 7,3 ± 4,7 Monaten bei Patienten mit narbenbedingtem VT. Die vollständige Studie, die 50 Patienten einschließen soll, wird voraussichtlich 2025 abgeschlossen sein.

Catheter Precision wird VIVO auf mehreren Konferenzen im Oktober vorstellen, darunter das Internationale VT-Symposium, ISCAT und SCRN. Das Unternehmen erweitert seine kommerzielle Präsenz, da über 25 Zentren ihr Interesse bekräftigt haben und acht neue Zentren für Bewertungen vorgesehen sind. Darüber hinaus hat das Krankenhaus nach einer erfolgreichen Bewertung in Doha, Katar, das VIVO-System erworben und installiert und seine ersten kommerziellen Verfahren abgeschlossen.

Positive
  • 90% procedural success rate in patients with scar-related VT
  • Over 25 centers have confirmed interest in VIVO evaluations
  • Eight new centers scheduled to begin evaluations in the coming weeks
  • Successful commercial installation and procedures in Doha, Qatar
Negative
  • None.

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:

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

# # #

Contact Information

Missiaen Huck
COO
mhuck@catheterprecision.com
9736912000

SOURCE: Catheter Precision, Inc.



View the original press release on accesswire.com

FAQ

What is the procedural success rate of VIVO for patients with scar-related VT?

According to the study presented at the European Society of Cardiology meeting, VIVO showed a 90% procedural success rate at a mean follow-up of 7.3 ± 4.7 months in patients with scar-related VT.

How many centers have shown interest in evaluating Catheter Precision's VTAK VIVO system?

Catheter Precision reported that more than 25 centers have confirmed interest and scheduled evaluations for the VIVO system.

When is the full study on VIVO's accuracy expected to conclude?

The full study, which is expected to enroll a total of 50 patients, is anticipated to conclude in 2025.

At which conferences will Catheter Precision (VTAK) showcase VIVO in October 2024?

Catheter Precision will showcase VIVO at the International VT Symposium in New York City, ISCAT in Paris, and SCRN in Lisbon during October 2024.

Catheter Precision, Inc.

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