Catheter Precision, Inc. Receives CE Mark for LockeT
Catheter Precision (NYSE American: VTAK) has received CE Mark approval for LockeT, its advanced vascular closure device, enabling market access in the EU, UK, Switzerland, and Turkey. The European Vascular Closure Devices Market, valued at $3.1 billion in 2024, is projected to reach $4.3 billion by 2028 with a 7% CAGR.
The company has already secured its first order of 100 units and is in discussions with multiple distribution partners. LockeT offers economic advantages over competing products and features easy deployment, patient comfort, and intuitive recovery nursing processes.
Catheter Precision (NYSE American: VTAK) ha ottenuto l'approvazione CE per LockeT, il suo avanzato dispositivo per la chiusura vascolare, permettendo l'accesso al mercato nell'UE, Regno Unito, Svizzera e Turchia. Il mercato europeo dei dispositivi per la chiusura vascolare, valutato 3,1 miliardi di dollari nel 2024, è previsto raggiungere 4,3 miliardi di dollari entro il 2028 con un CAGR del 7%.
L'azienda ha già assicurato il primo ordine di 100 unità ed è in trattative con diversi partner distributivi. LockeT offre vantaggi economici rispetto ai prodotti concorrenti e si distingue per la facilità di utilizzo, il comfort del paziente e processi di assistenza infermieristica intuitivi durante il recupero.
Catheter Precision (NYSE American: VTAK) ha recibido la aprobación del marcado CE para LockeT, su avanzado dispositivo de cierre vascular, lo que permite el acceso al mercado en la UE, Reino Unido, Suiza y Turquía. El mercado europeo de dispositivos de cierre vascular, valorado en 3.1 mil millones de dólares en 2024, se proyecta que alcance 4.3 mil millones de dólares para 2028 con una tasa CAGR del 7%.
La compañía ya ha asegurado su primer pedido de 100 unidades y está en conversaciones con varios socios de distribución. LockeT ofrece ventajas económicas frente a productos competidores y destaca por su fácil despliegue, comodidad para el paciente y procesos de enfermería intuitivos durante la recuperación.
Catheter Precision (NYSE American: VTAK)는 고급 혈관 폐쇄 장치인 LockeT에 대해 CE 마크 승인을 받아 EU, 영국, 스위스, 터키 시장 진입이 가능해졌습니다. 2024년 기준 31억 달러 규모인 유럽 혈관 폐쇄 장치 시장은 2028년까지 43억 달러에 도달할 것으로 예상되며 연평균 성장률(CAGR)은 7%입니다.
회사는 이미 100대의 첫 주문을 확보했으며 여러 유통 파트너와 협의 중입니다. LockeT는 경쟁 제품 대비 경제적 이점이 있으며 간편한 설치, 환자 편안함, 직관적인 회복 간호 프로세스를 제공합니다.
Catheter Precision (NYSE American : VTAK) a obtenu l'approbation CE pour LockeT, son dispositif avancé de fermeture vasculaire, permettant l'accès au marché dans l'UE, au Royaume-Uni, en Suisse et en Turquie. Le marché européen des dispositifs de fermeture vasculaire, évalué à 3,1 milliards de dollars en 2024, devrait atteindre 4,3 milliards de dollars d'ici 2028 avec un taux de croissance annuel moyen (CAGR) de 7 %.
La société a déjà obtenu sa première commande de 100 unités et est en discussion avec plusieurs partenaires de distribution. LockeT offre des avantages économiques par rapport aux produits concurrents et se distingue par une mise en œuvre facile, le confort du patient et des processus de soins intuitifs lors de la récupération.
Catheter Precision (NYSE American: VTAK) hat die CE-Kennzeichnung für LockeT, sein fortschrittliches vaskuläres Verschlussgerät, erhalten, was den Marktzugang in der EU, Großbritannien, der Schweiz und der Türkei ermöglicht. Der europäische Markt für vaskuläre Verschlussgeräte, der im Jahr 2024 auf 3,1 Milliarden US-Dollar geschätzt wird, soll bis 2028 auf 4,3 Milliarden US-Dollar mit einer jährlichen Wachstumsrate (CAGR) von 7 % anwachsen.
Das Unternehmen hat bereits die erste Bestellung von 100 Einheiten gesichert und befindet sich in Gesprächen mit mehreren Vertriebspartnern. LockeT bietet wirtschaftliche Vorteile gegenüber Konkurrenzprodukten und zeichnet sich durch einfache Anwendung, Patientenkomfort und intuitive Pflegeprozesse während der Genesung aus.
- CE Mark approval received for LockeT device, enabling access to European markets
- First order of 100 units already secured from EU
- Large market opportunity: European market valued at $3.1B (2024) growing to $4.3B (2028)
- Multiple distribution partnerships in discussion
- Product offers economic advantages compared to competitors
- None.
Insights
CE Mark approval for LockeT vascular closure device opens $3.1B European market with first 100-unit order already secured.
Catheter Precision's newly CE-marked LockeT device represents a significant market expansion into the European vascular closure space. The approval grants access to the EU, UK, Switzerland, and Turkey – markets collectively valued at
This regulatory milestone is particularly notable as European approvals have become increasingly stringent. The immediate commercial traction, evidenced by their first 100-unit order, validates both market demand and the company's preparedness for European commercialization. Management has strategically laid groundwork through distribution partner discussions ahead of approval.
LockeT's value proposition centers on economic advantages versus competitors while maintaining clinical efficacy. The device architecture focuses on three key attributes that drive adoption in vascular closure: ease of deployment for physicians, patient comfort, and workflow efficiency for recovery nursing staff.
For Catheter Precision, this approval transforms their addressable market. Their strategic focus on cost-effective cardiac solutions is well-aligned with European healthcare systems' procurement priorities. The company now faces execution challenges of establishing distribution networks and generating clinical evidence specific to European practice patterns to drive adoption.
Opens Multi-Billion Market Opportunity for the Company
First Order for 100 Units Received
FORT MILL, S.C., May 27, 2025 (GLOBE NEWSWIRE) -- Catheter Precision, Inc. (NYSE American: VTAK), a US based medical device company focused on developing technologically advanced products for the cardiac electrophysiology market announced that it has received CE Mark approval for LockeT, the latest advanced vascular closure device.
Receipt of the CE Mark indicates compliance with European Union (EU) regulations, specifically health, safety, and environmental protection standards. With this approval, LockeT is now eligible to be placed in markets within the EU and additional countries such as the UK, Switzerland and Turkey.
According to Market Data Forecast, The European Vascular Closure Devices Market in Europe was worth
Marie-Claude Jacques, Chief Commercialization Officer of Catheter Precision, stated, “We are very excited by the news of the receipt of our CE Mark. This expands the footprint for new LockeT sales. In anticipation of the CE Mark, we have been engaged in discussion with multiple strong distribution partners to market LockeT within the new countries which the CE Mark has opened for us, have received positive feedback, confirmed interest from many potential LockeT users both in Interventional Cardiology and Electrophysiology and have already received our first order from the EU.”
David Jenkins, CEO of VTAK, further commented, “This is exciting news for our company. We are continuing to execute our strategy of selling innovating cost-effective solutions into the cardiac marketplace. As European approvals are becoming increasingly difficult to obtain, we are proud of our team for achieving this milestone. European hospitals are an ideal market for our closure device, which provides economic advantages compared to other products on the market. And at the forefront, LockeT is easy to deploy, comfortable for the patient, and intuitive for recovery nursing. We are pleased to have this approval and eager to get launched in Europe.”
About LockeT
Catheter Precision’s LockeT is a suture retention device intended to assist in wound closure after percutaneous venous punctures. LockeT is a Class 1 device registered with the FDA and has received CE Mark approval.
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.
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
FAQ
What is the significance of VTAK receiving CE Mark approval for LockeT?
How many LockeT units has VTAK secured in their first European order?
What is the projected market size for Vascular Closure Devices in Europe by 2028?
What are the key advantages of VTAK's LockeT device?
