Company secures first purchase order and multi-year commitment at Ireland’s largest electrophysiology centerFort Mill, SC, Dec. 18, 2025 (GLOBE NEWSWIRE) -- Catheter Precision, Inc. (VTAK - NYSE/American), a leader in advanced electrophysiology solutions, today announced the successful implementation of LockeT and the first LockeT purchase order at Mater Private Hospital, located in Dublin, Ireland. This marks a significant milestone in the company’s global expansion strategy and reinforces its commitment ...

Core Insights - Catheter Precision, Inc. has successfully secured a significant tender for its VIVO™ system at Albert Szent-Györgyi Health Centre in Hungary, marking its first installation in the country and reinforcing its growth strategy in Central and Eastern Europe [1][2][3] Company Overview - Catheter Precision is a U.S.-based medical device company focused on innovative solutions for cardiac arrhythmias, emphasizing collaboration with physicians and continuous product advancement [5] Product Details - The VIVO system is a non-invasive 3D imaging technology designed to identify the origin of ventricular arrhythmias prior to procedures, thereby streamlining workflow and reducing procedure time. It has received FDA marketing clearance and holds the CE Mark [4] Market Expansion - The tender at Szeged University Hospital is part of a broader strategy for Catheter Precision to expand into emerging markets, with Hungary identified as a key region for growth. This installation is expected to facilitate wider adoption of the VIVO system throughout Central Europe [2][3]

Core Insights - Catheter Precision, Inc. has successfully launched its LockeT suture retention device in Switzerland, marking a significant milestone for the company in the cardiac electrophysiology market [1][2] Company Overview - Catheter Precision is a U.S.-based medical device company focused on developing innovative solutions for the treatment of cardiac arrhythmias, particularly through advancements in electrophysiology procedures [4] Product Launch and Clinical Outcomes - The first clinical cases of the LockeT device were performed at Spitalzentrum Biel, led by PD Dr. Rainer Zbinden, resulting in excellent procedural outcomes and positive feedback from clinical and nursing teams [2] - The LockeT device is designed to assist in wound closure after percutaneous venous punctures and is classified as a Class 1 device registered with the FDA, also having received CE Mark approval [3] Strategic Partnerships - The launch follows a strategic distribution agreement with FuMedica AG, a prominent Swiss medical device distributor, which will facilitate the introduction of LockeT to hospitals and clinics across Switzerland, thereby expanding Catheter Precision's European presence [2][3] Market Growth - Over 10,000 LockeT devices have been shipped globally, indicating rapid growth and the company's commitment to working closely with partners to enhance patient care [3]

Core Insights - Catheter Precision, Inc. is positioned to expand the commercialization of its LockeT device following the recent addition of key electrophysiology (EP) ablation procedures to the ambulatory surgery centers (ASC) by the Centers for Medicare and Medicaid Services (CMS) [1][2] Company Overview - Catheter Precision is a U.S.-based medical device company focused on developing innovative solutions for cardiac arrhythmias and advancing electrophysiology procedures through collaboration with physicians [5] Product Information - The LockeT device is a suture retention device designed for wound closure after percutaneous venous punctures, classified as a Class 1 device registered with the FDA and has received CE Mark approval [4] Industry Impact - The addition of EP ablation codes to the ASC-Covered Procedures List (ASC-CPL) by CMS, effective January 1, 2026, significantly enhances Medicare beneficiary access to EP services, marking a major advancement in the delivery of EP care in over two decades [2] Market Opportunity - The new CMS codes will facilitate additional patient scheduling and allow for the use of LockeT in more facilities, supporting physicians and patients in post-ablation recovery while ensuring cost-effectiveness and safety [3]

Core Insights - Catheter Precision, Inc. has achieved rapid commercial uptake of its LockeT closure device in South Africa, indicating strong market demand for its product [1][2]. Group 1: Product Implementation - The LockeT device was successfully implemented in five hospitals within two months, with three hospitals using it daily and two using it routinely [2]. - All five hospitals have placed reorders for the LockeT device through the local distributor, HLC Medical [2]. Group 2: Market Importance - The swift adoption of LockeT highlights its significance in emerging markets, where cost-effectiveness and improved workflow are critical [3]. - LockeT is designed to enhance patient care by enabling rapid hemostasis, which allows for same-day discharge [3]. Group 3: Product Overview - LockeT is a suture retention device intended for wound closure after percutaneous venous punctures and is classified as a Class 1 device registered with the FDA, also holding CE Mark approval [4]. Group 4: Company Background - Catheter Precision is a U.S.-based medical device company focused on developing innovative solutions for the treatment of cardiac arrhythmias, emphasizing collaboration with physicians to advance its products [5].

Core Insights - Catheter Precision, Inc. has secured its first multi-year agreement in France for the VIVO™ system, marking a significant commitment to the French electrophysiology market [1][4] - The VIVO system will be installed at the Centre Hospitalier Régional Universitaire (CHRU) Nancy, enhancing the hospital's capabilities in complex arrhythmia ablation [1][2] - This follows a successful deployment at CHU Rennes, which was Catheter Precision's largest purchase order in Europe, indicating strong demand and positive early results [3][4] Company Overview - Catheter Precision is a US-based medical device company focused on developing advanced technologies for cardiac electrophysiology [6] - The company aims to improve treatment for cardiac arrhythmias through innovative solutions and collaboration with healthcare professionals [6] Product Details - The VIVO system is a non-invasive 3D imaging technology that helps physicians identify the origins of ventricular arrhythmias before procedures, thereby streamlining workflows and reducing procedure times [5] - VIVO has received marketing clearance from both the U.S. FDA and has the CE Mark, indicating its compliance with regulatory standards [5] Market Position - The installation of VIVO at prestigious hospitals like CHRU Nancy and CHU Rennes reflects the growing momentum and clinical value of the product in the French market [4] - The involvement of leading academic centers is crucial for the early adoption of VIVO among physicians, which is expected to drive long-term usage [4]

Financial Results Announcement - Catheter Precision, Inc. announced its financial results for the three and nine months ended September 30, 2025[4]. - The press release detailing the financial results was issued on November 13, 2025[4]. - The financial results include key metrics that will be detailed in Exhibit 99.1 attached to the report[5]. Company Information - The company is listed on the NYSE American under the trading symbol VTAK[2]. - The company is based in Fort Mill, SC, with a principal executive office address provided[1]. Regulatory Compliance - The report indicates that Catheter Precision, Inc. is not an emerging growth company[3]. - The report does not incorporate any information as "filed" under the Securities Exchange Act of 1934[5]. - The report is part of the requirements set forth by the Securities Exchange Act of 1934[8]. Report Details - The Chief Financial Officer, Philip Anderson, signed the report on November 14, 2025[10]. - The report includes an interactive data file formatted as inline XBRL[6].

Regulatory Approvals and Product Development - Catheter Precision, Inc. has received FDA clearance for the VIVO System as a pre-procedure planning tool for patients with structurally normal hearts undergoing ablation treatment for idiopathic ventricular arrhythmias [252]. - The VIVO System has been utilized in over 1,000 procedures in the U.S. and EU by more than 30 physicians, with no reported device-related complications [252]. - The company formed a new subsidiary, Cardionomix, to acquire assets related to the Cardiac Pulmonary Nerve Stimulation (CPNS) System, which is in development and has yet to obtain regulatory approval [249]. - KardioNav, another subsidiary, is focused on developing a system that interfaces with implanted cardiac devices to improve pre-ablation mapping and localization of arrhythmogenic tissue [250]. - The company has commenced limited sales of the VIVO System in Europe and the UK through independent distributors [254]. - LockeT, a suture retention device, was first sold in May 2024 and received its first patent in China in September 2024 [255]. - In April 2025, LockeT obtained CE Mark approval for marketing in the EU, Switzerland, and Turkey, leading to new distribution agreements in multiple countries [256]. - Clinical studies for LockeT began in 2023, aiming to demonstrate faster wound closure and lower healthcare costs [258]. - The acquisition of PeriKard was completed on January 24, 2025, for $113 thousand in stock, with potential royalty payments of 10% on net sales for five years [260]. - Cardionomic acquired the CPNS System on May 5, 2025, with total consideration of $1.9 million recognized as acquired in-process research and development [262]. Financial Performance and Revenue - Revenue for the three months ended September 30, 2025, increased by approximately $130 thousand, driven by a $92 thousand increase in LockeT sales and a $38 thousand increase in VIVO System sales compared to the same period in 2024 [287]. - For the nine months ended September 30, 2025, revenue increased by approximately $310 thousand, primarily due to a $322 thousand increase in LockeT sales, partially offset by a $12 thousand decrease in VIVO System sales [287]. - Cost of revenues increased by approximately $8 thousand and $12 thousand for the three and nine months ended September 30, 2025, respectively, mainly due to increased LockeT sales [288]. - Selling, general and administrative expenses rose by approximately $0.1 million for the three months and $1.1 million for the nine months ended September 30, 2025, attributed to increased professional fees and stock-based compensation [289][290]. - Research and development expenses increased by approximately $0.2 million for the three months and $0.4 million for the nine months ended September 30, 2025, primarily due to higher professional fees and salaries [291][292]. - Acquired in-process research and development expenses recognized as R&D expense totaled $119 thousand for the nine months ended September 30, 2025 [261]. - Acquired in-process research and development expenses increased by approximately $2.0 million for the nine months ended September 30, 2025, related to two asset acquisitions completed in 2025 [293]. Cash Flow and Financing - Net cash used in operating activities was $6.8 million for the nine months ended September 30, 2025, primarily due to a net loss of $11.8 million [303]. - As of September 30, 2025, the company had cash and cash equivalents of $1.1 million and an accumulated deficit of $303.8 million [298]. - The company expects operating losses and negative cash flows to continue unless sales and gross profit increase sufficiently to cover operating expenses [300]. - During the nine months ended September 30, 2024, net cash provided by financing activities was $4.2 million, consisting of $2.6 million from the issuance of common stock and $1.5 million from notes payable due to related parties [307]. - The May 2025 PIPE Financing raised gross proceeds of $1.5 million, with additional shares of preferred stock and warrants issued [264]. - As of September 30, 2025, 868,582 shares were sold under the At Market Offering Agreement for gross proceeds of $4.0 million [274]. Internal Controls and Regulatory Risks - The company has identified material weaknesses in its internal control over financial reporting, which could affect its ability to report results accurately [243]. - The company is subject to extensive regulatory scrutiny, and its products may face recalls or suspensions after receiving FDA approval [243]. - The company has not engaged in any off-balance sheet arrangements during the periods presented, indicating a straightforward financial structure [308]. - The company regularly evaluates estimates related to asset acquisitions, including provisions for legal contingencies and income taxes, which could materially affect financial results [310]. Accounting and Valuation - The fair value of trading debt securities is determined using a probability weighted expected return model, which incorporates significant unobservable inputs [314]. - The company recognizes a liability for royalty fees based on actual sales of products, with future estimated royalty payments remeasured at each reporting period [316]. - The fair value measurement of royalties payable includes significant unobservable inputs and is based on an internally developed revenue adjusted discount rate [317]. - New accounting pronouncements are discussed in the financial statements, detailing expected adoption dates and estimated effects on operations [318].

Financial Highlights - Total revenue for Q3 2025 was reported at $226,000, marking a 135% increase from $96,000 in Q3 2024 [9] - For the nine months ended September 30, 2025, total revenue reached $581,000, up 114% from $271,000 in the same period of 2024 [9] - GAAP net loss for Q3 2025 was $2,251,000, a 45% reduction compared to $4,120,000 in Q3 2024 [9] - GAAP net loss for the nine months ended September 30, 2025, was $11,405,000, compared to $11,015,000 for the same period in 2024 [9] Commercial Highlights - Sales activities for the LockeT device outside the U.S. are increasing, with CE Mark approval generating interest in countries such as Germany, France, Italy, Spain, Portugal, the UK, and South Africa [2] - In October, five accounts in South Africa placed reorders for LockeT [2] - VIVO product line is gaining traction internationally, with the first purchase order from France received in October [2] Clinical Studies and Publications - Clinical studies and publications remain a priority, with an interview in EP Lab Digest highlighting the economic benefits of the LockeT device for venous closure after electrophysiology procedures [3] Company Outlook - The CEO of Catheter Precision expressed confidence in a pivotal growth period ahead, supported by a well-established pipeline and the completion of two VIVO clinical studies in 2025 [4] - The company anticipates a major expansion of its approved product lines across U.S. and international markets [4] - VIVO is positioned as a transformative approach to treating ventricular arrhythmias, potentially capturing a significant share of an underserved market [4]

Core Insights - Catheter Precision, Inc. has entered into a strategic distribution agreement with FuMedica AG to introduce its LockeT suture retention device in Switzerland [1][4] - The LockeT device is designed to simplify and secure the closure of vascular access sites after cardiac procedures, enhancing procedural outcomes [2][5] - FuMedica AG is recognized for its excellence in distributing advanced medical technologies, particularly in cardiology, making it a suitable partner for Catheter Precision [3][7] Company Overview - Catheter Precision is a U.S.-based medical device company focused on innovative solutions for cardiac arrhythmias and electrophysiology procedures [6] - The company aims to improve treatment outcomes through collaboration with physicians and continuous product advancement [6] Product Details - The LockeT device is classified as a Class 1 medical device registered with the FDA and has received CE Mark approval, indicating its compliance with European health standards [5] - Its intuitive design and reliable performance have made it a valuable tool in electrophysiology labs and interventional suites globally [2] Partnership Significance - The agreement with FuMedica AG is a key milestone in Catheter Precision's European growth strategy, leveraging FuMedica's market knowledge and commitment to quality [4] - The partnership reflects Catheter Precision's dedication to global collaboration and innovation in cardiac care [4]