Catheter Precision(VTAK)
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Catheter Precision(VTAK) - 2025 Q2 - Quarterly Results
2025-08-11 20:16
[Catheter Precision, Inc. Second Quarter 2025 Results of Operations](index=1&type=section&id=Catheter%20Precision%2C%20Inc.%20Reports%20Results%20of%20Operations%20for%20Second%20Quarter%202025) Catheter Precision, Inc. achieved strong Q2 2025 operational and financial growth, driven by revenue increase, product approvals, and strategic acquisitions, despite liquidity and control challenges [Q2 2025 Operational and Strategic Highlights](index=1&type=section&id=Q2%202025%20Operational%20and%20Strategic%20Highlights) Catheter Precision achieved significant Q2 2025 operational momentum through strong revenue growth, European LockeT approval, positive clinical data, and strategic acquisitions - The company achieved significant revenue growth, with a **128% increase year-over-year for Q2** and a **48% increase sequentially** over the previous quarter[1](index=1&type=chunk) - Received the **CE Mark for the LockeT product**, enabling sales to commence in Europe during the third quarter of 2025[1](index=1&type=chunk) - Presented significant positive clinical data at the Heart Rhythm Society symposium, demonstrating **VIVO's high accuracy (over 94%)** in localizing ventricular arrhythmias and **LockeT's safety and efficacy** in large-bore access procedures[1](index=1&type=chunk) - Completed the acquisition of Cardionomic's heart failure assets through its new subsidiary, Cardionomix, and formed Kardionav, Inc., a joint venture to develop a new software product for treating ventricular tachyarrhythmia[1](index=1&type=chunk) [Financial Highlights](index=2&type=section&id=Financial%20Highlights) Catheter Precision reported Q2 2025 revenue growth of **128% to $212 thousand**, alongside a **$5.4 million net loss** primarily due to non-cash charges, ending with **$838 thousand cash** Q2 2025 Financial Summary | Metric | Q2 2025 ($) | Q2 2024 ($) | YoY Change | | :--- | :--- | :--- | :--- | | Revenue | $212 thousand | $93 thousand | +128% | | Net Loss | ($5.4 million) | N/A | N/A | | Metric | H1 2025 ($) | H1 2024 ($) | YoY Change | | :--- | :--- | :--- | :--- | | Revenue | $355 thousand | $175 thousand | +103% | | Net Loss | ($9.5 million) | N/A | N/A | | Balance Sheet (as of June 30, 2025) | ($) | | | :--- | :--- | :--- | :--- | | Total Assets | $25.6 million | | | | Total Shareholders' Equity | $6.5 million | | | | Cash Position | $838 thousand | | | - Non-cash charges constituted a significant portion of the net loss, amounting to **$3.2 million for the three months** and **$4.4 million for the six months** ended June 30, 2025[7](index=7&type=chunk) [Company and Product Overview](index=2&type=section&id=Company%20and%20Product%20Overview) Catheter Precision is a U.S. medical device company focused on improving cardiac arrhythmia treatment, with key commercial products LockeT and VIVO™ both holding FDA clearance and CE Mark approval - **LockeT:** A Class 1 suture retention device used for wound closure after percutaneous venous punctures, registered with the FDA and holding CE Mark approval[4](index=4&type=chunk) - **VIVO™ (View Into Ventricular Onset):** A non-invasive 3D imaging system that helps physicians locate the origin of ventricular arrhythmias pre-procedure, with both U.S. FDA marketing clearance and CE Mark approval[5](index=5&type=chunk) [Forward-Looking Statements and Risk Factors](index=3&type=section&id=Cautionary%20Note%20Regarding%20Forward-Looking%20Statements) The company's forward-looking statements are subject to significant risks, including the need for additional financing, ineffective internal controls, and challenges related to clinical trials, competition, and supply chain - The company lacks sufficient liquidity to fund operations through December 31, 2025, necessitating additional financing or a strategic transaction[8](index=8&type=chunk) - Material weaknesses in internal and disclosure controls as of June 30, 2025, may impair accurate financial reporting or fraud prevention[8](index=8&type=chunk) - Development of assets acquired by KardioNav and Cardionomix is contingent upon obtaining additional financing, which may not be available[8](index=8&type=chunk) - Other significant risks include dependence on successful clinical trials, competition from larger companies, supply chain vulnerabilities, and pervasive FDA regulatory requirements[8](index=8&type=chunk)
Catheter Precision, Inc. Reports Results of Operations for Second Quarter 2025
Globenewswire· 2025-08-11 12:00
Financial Performance - Revenue from product sales increased 128% year over year in Q2 2025, reaching approximately $212 thousand compared to $93 thousand in Q2 2024 [2] - First half 2025 revenue increased 103% over the first half of 2024, totaling approximately $355 thousand compared to $175 thousand [2] - Sequential quarter-over-quarter sales increased by 48% [2] - Net loss for Q2 2025 was approximately $5.4 million, with about $3.2 million attributed to non-cash charges [2] - Total assets as of June 30, 2025, were $25.6 million, and total shareholders' equity was $6.5 million [2] Product Developments - The CE Mark for the LockeT product was received during the quarter, with sales expected to commence in Europe in Q3 2025 [2] - Significant clinical data was presented at the annual Heart Rhythm Society symposium, showcasing the accuracy and long-term outcomes of the VIVO system, which demonstrated over 94% accuracy in a multi-center study involving 125 patients [2] - VIVO's long-term procedural success rate was over 83% [2] - The efficacy and safety of LockeT in large-bore access electrophysiological procedures were validated in a study involving 139 patients [2] - VIVO predicted exit site locations with 89% accuracy in a novel study related to scar-dependent VT [2] Strategic Initiatives - The acquisition of Cardionomic's heart failure assets was completed, forming an 82%-owned subsidiary, Cardionomix [2] - The formation of Kardionav, Inc., a majority-owned joint venture, was completed to develop an implant-based software product for precise ablation site localization [2] - CEO David Jenkins expressed excitement about increasing sales, strong clinical data, and strategic transactions aimed at enhancing the future value of the company [3]
Milestone Achievement for Hospital Using Catheter Precision’s VIVO System
Globenewswire· 2025-08-07 12:00
Core Insights - Heart Hospital of New Mexico has successfully completed 200 ventricular ablation procedures using Catheter Precision's VIVO system, marking a significant milestone for both the hospital and the technology [1][3]. Company Overview - Catheter Precision, Inc. is a U.S.-based medical device company focused on developing advanced products for the cardiac electrophysiology market [5]. - The company aims to improve the treatment of cardiac arrhythmias through innovative technology and collaboration with healthcare professionals [5]. Product Details - The VIVO system (View Into Ventricular Onset) is a non-invasive 3D imaging tool that helps physicians identify the origin of ventricular arrhythmias before procedures, thereby enhancing workflow and reducing procedure time [4]. - VIVO has received marketing clearance from the U.S. FDA and holds the CE Mark, indicating its compliance with European health standards [4]. Hospital Context - Heart Hospital of New Mexico is part of the Lovelace Health system, which includes five hospitals and over 300 healthcare providers, and is dedicated exclusively to cardiovascular care [2].
Catheter Precision, Inc. Announces First Purchase Order From University Hospital in Rennes, France
Globenewswire· 2025-07-07 12:00
Group 1 - Catheter Precision, Inc. has received its largest purchase order to date from Centre Hospitalier Universitaire (CHU) de Rennes for its VIVO product line [1] - CHU Rennes serves nearly 500,000 patients annually and is recognized for its mission in teaching, research, and innovation [2] - The hospital performs over 150 ventricular ablations (VA) per year, positioning it as one of the largest centers for this procedure in Europe [3] Group 2 - The VIVO system is a non-invasive 3D imaging technology that helps physicians identify the origin of ventricular arrhythmias before procedures, enhancing workflow and reducing procedure time [4] - Catheter Precision focuses on developing innovative solutions for cardiac arrhythmias and collaborates with physicians to advance its product offerings [5]
Catheter Precision, Inc. Forms new Joint Venture Called Kardionav to Exploit patented AI Techniques to Create New VT Software platform
Globenewswire· 2025-06-30 12:00
Core Viewpoint - Catheter Precision, Inc. has formed a joint venture named Kardionav with Chelak iECG, Inc. to develop advanced ablation technology for ventricular tachycardia, aiming to improve patient outcomes and reduce treatment times [1][2][3]. Group 1: Joint Venture Details - Kardionav is a joint development company where Catheter Precision will own approximately 56% and Chelak iECG will own 33%, with management holding 10% [1]. - The venture will leverage significant research and intellectual property related to AI for pinpointing ventricular arrhythmias [2]. Group 2: Leadership and Expertise - Dr. Jie Cheng, a prominent figure in cardiac electrophysiology, will serve as the primary researcher for the venture, bringing extensive experience and academic credentials [2]. - Dr. Cheng's background includes a PhD in Biomedical Engineering and positions at Baylor College of Medicine and Texas Heart Institute [2]. Group 3: Technology and Market Impact - The new Kardionav venture aims to enhance the existing VIVO technology by integrating vector technology and imaging to improve the precision of ablation procedures [3]. - Current ablation techniques are criticized for being lengthy and ineffective, often leading to poor patient outcomes, which Kardionav seeks to address [3]. Group 4: Company Overview - Catheter Precision is focused on innovating medical devices to improve cardiac arrhythmia treatments through collaboration with physicians [4].
Catheter Precision, Inc. Comments on Recent Market Activity
Globenewswire· 2025-06-12 18:14
Core Viewpoint - Catheter Precision, Inc. is responding to increased trading activity in its common stock, indicating no known information that would explain this surge [1] Group 1: Company Operations - The company is focused on electrophysiology products and continues to pursue its strategic plans as previously disclosed [1] - Catheter Precision is actively working to secure financing to meet its liquidity needs [1]
Catheter Precision (VTAK) Reports Key Progress for the LockeT Product
Globenewswire· 2025-06-12 11:00
Core Insights - Catheter Precision, Inc. is experiencing significant growth in sales of its LockeT device, with Q2 2025 sales projected to be the highest to date, showing a 200% increase compared to Q2 2024 [1] - Several US hospitals are expected to place purchase orders exceeding $100,000 each for LockeT by the end of 2025, including notable institutions like Montefiore, Eisenhower Health, and Overland Park Regional Medical Center [2] - The company has received CE Mark approval for LockeT, allowing sales in Europe, and is actively expanding its distribution network in Italy, Spain, Portugal, and the UK [3] Company Activities - The CEO of Catheter Precision expressed enthusiasm about the sales pipeline and upcoming activities, including a live demonstration of LockeT at an Italian symposium scheduled for June 16 [4] - The company is focused on increasing product awareness and usage while expanding its market presence in Europe [4] Product Information - LockeT is a Class 1 medical device designed for wound closure after percutaneous venous punctures, registered with the FDA and having received CE Mark approval [5] - Catheter Precision is dedicated to developing innovative solutions for cardiac arrhythmias and advancing electrophysiology procedures through collaboration with physicians [6]
Catheter Precision, Inc. Secures VIVO Purchase Order From Sahlgrenska University Hospital
Globenewswire· 2025-06-09 12:30
Company Overview - Catheter Precision, Inc. is a US-based medical device company focused on developing advanced products for the cardiac electrophysiology market [5] - The company aims to improve the treatment of cardiac arrhythmias through innovative technology and collaboration with physicians [5] Recent Developments - Catheter Precision has received its first purchase order for the VIVO product from Sahlgrenska University Hospital, the largest hospital in Sweden [1][2] - Sahlgrenska University Hospital handles approximately 350,000 patients annually and has the largest ventricular ablation program in Scandinavia [2] Product Information - VIVO™ (View Into Ventricular Onset) is a non-invasive 3D imaging system that helps physicians identify the origin of ventricular arrhythmias before procedures, thus streamlining workflow and reducing procedure time [4] - The VIVO product has received marketing clearance from the U.S. FDA and holds the CE Mark, indicating its compliance with European health standards [4] Strategic Partnerships - The partnership with Sahlgrenska University Hospital is significant as it is a teaching hospital, which allows for training new physicians on the VIVO product, potentially leading to future sales opportunities [3]
Catheter Precision, Inc. Receives CE Mark for LockeT
Globenewswire· 2025-05-27 13:58
Core Insights - Catheter Precision, Inc. has received CE Mark approval for its advanced vascular closure device, LockeT, allowing it to enter European markets [2][3] - The European Vascular Closure Devices Market is projected to grow from $3.1 billion in 2024 to $4.3 billion by 2028, with a CAGR of 7% from 2023 to 2028 [3] - The company has already received its first order for 100 units of LockeT, indicating strong initial demand [1][4] Company Overview - Catheter Precision is a U.S.-based medical device company focused on developing innovative solutions for cardiac arrhythmias and electrophysiology procedures [6] - LockeT is a Class 1 device designed for wound closure after percutaneous venous punctures and has received both FDA registration and CE Mark approval [5] Market Strategy - The company is actively engaging with distribution partners to market LockeT in newly accessible countries following CE Mark approval [4] - The CEO emphasized the economic advantages of LockeT compared to competitors, highlighting its ease of deployment and patient comfort [4]
Catheter Precision(VTAK) - 2025 Q1 - Quarterly Results
2025-05-19 20:17
Transaction Details - The Buyer, Cardionomix, Inc., will acquire Purchased Assets from Seller, Cardionomic, LLC, for a total consideration of $1,500,000 in the form of a promissory note and 1,000,000 shares of common stock from Catheter Precision, Inc. (VTAK) [13][14] - The Closing Date for the transaction is set to occur ten days from the Effective Date, which is April 22, 2025 [15] - The Purchased Assets do not include cash, accounts receivable, or any other excluded assets as defined in the agreement [8] - Seller will retain all liabilities and obligations not assumed by Buyer, referred to as Excluded Liabilities [17] - Buyer has confirmed that it is duly organized and has the necessary authority to enter into this Agreement [19][20] - The execution of this Agreement does not violate any provisions of Buyer or Seller's governing documents or applicable laws [28] - No broker or finder is entitled to any fees in connection with this transaction based on arrangements made by Buyer [29] - Seller has good and marketable title to all Purchased Assets, which are sold on an "AS IS" basis [33] - Buyer acknowledges that the aggregate consideration reflects the "AS IS" condition of the Purchased Assets [35] - There are no claims or proceedings pending against Seller that might affect the Purchased Assets [38] - No governmental approvals are required for the consummation of the transactions contemplated by this Agreement [39] - Seller is not required to be registered as an investment company under the Investment Company Act of 1940 [41] - The VTAK Shares will be validly issued and fully paid upon issuance, free of restrictions other than those imposed by applicable laws [24] - The Absolute Holding Period for the VTAK Shares extends through six months from the date of Closing [44] - Buyer agrees to pay all sales, transfer, use or other taxes related to the sale of the Purchased Assets under this Agreement [56] - Buyer and VTAK shall use commercially reasonable efforts to maintain the listing of VTAK's shares of common stock on NYSE American or another nationally recognized securities exchange [58] - Seller shall deliver complete and correct digital copies of all documents and materials made available to Buyer within ten business days after the Closing [65] - The NYSE American shall have approved the listing of the VTAK Shares upon notice of issuance [71] - Seller acknowledges that it has had an opportunity to ask questions and receive answers concerning the terms and conditions of this transaction [52] - The agreement specifies that each party shall bear its own expenses related to the negotiation and consummation of the transaction [83] - The governing law for the agreement is the internal laws of the State of California [92] - The agreement includes a limitation of liability clause, preventing Buyer from asserting claims against Seller's officers or employees [95] - The agreement allows for execution in counterparts, making electronic signatures valid and binding [90] Financial Terms - The principal amount of the loan is $1,500,000 with a fixed interest rate of 4% per annum [109][110] - Interest accrues daily, calculated by dividing the applicable rate by 360, and is due in full on the maturity date of April [■], 2028 [110] - Borrower can prepay the principal balance at any time without penalty, with prepayments applied first to costs, then to accrued interest, and finally to the principal [111] - All outstanding principal and accrued interest will become immediately due if the borrower files for bankruptcy or similar proceedings [112] - Borrower agrees to pay all costs incurred by the payee in collecting this note, including attorney fees [114] - The note is governed by the laws of the State of Nevada [115] - The borrower is Cardionomix, Inc., represented by David Jenkins as the authorized signatory [121] Intellectual Property - The assets acquired by the Buyer include all U.S. and foreign issued patents, patent applications, and statutory invention registrations [106] - The company has filed multiple patents related to cardiac modulation and neurostimulation systems across various countries, including the US, Europe, and Australia, with significant publications dating from 2017 to 2023 [131][132][133][135][138] - The patent for "Cardiac Contractility Neurostimulation Systems and Methods" was published in the US with application number 62/558,169 on September 13, 2017, indicating ongoing innovation in cardiac treatment technologies [132] - The company has received patent approvals for systems and methods affecting cardiac contractility, with a notable patent issued in Australia (2017229496 B2) on July 14, 2022, enhancing its intellectual property portfolio [132] - A recent patent related to "Methods for Detecting Catheter Movement" was published in the US, with application number 16/816,681, reflecting advancements in medical device technology [132] - The company is actively pursuing international patent protection, with filings in countries such as Canada, China, and India, demonstrating a strategic approach to global market expansion [135][138] - The patent for "Systems and Methods for Denoising Physiological Signals During Electrical Neuromodulation" was published in the US, indicating a focus on improving the accuracy of physiological monitoring technologies [138] - The company has a diverse range of patents related to neurostimulation, with multiple applications filed in the US and PCT, showcasing its commitment to research and development in this field [135][138] - The patent portfolio includes innovations aimed at reducing duty cycles during neurostimulation, which could enhance the efficiency of cardiac treatments [131] - The company has made significant strides in developing electrode assemblies for neuromodulation, with a patent issued on May 16, 2023, indicating progress in device technology [135] - The ongoing patent filings and approvals reflect the company's strategic focus on expanding its technological capabilities and market presence in the cardiac and neuromodulation sectors [132][138] - The company has filed multiple patents related to "Chronically Implantable Systems and Methods for Affecting Cardiac Contractility and/or Relaxation" across various countries, including the US, Japan, and China, with the latest filing on August 17, 2023 [139] - The "CARDIONOMIC" trademark is registered in multiple jurisdictions, including the US, Canada, and Europe, indicating a strong brand presence in the medical device market [141] - The company has also registered the "NVAD" trademark in several countries, showcasing its commitment to expanding its product offerings in neuromodulation technology [142] - The "CPNS" trademark is registered in various regions, including the US and Australia, further emphasizing the company's focus on cardiac and pulmonary nerve stimulation technologies [144] - The company has a significant number of patents pending and granted, which may enhance its competitive advantage in the medical technology sector [139] - The latest patent related to "Methods and Systems for Neuromodulation" was published on August 10, 2023, indicating ongoing innovation efforts [140] - The company is actively pursuing international patent protection, with filings in regions such as Europe, Asia, and North America, reflecting its global strategy [139] - The company has established a robust intellectual property portfolio, which is crucial for maintaining market leadership and driving future growth [141] - The filing dates for various patents span from 2020 to 2023, demonstrating a consistent pipeline of new technologies and solutions [139] - The company is positioned to leverage its patented technologies for market expansion and potential partnerships in the healthcare sector [139]