Core Points - Catheter Precision, Inc. announced that its audited financial statements for the year ended December 31, 2024, included an audit opinion with a Substantial Doubt Regarding Going Concern paragraph [1] - This announcement complies with NYSE American Company Guide Section 610(b), which mandates a separate public announcement for audit opinions containing a going concern paragraph [2] Financial Information - The audit opinion indicating substantial doubt about the company's ability to continue as a going concern was disclosed in the Annual Report on Form 10-K filed on March 31, 2025 [1] - The announcement does not alter the company's consolidated financial statements or its Annual Report on Form 10-K for the year ended December 31, 2024 [2]

Core Insights - Catheter Precision, Inc. has received a notice of allowance for its first US patent for the LockeT product, a surgical closure device for orthoscopic entry wounds, filed in December 2022 [1][2] - The company has also secured international patents for LockeT in China, Europe, and the United Kingdom, which is significant for its distribution discussions in these markets [2] - The company anticipates receiving the CE mark for LockeT within the current quarter, enabling revenue generation in Europe [2] Company Overview - Catheter Precision is a US-based medical device company focused on innovative solutions for cardiac arrhythmias, emphasizing the development of advanced technology for electrophysiology procedures [4] - The LockeT device is a Class 1 suture retention device designed to assist in wound closure after percutaneous venous punctures and is registered with the FDA [3] Market Position - The company has begun rolling out LockeT in the US market and has received positive feedback from hospitals, indicating a demand for products that improve outcomes while reducing costs per procedure [2]

Financial Performance - Total assets as of December 31, 2024, were $27.7 million[7] - Total shareholders' equity as of December 31, 2024, was $11.8 million[7] - Fourth quarter revenue was $149 thousand, representing a sequential increase of 55% over Q3 2024[7] - Full year 2024 revenue totaled $420 thousand[7] - Net loss for the fourth quarter was $5.6 million, with $3.1 million attributed to non-cash charges[7] - Total net loss for 2024 was $16.6 million, of which $7.5 million were non-cash charges[7] Product Development and Sales - The first sales of LockeT occurred in Q2 2024 and grew sequentially each quarter through the end of the year[1] - 26 institutions evaluated LockeT by year-end, either conducting or having completed their evaluations[1] - CE Mark for LockeT is anticipated in Q2 2025, allowing sales in 32 European countries[1] - Randomized Controlled Trial (RCT) for VIVO is planned to begin in Q3 2025[1]

Company Merger and Focus - The Company merged with Catheter Precision, Inc. on January 9, 2023, shifting focus to cardiac electrophysiology technologies[297]. Product Performance - The VIVO System has been utilized in over 1,000 procedures in the U.S. and EU, with no reported device-related complications[302]. - The Company recognized its first sale of the LockeT device in May 2024, with CE Mark approval expected in the first half of 2026[304]. - VIVO System product sales decreased by $214,000 from $442,000 in 2023 to $228,000 in 2024, while LockeT sales increased by $191,000[323]. Financial Performance - Revenues for the year ended December 31, 2024, were $420,000, a decrease of $22,000 compared to $442,000 in 2023[322]. - The cost of revenues increased by $12,000 for the year ended December 31, 2024, due to order fulfillment charges for LockeT[324]. - Selling, general and administrative expenses decreased by $5,773,000 from $17,122,000 in 2023 to $11,349,000 in 2024[322]. - Research and development expenses decreased by $203,000 from $475,000 in 2023 to $272,000 in 2024[322]. - Selling, general and administrative expenses decreased by approximately $5.8 million for the year ended December 31, 2024, primarily due to a $2.0 million decrease in legal fees and a $1.4 million decrease in professional accounting fees related to the Merger in 2023[325]. - Research and development expenses decreased by approximately $0.2 million for the year ended December 31, 2024, mainly due to a $0.1 million decrease in product development costs and regulatory affairs expenditures[326]. - The company recognized a goodwill impairment charge of $60.9 million for the year ended December 31, 2023, with no remaining goodwill balance as of December 31, 2023[328][329]. - The fair value of royalties payable decreased by $9.4 million for the year ended December 31, 2024, driven by changes in forecasted royalty payments and discount rates[330]. - The company recorded an income tax provision of $3.1 million in 2024, compared to zero in 2023, primarily due to a nonrecurring adjustment from an ownership change[332]. Cash Flow and Financing - As of December 31, 2024, the company had cash and cash equivalents of approximately $2.9 million and an accumulated deficit of approximately $292 million[333]. - Net cash used in operating activities was approximately $9.3 million for the year ended December 31, 2024, compared to $20.6 million in 2023[337][338]. - Net cash provided by financing activities was $8.6 million for the year ended December 31, 2024, primarily from the issuance of common stock and warrants[342]. - The company expects operating losses and negative cash flows to continue as it invests in commercial capabilities and anticipates the need for additional financing within the next three to six months[335][336]. Going Concern - Management has concluded there is substantial doubt about the company's ability to continue as a going concern for a period of one year after the issuance of the consolidated financial statements for the year ended December 31, 2024[336].

Financial Highlights - Catheter Precision reported total assets of $27.7 million and total shareholders' equity of $11.8 million as of December 31, 2024 [3] - The company had 8,004,633 outstanding shares of common stock by the end of 2024 [3] - Fourth quarter revenue reached $149 thousand, marking a sequential increase of 55% over Q3 2024, while full year 2024 revenue totaled $420 thousand [3] - The net loss for the fourth quarter was $5.6 million, with $3.1 million attributed to non-cash charges; total net loss for 2024 was $16.6 million, including $7.5 million in non-cash charges [3] Operational Updates - A new Chief Commercial Officer joined in Q2 2024, leading to a significant overhaul of the sales team [3] - The first sales of the LockeT device occurred in Q2 2024, with sales growing sequentially each quarter [3] - By year-end 2024, 26 hospitals had evaluated the LockeT device through surgical procedures [3] - The company completed audits for LockeT's CE Mark in Q4 2024, with expectations to receive the CE Mark in Q2 2025, allowing sales in 32 European countries starting Q3 2025 [3] - VIVO marketing and sales efforts are ongoing in the US and several international markets, including Germany, Turkey, and the UK [3] Clinical Studies and Publications - Two clinical studies were published in 2024, focusing on non-invasive mapping systems and the combination of cardiac imaging with electrocardiographic information [3] - The first LockeT journal manuscript and two abstracts were published in 2024, detailing the feasibility, safety, and efficacy of the LockeT device [3] - Additional clinical studies for both VIVO and LockeT are ongoing or planned for 2025, including a Randomized Controlled Trial (RCT) for VIVO set to begin in Q3 2025 [3]

FORT MILL, S.C., March 28, 2025 (GLOBE NEWSWIRE) -- Catheter Precision, Inc. (NYSE American: VTAK), a U.S.-based innovative medical device company focused on electrophysiology products, today announced its financial results and operational update for the period ending December 31, 2024. Highlights of 2024 and the fourth quarter include: New Chief Commercial Officer (CCO) joined in Q2, 2024.Replaced the majority of our prior sales team with new salespeople selected by our new CCO and our CEO. Training was c ...

Core Insights - Catheter Precision, Inc. is participating in three upcoming medical conferences to showcase its products, particularly the LockeT device and VIVO system [1][2][9] - The LockeT device has demonstrated clinical advantages over manual compression in a study involving 97 patients, including reduced time to ambulation and lower costs [1][4] - VIVO is a non-invasive 3D imaging system that aids in identifying the origin of ventricular arrhythmias, enhancing workflow and reducing procedure time [5] Conference Participation - Catheter Precision will attend the American College of Cardiology (ACC) meeting from March 29-31, 2025, where the LockeT device will be featured [9] - The company will also have a presence at the European Heart Rhythm Association (EHRA) and Society of Interventional Radiology (SIR) conferences, marking its first participation in an interventional radiology event [2][9] Product Highlights - LockeT is a Class 1 FDA-registered suture retention device designed for wound closure after percutaneous venous punctures [6] - VIVO has received marketing clearance from the U.S. FDA and holds a CE mark, indicating its regulatory approval for use [5] Company Overview - Catheter Precision is focused on developing innovative solutions for cardiac arrhythmias, emphasizing collaboration with physicians to advance its product offerings [7]

Core Viewpoint - Catheter Precision, Inc. is actively participating in the 18th Western Atrial Fibrillation Symposium to promote its LockeT product line, which is designed to enhance atrial fibrillation procedures and improve patient outcomes [1][3]. Company Overview - Catheter Precision is a U.S.-based medical device company focused on developing innovative solutions for cardiac arrhythmias, particularly in the electrophysiology market [5]. - The company aims to collaborate with physicians to continuously advance its product offerings [5]. Product Information - The LockeT is a suture retention device that assists in hemostasis after vascular catheter access and is classified as a Class 1 device registered with the FDA [4]. - The product is positioned as an adjunctive tool for atrial fibrillation procedures, with the potential to benefit recovery room staff, hospitals, and patients [3]. Industry Event - The Western Atrial Fibrillation Symposium is an internationally recognized event aimed at improving atrial fibrillation outcomes, featuring over 80 leading experts discussing advancements in diagnosis and treatment [2].

Company Overview - Catheter Precision Inc. is a U.S.-based medical device company focused on developing advanced products for the cardiac electrophysiology market [1][4] - The company is entering the commercial phase of its mission to deliver long-term value to shareholders and the healthcare sector [3] Strategic Partnership - Catheter Precision has engaged PCG Advisory to enhance investor outreach and communication efforts [1][2] - The partnership aims to strengthen engagement with institutional and retail investors and effectively communicate the company's strategic vision [2][3] Product Focus - The company is promoting its innovative technologies, LockeT and VIVO™, which address challenges in electrophysiology and vascular closure [2][3] - These technologies are designed to improve procedural efficiency, reduce complications, and enhance patient care [3] Market Potential - The electrophysiology market is projected to reach $15.1 billion by 2028, driven by increasing demand for ventricular ablation and vascular closure solutions [3]

Core Viewpoint - Catheter Precision, Inc. is participating in the 13th International Symposium on Left Atrial Appendage (ISLAA) to showcase its innovative medical device, LockeT, which aids in wound closure after cardiac procedures [1][2][4]. Company Overview - Catheter Precision is a U.S.-based medical device company focused on developing advanced solutions for cardiac arrhythmias and electrophysiology procedures [5]. - The company collaborates with physicians to continuously advance its product offerings [5]. Event Participation - The ISLAA meeting is a multi-specialty cardiovascular educational symposium featuring leading physicians and institutions [2]. - Catheter Precision will engage in hands-on demonstrations and product education for electrophysiology fellows, allowing them to experience LockeT and understand its benefits [3]. Product Information - LockeT is a Class 1 FDA-registered suture retention device designed to assist in wound closure after percutaneous venous punctures [4]. - The device addresses challenges associated with closing large access sites after left atrial appendage procedures, providing a safe and effective solution [4].