PART I. FINANCIAL INFORMATION [FINANCIAL STATEMENTS](index=4&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS) Presents Catheter Precision's unaudited condensed consolidated financial statements as of June 30, 2025, detailing financial position and performance [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$25.6 million** while liabilities rose to **$19.0 million**, leading to a significant decline in **stockholders' equity** to **$6.5 million** Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 (Unaudited) | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $838 | $2,873 | | Total current assets | $2,046 | $3,292 | | Intangible assets, net | $23,252 | $24,274 | | **TOTAL ASSETS** | **$25,563** | **$27,770** | | **Liabilities & Equity** | | | | Total current liabilities | $4,642 | $2,230 | | Total liabilities | $19,014 | $16,013 | | Total stockholders' equity | $6,549 | $11,757 | | **TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY** | **$25,563** | **$27,770** | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Q2 2025 revenues doubled to **$212 thousand**, yet increased operating expenses and **$1.8 million** acquired R&D led to a **$5.1 million** net loss Condensed Consolidated Statements of Operations (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | Six Months 2025 | Six Months 2024 | | :--- | :--- | :--- | :--- | :--- | | Revenues | $212 | $93 | $355 | $175 | | Gross profit | $198 | $77 | $330 | $154 | | Total operating expenses | $4,884 | $2,794 | $8,591 | $5,487 | | Operating loss | $(4,686) | $(2,717) | $(8,261) | $(5,333) | | Net loss attributable to Catheter Precision, Inc. | $(5,109) | $(4,220) | $(9,154) | $(6,895) | | Net loss per share, basic and diluted | $(0.38) | $(5.57) | $(0.74) | $(9.19) | [Condensed Consolidated Statements of Stockholders' Equity](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Stockholders' equity declined from **$11.8 million** to **$6.5 million** due to a **$9.5 million** net loss, partially offset by capital raising efforts - Total stockholders' equity decreased by **$5.2 million** in the first six months of 2025, from **$11.8 million** to **$6.5 million**[15](index=15&type=chunk) - The decrease in equity was mainly due to a net loss of **$9.5 million**, partially offset by proceeds from stock issuances, including a PIPE financing (**$2.0M**), an ATM offering (**$1.6M**), and stock issued for asset acquisitions (**$0.4M**)[15](index=15&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Operating activities used **$4.6 million** cash, offset by **$2.6 million** from financing, resulting in a **$2.0 million** decrease in cash, ending at **$0.8 million** Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(4,601) | $(3,639) | | Net cash used in investing activities | $(23) | $(67) | | Net cash provided by financing activities | $2,589 | $157 | | **NET CHANGE IN CASH AND CASH EQUIVALENTS** | **$(2,035)** | **$(3,549)** | | Cash and cash equivalents, beginning of period | $2,873 | $3,565 | | **Cash and cash equivalents, end of period** | **$838** | **$16** | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes detail business operations, accounting policies, asset acquisitions, equity offerings, related party transactions, and a critical going concern warning [Note 1. Organization and Nature of Operations](index=11&type=section&id=Note%201.%20Organization%20and%20Nature%20of%20Operations) Catheter Precision designs cardiac electrophysiology medical technologies, forming two new subsidiaries for heart failure and mapping advancements - The company's main products are the VIVO System (non-invasive 3D cardiac mapping) and LockeT (suture retention device)[23](index=23&type=chunk)[24](index=24&type=chunk) - In February 2025, the company formed Cardionomix, Inc. (**82%** owned) to acquire and develop the Cardiac Pulmonary Nerve Stimulation (CPNS) System for acute heart failure[26](index=26&type=chunk)[27](index=27&type=chunk) - In June 2025, the company formed KardioNav, Inc. (**57%** owned) to develop new electrophysiology mapping technologies by integrating VIVO IP with patents from a third party[28](index=28&type=chunk)[29](index=29&type=chunk) [Going Concern](index=13&type=section&id=Going%20Concern) Substantial doubt exists about the company's going concern due to recurring losses, negative cash flows, and a **$0.8 million** cash balance, requiring urgent financing - Management has concluded there is **substantial doubt** about the Company's ability to continue as a going concern within 12 months from the financial statement issuance date[36](index=36&type=chunk) Key Financial Indicators (as of June 30, 2025) | Metric | Value (in millions) | | :--- | :--- | | Net Loss (Six Months Ended) | $9.5 | | Cash Used in Operations (Six Months Ended) | $4.6 | | Accumulated Deficit | $301.5 | | Working Capital Deficit | $2.6 | | Cash and Cash Equivalents | $0.8 | - The company plans to raise additional capital through equity or debt financing but acknowledges it may not be able to secure such financing on favorable terms, if at all[37](index=37&type=chunk) [Note 2. Summary of Significant Accounting Policies](index=14&type=section&id=Note%202.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines key accounting policies, including consolidation of VIEs, fair value measurements for **Level 3** instruments, and revenue recognition - The company consolidates two Variable Interest Entities (VIEs), Cardionomix and KardioNav, as it is the primary beneficiary of both[77](index=77&type=chunk)[79](index=79&type=chunk)[82](index=82&type=chunk) - Royalties payable and trading debt securities are classified as **Level 3** financial instruments, valued using unobservable inputs like discounted future cash flows and probability-weighted models[57](index=57&type=chunk)[58](index=58&type=chunk)[59](index=59&type=chunk) - Revenue from the VIVO System and LockeT device is recognized at a point in time when control is transferred to the customer upon delivery[90](index=90&type=chunk)[92](index=92&type=chunk) [Note 7. Notes Payable](index=31&type=section&id=Note%207.%20Notes%20Payable) The company holds **$1.3 million** in subsidiary notes and **$1.5 million** in related party notes to the CEO, maturing in January 2026 at **12%** interest - In May 2025, subsidiary Cardionomix issued a **$1.5 million** promissory note (present value **$1.3 million**) in connection with the CPNS System asset acquisition, maturing in three years[116](index=116&type=chunk)[117](index=117&type=chunk) - The company has **$1.5 million** in short-term promissory notes outstanding to CEO David A. Jenkins and his affiliates. These notes were amended to extend the maturity to January 31, 2026, and increase the interest rate to **12%** per annum[120](index=120&type=chunk)[121](index=121&type=chunk)[123](index=123&type=chunk) [Note 8. Royalties Payable](index=32&type=section&id=Note%208.%20Royalties%20Payable) Significant royalty obligations for LockeT, primarily to the CEO, increased in fair value from **$9.2 million** to **$12.0 million**, resulting in a **$2.8 million** non-cash expense - The company is obligated to pay a royalty of **11.82%** of LockeT net sales to former noteholders, who are primarily CEO David A. Jenkins and his affiliates[129](index=129&type=chunk) - The fair value of the total royalty payable increased from **$9.2 million** at year-end 2024 to **$12.0 million** as of June 30, 2025[129](index=129&type=chunk) - The company recorded a non-cash expense of **$2.8 million** for the change in fair value of royalties payable for the six months ended June 30, 2025[132](index=132&type=chunk) [Note 11. Equity Offerings](index=37&type=section&id=Note%2011.%20Equity%20Offerings) In 2025, the company raised **$1.5 million** cash via PIPE financing and **$1.7 million** gross proceeds from an ATM offering of **4.2 million** shares - On May 12, 2025, the company completed a PIPE financing, selling Series B Convertible Preferred Stock and Series L Warrants. It received **$1.5 million** in cash and QHSLab Notes valued at **$864 thousand**, before **$0.4 million** in fees[164](index=164&type=chunk) - On May 19, 2025, the company entered into an At Market (ATM) Offering Agreement. As of June 30, 2025, it had sold **4,183,589 shares** for gross proceeds of **$1.7 million**, before **$0.2 million** in commissions and expenses[175](index=175&type=chunk)[177](index=177&type=chunk) [Note 14. Asset Acquisitions](index=49&type=section&id=Note%2014.%20Asset%20Acquisitions) In 2025, the company expensed **$119 thousand** for a patent and **$1.8 million** for the CPNS System acquisition as acquired in-process R&D - On January 24, 2025, the company acquired a patent for pericardial access technology, expensing **$119 thousand** as acquired IPR&D[215](index=215&type=chunk) - On May 5, 2025, the company's subsidiary acquired the CPNS System, expensing **$1.8 million** as acquired IPR&D. Consideration included **$0.3 million** in stock, a **$1.3 million** note, and **$0.3 million** in transaction costs[217](index=217&type=chunk) [Note 17. Related Parties](index=49&type=section&id=Note%2017.%20Related%20Parties) Extensive related party transactions exist with CEO David A. Jenkins and affiliates, including significant stock holdings, **12%** LockeT royalties, and **$1.5 million** in loans - CEO David A. Jenkins and his affiliates hold a majority of the Series X Convertible Preferred Stock and have royalty rights equal to approximately **12%** of LockeT net sales[224](index=224&type=chunk)[226](index=226&type=chunk) - The company owes **$1.5 million** in principal plus accrued interest to Mr. Jenkins and his affiliates under various short-term promissory notes[229](index=229&type=chunk)[230](index=230&type=chunk) - Mr. Jenkins and his affiliates also hold significant equity stakes in the company's new subsidiaries, Cardionomix (**12%**) and KardioNav (**10%**)[233](index=233&type=chunk)[234](index=234&type=chunk) [Note 18. Subsequent Events](index=51&type=section&id=Note%2018.%20Subsequent%20Events) Stockholders approved a **1-for-19 ratio** reverse stock split, effective August 15, 2025, reducing outstanding shares from **18.9 million** to **1.0 million** - On July 25, 2025, stockholders approved a reverse stock split, which the Board set at a **1-for-19 ratio**[238](index=238&type=chunk) - The reverse stock split will be effective August 15, 2025, and is expected to decrease the number of issued and outstanding shares from approximately **18.9 million** to **1.0 million**[238](index=238&type=chunk)[240](index=240&type=chunk) [MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS](index=53&type=section&id=ITEM%202.%20MANAGEMENT'S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) Management discusses financial performance, liquidity, and capital resources, highlighting revenue growth, widening losses, and **substantial doubt** about going concern due to **insufficient** cash [Results of Operations](index=60&type=section&id=Results%20of%20Operations) Q2 2025 revenues increased by **$119 thousand** from LockeT sales, but net loss widened due to **$1.8 million** acquired IPR&D and higher operating expenses - Revenue for Q2 2025 increased by **$119 thousand** YoY, driven by a **$102 thousand** increase in LockeT sales[285](index=285&type=chunk) - SG&A expenses for Q2 2025 rose by **$0.2 million** YoY, mainly due to increased salaries and benefits from a higher employee headcount (**21 vs. 15**)[287](index=287&type=chunk) - Acquired in-process R&D expense was **$1.8 million** in Q2 2025, related to the Cardionomic asset acquisition, with no comparable expense in Q2 2024[289](index=289&type=chunk) [Liquidity and Capital Resources](index=63&type=section&id=Liquidity%20and%20capital%20resources) With **$0.8 million** cash and a **$301.5 million** accumulated deficit, the company faces critical liquidity issues, requiring urgent financing and raising **substantial doubt** about its going concern - As of June 30, 2025, the company had cash and cash equivalents of **$0.8 million** and an accumulated deficit of **$301.5 million**[294](index=294&type=chunk) - Management has concluded there is **substantial doubt** about the Company's ability to continue as a going concern for one year[297](index=297&type=chunk) - The company expects the need for additional financing before the end of the current quarter to fund operations and pay debts, as current cash is **insufficient** to cover costs and repay notes due January 31, 2026[296](index=296&type=chunk) [QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK](index=69&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) This section is **not applicable** to the company for the current reporting period - The company states that this item is **not applicable**[316](index=316&type=chunk) [CONTROLS AND PROCEDURES](index=69&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) Disclosure controls and procedures were **not effective** as of June 30, 2025, due to **Material weaknesses** including **lack of segregation of duties** and **inadequate review controls** - The CEO and CFO concluded that as of June 30, 2025, the company's disclosure controls and procedures were **not effective**[317](index=317&type=chunk) - **Material weaknesses** were identified related to: (1) **lack of segregation of duties**, (2) **lack of designed and operating review controls**, and (3) **insufficient review of work** performed by third-party service providers, particularly for valuations and tax provision calculations[317](index=317&type=chunk) - A remediation plan is being developed, which includes assessing the need for more accounting staff and establishing new policies for reviewing third-party work and internal calculations. A new CFO was hired in January 2025 to help address these issues[318](index=318&type=chunk) PART II. OTHER INFORMATION [LEGAL PROCEEDINGS](index=71&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) The company refers to legal proceedings information disclosed in its Annual Report on Form 10-K for fiscal year 2024 - As of June 30, 2025, the Company had **no outstanding litigation**[223](index=223&type=chunk) [RISK FACTORS](index=71&type=section&id=ITEM%201A.RISK%20FACTORS) **No material changes** occurred from risk factors previously disclosed in the Annual Report on Form 10-K for the year ended December 31, 2024 - There have been **no material changes** from the risk factors previously disclosed in the Company's Annual Report on Form 10-K for the year ended December 31, 2024[324](index=324&type=chunk) [EXHIBITS](index=72&type=section&id=ITEM%206.%20EXHIBITS) This section lists exhibits filed with Form 10-Q, including agreements, governance documents, and officer certifications

[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)

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]

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].

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]

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].

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]

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]

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]

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]