Core Insights - Catheter Precision, Inc. has received its first European purchase order for its product LockeT, marking a significant milestone in its market expansion efforts [1][3] - The successful evaluation of LockeT in Italy follows its acceptance in France and Germany, indicating strong clinical value and versatility [2][4] - The product is designed to assist in wound closure after percutaneous venous punctures and has received both FDA registration and CE Mark approval [4] 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 collaborates with physicians to continuously advance its product offerings [5] Product Details - LockeT is a suture retention device aimed at streamlining closure after catheter ablation procedures while being cost-effective [4] - The device is classified as Class 1 and is registered with the FDA, having also received CE Mark approval [4]

Core Insights - Catheter Precision, Inc. has successfully completed the first LockeT procedures in France, marking a significant step in the adoption of its cardiac electrophysiology technologies in Europe [1][2] - The procedures were conducted at CHU Rennes, which is also a commercial partner for the company's VIVO product line [2] - The LockeT device is designed to improve procedural efficiency and patient outcomes following cardiac ablation procedures, indicating a strong market need in Europe [3] Product Information - LockeT is a suture retention device aimed at assisting in wound closure after percutaneous venous punctures, classified as a Class 1 device with FDA registration and CE Mark approval [4] - VIVO (View Into Ventricular Onset) is a non-invasive 3D imaging system that helps identify the origin of ventricular arrhythmias before procedures, thus streamlining workflow and reducing procedure time; it has also received FDA marketing clearance and CE Mark [5] Company Overview - 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 and continuous product advancement [6]

Core Viewpoint - Catheter Precision, Inc. has received a new patent for its VIVO technology, enhancing its intellectual property portfolio and supporting its mission to improve non-invasive identification of ventricular arrhythmias [1][2]. Company Overview - Catheter Precision is a U.S.-based medical device company focused on developing innovative solutions for cardiac arrhythmias, emphasizing collaboration with physicians and continuous product advancement [4]. 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, thereby improving workflow and reducing procedure time. It has received marketing clearance from the U.S. FDA and holds the CE Mark [3]. Patent Significance - The newly granted patent titled "Methods of Ventricular Arrhythmia Localization Using a 3D Heart Model" allows the company to further advance its identification methods, providing essential information to physicians for successful patient treatment [1][2].

Core Insights - Catheter Precision, Inc. has initiated the LockeT Compare Study, enrolling its first three patients, aimed at evaluating the safety profile of the LockeT suture retention device [1][2] - The study will enroll up to 100 patients and compare the LockeT device with internal closure devices, focusing on reducing groin complications post-cardiac catheter procedures [2] - The LockeT device has shown clinical data indicating safety, effectiveness, and cost reduction without altering hospital practices [2][3] Company Overview - Catheter Precision is a U.S.-based medical device company dedicated to improving cardiac arrhythmia treatment through innovative technology and collaboration with physicians [4] - The LockeT device is a Class 1 device registered with the FDA and has received CE Mark approval, designed for wound closure after percutaneous venous punctures [3][4]

Core Insights - Catheter Precision, Inc. has received registration and approval for its LockeT product in the United Kingdom, which is a significant step for the company to launch sales in the UK market [1] - The LockeT product, a suture retention device, previously received CE Mark approval for European distribution in May 2025 [1][4] - The partnership with HC21, a UK-based distributor, aims to enhance market access for LockeT, leveraging HC21's annual revenue of €180 million and extensive network in the medical device sector [2] Product Details - LockeT is designed to assist in wound closure after percutaneous venous punctures and is classified as a Class 1 device registered with the FDA [4] - The product's intuitive design is expected to improve patient comfort and recovery, facilitating earlier discharge after cardiac procedures [3] Market Impact - The introduction of LockeT is aligned with the NHS's efforts to reduce waiting lists, which recently saw its first reduction in 17 years, potentially allowing clinicians to deliver more treatments efficiently [3] - Catheter Precision aims to collaborate closely with UK healthcare providers to maximize the benefits of LockeT for patients across the nation [3]

Core Points - Catheter Precision, Inc. has executed a 1-for-19 reverse stock split effective August 15, 2025, with trading continuing under the symbol "VTAK" on a split-adjusted basis [1][2] - The reverse stock split will reduce the number of issued shares from approximately 23,316,520 to about 1,657,640 shares [4] - Stockholders will not receive fractional shares; instead, they will receive a pro rata portion of the net proceeds from the sale of fractional shares [3] Company Details - The reverse stock split will not change the par value per share and will affect all stockholders uniformly [2][3] - Stockholders holding shares in brokerage accounts should direct inquiries to their brokers, while all stockholders of record can contact the Company's transfer agent for assistance [4] - Additional information regarding the reverse stock split is available in the Company's definitive proxy statement filed with the SEC [5]

Core Insights - Catheter Precision, Inc. has successfully completed the first LockeT cases in Germany, specifically at Zentralklinik Bad Berka, one of the largest hospitals in Thuringia [1] - The physician team has performed 10 successful cases using the LockeT device, showcasing its versatility across various sheath sizes from 6F to 17Fr [2] - The CEO of Catheter Precision highlighted Germany as a significant market in Europe, emphasizing the potential for expanding the use of LockeT in other centers within the country [3] Product Information - LockeT 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] - The company focuses on developing innovative solutions for cardiac arrhythmias and collaborates with physicians to advance its product offerings [5]

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]