Regulatory Approvals and Product Development - Catheter Precision, Inc. has received FDA clearance for the VIVO System as a pre-procedure planning tool for patients with structurally normal hearts undergoing ablation treatment for idiopathic ventricular arrhythmias [252]. - The VIVO System has been utilized in over 1,000 procedures in the U.S. and EU by more than 30 physicians, with no reported device-related complications [252]. - The company formed a new subsidiary, Cardionomix, to acquire assets related to the Cardiac Pulmonary Nerve Stimulation (CPNS) System, which is in development and has yet to obtain regulatory approval [249]. - KardioNav, another subsidiary, is focused on developing a system that interfaces with implanted cardiac devices to improve pre-ablation mapping and localization of arrhythmogenic tissue [250]. - The company has commenced limited sales of the VIVO System in Europe and the UK through independent distributors [254]. - LockeT, a suture retention device, was first sold in May 2024 and received its first patent in China in September 2024 [255]. - In April 2025, LockeT obtained CE Mark approval for marketing in the EU, Switzerland, and Turkey, leading to new distribution agreements in multiple countries [256]. - Clinical studies for LockeT began in 2023, aiming to demonstrate faster wound closure and lower healthcare costs [258]. - The acquisition of PeriKard was completed on January 24, 2025, for $113 thousand in stock, with potential royalty payments of 10% on net sales for five years [260]. - Cardionomic acquired the CPNS System on May 5, 2025, with total consideration of $1.9 million recognized as acquired in-process research and development [262]. Financial Performance and Revenue - Revenue for the three months ended September 30, 2025, increased by approximately $130 thousand, driven by a $92 thousand increase in LockeT sales and a $38 thousand increase in VIVO System sales compared to the same period in 2024 [287]. - For the nine months ended September 30, 2025, revenue increased by approximately $310 thousand, primarily due to a $322 thousand increase in LockeT sales, partially offset by a $12 thousand decrease in VIVO System sales [287]. - Cost of revenues increased by approximately $8 thousand and $12 thousand for the three and nine months ended September 30, 2025, respectively, mainly due to increased LockeT sales [288]. - Selling, general and administrative expenses rose by approximately $0.1 million for the three months and $1.1 million for the nine months ended September 30, 2025, attributed to increased professional fees and stock-based compensation [289][290]. - Research and development expenses increased by approximately $0.2 million for the three months and $0.4 million for the nine months ended September 30, 2025, primarily due to higher professional fees and salaries [291][292]. - Acquired in-process research and development expenses recognized as R&D expense totaled $119 thousand for the nine months ended September 30, 2025 [261]. - Acquired in-process research and development expenses increased by approximately $2.0 million for the nine months ended September 30, 2025, related to two asset acquisitions completed in 2025 [293]. Cash Flow and Financing - Net cash used in operating activities was $6.8 million for the nine months ended September 30, 2025, primarily due to a net loss of $11.8 million [303]. - As of September 30, 2025, the company had cash and cash equivalents of $1.1 million and an accumulated deficit of $303.8 million [298]. - The company expects operating losses and negative cash flows to continue unless sales and gross profit increase sufficiently to cover operating expenses [300]. - During the nine months ended September 30, 2024, net cash provided by financing activities was $4.2 million, consisting of $2.6 million from the issuance of common stock and $1.5 million from notes payable due to related parties [307]. - The May 2025 PIPE Financing raised gross proceeds of $1.5 million, with additional shares of preferred stock and warrants issued [264]. - As of September 30, 2025, 868,582 shares were sold under the At Market Offering Agreement for gross proceeds of $4.0 million [274]. Internal Controls and Regulatory Risks - The company has identified material weaknesses in its internal control over financial reporting, which could affect its ability to report results accurately [243]. - The company is subject to extensive regulatory scrutiny, and its products may face recalls or suspensions after receiving FDA approval [243]. - The company has not engaged in any off-balance sheet arrangements during the periods presented, indicating a straightforward financial structure [308]. - The company regularly evaluates estimates related to asset acquisitions, including provisions for legal contingencies and income taxes, which could materially affect financial results [310]. Accounting and Valuation - The fair value of trading debt securities is determined using a probability weighted expected return model, which incorporates significant unobservable inputs [314]. - The company recognizes a liability for royalty fees based on actual sales of products, with future estimated royalty payments remeasured at each reporting period [316]. - The fair value measurement of royalties payable includes significant unobservable inputs and is based on an internally developed revenue adjusted discount rate [317]. - New accounting pronouncements are discussed in the financial statements, detailing expected adoption dates and estimated effects on operations [318].
Catheter Precision(VTAK) - 2025 Q3 - Quarterly Report