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Catheter Precision(VTAK) - 2025 Q1 - Quarterly Report
VTAKCatheter Precision(VTAK)2025-05-14 20:16

Product Development and Regulatory Approvals - 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[200]. - The company received FDA clearance for the VIVO System as a pre-procedure planning tool for patients with structurally normal hearts undergoing ablation treatment[200]. - LockeT, a new suture retention device, was registered with the FDA in February 2023, with initial shipments to distributors beginning shortly thereafter[202]. - The company recognized its first sale of LockeT in May 2024, following CE Mark approval received in April 2025[202]. - Cardionomix, a new subsidiary, was formed to acquire assets related to late-stage treatment for acute decompensated heart failure, with a transaction closing on May 5, 2025[208]. Financial Performance - Revenue for the three months ended March 31, 2025, was 143thousand,anincreaseofapproximately143 thousand, an increase of approximately 61 thousand compared to 82thousandforthesameperiodin2024[222].LockeTsalesincreasedby82 thousand for the same period in 2024[222]. - LockeT sales increased by 128 thousand from 0forthethreemonthsendedMarch31,2024,to0 for the three months ended March 31, 2024, to 128 thousand for the three months ended March 31, 2025[223]. - VIVO System product sales decreased by 67thousandfrom67 thousand from 82 thousand for the three months ended March 31, 2024, to 15thousandforthesameperiodin2025[223].Netcashusedinoperatingactivitieswas15 thousand for the same period in 2025[223]. - Net cash used in operating activities was 2.3 million for the three months ended March 31, 2025, compared to 1.9millionforthesameperiodin2024[235].AsofMarch31,2025,thecompanyhadcashandcashequivalentsof1.9 million for the same period in 2024[235]. - As of March 31, 2025, the company had cash and cash equivalents of 0.5 million and an accumulated deficit of 296.4million[231].ExpensesandFinancialObligationsSelling,generalandadministrativeexpensesincreasedbyapproximately296.4 million[231]. Expenses and Financial Obligations - Selling, general and administrative expenses increased by approximately 829 thousand for the three months ended March 31, 2025, primarily due to an increase in salaries and benefits[225]. - Research and development expenses increased by approximately 66thousandforthethreemonthsendedMarch31,2025,primarilyduetohiringafulltimeemployee[226].Acquiredinprocessresearchanddevelopmentexpensesrecognizedwere66 thousand for the three months ended March 31, 2025, primarily due to hiring a full-time employee[226]. - Acquired in-process research and development expenses recognized were 119 thousand for the three months ended March 31, 2025, related to the acquisition of Perikard, LLC[227]. - The change in fair value of royalties payable due to related parties decreased by 1.1millionfromMarch31,2024,toMarch31,2025,duetoadecreaseinthediscountrate[228].FutureExpectationsandRoyaltiesThecompanyexpectsoperatinglossesandnegativecashflowstocontinueuntilsalesandgrossprofitincreasesufficientlytocoveroperatingexpenses[233].Thecompanywillpayatotalroyaltyofapproximately121.1 million from March 31, 2024, to March 31, 2025, due to a decrease in the discount rate[228]. Future Expectations and Royalties - The company expects operating losses and negative cash flows to continue until sales and gross profit increase sufficiently to cover operating expenses[233]. - The company will pay a total royalty of approximately 12% of net sales of LockeT, starting from the first commercial sale in 2024 until December 31, 2035[248]. - A 5% royalty on net sales of LockeT will be paid up to 1 million, after which a 2% royalty will apply until cumulative royalties reach 10million,contingentonaU.S.patentbeinggranted[249].ThecompanyisnotcurrentlysellingtheAMIGOSystem,whichhassalesbasedroyaltiesdueuponsuccessfulcommercialization[250].StrategicAcquisitionsOnJanuary14,2025,thecompanyacquiredPeriKard,LLCfor275,000sharesvaluedat10 million, contingent on a U.S. patent being granted[249]. - The company is not currently selling the AMIGO System, which has sales-based royalties due upon successful commercialization[250]. Strategic Acquisitions - On January 14, 2025, the company acquired PeriKard, LLC for 275,000 shares valued at 113,000, with potential royalty payments of 10% on net sales for five years[205]. - The company issued a promissory note for $1.5 million to Cardionomic, with a 4% annual interest rate, maturing three years after issuance[208]. Goals and Objectives - The company aims to establish VIVO as an integral tool for cardiac electrophysiologists, improving procedural success and reducing complications[204]. - As of March 31, 2025, the company held 2,157,000 shares of common stock in abeyance due to beneficial ownership limitations[210]. - During the three months ended March 31, 2025, the company released and issued 939,000 abeyance shares[211].