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,anincreaseofapproximately61 thousand compared to 82thousandforthesameperiodin2024[222].−LockeTsalesincreasedby128 thousand from 0forthethreemonthsendedMarch31,2024,to128 thousand for the three months ended March 31, 2025[223]. - VIVO System product sales decreased by 67thousandfrom82 thousand for the three months ended March 31, 2024, to 15thousandforthesameperiodin2025[223].−Netcashusedinoperatingactivitieswas2.3 million for the three months ended March 31, 2025, compared to 1.9millionforthesameperiodin2024[235].−AsofMarch31,2025,thecompanyhadcashandcashequivalentsof0.5 million and an accumulated deficit of 296.4million[231].ExpensesandFinancialObligations−Selling,generalandadministrativeexpensesincreasedbyapproximately829 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,primarilyduetohiringafull−timeemployee[226].−Acquiredin−processresearchanddevelopmentexpensesrecognizedwere119 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].FutureExpectationsandRoyalties−Thecompanyexpectsoperatinglossesandnegativecashflowstocontinueuntilsalesandgrossprofitincreasesufficientlytocoveroperatingexpenses[233].−Thecompanywillpayatotalroyaltyofapproximately121 million, after which a 2% royalty will apply until cumulative royalties reach 10million,contingentonaU.S.patentbeinggranted[249].−ThecompanyisnotcurrentlysellingtheAMIGOSystem,whichhassales−basedroyaltiesdueuponsuccessfulcommercialization[250].StrategicAcquisitions−OnJanuary14,2025,thecompanyacquiredPeriKard,LLCfor275,000sharesvaluedat113,000, 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].