Financial Performance - Total revenue for 2024 was 15,031,000,representinga8.913,801,000 in 2023[432]. - Product revenue increased to 7,874,000in2024,up25.66,270,000 in 2023[432]. - Service revenue decreased to 7,157,000in2024,down57,531,000 in 2023[432]. - Gross profit for 2024 was 9,019,000,comparedto8,271,000 in 2023, reflecting a gross margin improvement[432]. - Operating loss narrowed to 11,171,000in2024from17,296,000 in 2023[432]. - Net loss for 2024 was 11,136,000,animprovementfromanetlossof13,583,000 in 2023[432]. - The basic and diluted net loss per share for 2024 was 2.22,comparedto11.14 in 2023, showing a substantial improvement[564]. Cash and Assets - Cash and cash equivalents increased to 6,260,000attheendof2024,upfrom1,643,000 at the end of 2023[438]. - Total assets grew to 15,284,000in2024,comparedto10,730,000 in 2023, indicating a significant increase in the company's asset base[430]. - Total stockholders' equity rose to 7,954,000in2024from411,000 in 2023, reflecting improved financial health[430]. - As of December 31, 2024, the company had approximately 6.3millionincashandcashequivalents,whichisinsufficienttofundoperationsoverthenexttwelvemonths[499].RevenueSourcesandBusinessModel−Asubstantialportionoffuturerevenueisexpectedtoderivefromsalesofappliancesandtreatmentsthroughanewstrategicallianceandacquisitionmodel[17].−ThecompanyexpectstoderiveasignificantportionoffuturerevenuefromsalesthroughDentalServiceOrganizations(DSOs)andMedicalServiceOrganizations(MSOs)[17].−ThecompanyispivotingitsbusinessstrategytofocusoncontractualallianceswithOSAhealthcareproviders,movingawayfromdependenceondentistsales[448].−RevenuefromMyoCorrectservicesisrecognizedovera12−monthperformanceperiodastherapysessionsoccur[462].−RevenuefromappliancesalesisrecognizedwhencontrolistransferredtotheVIP,withproductrevenuerecordeduponshipmenttotheVIP[468].RegulatoryandOperationalRisks−Thecompanyfacesrisksrelatedtogovernmentregulationsandtheneedtoobtainregulatoryapprovalsforitsproducts[20].−ThecompanyissubjecttoextensivegovernmentalregulationthatcouldpreventitfrommanufacturingorobtainingVivosappliancesorintroducingnewproducts[20].−Thecompanyhasidentifiedmaterialweaknessesininternalcontrols,whichmayresultinmaterialmisstatementsofconsolidatedfinancialstatements[17].−Thecompanymaynotbeabletoprotectitspatentsandproprietarytechnology,exposingittointellectualpropertyclaimsorlitigation[20].EquityandFinancing−Theweightedaveragenumberofsharesoutstandingincreasedto5,019,886in2024from1,219,381in2023,indicatingsignificantequityfinancingactivity[432].−Thecompanyraisedequitycapitalinlate2023andthroughout2024toaddresscashneedsandbolsterstockholders′equityforNasdaqcompliance[500].−ThecompanyclosedaprivateplacementonNovember2,2023,raising4.0 million by selling 130,000 shares and warrants, with issuance costs of approximately 0.5million[518].−TheDecember2024Offeringraisedapproximately3.5 million, with offering expenses of about 0.5million[535].CustomerandSupplierDynamics−Thecompanyreliesonfivesuppliersforapproximately570.1 million for both years ended December 31, 2024 and 2023[485]. Employee and Compensation - The company entered into an employment agreement with Dr. Scott Simonetti for an annual salary of approximately 0.1millionandafive−yearwarrantfor16,000sharesatanexercisepriceof15.25, contingent on achieving specific FDA milestones[516]. - For the year ended December 31, 2024, share-based compensation expense was approximately 0.8million,downfrom1.1 million in 2023[544].