Financial Performance - Total revenue for September 2024 was 3,860,000,anincreaseof16.93,301,000 in September 2023[12] - Product revenue reached 1,958,000inSeptember2024,up33.51,466,000 in the same period last year[12] - Service revenue was 1,902,000forSeptember2024,slightlyupfrom1,835,000 in September 2023[12] - Gross profit for the quarter was 2,334,000,representingagrossmarginof60.51,747,000 and a margin of 52.9% in the prior year[12] - Operating loss narrowed to 2,645,000inSeptember2024from3,640,000 in September 2023[12] - Net loss for the quarter was 2,616,000,comparedtoanetlossof2,093,000 in the same quarter last year[12] - Total revenue for the nine months ended September 30, 2024, was 11.333million,anincreasefrom10.553 million for the same period in 2023, representing a growth of approximately 7.4%[85] - Product revenue for the three months ended September 30, 2024, was 1.958million,upfrom1.466 million in the same period of 2023, reflecting a growth of approximately 33.5%[85] - Service revenue for the three months ended September 30, 2024, was 1.902million,comparedto1.835 million for the same period in 2023, indicating a slight increase of approximately 3.7%[85] Cash and Assets - Cash and cash equivalents increased significantly to 6,311,000asofSeptember30,2024,from1,643,000 at the end of 2023[10] - Total assets grew to 15,347,000asofSeptember30,2024,comparedto10,730,000 at the end of 2023[11] - Total liabilities decreased to 7,682,000from10,319,000 at the end of 2023, indicating improved financial health[11] - Stockholders' equity increased to 7,665,000asofSeptember30,2024,upfrom411,000 at the end of 2023[11] Losses and Expenses - Net loss for the nine months ended September 30, 2024, was 8,309,000,comparedtoanetlossof9,324,000 for the same period in 2023, representing a 10.9% improvement[15] - The company reported a net cash used in operating activities of 9,751,000fortheninemonthsendedSeptember30,2024,comparedto9,198,000 for the same period in 2023[15] - The company recognized approximately 0.7millionand1.0 million of share-based compensation expense for the nine months ended September 30, 2024 and 2023, respectively[116] Revenue Recognition and Accounting - The Company utilizes a five-step model for revenue recognition, ensuring compliance with ASC Topic 606[32] - Revenue from appliance sales is recognized when control is transferred to the VIP, reflecting the expected consideration for those products[45] - The Company recognizes service revenue related to VIP enrollments when the underlying services are performed, with unearned revenue recorded as a contract liability[34] - Contract liabilities decreased from 2.613millionasofSeptember30,2023,to1.491 million as of September 30, 2024, representing a decline of approximately 43%[87] - Revenue recognized from contract liabilities for the nine months ended September 30, 2024, was 1.5million,comparedto1.4 million for the same period in 2023, indicating a slight increase of about 7%[87] Strategic Initiatives - The Company entered a strategic marketing and distribution alliance in June 2024 to enhance revenue generation by offering comprehensive solutions to OSA patients[24] - A strategic pivot announced in June 2024 aims to drive revenue through contractual alliances with dentists and healthcare providers, moving away from solely relying on enrollments in the VIP program[153] - The company secured a 7.5millionequitygrowthinvestmentfromV−COInvestorsLLC,whichhasstrengtheneditscashpositionandfacilitatedthelaunchofnewstrategicalliances[155]MarketandOperationalChallenges−ThecompanycontinuestomonitortheimpactofCOVID−19andinflationonitsbusiness,withongoinguncertaintiesaffectingnewenrollmentsinthedentalmarket[130][131]−Thecompanyhasadjusteditsstandardpricingforapplianceproductsduetoinflationarypressures,effectiveMay1,2022,andmayneedtodosoagainin2024[131]−Thecompanyexperiencedadeclineinproductsalesrevenueinlate2023,butthistrendbegantoreverseinQ22024,withapproximately324,296,000 during the nine months ended September 30, 2024[15] - The company raised approximately 7.4millionfromaprivateplacementinJanuary2023and4.0 million from another private placement in November 2023[95][99] - The Company intends to use net proceeds from the Private Placement and Offering for general working capital and corporate purposes[102][108] Clinical and Product Development - The Company offers three clinical pathways for treating obstructive sleep apnea (OSA) and related conditions, including Guided Growth and Development, Lifeline, and Complete Airway Repositioning and Expansion (CARE)[20] - The CARE program features patented appliances that have shown to reverse OSA symptoms in up to 80% of patients in a small study subset[21] - The company is conducting a clinical trial with Stanford University to evaluate the efficacy of its FDA-cleared DNA appliance compared to CPAP for treating sleep apnea, enrolling 150 patients[175]