Financial Performance - Revenues from product sales for the nine months ended September 30, 2022, were 169,943,adecreaseof31.7248,840 in the same period of 2021[23] - Gross profit for the nine months ended September 30, 2022, was 90,694,down50.1180,909 in the prior year[23] - The operating loss for the nine months ended September 30, 2022, was 4,390,447,comparedto3,131,966 in the same period of 2021, indicating an increase of 40.2%[23] - Net loss attributable to the Company's stockholders' equity for the nine months ended September 30, 2022, was 4,345,833,comparedto3,260,924 in the same period of 2021, reflecting a rise of 33.2%[23] - The net loss for the nine months ended September 30, 2022, was 4,372,949,comparedtoalossof3,295,803 for the same period in 2021, representing an increase of approximately 32.7%[28] - Total revenue for the nine months ended September 30, 2022 was 169,943,adecreaseof78,897, or 32%, compared to 248,840forthesameperiodin2021[95]−GrossprofitforthethreemonthsendedSeptember30,2022was26,831, an increase of 9,112,or5117,719 for the same period in 2021[88] - Total comprehensive loss for the three months ended September 30, 2022 was 1,769,175,anincreaseof468,892, or 36%, compared to 1,300,283forthesameperiodin2021[93]Expenses−Researchanddevelopmentexpensesincreasedto521,239 for the nine months ended September 30, 2022, compared to 363,003inthesameperiodof2021,representingariseof43.7198,501, an increase of 132,031,or19966,470 for the same period in 2021[89] - Selling and marketing expenses for the three months ended September 30, 2022 were 117,107,anincreaseof48,088, or 70%, compared to 69,019forthesameperiodin2021[90]−GeneralandadministrativeexpensesforthethreemonthsendedSeptember30,2022were1,495,395, an increase of 320,658,or271,174,737 for the same period in 2021[91] - The company recorded 105,358inshare−basedcompensationexpensesrelatedtotheFebruary2022WarrantduringtheninemonthsendedSeptember30,2022[41]−Thecompanyrecordedshare−basedcompensationexpensesof136,000 during the nine months ended September 30, 2022, related to a consulting agreement[49] - The company incurred stock-based compensation costs of 65,270fortheninemonthsendedSeptember30,2022,comparedto202,966 for the same period in 2021, indicating a decrease of approximately 67.8%[57] Cash Flow and Liquidity - Cash and cash equivalents as of September 30, 2022, were 6,689,979,slightlydownfrom6,750,938 as of December 31, 2021[21] - The total cash and cash equivalents at the end of the period was 6,739,686,adecreasefrom7,826,045 at the end of the same period in 2021, representing a decline of about 13.9%[29] - Cash used in operating activities for the nine months ended September 30, 2022, was 4,126,702,upfrom3,189,906 in 2021, indicating a year-over-year increase of about 29.4%[29] - Net cash used in operating activities was 4,126,702fortheninemonthsendedSeptember30,2022,comparedto3,189,906 for the same period in 2021, reflecting an increase primarily due to a net loss of 4,372,949[111]−Netcashusedininvestingactivitieswas35,430 for the nine months ended September 30, 2022, up from 23,760forthesameperiodin2021,mainlyduetoincreasedpurchasesofpropertyandequipment[112]−Netcashprovidedbyfinancingactivitieswas4,097,441 for the nine months ended September 30, 2022, a decrease from 10,766,033forthesameperiodin2021,attributedtolowerproceedsfromtheAugust2022UnderwrittenOfferingcomparedtotheMay2021UnderwrittenOffering[112]−Thecompanyanticipatesthatitscashbalanceswillbesufficienttoconductoperationsforatleasttwelvemonthsfromthedateofthefinancialstatements[109]ShareholderEquityandStock−Totalstockholders′equityincreasedto7,016,578 as of September 30, 2022, from 6,412,611asofDecember31,2021,markinganincreaseof9.4(1.39), compared to (1.49)inthesameperiodof2021[23]−Thecompanyissued1,600,000shares,netofissuancecostsof696,670, during the reporting period[26] - The company completed a public offering of 1,600,000 shares at a price of 3.00pershareonAugust15,2022[71]−Thecompanyraised4,800,000 from a public offering of 1,600,000 shares at 3.00pershareonAugust15,2022[33]−Thecompanyplanstoissue50,000sharesofCommonStocktoaconsultantunderaninvestorrelationsconsultingagreement,withquarterlyissuancesof9,000sharescommencingJanuary1,2023[66]−Thecompanyadoptedthe2022ShareIncentivePlan,allowingforthegrantofupto1,000,000optionstoserviceproviders[62]−Thecompanyhad234,674stockoptionsoutstandingasofSeptember30,2022,withaweightedaverageexercisepriceof3.00[56] - The aggregate intrinsic value of the stock options outstanding as of September 30, 2022, was 27,364,basedonthecompany′sstockpriceof1.90[56] Risks and Uncertainties - The company continues to face uncertainties due to the COVID-19 pandemic, impacting global supply chains and economic activity, although manufacturing operations remain uninterrupted[34] - The company faces various risks that could materially impact its business operations or financial results, as outlined in its 2021 Annual Report[122] Internal Controls - As of September 30, 2022, the company's disclosure controls and procedures were evaluated and deemed effective by the Chief Executive Officer and Chief Financial Officer[119] - There were no changes in internal control over financial reporting during the period covered by this report that materially affected the company's internal control[120]