Financial Performance - Total revenue for Q3 2024 reached 8,122,000,a415,762,000 in Q3 2023[13] - Product revenue for Q3 2024 was 5,474,000,up1282,410,000 in Q3 2023[13] - Gross profit for Q3 2024 was 4,847,000,comparedto3,273,000 in Q3 2023, reflecting a gross margin improvement[13] - Net loss for Q3 2024 was 4,974,000,slightlyhigherthanthenetlossof4,809,000 in Q3 2023[13] - Operating loss for Q3 2024 was (5,172,000),comparedto(4,897,000) in Q3 2023[13] - Interest income for Q3 2024 was 209,000,comparedto100,000 in Q3 2023, indicating improved financial management[13] - For the nine months ended September 30, 2024, the net loss was 13.5million,comparedtoanetlossof17.5 million for the same period in 2023, representing a 22% improvement[19] - Cash flows from operating activities resulted in a net cash outflow of 7.7millionfortheninemonthsendedSeptember30,2024,comparedto12.6 million for the year ended December 31, 2023, indicating a reduction in cash burn[19] Equity and Liabilities - Total stockholders' equity as of September 30, 2024, was 29,001,000,upfrom21,173,000 a year earlier[10] - Total liabilities and stockholders' equity as of September 30, 2024, was 40,193,000,downfrom42,661,000 a year earlier[10] - Cumulative deficit at September 30, 2024, reached 186.0million,reflectingongoingfinancialchallengessinceinception[26]RevenueBreakdown−BiologicsanddrugdeliveryrevenueforthethreemonthsendedSeptember30,2024,was4.431 million, up 27% from 3.487millionintheprioryear[56]−NeurosurgerynavigationandtherapyrevenueforthethreemonthsendedSeptember30,2024,was2.860 million, an increase of 49% compared to 1.918millioninthesameperiodlastyear[56]−CapitalequipmentandsoftwarerevenueforthethreemonthsendedSeptember30,2024,totaled831,000, representing a 133% increase from 357,000inthesameperiodin2023[56]−Thecompany’srevenueisprimarilyderivedfromproductsales,professionalservices,andlicensingagreementsrelatedtoneurosurgeryanddrugdeliverysystems[33]CashandAssets−Cashandcashequivalentsattheendoftheperiodwere21.6 million, down from 24.3millionattheendofthepreviousperiod[19]−AsofSeptember30,2024,accountsreceivablewas3.875 million, an increase from 3.211millionatDecember31,2023[59]−Totalinventorydecreasedto7.257 million as of September 30, 2024, from 8.297millionasofDecember31,2023,representingadeclineofapproximately12.521.6 million, down from 23.1millionasofDecember31,2023[64]DeferredRevenueandObligations−Thecompanyrecognizedapproximately2.2 million of revenue from deferred revenue during the nine months ended September 30, 2024[60] - Deferred revenues decreased to 1.732millionasofSeptember30,2024,downfrom3.154 million at December 31, 2023[60] - The company expects to recognize 71% of the remaining performance obligations, amounting to approximately 1.7million,overthenexttwelvemonths[62]CustomerandMarketEngagement−Thecompanyhasover50biologicsanddrugdeliverycustomerscurrentlyevaluatingorusingitsproductsandservicesintrials,indicatingsignificantmarketengagement[24]−Onepharmaceuticalcustomeraccountedfor93,315,000, an increase from 2,429,000inQ32023[13]−Share−basedcompensationexpenseforthethreemonthsendedSeptember30,2024,was1.904 million, an increase of 20.2% compared to 1.584millionforthesameperiodin2023[76]−Thecompanyincurred480,000 in interest expenses during the reporting period[19] Stock and Financing Activities - The company raised approximately 16.2millionfromapublicofferingof2,653,848sharesofcommonstockinMarch2024[27]−InMarch2024,thecompanycompletedapublicofferingof2,653,848sharesatapriceof6.50 per share, generating net proceeds of approximately 16.2million[72][73]−Thecompanyrepaid10 million under the remaining First Closing Note on August 23, 2024, along with accrued interest of 0.1million[68]LeaseandFacilities−Thecompanyrecordedaright−of−useassetofapproximately2.5 million in connection with a new lease for a manufacturing facility in Carlsbad, California, which commenced in June 2023[21] - The company has a lease for office and manufacturing space in Carlsbad, California, which commenced on June 1, 2023, and ends on May 31, 2033[70] Stock Options and Employee Plans - The company’s stock option activity shows 1,458,920 options outstanding as of September 30, 2024, with an intrinsic value of 8.187million[80]−Thecompanygranted1,197,646RestrictedStockUnits(RSUs)duringtheninemonthsendedSeptember30,2024,increasingthetotaloutstandingRSUsto1,680,608[84]−Thecompany’sEmployeeStockPurchasePlan(ESPP)allowedthepurchaseof62,800sharesatanaveragepriceof4.58 during the first offering period of 2024[85] Economic and Operational Considerations - The company continues to monitor macroeconomic trends that could impact its operations, including inflation and supply chain disruptions[25] - The company has not recorded significant foreign currency sales and does not currently engage in hedging to mitigate foreign currency risks[142]