Revenue Growth - Revenue increased by 3.9million,or2615.1 million for Q3 2023 to 19.0millionforQ32024[85]−RevenuefortheninemonthsendedSeptember30,2024,was51.7 million, up 10.2million,or2541.5 million for the same period in 2023[85] - Revenue increased by 3.9million,or2619.0 million for the three months ended September 30, 2024, compared to 15.1millionforthesameperiodin2023,drivenbyincreasedunitsalesandnewcustomers[108]−RevenuefortheninemonthsendedSeptember30,2024,increasedby10.2 million, or 25%, to 51.7millionfrom41.5 million for the same period in 2023, driven by increased unit sales and new customers[120] Market Opportunity - The annual U.S. total addressable market opportunity for OviTex products is estimated to be approximately 1.5billion[73]−TheannualU.S.currentaddressablemarketopportunityforOviTexPRSproductsisestimatedtobeapproximately700 million[79] Unit Sales - Unit sales of OviTex increased by 39% to 4,767 units for the three months ended September 30, 2024, compared to 3,426 units for the same period in 2023[110] - Unit sales of OviTex increased by 34% to 13,034 units for the nine months ended September 30, 2024, compared to 9,704 units for the same period in 2023[120] Financial Performance - The company has an accumulated deficit of 349.5millionasofSeptember30,2024[85]−Thecompanyhasnotbeenprofitablesinceinceptionandexpectstoincurlossesfortheforeseeablefuture[85]−NetlossfortheninemonthsendedSeptember30,2024,was28.6 million, a decrease of 5.1million,or1533.8 million for the same period in 2023[119] Operating Expenses - Total operating expenses for the nine months ended September 30, 2024, were 68.6million,anincreaseof8.3 million, or 14%, from 60.3millionforthesameperiodin2023[119]−Costofrevenue(excludingamortizationofintangibleassets)increasedby1.4 million, or 31%, to 6.0millionforthethreemonthsendedSeptember30,2024,from4.6 million for the same period in 2023[111] - Cost of revenue increased by 3.4million,or2716.1 million for the nine months ended September 30, 2024, compared to 12.7millionforthesameperiodin2023[121]−Salesandmarketingexpensesincreasedby2.0 million, or 14%, to 16.5millionforthethreemonthsendedSeptember30,2024,comparedto14.5 million for the same period in 2023[114] - Sales and marketing expenses rose by 8.2million,or1950.7 million for the nine months ended September 30, 2024, from 42.5millionintheprioryear[124]−Generalandadministrativeexpensesincreasedby0.3 million, or 3%, to 11.1millionfortheninemonthsendedSeptember30,2024,comparedto10.8 million for the same period in 2023[125] - Research and development expenses decreased by 0.2million,or26.8 million for the nine months ended September 30, 2024, from 6.9millionintheprioryear[126]CashFlowandFinancing−Cashandcashequivalentsdecreasedto17.3 million as of September 30, 2024, down from 46.7millionasofDecember31,2023[130]−Cashusedinoperatingactivitieswas34.1 million for the nine months ended September 30, 2024, compared to 29.8millionforthesameperiodin2023[136]−Thecompanycompletedapublicofferingof14,670,000sharesatapriceof2.25 per share, resulting in gross proceeds of 46.0million[132]−TheMidCapCreditAgreementhasatermloanof40.0 million, maturing in May 2027, with an interest rate of 6.25% plus the greater of one-month Term SOFR or 1.0%[145] - MidCap Credit Facility bears interest at a floating rate of 6.25% plus the greater of one-month Term SOFR or 1.0%[152] - A 1% increase in interest rates would result in a 0.3millionincreaseininterestexpensefortheninemonthsendedSeptember30,2024[152]StrategicInitiatives−InSeptember2023,thecompanyenteredintoadistributionagreementwithAdvancedMedicalSolutionsLimitedforLiquiFixHerniaMeshFixationDevices[81]−ThecompanylaunchedOviTexIHRReinforcedTissueMatrixinApril2024,specificallydesignedforinguinalherniaprocedures[74]−Thecompanyimplementedcost−cuttingmeasuresstartinginQ32024,expectedtoreduceoperatingexpensesinfutureperiods[85]InventoryandInflation−Grossmargindecreasedto687.6 million from the sale of certain assets related to NIVIS during the nine months ended September 30, 2024[127] - Gain on sale of product line amounted to $7.6 million during the nine months ended September 30, 2024[104]