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enVVeno Medical (NVNO) - 2024 Q3 - Quarterly Report
NVNOenVVeno Medical (NVNO)2024-10-30 23:20

Clinical Trials and Device Development - The VenoValve is currently being evaluated in the SAVVE trial, with definitive one-year data expected in Q4 2024[33]. - The SAVVE trial achieved full enrollment of 75 subjects on September 1, 2023, across 21 U.S. sites[46]. - Preliminary data from the SAVVE study indicated an 8% rate of device-related material adverse events (MAEs) among the 75 subjects, with no deaths reported[48]. - At six months, 97% of patients showed clinical improvement as measured by the revised Venous Clinical Severity Score (rVCSS), with 74% achieving a clinically meaningful benefit[49]. - The average improvement in rVCSS among the clinically meaningful benefit cohort was 8 points, significantly exceeding the required improvement[50]. - For venous ulcer patients in the SAVVE study, 91% showed healing or improvement at one year, with 100% of ulcers lasting one year or less fully healed[51]. - The company expects to file the final module of its premarket approval (PMA) application for the VenoValve in Q4 2024, having already filed four of the five required modules[52]. - The enVVe valve is being developed for non-surgical treatment of CVI, targeting an estimated market of 3.5 million patients in the U.S.[53]. - The company is conducting pre-clinical testing on enVVe, with plans to file for IDE approval for its pivotal trial in mid-2025[34]. - The company plans to file for IDE approval for the enVVe pivotal study in mid-2025, following the completion of a six-month pre-clinical GLP study[54]. Financial Performance - The company reported a net loss of 5.6millionforthethreemonthsendedSeptember30,2024,anincreaseof125.6 million for the three months ended September 30, 2024, an increase of 12% compared to a net loss of 5.0 million for the same period in 2023[59]. - Research and development expenses for the three months ended September 30, 2024, increased by 2% to 2.9millionfrom2.9 million from 2.8 million in the prior year[60]. - Selling, general and administrative expenses rose by 27% to 3.3millionforthethreemonthsendedSeptember30,2024,comparedto3.3 million for the three months ended September 30, 2024, compared to 2.6 million in the same period in 2023[60]. - The company closed a public offering on September 30, 2024, raising approximately 13.6millioninnetcashproceeds,whichisexpectedtofundoperationsthroughsignificantmilestones[57].−AsofSeptember30,2024,thecompanyhadapproximately13.6 million in net cash proceeds, which is expected to fund operations through significant milestones[57]. - As of September 30, 2024, the company had approximately 48.4 million in cash and investments, up from 46.4millionattheendof2023[55].−Theanticipatedcashburnrateisexpectedtoincreaseto46.4 million at the end of 2023[55]. - The anticipated cash burn rate is expected to increase to 4 million to 5millionperquarterasclinicaltrialsprogress[56].−FortheninemonthsendedSeptember30,2024,thecompanyreportedanetlossof5 million per quarter as clinical trials progress[56]. - For the nine months ended September 30, 2024, the company reported a net loss of 15.6 million, a decrease of 13% from a net loss of 17.9millionforthesameperiodin2023[61].−Otherincomeincreasedby5217.9 million for the same period in 2023[61]. - Other income increased by 52% to 0.5 million for the three months ended September 30, 2024, compared to 0.3millionintheprioryear[61].−Thecompanyincurred0.3 million in the prior year[61]. - The company incurred 11.7 million in cash used in operating activities for the nine months ended September 30, 2024, a decrease of 2.2millionfrom2.2 million from 13.9 million in the same period in 2023[67].