enVVeno Medical (NVNO) - 2023 Q3 - Quarterly Report

Product Development and Clinical Studies - The VenoValve® is currently being evaluated in a U.S. pivotal study, with expectations for FDA approval in Q4 of 2024[46][65]. - The first-in-human study for the VenoValve showed a 54% improvement in reflux time, a 56% improvement in Venous Clinical Severity Scores (VCSS), and a 76% improvement in visual analog scale (VAS) pain scores after one year[57]. - The VenoValve has received Breakthrough Device Designation from the FDA, facilitating priority review for its approval[60]. - The SAVVE pivotal study has achieved full enrollment of 75 subjects, four months ahead of schedule, with initial safety data expected in Q4 of 2023[65]. - The company plans to expedite the development of enVVe, with a six-month GLP animal study expected to begin in Q1 of 2024[67]. - The VenoValve is estimated to be suitable for approximately 2.5 million patients with severe deep venous CVI in the U.S.[54]. - The enVVe® non-surgical transcatheter valve is expected to target approximately 3.5 million patients in the U.S. market[68]. Financial Performance - The company reported net losses of $5.0 million for the three months ended September 30, 2023, a decrease of 18% from a net loss of $6.1 million in the same period of 2022[71]. - The company incurred a net loss of $17.9 million for the nine months ended September 30, 2023, a decrease of 3% from a net loss of $18.5 million in the same period of 2022[76]. - Selling, general and administrative expenses decreased by $1.1 million or 30% to $2.6 million for the three months ended September 30, 2023, compared to $3.7 million in the prior year[73]. - Selling, general and administrative expenses decreased by $3.0 million or 26% to $8.4 million for the nine months ended September 30, 2023, compared to $11.4 million in the prior year[79]. - Research and development expenses increased by $0.3 million or 12% to $2.8 million for the three months ended September 30, 2023, primarily due to increased personnel and lab costs for the SAVVE study[74]. - Research and development expenses increased by $3.5 million or 49% to $10.6 million for the nine months ended September 30, 2023, primarily due to costs related to the SAVVE study[81]. - The company used $13.9 million in cash for operating activities for the nine months ended September 30, 2023, an increase of $2.1 million from $11.8 million in the same period of 2022[83]. - The company raised approximately $25.7 million in net cash proceeds from a financing offering closed on October 11, 2023, which is expected to fund operations through significant milestones[87]. - As of October 23, 2023, the company had cash and investment balances of $1.9 million and $48.6 million, respectively[88]. - The company does not currently generate revenue and does not expect significant revenue until successful commercialization of its product candidates[76]. Market Context - Approximately 20 million people in the U.S. are estimated to suffer from severe deep venous Chronic Venous Insufficiency (CVI), with 3.5 million new cases diagnosed annually[53]. - The average annual treatment cost for a patient with a venous ulcer is estimated at $30,000, contributing to total direct medical costs exceeding $3 billion annually in the U.S.[53].