enVVeno Medical (NVNO) - 2024 Q1 - Quarterly Report

Clinical Trials and Device Development - The VenoValve is currently being evaluated in the SAVVE trial, with patients reporting reduced pain and enhanced quality of life[41] - The SAVVE trial achieved full enrollment of 75 subjects on September 1, 2023, four months earlier than expected due to increased demand[59] - Preliminary device-related adverse event data from the SAVVE study indicated an 8% rate of material adverse events within 30 days of enrollment[60] - At the six-month mark, 97% of patients in the SAVVE study showed clinical improvement as measured by rVCSS, with an average improvement of 8 points[61] - The VenoValve has been granted Breakthrough Device designation by the FDA, indicating its potential significance in treating severe CVI[51] - The VenoValve showed a clinical improvement in 94% of study patients, with an average improvement of 8.46 points in rVCSS[62] - The company expects to file the PMA application for the VenoValve in Q4 2024, pending one-year data for all 75 patients[63] - The company expects to file for IDE approval for the enVVe pivotal trial in Q2 of 2025[42] - The company plans to start a six-month chronic GLP study for the enVVe valve in Q3 2024, with IDE approval expected to be filed in Q2 2025[65] Market and Financial Overview - Approximately 20 million people in the U.S. are estimated to suffer from severe deep venous CVI (C4 to C6 disease) with reflux[50] - The average annual treatment cost for a patient with a venous ulcer is estimated at $30,000, with total direct medical costs exceeding $3 billion annually in the U.S.[50] - The enVVe system targets an estimated U.S. market of approximately 3.5 million patients with less severe CVI[64] - The company reported net losses of $5.0 million for Q1 2024, a decrease of 22% from $6.4 million in Q1 2023[67] - Research and development expenses decreased by 14% to $3.1 million in Q1 2024, down from $3.6 million in Q1 2023[69] - Selling, general and administrative expenses decreased by 22% to $2.5 million in Q1 2024, compared to $3.2 million in Q1 2023[70] - Other income increased by 25% to $0.5 million in Q1 2024, up from $0.4 million in Q1 2023[71] - The company finished 2023 with approximately $46.4 million in cash and investments, and had approximately $42.9 million as of March 31, 2024[66] - The company anticipates a cash burn rate increase from approximately $4 million to $5 million per quarter as clinical trials progress[75] Regulatory and Approval Timeline - The VenoValve is projected to be eligible for FDA approval in Q4 of 2024, with enVVe expected to follow two to three years later[44]