Clinical Trials and Product Development - The VenoValve is currently being evaluated in the SAVVE trial, with patients reporting reduced pain and enhanced quality of life[26] - The company expects to file for FDA approval of the VenoValve in Q4 2024, followed by the enVVe in 2026[27] - The SAVVE trial achieved full enrollment of 75 subjects on September 1, 2023, four months earlier than expected due to increased demand[38] - Preliminary data from the SAVVE study indicated an 8% rate of device-related material adverse events within 30 days of enrollment[40] - At the six-month mark, 97% of patients showed clinical improvement as measured by rVCSS, with an average improvement of 8 points[41] - The VenoValve has been granted Breakthrough Device designation by the FDA, indicating its potential significance in treating severe CVI[34] - The company is also developing the enVVe, a non-surgical replacement venous valve system, with IDE approval expected in Q2 2025[26] - The average improvement in the Clinical Meaningful Benefit cohort was 8.46 points, with 94% of patients showing clinical improvement at a follow-up of 11.04 months[42] - In the SAVVE study, 91% of venous ulcer patients evaluated at one year either had fully healed ulcers or ulcers that had improved, with 100% of ulcers lasting one year or less fully healed[43] - The company expects to file the PMA application for the VenoValve in Q4 of 2024, pending one-year data for all 75 patients[44] - The enVVe system targets approximately 3.5 million patients in the U.S. market for the treatment of chronic venous insufficiency (CVI)[44] Financial Performance - Research and development expenses decreased by 33.3% to 4.2 million for the same period in 2023[48] - The company reported net losses of 6.5 million in the same period in 2023[46] - Selling, general and administrative expenses remained flat at 10.0 million for the six months ended June 30, 2024, a decrease of 22.5% from 4 million to 39.1 million in cash and investments as of June 30, 2024[46] Market Impact and Patient Statistics - Approximately 20 million people in the U.S. suffer from severe deep venous CVI (C4 to C6 disease) with reflux[32] - The average annual treatment cost for a patient with a venous ulcer is estimated at 3 billion annually in the U.S.[32] - Severe CVI patients miss approximately 40% more workdays than the average worker, highlighting the condition's impact on quality of life[31]
enVVeno Medical (NVNO) - 2024 Q2 - Quarterly Report