Product Development and Clinical Trials - enVVeno Medical Corporation is focused on developing innovative bioprosthetic solutions for Chronic Venous Disease (CVD), which affects approximately 71% of the adult population in the U.S.[45] - The lead product, VenoValve®, is currently in a pivotal study and has shown an average improvement of 54% in reflux, 56% in Venous Clinical Severity Scores (VCSS), and 76% in pain scores (VAS) after one year in a first-in-human study[56] - The VenoValve is expected to be eligible for FDA approval first, followed by the enVVe® valve two to three years later, with an estimated 2.5 million candidates for VenoValve in the U.S.[47][54] - The enVVe® valve is a non-surgical option currently awaiting approval for an early feasibility study, targeting an estimated market of approximately 3.5 million patients in the U.S.[63][64] - The company has enrolled 57 subjects in the SAVVE trial and expects to achieve full enrollment of 75 subjects by the end of 2023[62] - The VenoValve received Breakthrough Device Designation from the FDA, which aims to expedite the development and review of devices for life-threatening conditions[58] - The first-in-human study for VenoValve included 11 patients, with significant improvements in clinical outcomes and no reported safety issues from one year to three years post-surgery[60][61] - Severe CVI patients miss approximately 40% more workdays than average workers, highlighting the significant impact of the disease on quality of life[52] - The company hired 4 Clinical Technologists to assist in training site personnel for the SAVVE study, addressing staffing shortages in hospitals[85] Financial Performance - The company reported net losses of 7.1 million for the same period in 2022[67] - Selling, general and administrative expenses decreased by 2.6 million for the three months ended June 30, 2023, primarily due to a decrease in share-based compensation[69] - Research and development expenses increased by 4.2 million for the three months ended June 30, 2023, mainly due to costs related to the SAVVE study[71] - The company incurred a net loss of 12.4 million for the same period in 2022[73] - Cash and investments as of June 30, 2023, were approximately 4 - 5 million per quarter, expected to fund operations through the end of 2024 and into 2025[82] - The company purchased 0.3 million in realized gains and interest income from matured treasury bills[80] - Other income increased to 0.1 million for the same period in 2022, reflecting higher yields from investments in US Treasuries[72] - Research and development expenses for the six months ended June 30, 2023, increased by 7.8 million, primarily due to costs related to the SAVVE study[76] - The company has sufficient capital resources to meet obligations for at least one year after the date of the report[83] Operational Overview - The company operates in a 14,507 sq. ft. ISO 13485-2016 certified facility in Irvine, California, dedicated to the design and manufacturing of tissue-based implantable medical devices[48]
enVVeno Medical (NVNO) - 2023 Q2 - Quarterly Report