EnVVeno Medical Reports Positive 2023 Financials and Clinical Progress

enVVeno Medical Corporation, a leader in advanced treatments for venous diseases, delivered its financial outcomes and corporate achievements for the fourth quarter and the entirety of 2023. The Irvine, California-based company announced it concluded the year with $46.4 million in cash and investments, anticipated to sustain its operations and key milestones through the end of 2025. Of notable mention, the year ahead is looked forward to with the presentation of topline efficacy data from the SAVVE pivotal trial concerning the VenoValve® at the American Venous Forum Annual Meeting in March 2024.

CEO Robert Berman emphasized the strategic advancements made in the past year, highlighting the successful completion of the enrollment for the SAVVE U.S. pivotal trial and advancement towards the launch of the GLP study for its enVVe®. The company also celebrated the closure of a $28 million private placement, bolstering its financial stability for forthcoming projects, including the anticipated FDA approval for VenoValve. Moreover, the preliminary safety data from the SAVVE trial indicates a promising outlook for patient safety with an 8% MAE rate.

The financial records reflect a net loss reduction and an operational cash burn consistent with forecasts, ensuring the financial resilience of enVVeno as it progresses through its clinical and regulatory milestones. The firm’s R&D expenses have increased alongside its clinical trial activities, highlighting its commitment to advancing its pipeline of venous disease treatments. Selling, general, and administrative expenses have seen a significant decrease, primarily due to reduced share-based compensation expenses.