enVVeno Medical Corporation, a late clinical-stage medical device company, reported a net loss of $21.8 million for the fiscal year ending December 31, 2024, a decrease of 7% from the $23.5 million loss recorded in 2023. The reduction in losses was attributed to a $1.5 million decrease in operating expenses, primarily driven by lower research and development costs associated with the SAVVE pivotal trial for its lead product, the VenoValve®. The company has not yet generated revenue, as it awaits regulatory approval from the FDA for its product candidates.
The company’s research and development expenses decreased by 10% to $12.2 million in 2024, down from $13.6 million in 2023. This decline was largely due to reduced costs related to the SAVVE trial, which reached full enrollment in September 2023, shifting focus to ongoing monitoring and data collection. However, employee compensation costs increased by $0.9 million due to staffing expansions to support ongoing testing and preparation for the enVVe GLP study. Selling, general, and administrative expenses remained relatively stable, decreasing slightly to $11.6 million from $11.7 million, primarily due to lower share-based compensation.
As of December 31, 2024, enVVeno reported a cash balance of $1.8 million and $41.4 million in investments, totaling $43.2 million in cash and investments. The company utilized $16.8 million in operating activities during the year, a decrease from $18.9 million in 2023, reflecting the reduced research and development expenses. The company anticipates an increase in cash burn to approximately $5 million to $6 million per quarter in 2025 as it prepares for potential commercialization of the VenoValve, pending FDA approval expected in 2026.
Strategically, enVVeno is advancing its product pipeline, with the VenoValve currently undergoing a pivotal study and the enVVe, a non-surgical transcatheter valve, in pre-clinical testing. The company has initiated market research and visibility efforts in anticipation of a commercial launch. The VenoValve has received Breakthrough Device designation from the FDA, which may expedite its approval process. The company plans to file for IDE approval for the enVVe pivotal study in mid-2025.
Looking ahead, enVVeno's future financial performance will heavily depend on the successful regulatory approval and commercialization of its product candidates. The company acknowledges the inherent risks associated with clinical trials and regulatory processes, which could impact its ability to generate revenue. As it continues to navigate these challenges, enVVeno remains focused on its goal of improving treatment options for patients suffering from chronic venous disease.
About enVVeno Medical Corp
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