enVVeno Medical (NASDAQ:NVNO), a clinical-stage medical device company developing innovative solutions for the treatment of chronic venous insufficiency (CVI), today reported its financial results for the full year ended December 31, 2025.
The company’s performance over the past year reflects a strategic transition from early-stage R&D toward the execution of large-scale clinical programs for its next-generation enVVe™ system.
For the full year 2025, enVVeno reported a narrowed net loss of $19.5 million, compared to a net loss of $21.8 million in 2024.
This bottom-line improvement was driven by a disciplined reduction in operating expenses.
Research and development (R&D) costs fell 19% to $10 million as the company concluded the intensive pre-clinical development phase for the enVVe system.
Selling, general, and administrative (SG&A) expenses were $10.9 million, reflecting the ongoing administrative infrastructure required to support the company’s transition into a pivotal clinical phase.
The most significant operational milestone of 2025 was the completion of all required pre-clinical testing for enVVe, a non-surgical, transcatheter-based replacement venous valve.
enVVeno is currently in active discussions with the U.S. Food and Drug Administration (FDA) regarding the final design of a pivotal clinical trial, which the company expects to initiate in the second half of 2026.
This trial will build upon the foundational data from the ongoing VEST study for the company's first-generation Vanohealer product.
Financially, enVVeno is well-positioned to navigate its upcoming clinical catalysts.
The company ended the year with $28.2 million in cash and investments.
Management anticipates a quarterly cash burn of $4 million to $5 million throughout 2026 as clinical activity ramps up.
Based on this projection, the company’s current liquidity is expected to fund operations into mid-2027, provided that key clinical and regulatory milestones are achieved on schedule.