enVVeno Medical Reports $4.5 Million Net Loss in Q1 2025, Focuses on VenoValve Development

enVVeno Medical Corporation has reported its financial results for the first quarter of 2025, revealing a net loss of $4.5 million, a decrease of 10% from the $5.0 million loss recorded in the same period of 2024. The company’s operating expenses for the quarter were $4.9 million, down from $5.5 million year-over-year, primarily due to reduced research and development costs associated with its VenoValve pivotal study. The company continues to operate without generating revenue, as it remains in the developmental stage, focusing on the advancement of its bioprosthetic solutions for chronic venous insufficiency (CVI).

Total current assets as of March 31, 2025, stood at $39.5 million, a decline from $43.7 million at the end of 2024. This decrease was attributed to a reduction in short-term investments, which fell from $41.4 million to $36.0 million. The company’s cash and cash equivalents increased to $2.9 million from $1.8 million, reflecting a net increase in cash flow during the quarter. Total liabilities decreased to $2.3 million from $2.8 million, with current liabilities also declining, indicating improved financial management.

In terms of operational developments, enVVeno Medical is advancing its lead product, the VenoValve, which is currently in the post-enrollment follow-up phase of its U.S. pivotal study. The company has reported that the study reached full enrollment in September 2023, and it expects to submit a premarket approval (PMA) application to the FDA in the second half of 2025. Additionally, enVVeno is developing a second product, the enVVe, a non-surgical replacement venous valve, with plans to file for investigational device exemption (IDE) approval in the third quarter of 2025.

The company’s workforce has expanded, with the average number of common shares outstanding increasing to 20.4 million from 16.1 million year-over-year, reflecting ongoing efforts to bolster its team in preparation for potential commercialization. The management anticipates that cash burn will rise to between $4 million and $5 million per quarter as clinical trials progress and product development continues. Despite the current losses, management believes that the company has sufficient capital resources to meet its obligations for at least the next year, although additional capital may be required to sustain operations and support product development initiatives.

Looking ahead, enVVeno Medical remains focused on its strategic objectives, including the successful completion of clinical trials and the eventual commercialization of its products. The company acknowledges the inherent risks and uncertainties associated with its forward-looking statements, particularly regarding FDA approvals and market penetration. As it navigates these challenges, enVVeno aims to establish itself as a leader in the treatment of deep venous disease, addressing a significant unmet medical need in the market.