enVVeno Medical Reports $6.7 Million Net Loss in Q2 2025, Increased Operating Expenses

enVVeno Medical Corporation has reported its financial results for the second quarter of 2025, revealing a net loss of $6.7 million, an increase of 35% from the $5.0 million loss recorded in the same period of 2024. For the first half of 2025, the company reported a net loss of $11.2 million, compared to a loss of $10.0 million in the first half of 2024. The increase in losses is attributed to higher operating expenses, which rose by $1.6 million in the second quarter and $1.0 million in the first half, alongside a decrease in other income.

Total operating expenses for the second quarter of 2025 reached $7.0 million, up from $5.5 million in the prior year. Research and development expenses saw a slight increase of 2% to $2.9 million, primarily due to higher personnel costs. In contrast, selling, general, and administrative expenses surged by 58% to $4.2 million, driven by increased compensation costs, a non-recurring severance expense, and a reserve for potentially uncollectible prepaid clinical costs. The company continues to operate without generating significant revenue, as it remains in the developmental stage, focusing on the commercialization of its lead product, the VenoValve.

As of June 30, 2025, enVVeno Medical reported total assets of $36.6 million, a decrease from $44.9 million at the end of 2024. The decline in assets is primarily due to a reduction in short-term investments, which fell from $41.4 million to $33.1 million. The company’s cash and cash equivalents increased slightly to $2.0 million from $1.8 million, while total liabilities rose to $3.5 million from $2.8 million, reflecting higher accounts payable and accrued expenses.

In terms of operational developments, enVVeno Medical is advancing its clinical trials for the VenoValve, which is currently in the post-enrollment follow-up phase of its pivotal study. The company has also initiated pre-clinical testing for its second product, the enVVe, a non-surgical replacement venous valve. The VenoValve has received Breakthrough Device designation from the FDA, and the company anticipates submitting a pre-market approval application in the second half of 2025. The company’s management believes that its current capital resources are sufficient to meet obligations for at least the next year, although it may need to raise additional funds to support ongoing operations and product development.

Looking ahead, enVVeno Medical expects to continue incurring losses as it progresses through its clinical trials and prepares for commercialization. The company projects an increase in its cash burn rate to between $5 million and $7 million per quarter as it advances its product candidates. The successful completion of clinical studies and subsequent FDA approvals will be critical for the company’s future revenue generation and overall financial health.