Overview

enVVeno Medical Corporation is a late clinical-stage medical device company focused on developing innovative bioprosthetic (tissue-based) solutions to improve the treatment of venous disease. Chronic Venous Disease (CVD) is a highly prevalent condition, affecting approximately 70% of the adult population in the U.S. The company’s lead product, the VenoValve®, is a first-in-class surgical replacement venous valve currently being evaluated in a U.S. pivotal study. The company is also developing a second product, enVVe®, a first-in-class non-surgical, transcatheter-based replacement venous valve, which is currently in pre-clinical testing.

Results of Operations

Comparison of the year ended December 31, 2024 to the year ended December 31, 2023

Revenues As a late-stage clinical medical device company, enVVeno Medical is not currently generating revenue. The company’s future revenue will depend on its ability to commercialize its product candidates, which is contingent on obtaining FDA approval.

Net Loss The company reported net losses of $21.8 million and $23.5 million for the years ended December 31, 2024 and 2023, respectively, representing a decrease in net loss of $1.7 million or 7%. This was due to a decrease in operating expenses of $1.5 million and an increase in other income of $0.2 million.

Research and Development Expenses Research and development expenses decreased by $1.4 million or 10%, from $13.6 million in 2023 to $12.2 million in 2024. This was primarily due to a decrease in costs for the SAVVE trial, partially offset by increases in employee compensation and costs related to the GLP study for the enVVe.

Selling, General and Administrative Expenses Selling, general and administrative expenses decreased by $0.1 million or 1%, from $11.7 million in 2023 to $11.6 million in 2024. This decrease was driven by a reduction in share-based compensation, travel costs, and insurance costs, partially offset by increases in legal costs and costs related to conferences and market research.

Other Income Other income increased by $0.3 million, from $1.7 million in 2023 to $2.0 million in 2024, reflecting realized gains, interest, and unrealized gains from the company’s investment of excess cash in U.S. Treasury securities.

Liquidity and Capital Resources

For the year ended December 31, 2024, the company incurred losses from operations of $23.8 million and used $16.8 million in cash for operating activities. The net cash used in operating activities decreased by $2.1 million from 2023, primarily due to the decrease in research and development expenses.

As of December 31, 2024, the company had a cash balance of $1.8 million and $41.4 million in investments, for a total of $43.2 million in cash and investments. The company expects its cash burn rate to increase from approximately $4 million to $5 million per quarter to $5 million to $6 million per quarter in 2025, but it should have sufficient cash to fund operations through mid-2026.

The company has historically funded its operations through financing activities, and it will need to raise additional capital in the future. Any inability to raise additional financing would have a material adverse effect on the company.