enVVeno Medical Corporation is a late clinical-stage medical device company focused on the advancement of innovative bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of venous disease. The company is developing surgical and non-surgical replacement venous valves for patients suffering from severe Chronic Venous Insufficiency (CVI) of the deep venous system of the leg.
Business Overview
enVVeno's lead product is the VenoValve®, which is a potential first-in-class surgical replacement venous valve currently being evaluated in a U.S. pivotal study. The company is also developing a second product called enVVe®, a potential first-in-class, non-surgical, transcatheter-based replacement venous valve system. Both the VenoValve and enVVe are designed to act as one-way valves, helping to propel blood up the veins of the leg and back to the heart and lungs.The VenoValve is currently in a U.S. pivotal study called the SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) trial, which enrolled 75 patients across 21 U.S. sites. The company has reported positive preliminary data from the SAVVE trial, with 97% of patients showing clinical improvement as measured by revised Venous Clinical Severity Score (rVCSS) at six months, and 74% of patients achieving the clinically meaningful benefit of a 3-point or greater improvement in rVCSS. Additionally, the company has presented data showing significant improvement in venous ulcer healing for patients enrolled in the SAVVE study.
The enVVe system is currently in pre-clinical development, with the company expecting to file for IDE approval to begin the enVVe pivotal trial (the Transcatheter Anti-Thrombotic, Venous Valve Endoprosthesis or TAVVE) in Q2 of 2025.
Financials
For the fiscal year ended December 31, 2023, enVVeno reported an annual net loss of $23.5 million, with no revenue generated. The company's annual operating cash flow was -$18.9 million, and its annual free cash flow was -$18.9 million.In the first six months of 2024, the company reported a net loss of $10.0 million, with no revenue generated. Research and development expenses decreased by 24.4% to $5.9 million, while selling, general, and administrative expenses decreased by 12.1% to $5.1 million. The company's cash and investment balance as of June 30, 2024, was $39.1 million, providing sufficient capital resources to meet its obligations for at least one year.
Liquidity
As of June 30, 2024, enVVeno had a cash and investment balance of $39.1 million and working capital of $37.8 million. The company expects its cash burn rate to increase from the current level of $4 million to $5 million per quarter as it conducts its clinical trials and works toward bringing its product candidates to market.Management believes that the company's capital resources are sufficient to meet its obligations as they become due within one year after the date of the Q2 2024 report and sustain operations. However, the company will need to raise additional capital in the future to fund its ongoing operations and product development initiatives.
Risks and Challenges
enVVeno faces several risks and challenges, including the successful completion of its clinical trials, obtaining regulatory approvals for its product candidates, and successfully commercializing its products. The company also faces competition from other medical device companies developing treatments for CVI.Additionally, the company is involved in litigation with a former employee, Robert Rankin, who has filed several complaints against the company and its CEO. While the company believes it has meritorious defenses to these claims, the outcome of the litigation could have a material impact on the company's financial condition and operations.