enVVeno Medical completes final wave of implants in pre-clinical GLP study

enVVeno Medical (NVNO) announced the completion of the final wave of implants for shorter-term subjects in its six-month pre-clinical GLP study for enVVe, its transcatheter-delivered replacement venous valve. The completion of all planned implants in the GLP study, including both long-term and short-term subjects, completes a critical phase of the study. The follow-up period, which began with the first wave of implants, is ongoing as scheduled. Pending successful completion of the GLP study, the Company anticipates submitting its IDE application to the FDA in mid-2025. The submission, if approved, would allow the Company to initiate the pivotal clinical trial for enVVe. Beginning early next year, the Company will begin to implement its strategy to transition from a development stage to a commercial entity for the VenoValve, while completing the necessary non-clinical and GLP testing for enVVe in preparation for its IDE application.