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NEWS
enVVeno Medical Successfully Completes Final Wave of Implants in Pre-Clinical GLP Study for enVVe
Monday, 16th December at 8:50 am
Successful Completion of All Planned Implants in GLP Study
enVVe Delivery System Demonstrates Consistent Performance
Company Maintains Timeline for IDE Application Submission by Mid-2025, Pending GLP Study Results
IRVINE, CA / ACCESSWIRE / December 16, 2024 / enVVeno Medical Corporation (NASDAQ: NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today announced the successful 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 successful 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.
Monday, 16th December at 8:50 am
Successful Completion of All Planned Implants in GLP Study
enVVe Delivery System Demonstrates Consistent Performance
Company Maintains Timeline for IDE Application Submission by Mid-2025, Pending GLP Study Results
IRVINE, CA / ACCESSWIRE / December 16, 2024 / enVVeno Medical Corporation (NASDAQ: NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today announced the successful 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 successful 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.
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