- The FDA has granted Breakthrough Device Designation status to Hancock Jaffe Laboratories Inc's HJLI VenoValve, the Company's lead product, currently set to begin its U.S. pivotal trial.
- The VenoValve, a porcine-based valve, is a potential treatment for Chronic Venous Insufficiency that occurs when valves inside the leg's veins fail, causing blood to flow in the wrong direction (reflux), creating increased pressure inside of the veins of the leg.
- Preparation to begin enrollment of 75 patients at up to 20 centers throughout the U.S. for the SAVVE pivotal trial is being finalized.
- Enrollment will start within the next 60 days.
- Price Action: HJLI shares are up 25.6% at $8.25 during the premarket session on the last check Tuesday.
- Related content: Benzinga's Full FDA Calendar.
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