Hancock Jaffe Concludes Successful VenoValve Pre-IDE Meetingwith FDACompany to Move Forward with Application for VenoValve U.S. Pivotal Trial
IRVINE, California, January 12, 2021 – Hancock Jaffe Laboratories, Inc.(Nasdaq: HJLI), a developer of medical devices that restore cardiac and vascular health, today announced that it has successfully concluded its VenoValve Pre-IDE meeting with the U.S. Food and Drug Administration (“FDA”). Topics presented at the meeting included the background and clinical need for the VenoValve, proposed study design, patient monitoring for safety and efficacy, bench testing protocols, and the VenoValve first-in-human results.
The proposed protocol for the U.S. pivotal trial is expected to be very similar to the protocol that was used for the VenoValve first-in-human study, which was successfully completed at the end of 2020, and which included endpoints for reflux time (the backwards flow of blood), VCSS scores (disease manifestations), VAS scores (pain), and VIENES quality of life scores. Patients enrolled in the first-in-human study experienced significant improvements in all study endpoints with no device related adverse events. Robert Berman, Hancock Jaffe’s Chief Executive Officer stated, “The Pre-IDE meeting with the FDA could not have gone better and is the last step before we file our application seeking approval to begin the VenoValve U.S. pivotal trial. Our first-in-human trial design provides an excellent roadmap for what we hope will be a successful pivotal trial and we look forward to filing our IDE application and working with the FDA to obtain IDE approval to begin patient enrollment.”
HJLI expects to propose a single-arm, multi-center study of an estimated seventy-five (75) patients. Depending on the results of the proposed pivotal study, HJLI could be eligible to apply for pre-market approval (“PMA Approval”) to market the VenoValve as early as six (6) months after the last patient in the pivotal trial receives their VenoValve implant. The proposed study will also include a multi-year follow-up observation period. Premarket approval is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of a Class III medical device before the device can be marketed to the public. Due in part to HJLI’s positive first-in-human results, provided that HJLI experiences similar results in the U.S. pivotal trial, feedback from the FDA indicated that a six (6) month study period prior to filing for PMA approval could be sufficient.
{00889796.DOCX.1}Several key opinion leaders and well-respected vascular surgeons from leading hospitals around the country have already expressed significant interest in participating in the VenoValve U.S. pivotalstudy. HJLI expects to file its IDE application in the first quarter of 2021 and will provide periodicupdates regarding site selection, IDE approval, and other important factors related to the proposed U.S. pivotal trial as HJLI progresses through the IDE approval process. In the event that the FDA has no major changes to the Pre-IDE testing that has been completed, HJLI expects to be in a position to begin patient enrollment for the U.S. pivotal trial as early as the end of the second quarter of 2021. The VenoValve was designed to treat a condition called chronic venous insufficiency (“CVI”), which occurs when the valves in the veins of the leg are injured or destroyed, causing blood to flow backwards, which is known as reflux. Reflux results in increased venous pressure (venous hypertension), damage to the veins, and results in the pooling of blood in the lower leg. Deep venous CVI is a serious condition, often resulting in debilitating pain, swelling, and open sores (venous ulcers) on the lower leg.Approximately 2.4 million people in the U.S. suffer from CVI due to reflux in the deep venous system. Estimates indicate that direct medical costs from CVI in the U.S. exceed $38 Billion
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