VenoValve Patients Continue to Show Improvement at 6 Months and 1 Year
IRVINE, CA / ACCESSWIRE / March 5, 2020 / Hancock Jaffe Laboratories, Inc. (Nasdaq:HJLI, HJLIW), a developer of medical devices that restore cardiac and vascular health, announced today that Dr. Jorge Hernando Ulloa, the Principal Investigator for HJLI’s first-in-man VenoValve study in Colombia, presented new VenoValve data at the 32nd Annual Meeting of the American Venous Forum (“AVF”) at the Omni Amelia Island Plantation Hotel at Amelia Island, Florida.
Dr. Ulloa’s presentation included data on 8 VenoValve patients that are six months post VenoValve surgery (including one patient that is one year post surgery), 2 patients that are 90 days post-surgery, and 1 patient that is 60 days post-surgery.
For the first patient to receive the VenoValve, who is now one year post surgery, Reflux has improved 73% and is now normal, the severity of her Chronic Venous Insufficiency has improved 94%, and her pain has improved 75%. This patient showed continued improvement between her six month and one year visits. Now that proper directional blood flow in the leg has been restored on a long term basis, the venous system has normalized and there are barely any manifestations of the disease.
Overall, VenoValves have been implanted in 11 patients in Colombia. Across all 11 patients and when comparing pre-operative levels to data recorded at their most recent office visits, Reflux, VCSS Scores, and VAS scores have improved 51%, 61%, and 65% respectively. That includes one patient who is currently occluded, and whose VenoValve if currently not functioning as intended.
CVI 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.
Endpoints for the VenoValve first-in-man study include reflux, measured by doppler, a VCSS score used by the clinician to measure disease severity, and a VAS score used by the patient to measure pain.
Dr. Marc H. Glickman, Hancock Jaffe’s Senior Vice President and Chief Medical Officer stated, “Dr. Ulloa’s presentation and the AVF meeting was well attended and our presentation was very well received. We have definitely garnered the attention of the vascular community and as we continue to monitor our patients and our data set increases, the interest level will continue to grow.”
Select slides from Dr. Ulloa’s AVF presentation are available on Hancock Jaffe’s website at: https://ir.hancockjaffe.com/articles-publications
VenoValve safety incidences have been unchanged since last reported, and include one (1) fluid pocket (which was as aspirated), intolerance from Coumadin anticoagulation therapy, and two (2) minor wound infections (treated with antibiotics). In addition to the updated data, Dr. Ulloa’s presentation included video testimonials from five VenoValve patients. A copy of the video is available at Hancock Jaffe’s website at: https://ir.hancockjaffe.com/investor-presentation
Robert Berman, Hancock Jaffe’s Chief Executive Officer stated, “While the medical community is focused on our data, what is equally as impressive is the difference that the VenoValve is making in the lives of our patients. The testimonial video was completely unscripted. I urge everybody to spend 2 minutes on the Hancock Jaffe website to listen to what our patients are saying about the VenoValve and how it has changed their lives.”
Next steps for the VenoValve include the continual monitoring of the Colombia patients, a Pre-IDE meeting with the U.S. Food and Drug Administration (“FDA”), and other mandated testing required for HJLI to file its IDE application seeking FDA approval for the U.S. pivotal trial, which HJLI expects to file in Q3 of 2020.
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 a year. There are currently no FDA approved devices, or effective treatments for deep venous CVI.
About Hancock Jaffe Laboratories, Inc.
Hancock Jaffe Laboratories (NASDAQ: HJLI) specializes in developing and manufacturing bioprosthetic (tissue based) medical devices to establish improved standards of care for treating cardiac and vascular diseases. Hancock Jaffe currently has two lead product candidates: the VenoValve®, a porcine based valve which is intended to be surgically implanted in the deep venous system of the leg to treat reflux associated with Chronic Venous Insufficiency; and the CoreoGraft®, a bovine tissue based off the shelf conduit intended to be used for coronary artery bypass surgery. Hancock Jaffe has a 20-year history of developing and producing FDA approved medical devices that sustain or support life. The current management team at Hancock Jaffe has been associated with over 50 FDA or CE marked medical devices. For more information, please visit HancockJaffe.com.
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