VenoValve Patients Continue to Show Significant Improvement at One Year
IRVINE, CA / ACCESSWIRE / April 28, 2020 / Hancock Jaffe Laboratories, Inc. (HJLI)(HJLIW), a developer of medical devices that restore cardiac and vascular health, announced today that five VenoValve patients from HJLI's first-in-man, clinical study in Colombia have now reached the one-year milestone following VenoValve surgery, and that chronic venous insufficiency ("CVI") has significantly improved in all five patients when compared to pre-surgery levels. For the five patients that are now one-year post VenoValve surgery, Venous Clinical Severity Scores ("VCSSs") have improved an average of 72%.
Improvement percentages in VCSS scores ranged from 31% to 100%, with three of the five patients showing improvement of 90% or more at one year, compared to pre-surgery levels. On average, the five patients showed an 8.2 point improvement in VCSS scores at one year, compared to pre-surgery levels. The improvements in VCSS scores is significant and indicates that VenoValve patients who had severe CVI pre-surgery, now have mild CVI or the complete absence of disease at one-year post surgery. VCSS scores are commonly used to objectively assess outcomes in the treatment of venous disease, and include ten characteristics including pain, inflammation, skin changes such as pigmentation and induration, the number of active ulcers, and ulcer duration. None of the five VenoValve patients experienced ulcer recurrence during the one-year period post-surgery. Venous ulcer recurrence is common for patients suffering from deep venous CVI.
Dr. Marc H. Glickman, Hancock Jaffe's Senior Vice President and Chief Medical Officer stated, "At the outset, our goal for the VenoValve was to demonstrate incremental improvement of a few points in VCSS scores for our patients. The results that we are seeing at one-year post-surgery are well beyond those expectations. When a patient that has suffered for years from severe CVI improves to a mild form of the disease for as long as one year, it is life-changing for the patient, and a significant breakthrough in the treatment of deep venous CVI, for which there are currently no effective alternatives".
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. HJLI has implanted VenoValves in 11 patients over the course of a year as part of its first-in-man, Colombian study, which is the pre-cursor to the U.S. pivotal trial. Data is being reported today for the first five VenoValve patients to reach the critical, one-year milestone. The five VenoValve patients that are one-year post surgery have now completed the first-in-man, clinical study.
Robert Berman, Hancock Jaffe's Chief Executive Officer stated, "We were originally scheduled to present our new, one-year VenoValve data at the Charing Cross Symposium in the U.K., which has been cancelled due to the corona virus. Due to severe travel and stay-at-home restrictions in California and Bogota, it is a credit to the resourcefulness and dedication of Dr. Glickman, Dr. Jorge Ulloa, our Principal Investigator in Colombia, and the rest of our clinical VenoValve team, to be able to continue to monitor our patients as they reached the critical, one year milestone."
Video testimonials from five VenoValve patients are available at Hancock Jaffe's website at: https://ir.hancockjaffe.com/investor-presentation
Next steps for the VenoValve include the continued monitoring of the remaining six VenoValve patients in Colombia, the completion of a series of functional tests mandated by the U.S. Food and Drug Administration ("FDA") which are necessary for the filing of an IDE application with the FDA, and approval of the IDE application by the FDA to begin the U.S. pivotal trial.
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 (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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