Clinical Manifestations of CVI Improved an Average of 46% Across All Five VenoValve Patients
IRVINE, CA / ACCESSWIRE / June 24, 2019 / Hancock Jaffe Laboratories, Inc. (NASDAQ: HJLI, HJLIW), a developer of medical devices that restore cardiac and vascular health, announced today that on Sunday, June 23, 2019, Dr. Jorge Hernando Ulloa, the Primary Investigator for HJLI’s first-in-human VenoValve study in Bogota, Colombia, reported new and updated data for Hancock Jaffe’s first-in-human VenoValve study at the 2019 C3 Global Conference in Orlando, Florida. Dr. Ulloa’s report indicated that for the first five VenoValve patients, VCSS scores, a measurement of venous disease severity graded by the clinician, have improved an average of forty-six (46%) compared to Pre-VenoValve levels. In addition, Dr. Uolla reported that reflux for the first VenoValve recipient, who is now more than 90 days post VenoValve surgery, has been reduced to a level that is within the range seen in patients without Chronic Venous Insufficiency (“CVI”).
CVI is a condition that occurs when the valves in the veins of the venous system of the leg are injured or destroyed, causing blood to flow backwards. The backwards flow of blood is known as reflux. The VCSS or Venous Clinical Severity Score consists of ten parameters that are used by clinicians to assess venous disease. Both reflux and VCSS are end points in Hancock Jaffe’s first-in-human study.
Dr. Marc H. Glickman, Hancock Jaffe’s Senior Vice President and Chief Medical Officer stated, “With this new 60 day VCSS data, we now have the numbers to support what we have predicted and what we are observing in the clinic: with reductions in reflux, the manifestations of CVI in VenoValve recipients are disappearing. In our first patient, who is now more than 90 days post VenoValve surgery, it is difficult to see any remaining signs of the disease. That patient continued to experience marked improvements between 60 and 90 days post VenoValve surgery, so we are optimistic that we will continue to see improvements in our VenosValve patients.”
On June 7, 2019, Dr. Ulloa presented 30 day data at the Expert Venous Management Conference in Englewood, New Jersey, which indicated that the VenoValve was working in four out of five patients, and that the average reflux reduction across all VenoValve recipients was 45%. The new 60 day VCSS data presented at the C3 Global Conference shows that reductions in reflux are directly correlated to improvements in CVI symptoms, and provides support for HJLI’s contention that even modest reductions in reflux can lead to significant improvements for CVI patients. The reflux reduction data, and the VCSS data, includes one patient where the VenoValve is currently not functioning. That patient has shown modest improvement since the implantation of the VenoValve, and is an important part of the study to show the regulators that the VenoValve does not cause significant harm, even in instances where the VenoValve does not function properly.
The VenoValve is a bioprosthetic replacement for damaged native valves in the deep veins of the leg. HJLI implanted a VenoValve in a sixth patient in early June, which also seems to be functioning properly. Patient six will next be checked approximately 30 days after implantation, pursuant to the study protocol. All patients in the first-in-human trial had severe CVI prior to receiving their VenoValves. In addition, to date there have been no serious device related adverse events associated with the VenoValves.
Robert Berman, Hancock Jaffe’s Chief Executive Officer stated, “I’d like to thank Dr. Ulloa for making the trip from Bogota to Orlando to update the C3 global audience on our latest VenoValve data. It has been a very busy month of June for Hancock Jaffe. In addition to presenting our initial VenoValve data at the Expert Venous Management Conference in New Jersey, and the latest VenoValve data at the C3 Global Conference in Orlando, we raised approximately $3.9 million via a public offering of our common stock, and hired a new Director of Research and Development to assist in preparing the VenoValve for the U.S. pivotal trial. We now have the data, capital, and personnel that we need to advance the VenoValve past several new milestones.”
The next milestones for the VenoValve include: enrollment and implantations for the remaining four patients that will be included in the initial phase of the first-in-human VenoValve study; updated data which is expected to be released in September of 2019; and design verification and validation activities in preparation for the filing of the Investigational Device Exemption (“IDE”) application for the VenoValve U.S. pivotal trial. The September data will include the first VenoValve patient who will be approximately 7 months post VenoValve surgery, patients two through five who will be approximately 5 months post VenoValve surgeries, patient six who will be approximately 3 months post VenoValve surgery, and the remaining four VenoValve recipients who are expected to be between 1 and 3 months post VenoValve surgeries.
The C3 Global Conference draws over one thousand attendees and has been specifically designed for physicians who specialize in interventional cardiology, vascular surgery, and interventional radiology, as well as fellows, residents, and other healthcare professionals interested in atherosclerotic cardiovascular disease. The Venous Summit is a two (2) day course within the C3 Global Conference focusing on venous disease starting from Superficial Venous Disease, Pulmonary Embolism Treatment, DVT, Venous CTO & New Venous Stents. Deep venous CVI afflicts approximately 2.6 million people in the U.S., representing a potential addressable U.S. market of approximately $14 billion. There are currently no 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 80 FDA or CE marked medical devices. For more information, please visit HancockJaffe.com.
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