Hancock Jaffe Laboratories Selects bioaccess.™ as CRO for its First-in-Human VenoValve® Study in Colombia

Hancock Jaffe Laboratories Selects Site for First-in-Human VenoValve Clinical Research Study (Trial) in Colombia
Obtaining approval for a foreign study is always a challenge. bioaccess.™’s assistance was invaluable in getting our study approved in Colombia. In addition to having an in-depth knowledge of the regulatory approval process, they also have a deep understanding of the culture. As a result, bioaccess.™ has the ability to identify and troubleshoot potential problems before they arise. For companies considering a trial in Colombia I recommend bioaccess.™ without hesitation.
— Robert Berman, CEO, Hancock Jaffe Laboratories, Inc.

[ORLANDO, FL., August 16, 2018] — Hancock Jaffe Laboratories, Inc. (Nasdaq:HJLI) (Nasdaq:HJLIW), a company specializing in bioprosthetic medical devices to establish improved standards of care for treating cardiac and vascular diseases, has selected bioaccess.™ as its contract research organization (CRO) for a first-in-human clinical trial of its VenoValve® bioprosthetic medical device. The clinical trial will be conducted at Cirulaser Andes (“Cirulaser”) in Bogota, Colombia — a specialized vascular center affiliated with Hospital Universitario de la Fundación Santa Fé de Bogotá ("FSFB"). FSFB owns a 205-bed university hospital in Bogota, and was the first hospital in Colombia to receive the distinguished Joint Commission International accreditation; FSFB also boasts an academic affiliation with John’s Hopkins Medical International in Baltimore, MD.

bioaccess.™ will assist Hancock Jaffe to obtain Cirulaser’s research and ethics committee approval for its planned VenoValve’s first-in-human trial. bioaccess.™ will also handle the regulatory submission to help Hancock Jaffe obtain Ministry of Health (INVIMA) approval in Colombia; along with the importation of the investigational devices, project management, study monitoring, and other necessary activities to ensure a successful trial. No specific time frame is being announced for the approvals, however, the companies expect to have all necessary approvals and paperwork in place to begin recruiting patients by the fourth quarter of this year. 

“The Colombian first-in-human study is a monumental milestone for our company and we are currently on schedule to begin the trial in December of 2018,” said Robert Berman, Hancock Jaffe’s CEO. “Preparation for the Colombia trial entailed an enormous amount of time and effort, and it is a credit to our internal team and the folks at bioaccess.™, who worked together seamlessly to meet our tight submission schedule.”

Hancock Jaffe is developing the VenoValve® to treat severe cases of chronic venous Insufficiency (“CVI”). CVI occurs when the valves in the in the veins of the deep venous system of the leg are injured or destroyed, causing blood to pool in the lower extremities, which leads to swelling, debilitating pain, and skin ulcerations. Practitioners rate the severity of CVI based upon a system known as CEAP, which stands for Clinical-Etiology-Anatomy-Pathophysiology and has a rating system of C0 to C6, with C4, C5, and C6 being the most severe cases. Approximately 4.5 million people in the U.S. suffer from severe CVI, and the condition results in over 700,000 hospitalizations per year. There are currently no FDA approved treatments for deep venous CVI.

The Journal of Vascular Surgery Venous and Lymphatic Disorders published an article on present and future options for treating deep vein disease. The article features the Hancock Jaffe’s VenoValve® implant. The Journal of Vascular Surgery Venous and Lymphatic Disorders is the official peer-reviewed journal of the Society for Vascular Surgery and the American Venous Forum. 

We have already received more than 100 inquiries from patients in Colombia wanting to participate in our study.

The article titled “Present and Future Options for Treatment of Infrainguinal Deep Vein Disease” addresses post thrombotic syndrome, a disease that occurs when a blood clot in the deep venous system creates chronic venous obstruction, reflux, or a combination of both, a condition that afflicts approximately 4.5 million people in the United States alone. The article focuses on the limitations doctors currently face in their ability to treat post thrombotic syndrome through existing measures, such as compression stockings and leg elevation. The article goes on to describe thrombotic syndrome as an “area of intense interest” among the vascular community and as “the final frontier in venous disease.” The article highlights Hancock Jaffe’s VenoValve® as a potentially curative treatment for venous reflux; a large and unmet medical need.

A recent Hancock commissioned report titled Chronic Venous Disease: Epidemiology and Economics has identified the total number of CVI sufferers in the U.S. as 22.6 million, including 3.1 million new diagnoses each year. The report also estimated the U.S. economic burden of venous ulcers from CVI to be $38 Billion a year. According to the author of the report, Mary Yost, “CVI affects twice as many people as all cardio vascular diseases combined, and 6 times more than diabetes. It is one of our most prevalent diseases. However, CVI is significantly underestimated, under diagnosed, and under treated.”

About Hancock Jaffe Laboratories, Inc.

Hancock Jaffe specializes in developing and manufacturing bioprosthetic medical devices to establish improved standards of care for treating cardiac and vascular diseases. Hancock Jaffe currently has three product candidates: the porcine tissue based VenoValve®, which is intended to be surgically implanted in the deep venous system of the leg to treat chronic venous Insufficiency; the CoreoGraft®, a bovine tissue based off the shelf conduit intended to be used for coronary artery bypass surgery, and a porcine tissue-based heart valve, which based upon its relatively small size and increased output, is an ideal candidate for pediatric aortic/mitral valve replacement. More information at www.hancockjaffe.com.

About bioaccess.™

bioaccess.™ is a Florida-based clinical research organization (CRO) and market access consulting company which mission is to help innovative life science companies conduct clinical research and commercialize their innovations in Colombia and the rest of Latin America. The company will provide Hancock Jaffe with support services (e.g., regulatory submission, logistical support, project management, and study monitoring; among others). More information at www.bioaccessla.com.


bioaccess™ Press Contact:

Julio G. Martinez-Clark, CEO
Tel: +1 (954) 903-7210
Email: jmclark@bioaccessla.com