Bioprosthetic medical device-maker Hancock Jaffe has secured approval from Ethics Committee at Fundación Santa Fe de Bogotá (FSFB), in Bogota, Colombia, for the first-in-human testing of its VenoValve medical device.
The company selected FSFB in late June this year, as the first site for its in-human testing of its VenoValve device.
FSFB owns the 205 bed University Hospital in Bogata, which was the first hospital in Colombia to receive the Joint Commission International accreditation, and which is a research collaboration partner with John’s Hopkins Medical International.
Hancock Jaffe (HJLI) is also yet to receive approval from FSFB’s Medical Research Committee. The company has been in the development of VenoValve for treating severe cases of Chronic Venous Insufficiency (CVI).
CVI occurs when the valves within the deep venous system of the leg are injured or destroyed, causing blood to pool in the lower extremities. It can result in swelling, debilitating pain, and skin ulcerations.
Practitioners rate the severity of CVI based upon a system called Clinical-Etiology-Anatomy-Pathophysiology (CEAP), a rating system of C0 to C6, with C4, C5, and C6 being the most severe cases.
It is estimated that nearly 4.5 million people in the US suffer from severe CVI and the condition results between 400,000 to 700,000 hospitalizations per year. Presently, there are no FDC approved treatments for deep venous CVI.
Hancock Jaffe has started the process of having the protocol for the VenoValve’s first-in-human testing approved by FSFB’s research and ethics committees. As part of the VenoValve development work, the company is also preparing to start a thirty (30) day biocompatibility study.
The porcine tissue based VenoValve, is intended to be surgically implanted in deep venous system of the leg to treat CVI.
The company is also working on CoreoGraft is a bovine tissue based off the shelf conduit intended to be used for coronary artery bypass surgery and 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.