CryoLife to Distribute Hancock Jaffe's ProCol Vascular Bioprosthesis for Hemodialysis Access

March 27, 2014—CryoLife, Inc. (Kennesaw, GA) announced that it has acquired the exclusive worldwide distribution rights for the ProCol vascular bioprosthesis from Hancock Jaffe Laboratories, Inc. (Irvine, CA), and it has the right to acquire the ProCol product line from Hancock Jaffe, beginning 24 months after execution of the agreement.

According to CryoLife, ProCol is a natural biological graft derived from a bovine mesenteric vein that provides vascular access for end-stage renal disease (ESRD) hemodialysis patients. It is intended for the creation of a bridge graft for vascular access subsequent to at least one previously failed prosthetic access graft. ProCol received FDA premarket approval in 2004 and is available for sale in the United States.

The company noted that ProCol is complementary to CryoLife’s Hero (hemodialysis reliable outflow) graft, which is also for the treatment of patients with ESRD. ProCol provides vascular access for earlier-stage ESRD patients, and the Hero graft is designed for patients with limited access options and central venous obstruction.

Hancock Jaffe Laboratories noted that the ProCol vascular bioprosthesis has been shown to provide patients with ESRD with a viable access option, and the ProCol demonstrated improved patency compared with ePTFE grafts in clinical studies in the United States

Marc H. Glickman, MD, Chief of Vascular Surgery at Sentara Healthcare in Norfolk, Virginia, commented in CryoLife’s press release. “There is an increasing demand for vascular access options to address the growing number of ESRD hemodialysis patients. The ProCol vascular bioprosthesis is an excellent option for these patients, and clinical data show that it provides excellent patency when patients are faced with repeated failures of other grafts. In addition, ProCol is flexible and easy to suture, making it easy to implant in difficult cases, and it can be used in a variety of configurations and access sites.”

In exchange for four quarterly payments of up to $2.3 million for ProCol production costs, CryoLife will receive exclusive worldwide distribution rights for ProCol for up to 5 years (a 3-year term with two 1-year renewal terms at CryoLife’s option), a purchase option on the ProCol product line, first right of refusal on certain other applications of the ProCol technology, and approximately 4,000 units of ProCol inventory, advised CryoLife.