WOBURN, Mass.-CardioTech International Inc. has completed the first phase of testing on its CardioPass synthetic coronary artery bypass graft, a product it claims has a potential market of $1.5 billion.
A developer and manufacturer of polyurethane devices used in the treatment of heart disease, the company said its CardioPass graft would replace parts of diseased heart arteries that have become narrowed or blocked. Currently, heart surgeons often remove part of the saphenous vein in the leg to use as a coronary bypass graft. The synthetic graft would substitute for the leg vein and prevent the extra surgery required to obtain the vein from the leg.
The initial 30-day study of the CardioPass graft was conducted on laboratory animals at the UMDNJ-Robert Wood Johnson Medical School in New Brunswick, N.J., by a team under the direction of Gary Nackman, director of Vascular Research and assistant professor of surgery.
The tests involved grafting 3-millimeter diameter synthetic grafts into animals' natural vessels. They confirmed the handling characteristics of the grafts are acceptable and the grafts have the potential for clinical utility, CardioTech said.
Nackman emphasized the preliminary nature of the study, but added, ``Early results are encouraging, and this will allow us to move on to the next step in the process.''
The graft will move on to more advanced animal tests and, assuming continued success and Food and Drug Administration clearance, should be ready for human clinical trials within a year, said CardioTech CEO Michael Szycher. Clinical trials would then take two to three years and, assuming continued success and FDA clearance, the graft would become available on the commercial market.
There is a substantial need for a synthetic coronary bypass graft in the medical market, Nackman said.
``Currently, there is no FDA-approved small diameter synthetic graft that could be used for coronary bypass,'' he said. ``There is a real need for improvement in materials used in coronary bypass grafts.''
CardioTech estimates that 900,000 patients worldwide undergo coronary artery bypass surgery every year, procedures that typically require the placement of four grafts.
The secret to the CardioPass graft is that it is made with CardioTech's ChronoFlex polymer, Szycher said. ChronoFlex is a proprietary biocarbonate polyurethane formulation that is both biocompatible and biodurable, meaning it won't create toxicity in the body, nor be attacked by the body's natural enzymes, he said. CardioTech develops and produces all its ChronoFlex formulas.
``We make our own polyurethane,'' Szycher said. ``The type of polyurethane that we use to make the graft, I cannot go out and buy from anyone else.''
Major medical companies have tried to develop a synthetic coronary bypass graft for 30 years without success, he said. None successfully made it through the initial 30-day study phase that CardioTech just completed, Szycher claimed.
``Every large medical device company in the world has tried to develop a product like this,'' he said. ``We are in a position that other people have tried and couldn't get to.''
In addition to the CardioPass graft it is testing, CardioTech is developing a polyurethane-covered stint in conjunction with Implant Sciences Corp. for the treatment of cardiovascular disease, Szycher said.
CardioTech's financial results have improved through the first six months of fiscal 2001, ended Sept. 30, when compared with the year-earlier period. Sales for the first six months of 2001 were $1.59 million, an 83-percent increase over sales of $867,000 in 2000.
Despite the sales increase, the company reported an overall loss of $1.34 million for the first six months of 2001, compared to a year-earlier period loss of $840,000, an increase in losses of 60 percent. CardioTech attributed 54.3 percent of the loss to a one-time, non-cash charge for stock-based options it granted to consultants. Without the charge, CardioTech's losses in the first six months of 2001 decreased 26.9 percent to $614,000.
CardioTech runs a 16,000-sq.-ft. research and development laboratory in Woburn and a recently acquired manufacturing operation in Minneapolis, Catheter and Disposables Technology Inc., that comprises 14,000 square feet. Overall, CardioTech employs about 32.