The Need
According to the American Heart Association, in 1996, over 60 million Americans had one or more types of cardiovascular disease. In 1993, the latest data available, over 950,000 cardiovascular disease deaths occurred, making it the number one cause of death in the U.S. and 42% of all deaths. By comparison, the estimated 1993 total of U.S. cancer deaths was 530,000.
Not surprisingly, cardiovascular disease impacts the U.S. health care system tremendously and, as the population ages, it will almost assuredly continue to burden health care resources. Despite increases in cardiovascular disease incidences, advances in medical technology and scientific knowledge in the past 30 years are witness to dramatic death rate declines (over 50% in the U.S.) from cardiovascular disease.
Angioplasty, an intravascular balloon catheter that clears blocked arteries and places stents, has only been used for 20 years. According to the American Heart Association, half of all blood vessel blockages receive angioplasty treatment, with the remainder undergoing bypass or medical therapy.
Even though fewer bypasses are performed, restenosis, the re-blocking of a previously cleared artery, commonly occurs with angioplasty. In 1993, some 600,000 angioplasty procedures were performed worldwide (U.S. Insurance Claims Database) with over 40% of the patients developing restenosis within three to six months. Repeat angioplasty causes more than 2,500 deaths and costs approximately $3.5 billion.
Opportunities abound for companies that can develop cost-effective cardiovascular disease treatments while reducing trauma and improving patient outcome. Endovasc's management believes its goal of $100 million in revenue can be reached within three years of FDA approval of its cost-effective PGE-1 stent coating and related products.
Management views the Cook Endovascular research agreement as major step in validating PGE-1 as an effective restenosis reduction method. Endovasc anticipates strong subsequent demand for PGE-1 upon its approval. |
