Endovasc Ltd., Inc. (OTC BB: ENDV)
15001 Walden Road, Suite108
Montgomery, Texas 77356
Phone: (936) 448-2222
Corporate Web Site: http://www.endovasc.com/
Shares Outstanding: 59.7 million (as of 1/23/2002)
Insider Ownership: 31%
Market Capitalization: $ 6.0 million
Closing Price Friday 2/08/02: 10 cents
Coronary artery disease is the leading cause of death among men and women in the United States, taking an estimated 1 million lives each year. Nearly 60 million Americans suffer from some form of heart or coronary artery disease. Often referred to as "the silent killer," coronary artery disease typically remains undetected in many individuals until a major cardiac event occurs. Last year, for over 150,000 Americans, the first, last, and only symptom of heart disease was a fatal heart attack…
Medical innovations have helped to save lives. In addition to coronary by-pass surgery, doctors routinely perform balloon angioplasty whereby a tiny balloon attached to a catheter is threaded into patients’ constricted arteries. The balloon is then inflated to expand and push open the clogged vessel. The problem with this is that as many as 40% of the blood vessels opened by angioplasty close again within 6 months.
In the past decade, physicians began using stents - tiny wire mesh tubes that are implanted into a blood vessel. During the angioplasty procedure, when the balloon inflates, the stent is permanently expanded and presses against an artery wall, preventing the vessel from becoming blocked again. The trouble here is that the body naturally forms scar tissue around the stent, re-clogging the artery in up to 20% of the cases where the procedure was performed.
Recently, medical device makers have begun testing drug-coated stents. Johnson & Johnson coats its stents with a drug used to prevent rejection in kidney transplants. Guidant Corp. has been experimenting with the anti-cancer drugs Paclitaxel and ActinomycinD. All these drugs appear to make good stent coaters because of their ability to block cell growth. Coated stents have dramatically reduced the rate of restenosis, or a re-blockage of the arteries in patients tested. In one study involving 120 patients treated with a drug-coated stent, the restenosis rate was 0%.
U.S. stent sales currently total $1.3 billion a year. Analysts expect that the market for the improved coated stents to be double that or $2.6 billion. The drug-coated stents are expected to receive approval from the FDA sometime in 2003. The new stents are expected to sell in the $2700 - $3000 range vs. $1300 for conventional stents.
Incredibly, our pick this week, Endovasc, Ltd., Inc. (OTC BB: ENDV) appears to have gone the big players in this market one better… and, from what we can ascertain, ENDV is not yet on the Wall Street radar screen. Endovasc has developed a patented resorbable (biodegradable) stent that will not only maintain an open vessel and deliver a therapeutic drug, but also be totally absorbed by the body leaving the vessel both open and clear of any medical device in a 6 to 12-month period. The Endovasc stent literally dissolves in the artery thereby precluding eventual removal as may be the case with previously implanted non-biodegradable stents. In addition, unlike other medical device manufacturers pursuing stent technology, most if not all, are using cytotoxic or immunosuppressive cancer drugs. Endovasc's signature drug, Liprostin™ (liposomal encapsulated Prostaglandin E1, a naturally occurring hormone), is used to prevent common secondary blockages from occurring after angioplasty treatment. Liprostin™ is a patented drug and drug-delivery system that targets patients with cardiovascular and occlusive vascular disease and other indications. The drug can be delivered as adjunct therapy to an angioplasty procedure and is non-toxic. The company intends to develop its Liprostin™ product lines further to treat conditions such as ischemic ulcers, CLI (limb salvage), claudicants, liver disease, arthritis, and as a topical solution for wound healing. Other therapeutic treatments include anti-tumor agent coated stents placed in the main feeding vessels for treatment of malignant tumors, where the stent will continuously release anti-tumor drugs directly to the tumor site.
Another Endovasc product being tested is NRA (Nicotine Receptor Agonist), a newly discovered growth agent. While studying the damaging effects of tobacco smoke, researchers found that smokers appeared less susceptible to deaths due to infarction as compared to non-smokers. This counterintuitive discovery suggested that low-dose (non-smoked) nicotine had extraordinary angiogenic and vasculogenic growth factor potential. To develop technology based on this unique discovery, Endovasc obtained a worldwide exclusive right to the patent application for Nicotine Receptor Agonist in February 2000. NRA is an isolated molecule from the tobacco plant that has been found to promote the growth of new, healthy blood vessels and tissue at a wound or in occluded sites such as diseased hearts and limbs. Stanford University researchers, under direction of Dr. John Cooke, found that smokers or ex-smokers develop additional blood vessels in the heart area and have a better chance of surviving a heart attack than those who have never smoked. Endovasc Ltd. Inc. owns the exclusive world-wide rights for the development, marketing and distribution of NRA. This discovery may ultimately enable biological bypasses to take place in lieu of surgery for heart disease patients.
On February 4, 2002, Endovasc announced that it signed an Option Agreement with Stanford University to acquire an exclusive, worldwide patent license for the use of nicotine in stem cell and progenitor cell recruitment focused in the areas of cardiology and neurology. Dr. David P. Summers, chairman and CEO of Endovasc, said, “We are very excited about the data obtained from our NRA angiogenesis preclinical work. In the first half of this year, we anticipate advancing NRA into Phase III clinical trials to evaluate its safety and efficacy in the treatment of chronic myocardial ischemia. The Stem Cell Option Agreement announced today greatly expands the opportunities for NRA. In addition to the use of NRA in the area of angiogenesis, Endovasc now has the option to evaluate its use in the recruitment and mobilization of stem cells for regeneration of various organs, such as the heart. Although it is too early to predict the potential of this Stanford discovery, we believe that the implications are enormous.”
There are no competitors in the field of liposome manufacturing that directly compete with Endovasc’s patented and patent pending products. No truly effective anti-restenosis devices or drugs are commercially available today. Also, there are no competitors for nicotine's angiogenic use as a result of patents and patents pending held by Endovasc.
Because of the high economic burden on the global health care system and the severity of heart and vascular diseases, there is a substantial economic and public health interest in the successful treatment of these diseases. It appears that Endovasc has developed a medical breakthrough that is urgently needed by the medical community to enhance the quality of life and ongoing treatment for many facing debilitating heart disease and limb amputation while greatly reducing medical costs.
Readers take note that there has been very limited ENDV insider selling in the past 12 months… always a positive indicator.
Readers are encouraged to visit the Endovasc Ltd., Inc. company web site for further information. Readers are urged to read the company SEC filings and do their own due diligence before investing in this or any other stock.

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