Napa-Based Biotech Firm, EndoMatrix, Inc., Patents Revolutionary Vascular Technology.

Business Editors and Health/Medical Writers

NAPA, Calif.--(BW HealthWire)--July 27, 2001

New Cardiovascular Treatment Prevents Heart Attack and Stroke,

and Produces Rapid, Dramatic Growth of New Arteries

That Naturally Bypass Blockages

Engineered to help millions of Americans wage a winning war against heart disease, EndoMatrix, Inc., a developmental biotech company, announced today the granting of a U.S. Patent that enhances medicine's arsenal of prevention and treatment options for cardiovascular and degenerative diseases.

Entitled "Composition and Method for the Treating of a Patient Susceptible to or Suffering from a Cardiovascular Disorder or Disease," Patent No. 6,255,296 addresses endothelial dysfunction, which is a critical process in a number of degenerative diseases including heart disease, diabetes, hypertension, kidney failure, and Alzheimer's Disease. The company has initially developed a vascular health product, Endovase(R), and plans to introduce it as a new dietary supplement for the prevention and treatment of cardiovascular diseases after conducting confirming clinical studies. It is the first treatment specifically designed to preserve and enhance the normal anti-clotting and anti-inflammatory functions in arteries.

"It is time to move beyond treating symptoms after the arteries are severely diseased. We now have much more knowledge. We can help sick arteries by restoring some of their previously normal functions before the disease overwhelms their normal protective properties," said Bruce A. Daniels, M.D., the inventor of the patented discovery and chief medical and scientific officer for EndoMatrix. "The processes of atherosclerosis are diffuse. It is a generalized disease, which is simply worse in some locations than in others. By treating the arteries themselves rather than just the blood coursing through them, we can prevent stroke and heart attack far more effectively than by opening or bypassing a blockage in a few grossly involved areas," Daniels added.

Current cardiovascular treatments consist of cholesterol-lowering drugs, blood pressure-lowering drugs, and invasive procedures, which open or bypass blocked arteries. According to Daniels, no currently available treatment has yet addressed the underlying changes in the arteries themselves. "It is the change in the arteries' molecular properties that is responsible for the cumulative effects leading to inflammation, cholesterol deposits, and loss of normal clot-resistance on the arteries' surfaces. It is very clear from research of the last decade that cholesterol accumulation is only a part of the myriad changes ultimately leading to the clot formation, which finally causes stroke and heart attack," noted Daniels.

After working in the field for more than 20 years, Daniels grew increasingly frustrated with the outcomes for his patients who were treated with invasive cardiovascular procedures such as angioplasty and open-heart surgery only to have the problem recur in a short time in another area. The inherent limitations of such treatments prompted Daniels to look for a better solution. "I felt an obligation as a physician to search for a treatment, possibly a cure, for endothelial dysfunction. It had become quite clear to me that I could continue to prescribe less than perfect treatments to my patients or I could look for a new way to fight vascular disease and eventually, save lives. The research clearly tells us that atherosclerosis begins with inflammation causing molecular changes in the arteries. To prevent the disease and its dreaded complications, it is necessary to prevent the inflammation and other molecular changes, which lead to loss of normal endothelial function."

As a result of a decade of medical research in nitric oxide physiology, endothelial biology, and free radical chemistry, Daniels theorized that cardiovascular disease results from the dysfunction of the arterial endothelium's ability to sustain production of effective levels of the normally protective substances nitric oxide and anticoagulant heparans.

Daniels has treated hundreds of his patients with Endovase over a seven-year treatment term, and his clinical findings demonstrate that heart disease and numerous other diseases, including hypertension, arise as a result of changes in the molecular properties of the endothelium, which lines blood vessels. "The endothelium is responsible for which molecules pass between the blood and the tissues themselves. It directly controls clotting activity on its surface. Its molecular properties determine what adheres to its surface and it responds actively to the molecules that bind to and interact with it. LDL cholesterol is only one of a growing number of molecules and free radicals recognized to damage and change the normal properties and behavior of the endothelium. The initial question I investigated was why cholesterol accumulation should reduce the endothelium's normal ability to resist clot formation," said Daniels. "What I set out to do was to find a simple, safe, effective treatment using only substances normally present in the body to continuously restore these molecular changes back toward their usual, effective state. This allows the endothelium to maintain its inherent ability to resist inflammation and clot formation on its surfaces. Treating the entire endothelial surface continuously in this way prevents the usual scenario of multiple, local procedures over successive years, as well as sudden, unforeseen heart attack and sudden death."

By envisioning these molecular changes and the interrelated functions of endothelial nitric oxide and heparans, Daniels succeeded in designing a simple, effective treatment, which dramatically increases the endothelial production of nitric oxide and anticoagulant heparans simultaneously. These effects greatly reduce the inflammation, binding of clotting factors and cholesterol, and produce rapid growth of new arteries, which "auto-bypass" areas of severe blockage.

In addition, by directing the endothelium to increase its ability to resist clot formation rather than anticoagulating the blood, there are no risks for side effects of bleeding as occur with numerous currently available medications.

The Dean's office of the University of Oklahoma College of Medicine reviewed Daniels' treatment results. Comparing his results in a 12-month retrospective study with a study published in The American Journal of Cardiology for patients with unstable angina treated with invasive procedures revealed a profound improvement in event outcomes with the use of Endovase:

A 90% reduction in hospitalization,

A more than 90% reduction in the incidence of heart attacks,

A 95% reduction in the death rate, and

A 90% reduction in repeat invasive procedures.

EndoMatrix, Inc. is a privately funded biotech company that plans to develop and license a family of Endoceuticals(R) and drugs for the prevention and treatment of cardiovascular, inflammatory, and degenerative disease based on this seminal discovery. The Company has recently submitted six additional patent applications based on the initial discovery and molecular derivatives from it for other disease states. The Company is in the process of conducting confirming safety and efficacy studies, licensing the technology to drug companies, and plans to launch its first vascular health product, Endovase, immediately upon completing these studies.