HEPALIFE TECHNOLOGIES, INC. (OTCBB: HPLF)

Dear Reader,

Normally, we offer a snappy lead here, a brief and compelling foray into the subject company of the day. Usually, we greet you, our dear reader, with tidbits about the market at large or generalities about this issue of StockUpTicks.

However, the somber image above may be a better introduction, its stark statistics the most poignant “lead” we could ever use: 25 Million Americans – perhaps members of your families and neighbors on your street - and a strain of $10 billion a year on the health care system – are simultaneous victims of liver disease.

Our feature company today, HepaLife Technologies, Inc. (OTCBB: HPLF) is working to develop a device to provide relief for this malady.  We strongly encourage you to read this profile, not just as a company in which you may  wish to invest, but as a potentially life-changing product you may someday need to know about.

This is not light reading. This is important information and we encourage you to sit back in your chair and scroll through one of the most interesting and potentially life-changing profiles we’ve ever had the privilege to publish.

“$60 Billion-company, Medtronic (NYSE: MDT), created immense shareholder wealth by gambling on the Pacemaker 40 years ago…HepaLife could be next with the artificial liver”
-Scott Fraser of The Natural Contrarian

ABOUT HEPALIFE TECHNOLOGIES, INC. (www.hepalife.com)

HepaLife Technologies, Inc. is a development stage biotechnology company focused on the research, development and eventual commercialization of technologies and products to treat various forms of liver dysfunction and disease.

Through a Cooperative Research and Development Agreement with the USDA’s Agricultural Research Service, the primary tool linking government and industry researchers, HepaLife Technologies, Inc. (OTCBB: HPLF) is collaborating towards optimizing the hepatic functions of a patented cell line, whose hepatic characteristics have been demonstrated to have potential application in the production of an artificial liver device for use by human patients with liver failure.

The need for an artificial liver device able to remove toxins and improve immediate and long-term survival results for patients suffering from liver disease is more critical today than ever before.

Limited treatment options, a low volume of donor organs, the high price of transplants and follow up costs, a growing base of hepatitis sufferers, alcohol abuse, drug overdoses and other factors that result in liver disease, all clearly indicate that a strong need exists for an artificial liver device, now and into the foreseeable future. 
 
 

A Tragic Demand: 25 Million Americans Suffer From Liver Disease

According to the American Liver Foundation, 1 in every 11, or approximately 25 million Americans are afflicted with liver disease. During 2000 alone, 26,552 people died in the United States as a consequence of cirrhosis and chronic liver disease (National Vital Statistics Report, September 16, 2002). 

In purely economic terms, liver-related problems cost society over $10 billion per year. In human terms, the costs cannot be calculated. 

With over 500 documented functions, the liver is one of the most important and complex organs in the human body, primarily responsible for removing toxins and poisons from the bloodstream. Everything we eat, drink and even smell impacts the liver. 

Each year, hundreds of thousands of individuals worldwide experience acute or chronic liver failure caused by hepatitis and other infections, degenerative diseases, trauma, drug overdoses and alcohol abuse.  The last of these, alcohol abuse, is a major cause of liver disease in America today.
 
 

Of the nearly 14 million Americans (1 in every 20) that either abuse alcohol or are alcoholics (National Institute on Alcohol Abuse and Alcoholism), 10 to 20 percent will develop cirrhosis of the liver, one of the leading causes of death among young and middle-age adults in the US. Individuals with cirrhosis are particularly prone to developing fatal bacterial infections, kidney malfunctions, stomach ulcers, gallstones and cancer of the liver. 

Chronic alcohol consumption may also increase the adverse side effects to the liver of medications used in the treatment of other conditions. 
 
 

Everyday pain relievers such as Bayer, Tylenol and Excedrin and other medications such as Neo-Citran and Sinutab, which contain acetaminophen, can also lead to serious liver problems. A study led by Dr. William Lee of the University of Texas, which was reported in the December 17, 2002, issue of Annals of Internal Medicine, concluded that acetaminophen overdose and drug reactions have replaced viral hepatitis as the most frequent apparent cause of acute liver failure.

According to the National Hospital Ambulatory Medical Care Survey (April 22, 2002), there were 108 million patient visits to emergency rooms during 2000, with medications being used in 74% of all these visits. An average of 1.6 drugs were used per emergency department visit, with pain relief medications containing Acetaminophen being the most frequently administered class of drug.

One of the functions of the liver is the detoxification of drugs and poisons. When experienced in large amounts, often the case in hospital emergency wards, or in combination with alcohol, drugs or poisons, the toxic overload can destroy the liver quickly. Each year, tens of thousands of individuals die due to acute liver failure as a result of drug overloads in emergency rooms worldwide.
 
 

According to the Centers for Disease Control, between 15-25% (upwards of 312,500 Americans) of the estimated 1.25 million chronically infected hepatitis B sufferers will die from chronic liver disease. Globally, an estimated 300 million people are infected with hepatitis B, causing approximately 1,000,000 deaths per year.

Various studies, when combined together, suggest that over 200 million people around the world are infected with hepatitis C. Statistically, as many people are infected with hepatitis C as are with HIV, the virus that causes AIDS. Without large scale efforts to contain the spread of hepatitis C and treat infected populations, the death rate from hepatitis C will surpass that of AIDS by the turn of the century. 

Of the estimated 4.5 million Americans infected with hepatitis C, for which there is no cure, an estimated 70-80% will develop chronic liver disease and 20% will die. The annual health care costs for the affected U.S. population with chronic hepatitis C has been estimated to be as high as $9 billion, compared to annual cost of $360 million for hepatitis B sufferers.

In addition to alcohol abuse, drug overdoses and hepatitis, other causes of liver disease include primary biliary cirrhosis, hemochromatosis, Wilson’s disease, alpha1-antitrypsin deficiency, glycogen storage disease, autoimmune hepatitis, cardiac cirrhosis and schistosomiasis. In total, according to the American Liver Foundation, approximately 25 million Americans are afflicted with liver disease. 
 
 

For people with severe liver failure, orthotopic liver transplantation is the only effective treatment therapy; now an estimated $1.5 billion business. At present, there are upwards of 17,000 adults and children medically approved and waiting for liver transplants in the U.S., which, at approximately $300,000 per transplant, would increase the potential size of the liver transplant market to over $5 billion if enough donor organs were available. 

Unfortunately, there are just over 5,000 livers available for transplant annually. Due to a severe shortage of organ donors, the waiting time for potential liver recipients could be as long as two to three years, with 20-30% of these patients not surviving the wait period. 

For those who receive liver transplants, some 31% will die within 5 years, while the rest will endure a life time of immunosuppressive drugs, rendering them susceptible to life threatening infections such as kidney failure and increased risk of cancer, and follow up costs of $25,000 per year to the health care system.

Sadly, patients suffering from advanced liver failure who are either not whole organ transplant candidates or who cannot find an available organ in a timely fashion have limited prospects for survival.
 
 

A strong need exists for an artificial liver device, as evidenced by: limited treatment options; a low volume of donor organs; the high price of transplantations and follow-up costs; a growing base of hepatitis sufferers; alcohol abuse; drug overdoses; and other factors that result in liver disease. In fact, the need for an artificial liver device that would remove toxins and improve immediate and long-term survival results is more critical today than ever before.

It is anticipated that an artificial liver device, once approved for use by appropriate regulatory agencies, could be used as a temporary artificial liver for patients awaiting a liver transplant, thus lengthening the time they have available while an organ donor is located.  It could also provide support for post-transplantation patients until the grafted liver functions adequately to sustain the patient. 

Additionally, this device could also be used as support for patients with chronic liver disease, thus allowing their own liver time to heal and regenerate, as well as providing immediate temporary support for those patients suffering from acute liver failure, as is the case with drug overdoses. 

The successful development of an artificial liver device would enable HepaLife Technologies to pursue a number of commercial opportunities, including, but not limited to: outright sale of licensed technology, joint venture partnerships with major health care companies, or marketing and selling the device by itself. 

According to the American Liver Foundation, approximately 25 million Americans are afflicted with liver disease. Even if an artificial liver device attained market penetration of only a few percentage points, it would have the potential of help hundreds of thousands of patients suffering from liver disease. 
 

SELECTED FINANCIAL HIGHLIGHTS

Symbol: HPLF (OTCBB) Business: Research & Development Website: www.hepalife.com

Shares Outstanding: 56,613,332  Debt: None Recent Price: $2.18

For a current quote on HPLF, click here 
To review the SEC filings for HepaLife, click here 
 

SCIENTIFIC FOUNDERS

COMPANY CONTACT

HepaLife Technologies, Inc. 
Investor Relations 
800.518.4879 

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