SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
September 22, 2004
Date of Report (Date of earliest event reported)
HEPALIFE TECHNOLOGIES, INC.
(Exact name of registrant as specified in its charter)
Florida
(State or other jurisdiction of incorporation)
000-29819
(Commission File Number)
58-2349413
(I.R.S. Employer Identification No.)
1628 West 1st Avenue, Suite 216, Vancouver, British Columbia, V6J 1G1
(Address of principal executive offices)
(800) 518-4879
(Registrant’s telephone number, including area code)
SECTION 1. Registrant's Business and Operations
None.
SECTION 2. Financial Information
None.
SECTION 3. Securities and Trading Markets
None.
SECTION 4. Matters Related to Accountants and Financial Statements
None.
SECTION 5. Corporate Governance and Management
None.
SECTION 6. [Reserved]
N/A.
SECTION 7. Regulation FD
Except for the historical information presented in this document, the matters discussed in this Form 8-K, or otherwise incorporated by reference into this document, contain "forward-looking statements" (as such term is defined in the Private Securities Litigation Reform Act of 1995). These statements are identified by the use of forward-looking terminology such as "believes", "plans", "intend", "scheduled", "potential", "continue", "estimates", "hopes", "goal", "objective", expects", "may", "will", "should" or "anticipates" or the negative thereof or other variations thereon or comparable terminology, or by discussions of strategy that involve risks and uncertainties. The safe harbor provisions of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, apply to forward-looking statements made by the Registrant. The reader is cautioned that no statements contained in this Form 8-K should be construed as a guarantee or assurance of future performance or results. These forward-looking statements involve risks and uncertainties, including those identified within this Form 8-K. The actual results that the Registrant achieves may differ materially from any forward-looking statements due to such risks and uncertainties. These forward-looking statements are based on current expectations, and the Registrant assumes no obligation to update this information. Readers are urged to carefully review and consider the various disclosures made by the Registrant in this Form 8-K and in the Registrant's other reports filed with the Securities and Exchange Commission that attempt to advise interested parties of the risks and factors that may affect the Registrant's business.
Note: Information in this report furnished pursuant to Item 7 shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. The information in this current report shall not be incorporated by reference into any registration statement pursuant to the Securities Act of 1933, as amended. The furnishing of the information in this current report is not intended to, and does not, constitute a representation that such furnishing is required by Regulation FD or that the information this current report contains is material investor information that is not otherwise publicly available.
On September 22, 2004, HepaLife Technologies, Inc. issued a news release to announce that ongoing results from research into its proprietary cell line – PICM-19H – have surpassed Management’s initial expectations for potential application towards the development of a bio-artificial liver device for use by human patients with liver failure. This news release, dated September 22, 2004, is attached as Exhibit 99.1 to this Form 8-K and is incorporated herein by reference.
SECTION 8. Other Events
None.
SECTION 9. Financial Statements and Exhibits
The following exhibits are furnished as part of this report:
Exhibit 99.1 – Press Release dated September 22, 2004
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
HEPALIFE TECHNOLOGIES, INC.
/s/ Arian Soheili
Arian Soheili
President and CEO
Date: September 27, 2004
EXHIBIT 99.1
Proprietary Liver Cell Line Performs Beyond Expectations
Results from improved cell line continue to surpass initial expectations; Key enzyme systems indicate highly favorable results; PICM-19P cells now indexed as ‘PICM-19H’.
Vancouver, BC – September 22, 2004 - - HepaLife Technologies, Inc. (OTCBB: HPLF), a development stage biotechnology company focused on the research, development and eventual commercialization of technologies and products for liver toxicity detection and the treatment of various forms of liver dysfunction and disease, is pleased to announce that ongoing results from research into its proprietary cell line – PICM-19H – have surpassed Management’s initial expectations for potential application towards the development of a bio-artificial liver device for use by human patients with liver failure.
Ongoing research and testing has been actively conducted to specifically observe cell growth and assess particular hepatic functions of the PICM-19H cell line, previously referenced as ‘PICM-19P’ and developed as a subpopulation of the original, patented PICM-19 liver cell line.
Most notably, PICM-19H has now been in continuous culture for over 22 months without presenting any detectable changes in hepatocyte morphology and function, a significant achievement. During this time, the cells have been repeatedly passaged (split and cultured) more than 30 times and have consistently retained their ability to differentiate into hepatocytes with excellent morphology and function. Also, test cultures of PICM-19H have been maintained for as long as 5 months without passage. Key functional, hepatocyte-specific, morphological features such as biliary canaliculi were maintained in the cells over this extended time period.
“These research results mark a definitive step forward for the PICM-19 liver cell family,” explained Mr. Arian Soheili, President of HepaLife. “While we have always been guardedly optimistic in our research pursuits, the performance of the cells as corroborated by these favorable scientific outcomes achieves a significant precursory milestone towards development of the bio-artificial liver device.”
As early as January 2004, the PICM-19H cells first recorded growth of 2-3 times the cell density of the original PICM-19 cell line, a highly beneficial attribute, particularly desirous for use in a bio-artificial liver device. In addition to measuring cell growth and densities, determinations of inducible P-450, ammonia removal, and urea production were also conducted and similarly yielded markedly positive results.
While the liver is responsible for detoxifying numerous substances, these positive P-450 tests are of particular importance; the P-450 enzyme systems are key components in the overall hepatic detoxification pathway of drugs and other xenobiotics. Likewise, ureagenesis is another important hepatic function since urea production is required for the detoxification of ammonia derived from the catabolism of a number of nitrogen containing compounds.
HepaLife is continuing to actively conduct additional research, including the development of an experimental bioreactor that will be the prototype of a bio-artificial liver device. PICM-19H cells will be seeded into the bioreactor for tests of growth, differentiation, and hepatic function in a flow through system.
About HepaLife Technologies, Inc.
HepaLife Technologies, Inc. (OTCBB: HPLF) is a development stage biotechnology company focused on the research, development and eventual commercialization of technologies and products for liver toxicity detection and the treatment of various forms of liver dysfunction and disease.
Currently, HepaLife is concentrating its efforts on creating the first-of-its-kind artificial liver device and developing proprietary in vitro toxicology and pre-clinical drug testing platforms.
Artificial Liver Device
Presently, through a Cooperative Research and Development Agreement, HepaLife Technologies is working towards optimizing the hepatic functionality of the patented PICM-19 cell line. The hepatic characteristics of the PICM-19 cell line have been demonstrated to have potential application in the production of an artificial liver device for use by human patients with liver failure.
With 25 million Americans suffering from liver disease, the need for an artificial liver device able to remove toxins and improve immediate and long-term survival results is more critical today than ever before. Limited treatment options, a low number of donor organs, the high price of transplants and follow up costs, a growing base of hepatitis, alcohol abuse, drug overdoses, and other factors that result in liver disease all clearly indicate a strong need for an artificial liver device.
In Vitro Toxicology Testing
Hepatotoxicity, or liver damage caused by medications and other chemical compounds, is the single most common reason leading to drug withdrawal or refusal of drug approval by the Food and Drug Administration (FDA). In fact, about one third of all drugs fail pre-clinical or clinical trials due to the toxic nature of the compounds being tested, costing pharmaceutical companies around $2 billion annually on such toxicity-related drug failures.
With the cost to develop an FDA approved drug approaching $1 billion and taking 10 to 15 years, a 10% improvement in predicting failures before clinical trials could save $100 million in development costs per drug. Despite efforts to develop better methods, most of the tools used for toxicology and human safety testing are decades old.
The PICM-19 cells grown in vitro synthesize liver specific proteins such as albumin and transferrin, and display enhanced liver-specific functions such as ureagenesis and cytochrome P450 activity. As a result, HepaLife, using the patented PICM-19 cell line, plans to develop proprietary in vitro toxicological and pre-clinical drug testing platforms that will more accurately determine the potential toxicity and metabolism of new pharmacological compounds in the liver.
For additional information, please visit www.phytomedical.com.
Legal Notice Regarding Forward-Looking Statements
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although the Company believes that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, it can give no assurance that such expectations and assumptions will prove to have been correct. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous factors and uncertainties, including but not limited to adverse economic conditions, intense competition, lack of meaningful research results, entry of new competitors and products, adverse federal, state and local government regulation, inadequate capital, unexpected costs and operating deficits, increases in general and administrative costs, termination of contracts or agreements, technological obsolescence of the Company's products, technical problems with the Company's research and products, price increases for supplies and components, litigation and administrative proceedings involving the Company, the possible acquisition of new businesses or technologies that result in operating losses or that do not perform as anticipated, unanticipated losses, the possible fluctuation and volatility of the Company's operating results, financial condition and stock price, losses incurred in litigating and settling cases, dilution in the Company's ownership of its business, adverse publicity and news coverage, inability to carry out research, development and commercialization plans, loss or retirement of key executives and research scientists, changes in interest rates, inflationary factors, and other specific risks. In addition, other factors that could cause actual results to differ materially are discussed in the Company's most recent Form 10-QSB and Form 10-KSB filings with the Securities and Exchange Commission.
Contact:
HepaLife Technologies, Inc.
Investor Relations
Phone: (800) 518-4879
Web Site: www.HepaLife.com