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HepaLife's Bioartificial Liver Exceeds Expectations in New Tests Conducted over Prolonged Periods of Time.


HepaLife's patented PICM-19 liver cells and artificial liver artificial liver Biotech A cartridge with cloned human liver cells, through which blood flows to facilitate removal of waste products. See Extracorporeal liver assist device, Liver dialysis.  device 'bioreactor' show ability to mimic important human liver function with highest levels of liver-specific metabolic activity over 14 day period; Traditional 'primary' cells rapidly lose capabilities

BOSTON -- HepaLife Technologies, Inc. (OTCBB OTCBB

See OTC Bulletin Board (OTCBB).
: HPLF) (FWB (Fixed Wireless Broadband) See fixed wireless. : HL1) (WKN WKN Wertpapier-Kenn-Nummer (identifying number assigned to securities traded in Germany)
WKN Warrior Knowledge Network (US Army) 
: 500625) today announced that new tests of its bioartificial liver device A bioartificial liver device (BAL) is an artificial extracorporeal supportive device for an individual who is suffering from acute liver failure. Use
The purpose of BAL-type devices, currently, is not to permanently replace liver functions, but to serve as a supportive
 demonstrate the Company's bioreactor bioreactor

a container in which living organisms carry out a biological reaction.
 system and patented PICM-19 cells inside the device remain functional over prolonged periods time, far exceeding the number of treatment hours referenced in published research studies of human liver failure liver failure Clinical medicine Liver insufficiency that results in death, requires a liver transplant, or is characterized by recovery after encephalopathy, or while awaiting a transplant; also defined as a condition with ≥ 3 of following: albumin < 3.  patients undergoing conventional liver support therapies.

"Today's news marks yet another favorable outcome from a series of significant tests that researchers have recently conducted on our bioartificial liver device, all designed to progressively move us towards in vivo in vivo /in vi·vo/ (ve´vo) [L.] within the living body.

in vi·vo
adj.
Within a living organism.



in vivo adv.
 animal trials - a significant step towards the commercialization of our technology," explained Mr. Frank Menzler, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of HepaLife Technologies, Inc.

"Previous tests have shown the ability of our liver cells to consistently outperform other cell technologies, including the world's most widely used human liver cell line, HepG2. Importantly, these newest test results now confirm that our patented PICM-19 liver cells retain their functionality inside our liver device's bioreactor system for long periods of time. Moreover, the entire system can function far longer than conventional treatment periods for human liver failure patients, a key capability that could potentially provide physicians and clinicians with a more flexible, longer-lasting treatment option."

Outcomes from new tests show that HepaLife's bioartificial liver device system is able to successfully retain the highest levels of liver-specific metabolic activity -- mimicking the most important functions of the human liver -- for 14 days, a substantially longer period than the 6 to 48 hour conventional treatments described in published research papers. Researchers anticipate that the ability of HepaLife's patented liver cells in combination with its proprietary bioreactor system to remain functional for extended periods of time may provide for more efficient and flexible patient treatment options over prolonged periods of time, potentially improving patient outcomes as a result.

HepaLife's First-Of-Its-Kind Bioartificial Liver: Results Prompt In-Vivo Animal Trials

In tests conducted over a 14 day period, researchers observed that HepaLife's patented PICM-19 cells maintained 'differentiated hepatocyte hepatocyte /hep·a·to·cyte/ (hep´ah-to-sit?) a hepatic cell.

hep·a·to·cyte
n.
A parenchymal liver cell.


Hepatocyte
A liver cell.
 function', the key to their ability to remain functional as liver cells inside the Company's bioartificial liver device.

Researchers have also conducted studies designed to model the environment present when treating human liver failure patients, exposing the Company's liver cells to human blood plasma blood plasma
n.
The yellow or gray-yellow, protein-containing fluid portion of blood in which the blood cells and platelets are normally suspended.
 and toxic ammonia. Notably, HepaLife's PICM-19 cell line successfully removed toxic ammonia, produced urea, and expressed CYP-450 enzymes - - all leading indicators of liver function. While HepaLife's PICM-19 cells maintained their differentiated hepatocyte function and CYP-450 activity in the presence of human plasma, CYP-450 activity was rapidly lost in conventional cell technologies, including primary hepatocytes and the world's most widely-used human liver cell line, HepG2.

Exposure to human blood plasma did not affect the ability of HepaLife's PICM-19 cells to clear toxic ammonia. The clearance rate The area which would be cleared per unit time with a stated minimum percentage clearance, using specific minehunting and/or minesweeping procedures.  of ammonia utilized per hour was similar to the rate observed for ammonia challenges performed in culture medium. The conversion of ammonia to urea in culture medium occurred at near-theoretical levels and the average rate of ammonia clearance by the PICM-19 liver cells was equivalent to rates obtained for primary porcine porcine /por·cine/ (por´sin) pertaining to swine.

porcine

pertaining to pig. See also hog (1), swine.


porcine circovirus 1
a nonpathogenic virus.
 hepatocytes, thereby successfully replicating the closest in vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment.

in vi·tro
adj.
In an artificial environment outside a living organism.
 model of native liver function in nature.

When challenged with high amounts of toxic ammonia, present in patients with acute liver failure Acute liver failure is the appearance of severe complications rapidly after the first signs of liver disease (such as jaundice), and indicates that the liver has sustained severe damage (loss of function of 80-90% of liver cells). , HepaLife's bioartificial liver reduced ammonia levels by 75% within less than 24 hours. Published human clinical data of systems utilizing liver cells other than HepaLife's patented PICM-19 cells, have only reported ammonia reduction levels between 0 to 44%.

The primary mechanism for reducing toxic ammonia in the native liver is by producing urea. The theoretical ratio of urea formed from ammonia is 1:1. In recent tests of the Company's liver cells, 85% of the present ammonia was converted to urea. HepaLife's PICM-19 liver cells are the only cell line known to have a complete urea cycle urea cycle
n.
The sequence of chemical reactions that takes place in the liver and that results in the production of urea. The key reaction is the hydrolysis of arginine by arginase to ornithine and urea.
 producing significant amounts of urea.

Most importantly Adv. 1. most importantly - above and beyond all other consideration; "above all, you must be independent"
above all, most especially
, scientists' extrapolations based on the calculated rate of ammonia clearance indicate that HepaLife's bioartificial liver has sufficient capacity to treat the targeted acute liver failure animal model in HepaLife's anticipated initial in-vivo trials. In published studies of in-vivo clinical data from liver support technologies utilizing conventional primary porcine liver cells, the levels of reported ammonia reduction in an animal model are significantly less than the ammonia reduction observed in recent tests of HepaLife's bioartificial liver device by scientists. Researchers attribute the advanced performance of HepaLife's bioartificial liver to its unique use of the Company's patented PICM-19 liver cells in combination with the novel design of the bioreactor system in which the cells are housed.

Intended for the treatment of liver failure, the HepaLife[TM] Bioartificial Liver device consists of three basic components: (1) a plasma filter, separating the patient's blood into blood plasma and blood cells blood cells,
n.pl the formed elements of the blood, including red cells (erythrocytes), white cells (leukocytes), and platelets (thrombocytes).


blood cells

See erythrocyte and leukocyte. Platelets are classed separately.
; (2) the bioreactor, a unit filled with the patented PICM-19 liver stem cell line A stem cell line is a family of constantly-dividing cells, the product of a single parent group of stem cells. They are obtained from human or animal tissues and can replicate for long periods of time in vitro ("within glass"; or, commonly, "in the lab", in an artificial  which biologically mimics the liver's function; and (3), the HepaDrive[TM], a perfusion system for pumping the patient's plasma through the bioreactor while controlling gas supply and temperature for best possible performance of the cells.

ABOUT HEPALIFE TECHNOLOGIES, INC.

Based in Boston, Massachusetts “Boston” redirects here. For other uses, see Boston (disambiguation).
Boston is the capital and most populous city of Massachusetts.[3] The largest city in New England, Boston is considered the unofficial economic and cultural center of the entire New
, HepaLife Technologies, Inc. (OTCBB: HPLF) (FWB: HL1) (WKN: 500625) is a developer of cell-based medical technologies addressing prevalent human health concerns.

HepaLife is working towards the first-of-its-kind bioartificial liver device for acute liver failure using the Company's patented PICM-19 liver stem cell line. The HepaLife[TM] bioartificial liver, currently under development, is designed to serve as a supportive device, either allowing the liver to regenerate upon acute liver failure, or to bridge the patient's liver functions until a transplant is available.

Utilizing its patented liver stem cell line PICM-19, HepaLife is designing testing platforms to improve the pharmaceutical industry's capability to evaluate drug toxicity and possible side-effects before pharmaceutical compounds are commercially distributed.

For additional information, please visit www.HepaLife.com.

To receive future press releases via email, please visit:

http://www.hepalife.com/investor_alerts.php

To view the full HTML HTML
 in full HyperText Markup Language

Markup language derived from SGML that is used to prepare hypertext documents. Relatively easy for nonprogrammers to master, HTML is the language used for documents on the World Wide Web.
 text of this release, please visit:

http://hepalife.com/press_releases/20080512.html.php

Legal Notice Regarding Forward-Looking Statements

No statement herein should be considered an offer or a solicitation of an offer for the purchase or sale of any securities. This release contains forward-looking statements 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. Forward-looking statements, which involve assumptions and describe our future plans, strategies, and expectations, are generally identifiable by use of the words "may," "will," "should," "could," "expect," "anticipate," "estimate," "believe," "intend," or "project" or the negative of these words or other variations on these words or comparable terminology. 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 administrative costs,
n.pl the overhead expenses incurred in the operation of a dental benefits program, excluding costs of dental services provided.
, termination of contracts or agreements, technological obsolescence ob·so·les·cent  
adj.
1. Being in the process of passing out of use or usefulness; becoming obsolete.

2. Biology Gradually disappearing; imperfectly or only slightly developed.
 of the Company's products, technical problems with the Company's research and products, price increases for supplies and components, litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called 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. We currently have no commercial products intended to diagnose, treat, prevent or cure any disease. The statements contained in this press release regarding our on going research and development and the results attained by us to-date have not been evaluated by the Food and Drug Administration. There can be no assurance that further research and development, and /or whether clinical trial results, if any, will validate and support the results of our preliminary research and studies. Further, there can be no assurance that the necessary regulatory approvals will be obtained or that HepaLife will be able to develop commercially viable products on the basis of its technologies. In addition, other factors that could cause actual results to differ materially are discussed in the Company's most recent Form 10-Q Form 10-Q

See 10-Q.
 and Form 10-K Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
 filings with the Securities and Exchange Commission. These reports and filings may be inspected and copied at the Public Reference Room maintained by the U.S. Securities & Exchange Commission at 100 F Street, N.E., Washington, D.C. 20549. You can obtain information about operation of the Public Reference Room by calling the U.S. Securities & Exchange Commission at 1-800-SEC-0330. The U.S. Securities & Exchange Commission also maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the U.S. Securities & Exchange Commission at http://www.sec.gov. The Company undertakes no obligation to publicly release the results of any revisions to these forward looking statements that may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
COPYRIGHT 2008 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2008 Gale, Cengage Learning. All rights reserved.

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Publication:Business Wire
Date:May 12, 2008
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