Healthcare Industry News: artificial liver
News Release - February 11, 2008
HepaLife's Bioartificial Liver Dramatically Reduces Toxic Marker for Acute Liver FailureBOSTON--(HSMN NewsFeed)--HepaLife Technologies, Inc. (OTCBB: HPLF ) (FWB: HL1) (WKN: 500625) today announced important, positive results from new in-vitro studies in which the Company’s patented PICM-19 liver stem cells were placed inside its proprietary bioartificial liver device and were able to successfully and quickly remove high levels of toxic ammonia within a very short period of time.
“Acute liver failure leads to increased blood ammonia levels. The ammonia is taken up by the brain and can cause brain damage, coma, and even death. Reducing the present high levels of ammonia in those patients as soon as possible is a key target for successful patient treatment and patient recovery,” explained Stephen R. Ash, MD., a HepaLife Scientific Advisory Board Member, Physician at Clarian-Arnett Health and Medical Director at Wellbound, Inc. of Lafayette, IN.
When challenged with high amounts of toxic ammonia, present in patients with acute liver failure, HepaLife’s bioartificial liver reduced ammonia levels by 75% within less than 24 hours. Published in-vivo clinical data of other systems utilizing liver cells other than HepaLife’s patented PICM-19, have only reported ammonia reduction levels between 0 to 44%.
Mr. Frank Menzler, President and CEO of HepaLife Technologies, Inc., explained, “These test findings are especially important because ammonia is a highly dangerous by-product in patients with acute liver failure, and researchers have long considered the efficient removal or reduction of toxic ammonia an important requirement for an artificial liver device intended for human use.
“Our bioartificial liver technology not only removes this ammonia, but importantly, is capable of producing high levels of urea, a feature regarded vital in the biochemical improvement of acute liver failure patients undergoing clinical treatment by way an artificial liver. Our bioartificial liver achieves this essential outcome by making use of HepaLife’s patented PICM-19 cells, the only cell line of its kind able to produce such high levels of urea.”
Positive Outcomes from Tests of HepaLife’s Bioartificial liver
In recent tests, HepaLife’s bioartificial liver reduced levels of toxic ammonia by 75% in fewer than 24 hours, a feature considered necessary to the successful treatment of acute liver failure using an artificial liver.
According to researchers, biochemical improvement as a result of an artificial liver device treatment in clinical application is judged not only by the elimination of ammonia, but also by the production of urea. Importantly, HepaLife’s PICM-19 cells synthesized 80% of the ammonia present into urea, the normal pathway of ammonia reduction of the human liver. HepaLife’s PICM-19 cell line is the only known liver stem cell line of its kind with this ability to produce substantial amount of urea.
During these same tests HepaLife’s PICM-19 liver stem cells inside the Company’s bioartificial liver maintained differentiated hepatic (liver) function, showing typical hepatocyte morphology -- the characteristics representative of human liver cells -- including cell features such as intercellular canaliculi, extensive Golgi apparatus, endoplasmic reticulum, peroxisomes and mitochondria.
“The performance of our bioartificial liver device is exciting. The rate of ammonia reduction achieved mainly via the natural urea cycle is an important step towards successful clinical application,” continued Mr. Menzler. “Furthermore, the ability of our cells to produce substantial amounts of urea while maintaining liver-like function, and preserving liver cell-like characteristics, all clearly establish the superior performance of our PICM-19 cell line inside our bioartificial liver.”
Intended for the treatment of liver failure, the HepaLife™ Bioartificial liver device consists of three basic components: (1) a plasma filter, separating the patients blood into blood plasma and blood cells; (2) the bioreactor, a unit filled with the patented PICM-19 liver stem cell line which biologically mimics the liver’s function; and (3), the HepaDrive™, 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.
Incorporating the PICM-19 cell line, HepaLife is developing the first-of-its-kind bioartificial liver. HepaLife's bioartificial liver currently under development, is designed to operate outside the patient's body. The bioartificial liver is envisioned to mimic important functions of the human liver by circulating the patient's blood inside the device, where it is exposed to HepaLife's patented PICM-19 liver stem cells, thus processing the patient's blood-plasma by removing toxins, enhancing metabolic function, and ultimately, imitating the liver's natural function.
ABOUT HEPALIFE TECHNOLOGIES, INC.
Based in Boston, Massachusetts, HepaLife Technologies, Inc. (OTCBB: HPLF ) (FWB: HL1) (WKN: 500625) is a developer of cell-based medical technologies addressing prevalent human health concerns.
Current cell-based technologies under development by HepaLife include 1) the first-of-its-kind artificial liver device, 2) proprietary in-vitro toxicology and pre-clinical drug testing platforms, and 3) novel cell-culture based vaccine production methods for the manufacture of vaccines against H5N1 avian influenza and other viruses.
For additional information, please visit www.hepalife.com.
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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, 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. 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 and Form 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.
Source: HepaLife Technologies
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