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Organogenesis Selected for $2 Million NIST Award for Bioartificial Liver Program.


CANTON, Mass.--(BW HealthWire)--Oct. 7, 1999--

Organogenesis organogenesis /or·ga·no·gen·e·sis/ (or?gah-no-jen´e-sis) the origin and development of organs.organogenet´ic

or·gan·o·gen·e·sis
n.
The formation and development of the organs of living things.
 Inc. (AMEX AMEX

See: American Stock Exchange
:ORG) today announced it has been selected for a $2 million award under the Advanced Technology Program of the National Institute for Standards and Technology to support development of a bioartificial liver (liver assist device). The Organogenesis program was one of only 37 selected from over 430 proposals from a wide array of industries. ATP awards are made on the basis of a rigorous competitive review considering scientific and technical merit of each proposal and its potential benefits to the US economy. The ATP ATP: see adenosine triphosphate.
ATP
 in full adenosine triphosphate

Organic compound, substrate in many enzyme-catalyzed reactions (see catalysis) in the cells of animals, plants, and microorganisms.
 funding, to be received by Organogenesis over the next two years, will be used to develop an effective bioartificial liver prototype.

The Organogenesis bioartificial liver program is focused on developing a device that uses living liver cells housed in extracorporeal extracorporeal /ex·tra·cor·po·re·al/ (-kor-por´e-al) situated or occurring outside the body.

ex·tra·cor·po·re·al
adj.
Situated or occurring outside the body.
 (outside the body) cartridges to provide temporary liver function. For some medical conditions, the device would be used to keep patients alive and healthier until a transplantable liver becomes available. Currently, many patients die awaiting a transplant, while those receiving a liver often must undergo re-transplantation because their advanced deterioration overwhelms the first transplant. For other medical conditions, this device could replace the need for transplantation by providing minimally-invasive, short-term support until the patient's own liver recovers. The liver is a highly regenerative organ, while liver transplantation Liver Transplantation Definition

Liver transplantation is a surgery that removes a diseased liver and replace it with a healthy donor liver.
Purpose

The liver is the body's principle chemical factory.
 is invasive, risky and expensive.

Each year in the US, approximately 250,000 people are hospitalized with liver insufficiency and more than 43,000 people die from liver disease Liver Disease Definition

Liver disease is a general term for any damage that reduces the functioning of the liver.
Description

The liver is a large, solid organ located in the upper right-hand side of the abdomen.
. Those numbers are expected to increase with disease progression among the 4 million people now infected with Hepatitis C Hepatitis C Definition

Hepatitis C is a form of liver inflammation that causes primarily a long-lasting (chronic) disease. Acute (newly developed) hepatitis C is rarely observed as the early disease is generally quite mild.
. Liver transplantation costs over $300,000 per procedure and typically requires lifetime immunosuppression immunosuppression

Suppression of immunity with drugs, usually to prevent rejection of an organ transplant. Its aim is to allow the recipient to accept the organ permanently with no unpleasant side effects.
 therapy.

"Our bioartificial liver program is focused on addressing the medical need for a truly effective liver assist device that can be made, distributed and used in a practical manner," said Nancy Parenteau, Ph.D., Senior Vice President, Research and Development and Chief Scientific Officer. "Organogenesis is widely recognized for its achievement of the living skin construct Apligraf(R), the only product containing living human cells to have proven efficacy and gained FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 PMA PMA (papillary-marginal-attached),
n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation.

PMA Progressive muscular atrophy
 marketing approval. We are expanding upon our demonstrated expertise in cell-based therapies to develop other innovative products that address major medical needs. We are delighted to have been selected for an ATP award for this important project."

Organogenesis has unique expertise in cell procurement, culturing and optimization. Earlier this year, Organogenesis augmented its liver program by obtaining complementary intellectual property and equipment in the areas of extracorporeal blood processing and device design from Baxter Healthcare Corporation. This combination provides Organogenesis a unique skill set for achieving a bioartificial liver.

Organogenesis Inc. designs, develops and manufactures medical products containing living cells and/or natural connective tissue. The Company's product development focus includes living tissue replacements, cell-based organ assist devices and other tissue-engineered products. Lead product Apligraf living skin construct is the only product containing living human cells to gain FDA PMA approval. In addition to the bioartificial liver, programs in the pipeline include the VITRIX(TM) soft tissue replacement product and a vascular graft.

Statements in this press release which are not historical fact, such as those about the intended purpose of a bioartificial liver, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995 and involve risks and uncertainties. There can be no guarantee that Organogenesis will achieve an effective bioartificial liver or that its bioartificial liver will gain regulatory approval and commercialization in a timely manner. Apligraf(R) is a registered trademark of Novartis.
COPYRIGHT 1999 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1999, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Oct 7, 1999
Words:596
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