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Biotech / Medical : Organogenesis - a tissue engineering worth sneezing about?

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To: SemiBull who started this subject1/4/2002 9:48:36 PM
From: SemiBull  Read Replies (1) of 7
 
Organogenesis Inc. Announces Fourth Quarter of 2001 Apligraf Shipments

Shipments Increase 53% Over Fourth Quarter of 2000

CANTON, Mass.--(BW HealthWire)--Jan. 4, 2002--Organogenesis Inc. (AMEX:ORG - news) today announced that total unit shipments of its lead product Apligraf® were 6,822 in the fourth quarter of 2001. This represents a 53% increase over shipments of 4,462 in the fourth quarter of 2000 and a 3% increase over shipments of 6,606 in the third quarter of 2001. Total shipments for the year 2001 were 24,780, an increase of approximately 73% over shipments of 14,361 for the year 2000.

``We achieved record shipment levels during the first half of the fourth quarter,'' said Michael Sabolinski, M.D., President and Chief Executive Officer. ``As expected, sales were lower in the second half of the holiday-shortened quarter.''

Organogenesis Inc. (www.organogenesis.com) is the first tissue-engineering company to have developed and gained FDA approval for a mass-produced product containing living human cells. The Company's lead product, Apligraf - a cellular, bi-layered skin substitute - is FDA approved for the treatment of venous leg ulcers and diabetic foot ulcers; Novartis Pharma AG has global Apligraf marketing rights. The Company's second marketed product - FortaPerm(TM) - has been launched by the Company's own sales and marketing team. Additional products nearing commercialization include: FortaGen(TM) bioengineered tissue repair product, PuraPly(TM) wound dressing and Revitix(TM) Regenerative Skin Complex. The Company's research pipeline includes the Vitrix(TM) living dermal replacement product, a coronary vascular graft and a liver assist device.

This release contains forward-looking statements that are subject to risks and uncertainties, including statements about recent and expected product launches and sales development. Actual results may differ materially from those indicated or suggested by these forward-looking statements as a result of various factors, including, but not limited to: our expectation that we will incur operating losses in the near future; our ability to raise additional funds on acceptable terms, if at all; our reliance on Novartis for marketing of Apligraf and product development funding support; the actions of competitors and the development of competing products; uncertainties related to preclinical and clinical testing and trials; difficulties or delays in obtaining regulatory approvals to market products resulting from our development efforts; our ability to successfully transition to full-scale production of Apligraf; our ability to protect our patents and proprietary rights; patent infringement actions; our ability to commercialize some of our products without a marketing partner; and the requirement for substantial funding to conduct research and development and to expand commercialization activities. For a further list and description of uncertainties we face, please refer to our filings with the Securities and Exchange Commission, including our most recent filings on Forms 10-K and 10-Q. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Apligraf® is a registered trademark of Novartis.

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Contact:

Organogenesis Inc.
Laurie Doyle
781-575-0775
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