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Apligraf Monthly Sales Set New Record; Number of Sites Exceeds 900.


CANTON, Mass.--(BW HealthWire)--Sept. 2, 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 US commercial unit sales reached 655 in August - a new monthly record - up from 547 in July. The number of centers that have ordered Apligraf increased to 901 in August from 839 in July. The number of centers re-ordering the product increased by over 50 to 517 sites. Apligraf is marketed by Novartis Pharmaceuticals Corporation. -0-

                           # SITES ORDERING

                              # Sites            # Sites
      Time Period             Ordering         Re-Ordering
                             Apligraf(1)        Apligraf(2)

          3Q98                  135                 56
          4Q98                  316                170
          1Q99                  523                280
          2Q99                  757                427
       July 1999                839                464
      August 1999               901                517

(1) Have ordered Apligraf one or more times since launch
(2) Have re-ordered Apligraf one or more times since launch

                         COMMERCIAL UNIT SALES

                                Apligraf Commercial Units
      Time Period                Month           Quarter

          3Q98                                     548
          4Q98                                    1070
          1Q99                                    1585
          2Q99                                    1771
        July 1999                 547
       August 1999                655


"We are very pleased with the strong finish to the summer sales," said Alan Tuck, Chief Strategic Officer. "The breadth of the sales is encouraging and the new record is not dependent on just one or two centers. This provides an excellent base as we head into the fall."

"In addition, several Novartis Apligraf programs were implemented in late August," Mr. Tuck continued. Last week, Novartis launched its new website dedicated to Apligraf: www.Apligraf.com. On August 25, over 250 clinicians attended the Novartis-sponsored educational symposium, Advanced Therapy for Difficult-to-Heal Wounds, held in conjunction with the 3rd Joint Meeting of the European Tissue Repair Society/Wound Healing Society in Bordeaux, France. Novartis has applied and been accepted to sponsor another major educational symposium in conjunction with the American College of Surgeons This article or section needs sources or references that appear in reliable, third-party publications. Alone, primary sources and sources affiliated with the subject of this article are not sufficient for an accurate encyclopedia article.  meeting in October."

"August also marked several significant achievements in expanding the clinical support behind Apligraf. The results from the full Apligraf diabetic foot ulcer pivotal trial were presented at the medical symposium in Bordeaux. The data from this study show that Apligraf heals significantly more diabetic foot ulcers and heals them significantly faster than standard care alone. The Apligraf results are the best of any product in a large diabetic foot ulcer regulatory trial. Organogenesis plans to submit a 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
 supplement for diabetic foot ulcers within the next six months. Also in mid-August, the findings from the Beth Israel Deaconess Medical Center Both an international and regional referral center, Beth Israel Deaconess Medical Center (BIDMC) in Boston, Massachusetts is a major teaching hospital of Harvard Medical School. It was formed out of the 1996 merger of Beth Israel Hospital (founded in 1916) and  - the largest center in the Apligraf diabetic ulcer pivotal trial - were published in the peer-reviewed medical journal, Wounds. The prestigious Beth Israel Deaconess has now both presented and published its findings with Apligraf. In August, data on Apligraf in burn wounds were also presented at the World Congress of Surgery meeting in Vienna."

Like human skin, Apligraf is living, all-natural and bi-layered, with both an upper epidermal Epidermal
Referring to the thin outermost layer of the skin, itself made up of several layers, that covers and protects the underlying dermis (skin).

Mentioned in: Antiangiogenic Therapy, Histiocytosis X


epidermal
 and a lower dermal layer. It contains living human skin cells - epidermal keratinocytes Keratinocytes
Cells found in the epidermis. The keratinocytes at the outer surface of the epidermis are dead and form a tough protective layer. The cells underneath divide to replenish the supply.
 and dermal fibroblasts Fibroblasts
A type of cell found in connective tissue; produces collagen.

Mentioned in: Skin Grafting
. The keratinocytes are differentiated to form the strata of the human epidermis, including the outer stratum corneum. Unlike human skin, Apligraf does not contain Langerhans cells, melanocytes Melanocytes
Skin cells derived from the neural crest that produce the protein pigment melanin.

Mentioned in: Malignant Melanoma, Skin Pigmentation Disorders

melanocytes
, macrophages Macrophages
White blood cells whose job is to destroy invading microorganisms. Listeria monocytogenes avoids being killed and can multiply within the macrophage.
 or lymphocytes, or structures such as blood vessels, hair follicles Hair follicles
Tiny organs in the skin, each one of which grows a single hair.

Mentioned in: Alopecia
 and sweat glands. Novartis Pharma AG has global Apligraf marketing rights.

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. In addition to Apligraf, the pipeline includes VITRIX(TM) living soft tissue replacement product, a bioartificial liver and a vascular graft.

Statements in this press release which are not historical fact 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 assurance as to the rate of development of Apligraf sales, that a diabetic foot ulcer PMA supplement will be made within six months or that such a supplement will be approved by the 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.
 in a timely manner, if at all.

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:Sep 2, 1999
Words:649
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