Apligraf Awarded Seal of Approval by American Podiatric Medical Association.Business Editors/Health & Medical Writers CANTON, Mass.--(BW HealthWire)--April 17, 2000 Organogenesis Inc. (AMEX AMEX See: American Stock Exchange :ORG) today announced that its Apligraf(R) skin construct has been awarded the Seal of Approval of the American Podiatric Medical Association. To receive the APMA APMA American Podiatric Medical Association APMA Automotive Parts Manufacturers' Association APMA Australian Pharmaceutical Manufacturers Association APMA American Preventive Medical Association APMA Australian Packaging Machinery Association Seal of Approval, a product must be judged "an effective foot health aid and of significant value when used in a consistently applied program of daily foot care and regular professional treatment." This Seal of Approval can be used on Apligraf promotional materials to the medical community. Founded in 1912, the APMA is the leading US professional society for foot and ankle specialists and has over 9,000 active members. Apligraf is approved and marketed in the US for use in the treatment of venous leg ulcers. A regulatory supplement for Apligraf use in the treatment of diabetic foot ulcers is tentatively scheduled for 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. Advisory Panel review on May 8. "Apligraf is a novel product that is helping patients with hard-to-heal venous leg ulcers - ulcers that have resisted healing with traditional therapies," said Michael Sabolinski, MD, Senior Vice President, Medical and Regulatory Affairs, Organogenesis Inc. "We are pleased to have the APMA recognize the importance of Apligraf in helping clinicians help their patients. The APMA is a leading healthcare professional organization and is playing a critical role in increasing the awareness of the importance of good foot care." Like human skin, Apligraf is made of skin cells and structural protein. The lower dermal layer is formed by human fibroblasts Fibroblasts A type of cell found in connective tissue; produces collagen. Mentioned in: Skin Grafting (dermal cells), which organize the provided structural protein and produce additional matrix proteins. The upper epidermal layer is formed by prompting human 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. (epidermal cells) first to multiply and then to differentiate to replicate the architecture of the human epidermis. Unlike human skin, Apligraf does not contain 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 or sweat glands or other cell types such as 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. 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. The Organogenesis research pipeline includes the VITRIX(TM) living soft tissue replacement product, a vascular graft and a liver assist device. 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 that the Apligraf diabetic foot ulcer regulatory supplement will be approved by the FDA in a timely manner, if at all. Apligraf(R) is a registered trademark of Novartis. |
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