Apligraf PMA Supplement for Diabetic Foot Ulcers Tentatively Scheduled for FDA Advisory Panel Review On May 8, 2000.Business Editors and Health/Medical Writers CANTON, Mass.--(BW HealthWire)--April 7, 2000 Organogenesis Inc. (AMEX AMEX See: American Stock Exchange :ORG) today announced that it has been informed by the US Food and Drug Administration that the Company should be prepared for its Apligraf(R) diabetic foot ulcer 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 to be reviewed by the General and Plastic Surgery Devices Panel now scheduled for May 8, 2000. Final confirmation is pending additional discussions with 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. . Apligraf has already been approved by the FDA for use in the treatment of venous leg ulcers. An Advisory Panel discussion would focus on whether the Apligraf label should be expanded to enable marketing for diabetic foot ulcers. "We are delighted that our Apligraf PMA supplement may be presented to this FDA Advisory Panel in May," said Philip M. Laughlin, President and Chief Executive Officer of Organogenesis. "Diabetic foot ulcers represent an important medical need in the US." About Diabetic Foot Ulcers Between 600,000 to 800,000 people in the US currently suffer from diabetic foot ulcers. Foot complications are the most frequent cause of hospitalization among diabetics, and diabetic foot ulcers are a common cause of amputation amputation (ăm'pyətā`shən), removal of all or part of a limb or other body part. Although amputation has been practiced for centuries, the development of sophisticated techniques for treatment and prevention of infection has greatly . Approximately 1000 amputations are performed on diabetics each week in the US. About Apligraf Like human skin, Apligraf is made of skin cells and structural protein. The lower dermal layer combines collagen and human fibroblasts Fibroblasts A type of cell found in connective tissue; produces collagen. Mentioned in: Skin Grafting (dermal cells), which 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 or lymphocytes. Organogenesis developed and manufactures Apligraf, which is marketed in the US by Novartis Pharmaceuticals Corporation. About Organogenesis Inc. 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. Novartis Pharma AG has global Apligraf marketing rights. 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 guarantee the Apligraf PMA supplement for use in diabetic foot ulcers will be reviewed by an FDA Advisory Panel on May 8, 2000 or that the PMA supplement will be approved in a timely manner, if at all. Apligraf(R) is a registered trademark of Novartis. |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion