Apligraf Monthly Sales Sustained Above 900 Units.Business Editors/Health & Medical Writers CANTON Canton, cities, United States Canton. 1 City (1990 pop. 13,922), Fulton co., W central Ill., in the corn belt; inc. 1849. It is a trade and industrial center for a coal and farm area. 2 Town (1990 pop. 18,530), Norfolk co. , Mass.--(BW HealthWire)--July 5, 2000 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 that Apligraf(R) US commercial sales were 929 units in June 2000. By month's end, over 1700 medical centers across the US had ordered Apligraf and over 1000 centers had re-ordered the product at least once. Apligraf is marketed by Novartis Pharmaceuticals Corporation.
US COMMERCIAL UNIT SALES
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Apligraf
Time Period Commercial Units
--------------------- ------------------ -----------
Month Quarter
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3Q98 548
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4Q98 1070
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1Q99 1585
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2Q99 1755
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3Q99 1817
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4Q99 2192
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Jan. `00 785
--------------------- ------------------ -----------
Feb. `00 810
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Mar. `00 960 2555
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Apr. `00 853
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May `00 1032
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June `00 929 2814
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# US SITES ORDERING
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# Sites # Sites
Time Period Ordering Re-Ordering
Apligraf(1) Apligraf(2)
----------------------- ------------ ----------------
3Q98 135 56
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4Q98 316 170
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1Q99 523 280
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2Q99 757 427
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3Q99 959 551
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4Q99 1195 687
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1Q00 1450 842
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2Q00 1709 1001
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(1) Have ordered Apligraf at least once since launch
(2) Have re-ordered Apligraf at least once since launch
"US commercial sales of Apligraf exceeded 2800 units in the second quarter of this year, reflecting a sustained increase in average monthly sales compared with previous quarters," said Philip M. Laughlin, President and Chief Executive Officer. "Sales development continues to be affected by the lack of standardized standardized pertaining to data that have been submitted to standardization procedures. standardized morbidity rate see morbidity rate. standardized mortality rate see mortality rate. reimbursement Reimbursement Payment made to someone for out-of-pocket expenses has incurred. for Apligraf. Organogenesis and Novartis have activities directed at addressing this issue. During June, a communication was issued by the Health Care Financing Administration Health Care Financing Administration, n.pr department in the U.S. agency of Health and Human Services responsible for the oversight of the Medicaid and Medicare benefit programs, including guidelines, payment, and coverage policies. on the Medicare reimbursement process for use of Apligraf by office-based physicians. This communication clarifies that product cost reimbursement for a `tissue engineered skin graft' such as Apligraf is in addition to the reimbursement for the medical procedure of applying the product. This communication eliminates confusion that the reimbursement for the medical procedure is also intended to cover the cost of the Apligraf applied. We are now focussed on gaining a standardized level of reimbursement for Apligraf." Mr. Laughlin continued, "On June 20, Apligraf 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. marketing approval for use in diabetic foot diabetic foot A foot with a constellation of pathologic changes affecting the lower extremity in diabetics, often leading to amputation and/or death due to complications; the common initial lesion leading to amputation is a nonhealing skin ulcer, induced by ulcers - a second major indication - based on pivotal trial results showing the product heals significantly more patients, faster, than standard care alone. We expect use in diabetic foot ulcers to become a major market for Apligraf. These wounds are a leading cause of hospitalization hospitalization /hos·pi·tal·iza·tion/ (hos?pi-t'l-i-za´shun) 1. the placing of a patient in a hospital for treatment. 2. the term of confinement in a hospital. among diabetics. Over 50,000 amputations are performed on diabetics each year due to complications from foot ulcers." Apligraf is a cellular, bi-layered skin substitute. In addition to being approved for use in the treatment of diabetic foot ulcers, Apligraf is also approved for use in venous venous /ve·nous/ (ve´nus) pertaining to the veins. ve·nous adj. Of, relating to, or contained in the veins. venous pertaining to the veins. leg ulcers. Apligraf was developed and is manufactured by Organogenesis; Novartis Pharma AG has global Apligraf marketing rights. Organogenesis Inc. designs, develops and manufactures medical products containing living cells and/or natural connective connective - An operator used in logic to combine two logical formulas. See first order logic. 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 dermal dermal /der·mal/ (der´mal) pertaining to the dermis or to the skin. der·mal or der·mic adj. Of or relating to the skin or dermis. replacement product, a coronary vascular graft graft, in surgery: see transplantation, medical. graft In horticulture, the act of placing a portion of one plant (called a bud or scion) into or on a stem, root, or branch of another (called the stock) in such a way that a union forms and the and a liver assist device. Statements in the press release which are not historical fact are forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. 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, the magnitude of Apligraf sales including use in diabetic foot ulcers, or that an acceptable, standardized level of reimbursement for Apligraf will be obtained in a timely manner, if at all. Apligraf(R) is a registered trademark of Novartis. |
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