FDA approves use of pre-clinical research data on OrthoLogic 1000 bone growth stimulator.PHOENIX--(BUSINESS WIRE)--May 13, 1997--OrthoLogic Corp. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :OLGC OLGC Ontario Lottery and Gaming Corporation ) Tuesday said that the Food and Drug Administration has approved the use of pre-clinical research data in the marketing of the OrthoLogic 1000 bone growth stimulator. A year ago OrthoLogic discontinued dis·con·tin·ue v. dis·con·tin·ued, dis·con·tin·u·ing, dis·con·tin·ues v.tr. 1. To stop doing or providing (something); end or abandon: using some research data on the OrthoLogic 1000 in response to an 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. warning letter. OrthoLogic then compiled its pre-clinical data from laboratory cell studies in the form of a promotional brochure and submitted it to the FDA for review. The brochure, titled "Biophysical Stimulation of Fracture-Healing Mediated me·di·ate v. me·di·at·ed, me·di·at·ing, me·di·ates v.tr. 1. To resolve or settle (differences) by working with all the conflicting parties: by IGF-II," received what is called a pre-market approval supplement from the FDA. This means that the research data can again be used by the company in marketing the OrthoLogic 1000 to orthopaedic surgeons. "OrthoLogic is committed to basic research and obtaining additional scientific understanding of how our products work. We are involved in numerous research programs, both in our labs in Phoenix and in distinguished academic institutions. We are very pleased to be able to utilize this basic scientific research in the promotion of the OrthoLogic 1000. Although human clinical results cannot be extrapolated directly from animal and cell studies, it is important that surgeons be exposed to these data so that they can stay abreast of current thinking as to the mechanism of action of the OrthoLogic 1000," said Frank P. Magee, D.V.M., OrthoLogic's executive vice president for research and development. OrthoLogic develops, manufactures and markets proprietary technologically advanced orthopaedic devices designed to promote the healing Healing See also Medicine. Achilles’ spear had power to heal whatever wound it made. [Gk. Lit.: Iliad] Agamede Augeas’ daughter; noted for skill in using herbs for healing. [Gk. Myth. of musculoskeletal musculoskeletal /mus·cu·lo·skel·e·tal/ (-skel´e-t'l) pertaining to or comprising the skeleton and muscles. mus·cu·lo·skel·e·tal adj. Relating to or involving the muscles and the skeleton. tissue. Founded in 1987, the company has headquarters in Phoenix. CONTACT: OrthoLogic Corp., Phoenix Allan Weinstein, 602/437-5520 or The Financial Relations Board Daniel Saks or David Lawton (general information), Moira Conlon (analyst information), 310/442-0599 Darcy Bretz (media contact), 312/266-7800 |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion