To: Trader X who wrote (13135 ) 4/3/1998 1:42:00 PM From: Steven Messina,L.M.T. Respond to of 17305
EXGN's goin ta' JAPAN Baby !!!.......Erection forthcummin. Looks like volume definitely preceeds news. Check the volume yesterday in comparison to the volume today...hmmm <drip, drip, drip>. Friday April 3, 12:31 pm Eastern Time Company Press Release SOURCE: Exogen, Inc. Exogen's Sonic Accelerated Fracture Healing System (SAFHS Model 2000(R)) Receives CE Certification and Japanese Import Approval PISCATAWAY, N.J., April 3 /PRNewswire/ -- Exogen, Inc. (Nasdaq-NNM: EXGN - news) announced today it has successfully completed its first surveillance audit of its Quality System under Annex VI of the European Council Directive concerning Medical Devices, 93/42/EEC, and EN ISO 9003. This audit allows Exogen to retain its ISO certification, and grants Exogen the right to place the CE Mark on its current model SAFHS 2000(R), the second generation of the device. The CE Mark becomes a mandatory requirement for marketing a medical device in the European Community after June 1998. This certification also permits Exogen to place the CE Mark on future generations of its SAFHS devices. A third generation SAFHS device is currently in development. In other related international developments, Exogen's Japanese marketing partner, Teijin Limited, received import and reimbursement approval from Koseisho, Japan's government regulatory body. Plans are underway for a launch of SAFHS 2000 in Japan. Teijin, Japan's leading producer of synthetic fibers, established its medical and pharmaceutical business in 1974 with a key focus on the treatment of bone disease. In November 1995, Exogen and Teijin completed a marketing agreement for SAFHS in Japan. ''We are gratified to have the smaller, portable, more cost-effective, SAFHS 2000 receive this important certification, and we are very pleased that Teijin is cleared for marketing in Japan,'' stated Patrick A. McBrayer, Exogen's President and Chief Executive Officer. ''These events represent diligent efforts from Exogen and Teijin which has led to these approvals fromJapanese and European regulatory bodies. Each event prepares us for marketing opportunities in Japan and Europe,'' he further stated. SAFHS is a low-intensity, pulsed ultrasound device which has been demonstrated through two double-blind, placebo-controlled, multi-centered clinical studies to accelerate the healing of fresh fractures of the tibia and distal radius by 38% on average. Both clinical studies have been published in the peer-reviewed, Journal of Bone and Joint Surgery. Exogen designs, develops, manufactures and markets medical devices for the non-invasive treatment of musculoskeletal injury and disease. The Company's proprietary ultrasound and mechanical stress technologies are based on the principle that bone growth is stimulated by mechanical force. This press release contains forward-looking statements. All forward-looking statements involve risks and uncertainties, including, without limitation, the risks detailed in the Company's filings and reports with the Securities and Exchange Commission. Such statements are only predictions, and actual events or results may differ materially. SOURCE: Exogen, Inc.