To: Don Savage who wrote (1069 ) 3/3/1998 12:33:00 PM From: David Pawlak Read Replies (1) | Respond to of 1845
IMTI...Just came across this one! Up 40% today so far... Tuesday March 3, 8:18 am Eastern Time Imagyn gets FDA clearance for ErecAid NEWPORT BEACH, Calif., March 3 (Reuters) - Medical products maker Imagyn Medical Technologies Inc said Tuesday it has received FDA 510 clearance to begin marketing its ErecAid Vacuum Constriction Device (VCD) over-the-counter for treatment of erectile dysfunction in men. Imagyn chairman and chief executive Charles Laverty said in a news release, ''Clearance to market this product over-the-counter provides Imagyn with an important new market opportunity.'' Imagyn said VCDs are the least invasive approach for treating erectile dysfunction. The devices have been endorsed by the American Urological Association as a treatment of first choice for the condition, Imagyn said. Chronic erectile dysfunction is estimated to affect more than 16 million men in the United States with an additional 16 million men thought to experience intermittent erectile dysfunction, the company said. The company said in numerous studies ErecAid has achieved a 90 percent or greater success rate among users and without any significant complications related to use. ''While large numbers of men suffer from erectile dysfunction, many are reluctant to seek professional care,'' Laverty said. ''The ErecAid Classic will provide these men with a simple and effective treatment.'' Imagyn said it will market the ErecAid Classic through its Urology Division utilizing its extensive pharmacy network. Imagyn designs, makes and markets disease-specific urological, gynecological and general surgery medical products.