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Biotech / Medical : Cyberonics (cybx) epilepsy therapy recommonded -- Ignore unavailable to you. Want to Upgrade?

To: Dennis who wrote (313)	5/13/1998 9:07:00 AM
From: fred woodall	Read Replies (1) \| Respond to of 471

PR WIRE: Looks good from here: Cyberonics, Inc. (Nasdaq: CYBX) today announced that the Company has successfully completed a rigorous two week Good Manufacturing Practices ("GMP") and Post Pre-Market Approval ("PMA") inspection by the U.S. Food and Drug Administration ("FDA"). The recent inspection was concluded late last week and yielded no Notice of Violation or FDA Form 483 observations of any kind. Per Health Industry Manufacturers Association ("HIMA") statistics, only one in 50 companies completes a GMP inspection receiving no such observations. Commenting on the completion of the inspection, Cyberonics President and Chief Executive Officer Robert P. ("Skip") Cummins stated, "We are pleased with the outcome of the inspection since it adds yet another level of assurance to physicians and patients that our proprietary product is being developed and manufactured in a company which focuses on quality as well as operational compliance with Federal regulations and guidelines governing the industry. In a time when many manufacturers are receiving notices of violations and regulatory warning letters from FDA, we are delighted that we have not once, but now twice completed these rigorous inspections with a clean bill of health from FDA." The purpose of FDA's inspection was to determine whether Cyberonics was meeting all of its PMA and GMP requirements and to assess the adequacy and compliance of recent manufacturing process improvements. The inspection covered complaint handling, Medical Device Reporting ("MDR"), software development and validation, engineering change control, corrective actions, design controls, product and process improvements, labeling and sales training, promotional practices and Post Market Surveillance requirements. The inspection was carried out by two FDA Inspectors; a regional Inspector from the Houston FDA office and a specialist in software design and validation from the Dallas District office of FDA. The NCP(R) System, a vagus nerve stimulator (VNS(TM)) works as a pacemaker for the brain. Consisting of a small generator the size of a pocket watch, the device is implanted under the skin in the chest. Lead wires from the generator are surgically routed up the neck and wrap around the vagus nerve in the neck, sending preprogrammed electrical stimulation to the vagus nerve 24 hours a day. Cyberonics, Inc. was founded in 1987 to design, develop and market medical devices for the treatment of epilepsy and other debilitating neurological disorders using a novel therapy, vagus nerve stimulation. The company's initial target market is epilepsy, the world's second most prevalent neurological disorder, which is characterized by recurrent seizures. In addition to the U.S., the NCP System is currently approved for sale in all the member countries of the European Union, Canada and other markets. CYBX 20.187 (+.063)before open