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

To: Rex Dwyer who wrote (230)	4/1/1998 4:46:00 PM
From: Jim Lang	Read Replies (1) \| Respond to of 471

All, Here is some rather good news!!!! Good Trading, Jim Lang Wednesday April 1, 4:09 pm Eastern Time Company Press Release SOURCE: Cyberonics, Inc. Health Care Finance Administration (HCFA) Provides National Medicare Coverage For Vagus Nerve Stimulation Instructions to Medicare Claims Processors Being Issued HOUSTON, April 1 /PRNewswire/ -- Cyberonics, Inc. (Nasdaq: CYBX - news) was today notified that the Health Care Finance Administration (HCFA), the federal agency that administers the Medicare program for more than 36 million Americans, will provide national Medicare coverage for vagus nerve stimulation. When fully implemented and communicated to the contractors that process and pay Medicare claims, the national policy will state that vagus nerve stimulation is safe and effective treatment for patients with medically refractory partial onset seizures for whom surgery is not recommended or for whom surgery has failed. The contractors then will be required to cover and pay for vagus nerve stimulation procedures and services as long they are viewed as medically necessary and reasonable in an individual patient. The Cyberonics NeuroCybernetic Prosthesis (NCP) System is an implantable vagus nerve stimulator. Today's HCFA decision is notable because of the agency's rapid decision following the U.S. Food and Drug Administration's (FDA's) approval of the NCP system on July 16, 1997. The Medicare coverage decision also comes within 30 days of the announcement by the Blue Cross and Blue Shield Association that vagus nerve stimulation meets all of its Technology Evaluation Center (TEC) coverage criteria. This is the first time HCFA and Blue Cross Blue Shield have issued favorable coverage assessments within one year of approval for any neurostimulation therapy. Cyberonics learned of HCFA's coverage decision from U.S. Congressman Nick Lampson (D-9th District, TX), who received a letter from Nancy-Ann Min DeParle, HCFA Administrator. In that letter, DeParle states, ''We have reviewed scientific evidence regarding vagus nerve stimulation for treatment of patients with medially refractory partial onset seizures, for whom surgery has not been recommended or for whom surgery has failed. Based on that review, I have decided to proceed immediately with a national coverage decision on this device. I have also instructed the staff to proceed with implementing this decision as quickly as possible.'' ''The HCFA national coverage decision is a major step in securing widespread coverage and reimbursement for the NCP System,'' said Robert P. (''Skip'') Cummins, President and CEO of Cyberonics. ''The availability of any new medical technology is a function not only of FDA approval but also of adequate third party coverage and reimbursement. FDA approval in July 1997, just nineteen days after unanimous Advisory Panel recommendation, is a strong testament to the safety, efficacy and clinical utility of the NCP System. The HCFA national coverage decision and the recent favorable assessment by the Blue Cross Blue Shield TEC are equally strong testaments to the NCP System's clinical value. The combination of FDA approval, the HCFA national coverage decision and the Blue Cross Blue Shield assessment should make the NCP System readily available to the Americans and their families who are today trapped by refractory partial onset seizures. We at Cyberonics and all 200,000 of those Americans are very appreciative of the highly professional way in which HCFA staff members thoroughly evaluated the ten years of clinical research and the timely manner in which the policy decision was made.'' Acting as a ''pacemaker for the brain'' the Cyberonics NCP System delivers a unique treatment for patients with refractory epilepsy called Vagus Nerve Stimulation (VNS). The NCP System consists of an implantable generator and stimulating leads which apply small electrical pulses to the vagus nerve, which coordinates activity between the brain and internal organs. Stimulation of the vagus nerve has been shown to decrease the frequency of seizures or abolish them in some patients by conditioning the brain to better react to the interruptions in brain function common in epilepsy. The NCP System received U.S. Food & Drug Administration approval in July 1997 following more than ten years of research, preclinical and human studies. Cyberonics employed five separate clinical trials and 50 investigational centers to confirm the safety and efficacy of the NCP System for the treatment of refractory epilepsy patients. The first human implant of the NCP System occurred in 1988. Since then, more than 1,700 patients in 24 countries have accumulated over 2,500 patient years of experience using the NCP System. The NCP System is currently approved for sale in the U.S., all member countries of the European Union, Canada and other markets. 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 (VNS[TM]). 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 United States, the NCP System is currently approved for sale in all the member countries of the European Union, Canada and other markets. Portions of this press release contain forward looking statements. Actual results could differ materially from those projected in the forward looking statements as a result of a number of important factors, including: the rate at which physicians adopt the Company's product and therapy, the extent to which patients will accept and demand them, and the extent to which third party reimbursement for the Company's product becomes available and has an effect on usage of the product and therapy. For further discussion of these and other important factors that could affect the Company's activities and results, please refer to the Company's Annual Report on Form 10-K for the year ended June 30, 1997 and its Quarterly Reports on Form 10-Q for the quarters ended September 30, 1997 and December 31, 1997. SOURCE: Cyberonics, Inc.