To: seminole who wrote (1042 ) 6/30/1998 3:55:00 PM From: seminole Respond to of 1826
BISN; penny stock Salitron is a device not a drug. They seem to focus on stock sales not product sales. Hey I wonder, do you think they have a TUMORTRON? SALITRON. This device induces salivation in certain persons who otherwise do not salivate normally. Lack of normal salivation can be caused by Sjogrens Syndrome (an autoimmune disease), other diseases, medication, radiation, surgery or aging. U.S. Patent No. 4,519,400, covering the method for stimulating salivation utilized by a prior concept for the Salitron System, was issued to Biosonics on May 28, 1985. Biosonics believes, although there is no assurance,that the current versions of the Salitron are protected by such patent. U.S. Patent No. 4,637,405, covering the apparatus utilizing that prior concept, was issued to Biosonics on January 20, 1987. Biosonics also was issued parallel patents by seven foreign countries, although such foreign patents have lapsed due to a lack of funds. FDA clearance for commercial sale was received through a PMA approval application process in May 1988 for use in treating patients with dry mouth secondary to Sjogrens Syndrome. In 1988, Biosonics commenced marketing the Salitron through five "Dry Mouth Centers" that were owned by independent third parties. Centers were opened in Philadelphia, Pennsylvania; North Miami Beach, Florida; Baltimore, Maryland; Fairfield, Connecticut; and Denver, Colorado, and a center controlled by Biosonics was opened in Milwaukee, Wisconsin. The independent dry mouth centers were granted the exclusive marketing and distribution rights in their respective territories. In 1990, however, as a result of the failure of the dry mouth centers to meet minimum purchase requirements, Biosonics decided to discontinue the centers. Biosonics has lacked the necessary funds to implement a marketing program for any of its devices. Biosonics' initial marketing efforts were for the Salitron and involved efforts to obtain Medicare reimbursement for the Salitron. On May 23, 1994, a proposed notice was published in the Federal Register by the HCFA that it intended to disapprove Biosonics' application for Medicare, although no final notice has yet been published. In 1996, Biosonics met with HCFA officials to urge a reevaluation of its intent to disapprove the Company's request for reimbursement approval. In February 1997, HCFA advised Biosonics that it had examined its previous position and concluded that absent additional information, Medicare reimbursement for the Salitron was not warranted under current law. As a result, the Company has engaged a Washington DC law firm to explore with HCFA the extent of additional information that HCFA will require. Approximately 35 private insurance carriers have reimbursed Biosonics for patients' use of the Salitron and Medicaid reimbursement approval has been obtained in four states. There is no assurance that such reimbursement will continue to be available or will be at price levels sufficient to realize an appropriate return to Biosonics. Further, Biosonics cannot predict the effect, if any, on the reimbursement from the private plans and Medicaid in the event that HCFA does publish a final notice of non-coverage of the Salitron system for Medicare purposes, and there is a risk that some or all of the Medicaid reimbursement could be discontinued in such event. Biosonics has been directing the marketing of the Salitron to rheumotologists, ear nose and throat specialists, and dentists. Under this program each physician and dentist is supplied with a Salitron, training materials along with a video, and asked to test their patients who suffer from dry mouth. This marketing -19- 23 effort was put on hold, however, because too many potential patients a Medicare age who cannot afford to purchase the Salitron without Medicare coverage.