FDA Authorizes Marketing of Interneuron's Medical Device for Neurological Imaging.LEXINGTON, Mass.--(BW HeathWire)--July 15, 1998--Interneuron Pharmaceuticals, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :IPIC IPIC Intellectual Property Institute of Canada IPIC Indianapolis Private Industry Council IPIC International Petroleum Investment Co (Abu Dhabi) IPIC Inventory Price Index Computation IPIC Information Processing Interagency Conference ) today announced that it has received authorization for marketing from the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) of a medical device called the AnatoMark(tm) Non-Invasive Head Reference System, designed to provide reproducible anatomical markers non-invasively for brain imaging. The accuracy and reproducibility of images obtained with the use of the AnatoMark System are expected to help physicians in the diagnosis and monitoring of neurological diseases, such as brain tumors. "AnatoMark represents a natural extension of Interneuron's innovative approaches to various neurological conditions," said Takashi Kiyoizumi, M.D., Ph.D., senior vice president, business development and strategic planning, and general manager of the AnatoMark Systems division. "To date, stereotactic stereotactic /ster·eo·tac·tic/ (-tak´tik) 1. characterized by precise positioning in space; said especially of discrete areas of the brain that control specific functions. 2. pertaining to stereotactic surgery. imaging has primarily utilized invasive procedures. We believe that the AnatoMark System's accuracy and ease of use for both patients and physicians will facilitate diagnoses and follow-up for a number of brain-related disorders." The AnatoMark System consists of a "head localizer A directional radio beacon which provides to an aircraft an indication of its lateral position relative to a predetermined final approach course. See also instrument landing system. " providing anatomical reference markers allowing reproducible alignment of multiple successive images. No invasive procedure is required, as is typical with current devices. The AnatoMark System also enables "co-registration" of images obtained with different imaging modalities, including MRI 1. (application) MRI - Magnetic Resonance Imaging. 2. MRI - Measurement Requirements and Interface. (magnetic resonance imaging magnetic resonance imaging (MRI), noninvasive diagnostic technique that uses nuclear magnetic resonance to produce cross-sectional images of organs and other internal body structures. ) and CT (computer assisted tomography). The AnatoMark System was invented by radiologists at Brigham and Women's Hospital Brigham and Women's Hospital (BWH) is a hospital in the Longwood Area of the Boston, Massachusetts neighborhood of Mission Hill. With Massachusetts General Hospital, it is one of the two founding members of Partners HealthCare. in Boston, from whom Interneuron interneuron /in·ter·neu·ron/ (-noor´on) 1. a neuron between the primary sensory neuron and the final motoneuron. 2. licensed exclusive worldwide rights for the System. Availability of the AnatoMark System is planned for next year. In the first phase of commercialization, Interneuron expects the System to be sold initially to researchers, radiation oncologists and neurosurgeons for both pre- and post- treatment uses. Following the completion of ongoing clinical investigation of software to assist in the automatic adjustment of imaging machines using the AnatoMark System, Interneuron will undertake the second phase of commercialization. This effort will focus on expanding the market by working with individual manufacturers of imaging machines to develop and sell additional software for diagnostic applications by a broader neurology community. For further product information regarding the AnatoMark System, contact 1-888-24-ANATO or e-mail: info@anatomark.com. Interneuron Pharmaceuticals is a diversified biopharmaceutical company engaged in the development and commercialization of a portfolio of products and product candidates primarily for neurological and behavioral disorders. Interneuron is also developing products and technologies, generally outside the central nervous system field, through three subsidiaries: Intercardia, Inc. focused on cardiovascular disease and carbohydrate-based drug discovery; Progenitor, Inc. focused on developmental genomics; and InterNutria, Inc. focused on dietary supplement products. Except for the descriptions of historical facts contained herein, this press release contains forward-looking statements that involve risks and uncertainties as detailed from time to time in the Company's filings under the Securities Act of 1933 and the Securities Exchange Act of 1934, including in particular, risks relating to the withdrawal of Redux and Redux-related litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. , uncertainties relating to regulatory approvals and clinical trials; product liability; the need for additional funds; the early stage of products under development; risks relating to product launches and managing growth; government regulation, patent risks, dependence on third parties and competition. CONTACT: Interneuron Pharmaceuticals Takashi Kiyoizumi, M.D., Ph.D., 781/402-3415 OR William B. Boni, 781/402-3410 |
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