Celsion Files Final Clinical Module of BPH 800 PMA Submission.Business Editors/High-Tech Writers COLUMBIA, Md.--(BUSINESS WIRE)--March 24, 2003 Celsion Corporation (AMEX AMEX See: American Stock Exchange :CLN) today announced that the 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. has closed the Pre-Clinical Module (Module I) of its Microfocus BPH BPH abbr. benign prostatic hyperplasia BPH Benign prostatic hypertrophy, a very common noncancerous cause of prostatic enlargement in older men. 800 Microwave Urethroplasty(TM) Treatment System PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy submission, clearing the way for Celsion to file the final, clinical module (Module III), which was filed with the FDA today. As previously announced, the Manufacturing Module (Module II) was closed in July 2002. Celsion previously announced that it was filing its PMA submission on a modular basis and that it had agreed with the FDA that the final, Clinical Module would not be submitted until the first two (Pre-clinical and Manufacturing) modules had been closed. Assuming the FDA is satisfied with the Company's Module III filing, Celsion could receive Pre-Marketing Approval for its Microfocus BPH 800 Microwave Urethroplasty(TM) Treatment System from the FDA in the summer of 2003, and commence marketing the BPH system in the U.S. shortly thereafter. Celsion's pivotal trial compared AUA AUA American Urological Association, see there symptom scores of patients who received one treatment with Celsion's Microfocus BPH 800 Microwave Urethroplasty(TM) Treatment System to patients treated with a daily dose of the drug Proscar(R) (distributed by Merck (NYSE NYSE See: New York Stock Exchange :MRK)). Dan Reale, President of Celsion's BPH Division, commented, "we continue to be pleased with the results of the study. Our system is uniquely designed to offer patients an office-based treatment while providing rapid and sustained relief with limited side effects. We remain confident that with our recent submission of the final module, the FDA should be in a position to act on our pre-marketing application in an expeditious manner." BPH, more commonly referred to as an enlarged prostate, is a condition that afflicts millions of men as they get older. The prostate grows larger as men age constricting the urethra and restricting urine flow. BPH causes sufferers to have frequent urges to urinate and limits their ability to fully evacuate their bladders. On January 21, 2003 Celsion announced that it had formed a strategic alliance with Boston Scientific Corporation (NYSE:BSX) and that as part of the agreement Boston Scientific had obtained worldwide distribution rights (except for certain Asian, Central and South American markets) for Celsion's Microfocus BPH 800 Microwave Urethroplasty(TM) system. Dr. Augustine Cheung, Celsion's Founder and Chief Executive Officer, said "We are pleased that we have now entered the final stages of the approval process for our BPH product. If the FDA approves the product, our relationship with Boston Scientific should enable us to maximize the commercial potential of the BPH product while allowing our staff to focus on the development of our cancer treatment technologies." About Celsion: Celsion Corporation, based in Columbia, Maryland, is a research and development company dedicated to commercializing medical treatment systems for cancer and other diseases using focused-heat technology delivered by patented microwave technology. In January 2003, Celsion entered into a strategic alliance with Boston Scientific Corporation (NYSE:BSX) in which Boston Scientific will initially distribute Celsion's BPH product worldwide. Boston Scientific currently owns approximately 9% of Celsion's outstanding stock. Celsion has research, license or commercialization agreements with leading institutions such as Duke University Medical Center, Massachusetts Institute of Technology Massachusetts Institute of Technology, at Cambridge; coeducational; chartered 1861, opened 1865 in Boston, moved 1916. It has long been recognized as an outstanding technological institute and its Sloan School of Management has notable programs in business, , Harbor UCLA Medical Center UCLA Medical Center is a hospital located on the campus of the University of California, Los Angeles in Los Angeles, California. It is rated as one of the top three hospitals in the United States and is the top hospital on the West Coast according to US News & World Report. , the Center for Breast Surgery at Columbia Hospital in Florida, Montefiore Medical Center Montefiore Medical Center, in the Bronx, New York, is the university hospital of the Albert Einstein College of Medicine. The hospital, named after Moses Montefiore, is one of the 50 largest employers in New York State [1]. , Memorial Sloan-Kettering Cancer Center The Memorial Sloan-Kettering Cancer Center (MSKCC) in New York City is a cancer treatment and research institution founded in 1884 as the New York Cancer Hospital. The main campus is located at 1275 York Avenue, between 67th and 68th Streets, with other locations in New in New York, Roswell Park Cancer Institute The Roswell Park Cancer Institute is a cancer research and treatment center located in Buffalo, New York. Founded in 1898 by Dr. Roswell Park, it was the first dedicated medical facility for cancer treatment and research in the United States. in Buffalo, New York, and Duke University. For more information on Celsion, visit our website: www.celsion.com. Celsion wishes to inform readers that forward-looking statements in this release are made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, unforeseen changes in the course of research and development activities and in clinical trials by others; possible acquisitions of other technologies, assets or businesses; possible actions by customers, suppliers, competitors, regulatory authorities; and other risks detailed from time to time in the Company's periodic reports filed with the Securities and Exchange Commission. |
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