Celsion Receives FDA Approval for Prolieve Thermodilatation System; Approval of device clears the path for Celsion and Boston Scientific Corporation to introduce BPH Treatment.Business Editors/Health/Medical Writers COLUMBIA, Md.--(BUSINESS WIRE)--Feb. 19, 2004 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 approved its Prolieve(TM) Thermodilatation system for the treatment of the symptoms of Benign Prostatic Hyperplasia benign prostatic hyperplasia n. Abbr. BPH A nonmalignant enlargement of the prostate gland commonly occurring in men after the age of 50, and sometimes leading to compression of the urethra and obstruction of the flow of urine. (BPH BPH abbr. benign prostatic hyperplasia BPH Benign prostatic hypertrophy, a very common noncancerous cause of prostatic enlargement in older men. ) a condition affecting older men more commonly referred to as an enlarged prostate. The system is a dual action technology ("Thermodilatation"), employing heat and urethral dilatation to provide significant symptomatic improvement in two weeks. This device is used in an in-office procedure that minimizes patient discomfort and the need for post-treatment catheterization catheterization Threading of a flexible tube (catheter) through a channel in the body to inject drugs or a contrast medium, measure and record flow and pressures, inspect structures, take samples, diagnose disorders, or clear blockages. . In a randomized one-year clinical trial, conducted at 14 centers across the United States, patients undergoing treatment with Prolieve achieved measurably greater improvement in symptoms after 3 months compared to a control group using a drug, Proscar, which is commonly prescribed to treat this condition. This product offers millions of men, suffering from BPH, a treatment that provides significant symptom relief with minimal side effects. Dr. Augustine Cheung, Celsion's Chief Executive Officer said, "We are delighted that this device has been approved by the FDA. This is a largely underserved market with seven million of the nine million men afflicted with this condition choosing to forego treatment. We believe that our unique treatment offers a minimally invasive treatment for this condition and a realistic alternative to drug therapy." In January 2003, Celsion entered into a strategic relationship with Boston Scientific Corporation (NYSE NYSE See: New York Stock Exchange :BSX) in which Boston Scientific will initially distribute the Prolieve Thermodilatation system in the United States. Steve Moreci, Senior Vice President and Group President for Endosurgery said, "We are very pleased that Celsion has obtained approval for this product which offers features designed to overcome shortcomings of current minimally invasive therapies. We believe that BPH represents an underserved market offering substantial growth potential and should be a major factor in growing our presence in the Urology market. We are very excited to be working with Celsion in the introduction of this product." BPH is an age-related disorder; its incidence increases with maturation of the population. Industry estimates suggest that 9 million men in the United States experience BPH symptoms and that more than 26 million men are affected by BPH worldwide. As the United States population continues to age, the prevalence of BPH can be expected to continue to increase. It is generally estimated that approximately 50% of all men over the age of 55 and 90% of all men over 75 will have BPH symptoms at various times. Industry studies estimate the overall costs of BPH therapy for those patients currently seeking treatment to be approximately $2.5 to $3.0 billion annually in the United States. Approval and launch of this product triggers milestone payments aggregating $10 million, in the form of equity and licensing fees, from Boston Scientific to Celsion. According to Tony Deasey, Celsion's Chief Financial Officer, these funds combined with the proceeds from recent private placements and warrant exercises together with cash flow generated from product sales will significantly strengthen Celsion's balance sheet. About Celsion: Celsion Corporation, based in Columbia, Maryland, is a biotechnology company dedicated to the development and commercialization of treatment systems for cancer and other diseases using focused-heat energy, either administered alone, or in combination with other therapeutic devices, heat activated genes and heat activated drugs. In January 2003, Celsion entered into a strategic alliance with Boston Scientific Corporation (NYSE:BSX) in which Boston Scientific will initially distribute the Prolieve Thermodilatation system worldwide. Boston Scientific currently owns approximately 7% of Celsion's outstanding stock. Celsion has research, license or commercialization agreements with leading institutions such as the National Institute of Health, 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. , 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]. and 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 City New York City: see New York, city. New York City City (pop., 2000: 8,008,278), southeastern New York, at the mouth of the Hudson River. The largest city in the U.S. , 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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