CELSION CORPORATION (AMEX:CLN) today announced that the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration has approved its PMA supplement requesting changes in its manufacturing and inspection process for components in its disposable catheter kit for the Prolieve Thermodilatation system and also cleared commercial distribution of the modified product.
Dr. Lawrence Olanoff, Celsion's Chief Executive Officer, commented, "We are delighted that the FDA has agreed to the changes we requested in our supplement and we are arranging to start shipments of the finished catheter kits to our distributor Boston Scientific immediately."
ABOUT CELSION: Celsion Corporation, based in Columbia, Maryland, is a biotechnology company dedicated to the development and commercialization of heat activated treatment systems for cancer.
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, Harbor UCLA Medical Center, Montefiore Medical Center and Memorial Sloan-Kettering Cancer Center in New York City, Roswell Park Cancer Institute 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 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.