To: Larry Brew who wrote (799 ) 11/16/2001 10:57:24 AM From: TEDennis Read Replies (1) | Respond to of 966 Friday November 16, 10:17 am Eastern Time Press Release SOURCE: Celsion Corporation Celsion BPH Trials Clear Critical Milestone Patient Enrollment Completed and on Track for PMA Filing Spring 2002 COLUMBIA, Md., Nov. 16 /PRNewswire/ -- Celsion Corporation (Amex: CLN - news) reported today that it has successfully enrolled all 160 patients required for completion of its pivotal Benign Prostatic Hyperplasia (BPH) Phase II Clinical Trial. The company indicated that it expects to treat all enrolled patients by December 1. ``We are on track to file our application for pre-market approval with the FDA early next spring,'' said Dr. Augustine Cheung, Celsion's Chief Executive Officer. Dr. Cheung characterized this achievement as a ``watershed event that places Celsion squarely on the threshold of an important new revenue stream.'' BPH is a debilitating prostatic condition that impairs the ability to urinate in more than 50% of men over the age of 55. The population afflicted with BPH is estimated at nine million men in the United States alone. According to Dan Reale, President of Celsion's BPH Division and the architect of its enrollment efforts, ``Celsion's successful enrollment strategy was simple. We believed that an operator-friendly, minimally invasive treatment promising rapid relief and minimal side effects would be enormously attractive since it assists doctors in reaching the vast majority of BPH patients (approximately 75%) who currently choose not to undergo treatment. Our enrollment success demonstrates the validity of our premise.'' Reale continued, ``The urologists, across the country, who are participating in this trial are familiar with other, more complicated, minimally invasive treatments, which generally cause inflammation and require patients to wear a catheter for up to weeks after the procedure is completed.'' Celsion's system is designed to be simple to operate, considerably less painful and generally to allow a patient to go home within an hour of treatment and without a catheter. So, the system is highly attractive to patients as well as physicians. `` ``Based on our experience to date,'' Reale said, ``Celsion believes its BPH treatment system, if approved by the FDA, has the potential to become the new gold standard for the treatment of BPH.''biz.yahoo.com