Celsion to Begin Human Clinicals On Its Non-Surgical BPH Treatment At Montefiore Medical Center in NY; Phase One and Two Clinicals to be Completed in 1999; System has FDA IDE.

COLUMBIA, Md.--(BUSINESS WIRE)--Oct. 14, 1998--Celsion Corp. (OTC BB:CELN) today announced that it has received the necessary funding and regulatory approval to commence phase one clinical studies in patients of its microwave heating and balloon compression system that offers non-surgical treatment of benign prostatic hyperplasia (BPH).

BPH, which is caused by the enlargement of the prostate gland due to aging, affects an estimated 50% of men over 55 or 7.2 million men in the U.S. alone. Treatment of the condition is currently estimated to be a $3 billion business in the U.S. and $9 billion worldwide.

Celsion's system uses a unique microwave balloon catheter to deliver transurethral microwave heating which both shrinks the prostate and, with compression, creates a biological stent in the urethra. The treatment is designed to eliminate BPH symptoms which include pain in urination, frequent urination, weak urine flow, and in severe conditions the inability to urinate.

An Investigational Device Exemption (IDE) has been granted by the FDA for the Company to conduct a phase one clinical feasibility demonstration at the Montefiore Medical Center in New York City. This will be followed by multiple-site phase two studies to collect the efficacy data necessary to obtain an FDA Premarket Approval (PMA) for commercialization. The Company expects to complete both phases of the studies in 1999.

Competitive Advantage and Market Potential

Management expects its unique, in-the-office, non-surgical urethroplasty BPH treatment system to create a new gold standard of "walk-in be treated, walk-out with total relief."

Celsion believes the system to be a side-effect-free outpatient procedure that provides BPH patients immediate relief of urinary obstruction, a feature which is not available in current commercial microwave BPH treatment systems, as well as longer term symptom control without subsequent catheterization.

Since the Celsion system uses a lower treatment temperature of 45 degrees Celsius, it is believed to eliminate the potential danger of unwanted rectal wall heating that is caused by the higher temperatures (50 degrees and over) which are often used with competitive systems. Due to the belief that a compressed prostate is heated more uniformly, the system is also expected to minimize patient discomfort that results from unwanted hot spots which are often encountered during other BPH treatments.

Celsion believes that the painless, side-effect-free nature of its BPH treatment system will encourage more patient acceptance and thereby result in a higher percentage of individuals suffering from the condition to seek treatment. It is currently estimated that only 30% of BPH sufferers seek treatment, primarily due to the fear of surgery as well as the pain and side-effects associated with existing procedures.

Principal Investigator and Evaluation Site

Dr. Arnold Melman, professor and chairman of the urology departments at the Montefiore Medical Center and Albert Einstein College of Medicine, will be the principal investigator of the phase one studies which will be conducted at the Montefiore Medical Center to demonstrate the system's safety and efficacy in humans.

Dr. Melman previously conducted the preclinical evaluations in animals which confirmed the system's capability to create a biological stent (central urethral lumen) for immediate relief of urinary obstruction.

Dr. Melman stated, "Celsion Corporation has entered into a Clinical Study Agreement with Montefiore Medical Center which allows me to begin human studies using its BPH technology. I believe, based upon my completed animal studies, this should be a significant advance in the management of BPH. The treatment should be capable of being performed without anesthesia and will provide immediate relief of bladder outlet obstruction."

About Celsion

In addition to its BPH treatment system, Celsion is also preparing to conduct clinical studies of its breast cancer focused heat treatment system which has already obtained an FDA PMA. The Company is also expanding its line of cancer treatment systems to include prostate cancer and deep-seated cancer treatment systems.

Celsion Corporation is a research and development company dedicated to commercializing medical treatment systems for cancer and BPH using focused heat delivered by patented microwave technology. Clinicals and further development of the Company's treatment systems are being conducted by leading institutions such as the Massachusetts Institute of Technology, Massachusetts General Hospital, Montefiore Medical Center, and Duke University in the United States, and Hammersmith Hospital and Oxford University in England.

Forward-looking statements in this release are made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements involve risks and uncertainties, including, without limitation, possible changes in cost of materials, expense items, capital expenditures, capital structure, and other financial items; introduction of new products and possible acquisitions of 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.