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To: Patrick Slevin who wrote (13461)4/27/1998 9:45:00 AM
From: Tech Master  Read Replies (1) | Respond to of 17305
 
*** CGLB Press Release ***

Monday April 27, 8:36 am Eastern Time

Company Press Release

Cheung Laboratories Files IDE Application With FDA for Clinical Testing of Its Heat and Compression BPH Treatment System

COLUMBIA, Md.--(BW HealthWire)--April 27, 1998--Cheung Laboratories, Inc. (OTC BB: CGLB - news) announced today that it has filed an Investigational Device Exemption (IDE) application with the U.S. Food and Drug Administration (FDA) in order to commence clinical studies of its benign hyperplasia (BPH) treatment system. BPH affects an estimated 50% of men over 55, or 7.2 million men in the U.S.

Cheung's patented BPH system overcomes the problem of swollen prostates in two ways. First, a unique microwave balloon catheter delivers transurethral microwave heating which shrinks the prostate and is anticipated to yield long term treatment benefits. Second, the balloon catheter is simultaneously expanded and compresses the urethra wall. The combination of microwave heat and balloon catheter compression creates a natural biological stent in the urethra, providing immediate relief of urinary obstruction.

Unlike all other BPH treatments, Cheung's proprietary system offers a single, in the office procedure with immediate relief from obstruction and long term symptom control without pain or subsequent catheterization.

Principal Investigator and Clinical Evaluation Sites

Dr. Arnold Melman, professor and chairman of Urology at Albert Einstein College of Medicine, is the principal investigator of the proposed clinical studies. He previously conducted in vivo preclinical evaluations of Cheung's system in animals, at the Montefiore Medical Center in New York, which demonstrated the formation of the biological stent using large dogs with advanced BPH. His results indicate that biological stent creation using heat and compression is feasible, and that Cheung's system is safe for patient use.

Upon receipt of the IDE, patient studies utilizing Cheung's BPH treatment system are scheduled to begin at Montefiore Hospital and will be followed by studies at the Walter Reed Army Medical Research Institute in Washington, D.C. The Company is also considering several additional test sites for clinical studies.

Competitive Advantages & Market Potential

Cheung's system is a non-surgical urethroplasty procedure which provides BPH patients immediate urine-flow relief by forming the biological stent, a feature absent from all other current commercial BPH thermotherapy systems. Since the Company's BPH system uses lower temperatures than other thermotherapy systems, it assures long term treatment benefits without the side effects caused by other BPH treatments.

Cheung estimates the introduction of its pain-free system will encourage up to 50% of individuals who suffer from BPH to seek treatment; only 30% currently seek treatment. This should expand the market for BPH treatments, currently a $9 billion worldwide industry and $3 billion business in the U.S.

Cheung Laboratories, Inc. is a research and development company dedicated to commercializing medical treatment systems for cancer and benign prostate hyperplasia (BPH) utilizing deep focused heat delivered by patented microwave technology. Cheung is presently working with leading institutions to develop its focused heat treatments, including Massachusetts General Hospital (MGH), Montefiore Medical Center, and Duke University in the United States, and Oxford University and Hammersmith Hospital 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.