Celsion Corp. received federal approval yesterday for a new microwave-based treatment for enlarged prostates, opening the way for the Columbia company's first product to reach the commercial market.
Approval by the Food and Drug Administration also triggers a $10 million payment from Boston Scientific Corp., the Natick, Mass.-based company that is Celsion's marketing partner. Boston Scientific, which has a strong business in urological products, owns about 7 percent of Celsion's stock and signed on to market the Prolieve treatment in January last year.
The payment would be welcome revenue for Celsion, which lost $13.27 million in its last fiscal year and posted no revenue. The company said it also was working on using the same technology as a treatment for various cancers.
"From our point of view, we think this is the best product ... . on the market," said Anthony P. Deasey, Celsion's chief financial officer.
Called the "Prolieve Thermodilation System," Celsion's new therapy is aimed at treating enlarged-prostate syndrome, known medically as benign prostate hyperplasia, or BPH, a condition that typically surfaces in men of about 55 years of age. About 90 percent of all men older than 75 will suffer from BPH, which can cause severe discomfort, according to Celsion.
Treating BPH is about a $3 billion market, according to market research by Celsion and Boston Scientific. Roughly three-quarters of patients are treated with medications that either shrink the prostate or relax the muscles in and around the pelvic floor, relieving pressure on the urinary tract, although those medicines can have side effects. More serious cases are treated surgically, which can result in incontinence or impotence.
According to Celsion, Prolieve is an in-office procedure that uses targeted microwave heat and a small balloon. After the microwave heat softens up the prostate tissue, the balloon is inflated to open up the urethra. When the tissue subsequently cools, it remains in its new position, Celsion said.
Boston Scientific said it initially will be the lead firm marketing Prolieve, which Celsion's Deasy said will enable the firm to focus on the other products and therapies now in development - chief among them a microwave-based treatment for prostate cancer.
The company's shares closed yesterday at $1.72, down 7 cents, although the stock traded up to $2.10 - a 52-week high. Volume exceeded 10 million shares, compared with a six-month daily average of 781,000.