Laserscope Announces Compelling BPH Clinical Results.

Business Editors/Medical Writers

SAN JOSE, Calif.--(BW HealthWire)--March 22, 2001

Laserscope (Nasdaq:LSCP) today announced preliminary results from an ongoing clinical study being conducted to evaluate its new high power, 80 watt, KTP/532 laser system and sterile disposable fiber optic delivery devices for the minimally invasive treatment of Benign Prostatic Hyperplasia (BPH).

In this pilot study, conducted at Oakwood Annapolis Medical Center in Wayne, MI, 10 patients with severe bladder outlet obstruction caused by BPH were treated using the new laser system. All patients were treated in a 30 minute outpatient procedure with no complications or adverse events. After 1 month, the initial follow-ups indicate that all patients have experienced significant reductions in symptom scores, and dramatic improvement in their quality of life and urodynamic evaluations. In fact, the early results are comparable, if not superior, to data collected from the gold standard treatment of transurethral resection of the prostate (TURP) during the same follow-up time period but with no reported side effects. Forty percent (40%) of the patients that were treated with the laser did not require catheterization, while the remaining 60% of patients had less than 24 hours of catheterization. All 10 patients were able to continue with normal daily activity within 2-3 days after treatment. In addition to the impressive preliminary clinical data, a hospital cost analysis conducted at Oakwood hospital demonstrated the KTP laser procedure to be significantly more cost effective than traditional TURP surgical procedures.

Dr. Mahmood Hai, the clinical investigator conducting this most recent study, called the results "truly remarkable." He also added, "Our observation over a 1-month period indicates that this new 80 watt KTP laser vaporization prostatectomy is safe and effective for quickly relieving bladder outlet obstruction with virtually no postoperative complications, a high rate of patient satisfaction, and, so far, excellent urodynamic results."

Further, Dr. Hai stated, "This laser system appears to offer the clinician a revolutionary way to treat this disease in that it combines both the immediate symptom relief that is usually only possible by performing invasive procedures such as transurethral resection of the prostate (TURP) with faster operative times and the minimal side effects seen with less efficacious treatments. The fact that such a high percentage of the patients were catheter-free on the day of the procedure is quite extraordinary. Although this is a relatively small sample of patients and more studies are necessary to confirm these results in a wider patient population, I believe that this treatment system has a very promising future. If the short- and medium-term follow-up results confirm the earlier Mayo Clinic results in terms of long term efficacy, and I see no reason why they shouldn't, this solution may replace TURP as the 'gold standard' yet be more safe and effective."

As a point of reference, this latest study was initiated in December of 2000 with a brand new system which was developed based on the compelling clinical results obtained from a separate ongoing clinical study initiated three years ago at the Mayo Clinic in Rochester, MN. In the Mayo Clinic study, conducted using a 60 watt KTP laser system by Dr. Reza Malek, the post-operative and long-term 2-year follow-up clinical data indicated significant improvement in both the patient assessment and urodynamic parameters. Patients that were treated in the Mayo Clinic study had immediate symptom relief, very few, if any, side effects, and were catheter-free within a maximum of 24 hours. After two years, 95% of these patients remained "very satisfied" with the procedure, while the remaining 5% reported being "satisfied." None of the patients had any substantive degradation of their symptom scores or quality of life scores over the two-year period. The Mayo Clinic's results were published in the June 2000 issue of the Journal of Urology. Three-year follow-up results will be presented at this year's 2001 American Urological Association Meeting in Anaheim, California.

In commenting on the results of the most recent study from Oakwood Annapolis Medical Center, Eric Reuter, Laserscope President and CEO said, "This study indicates dramatic results in all facets of the treatment for this disease. The patients experienced virtually complete symptomatic relief immediately post-operative, there were no reported side effects, the catheterization times, if a catheter was required at all, were under 24 hours, and the operative times were significantly improved from those experienced during the Mayo Clinic study. The mean operative time was less than 16 minutes. From a financial perspective, less time required in the OR and in follow-up visits due to complications or poor patient satisfaction means more profitability for the hospital and surgeon.

"The market and demand for minimally invasive solutions to treat BPH is growing worldwide as the male population ages. In 1999, over 8 million men were diagnosed with the disease in the United States, and nearly 1.8 million of these men were treated in some way. Since 'watchful waiting' and drug therapy are only effective for a certain percentage of patients requiring treatment, the need still exists for a solution that offers patients immediate and complete relief but does not carry significant risks or side effects. Additionally, many patients who are currently taking drugs are not satisfied with the symptom relief, cannot live comfortably with the drug side effects, or are simply uneasy about having a surgical procedure done. This indicates that in addition to a growing market of new diagnoses, there may also be a growing backlog of patients who are dissatisfied with their existing treatment solutions and are looking for safe, effective, and complete ways to treat their symptoms. The ideal solution for the patient is complete symptomatic relief, no complications, and long term efficacy. These most recent clinical results indicate that we have established our new system as a top contender for meeting this need.

"We have just recently been granted FDA clearance for general soft tissue, including urological applications, and we have submitted for 510(k) clearance to market the system specifically for BPH. We will be expanding the aforementioned clinical studies to treat a larger group of patients at multiple clinical sites over the next few months in order to accumulate more data in preparation for our planned marketing launch of the new product later this year."

Except for historical information presented, the matters discussed in this announcement may contain forward-looking statements that involve risks and uncertainties. These risks are detailed from time to time in the Company's public disclosure filings with the U.S. Securities and Exchange Commission (SEC). Copies of Laserscope's most recent forms 10K and 10Q are available upon request from its Investor Relations Department.