Healthcare Industry News: benign prostatic hyperplasia
News Release - March 22, 2006
Laserscope Reports Major Purchase of GreenLight(TM) Products in China$7 Million Order for Laser Systems and Fiber Optic Delivery Devices Marks Laserscope's Largest Ever One-Time Order for GreenLight Products
SAN JOSE, Calif., March 22 (HSMN NewsFeed) -- Laserscope (Nasdaq: LSCP ), a pioneer in the development and commercialization of minimally-invasive medical devices including medical lasers and advanced fiber-optic delivery devices, today reported that Miracle Laser, Laserscope's distribution partner in China, has ordered over $7 million in GreenLight PV® laser systems and fiber optic delivery devices to be delivered over the next 12 months. This order represents Laserscope's largest ever one-time order for GreenLight products and a slight increase over expected 2006 orders from our China distribution partner. A portion of these lasers and fiber optic delivery devices will be used to build a Center of Excellence program at top teaching and academic centers in China.
"We are pleased to see the commitment that Miracle Laser has made toward helping Laserscope establish the GreenLight PV laser system and the Photo-Selective Vaporization of the Prostate (PVP) procedure as the new standard of care in this very exciting market," said Eric Reuter, Laserscope's President and CEO. "China, like many of our international markets, represents a tremendous long term opportunity for the GreenLight product line and PVP procedure. Miracle Laser's order represents a significant milestone toward Laserscope's ultimate goal of replacing the Trans-Urethral Resection of the Prostate (TURP) procedure with the PVP procedure in the largest BPH markets worldwide, including China. We believe that more than 100,000 TURPs are performed in China each year and we look forward to continuing to work with Miracle Laser to take full advantage of this market opportunity in the future.
"We expect that this order will help us gain a widespread customer base in China, contribute to our revenue growth in 2006 and lead to higher fiber sales and increased profit in 2007 and beyond."
About GreenLight(TM) and PVP
The PVP procedure is used to treat enlargement of the prostate, clinically known as benign prostatic hyperplasia ("BPH"). The Trans-Urethral Resection of the Prostate procedure ("TURP") has been the leading surgical procedure to treat BPH for many years. The primary market opportunity for the PVP procedure is to replace the TURP procedure. Industry sources and available data indicate that the number of TURP procedures performed worldwide likely exceeds one million each year.
Additionally, sources indicate that the number of men using pharmaceutical drug therapy to treat BPH symptoms is over 2.5 million annually in the United States and several times this number internationally.
The PVP procedure using the GreenLight PV laser system and GreenLight PV single-use fiber optic delivery device has been demonstrated to offer a relatively safe, durable, and clinically efficacious procedure to treat BPH with minimal side effects that can give patients quick and substantial relief from their BPH symptoms. Urologists performing the PVP procedure apply focused high power light energy at the 532 nm wavelength through a small, flexible sterile fiber optic delivery device to safely, efficiently and virtually bloodlessly vaporize and immediately remove thin layers of the unwanted prostatic tissue to restore the patient's urinary channel through the prostate. A PVP treatment often results in nearly immediate symptom relief for the patient. PVP is often done on an outpatient basis and patients often can go home without an in-dwelling catheter the same day following their surgery. Long term clinical data demonstrates that PVP offers clinical outcomes equivalent to TURP, the current "gold-standard", but with a more patient-friendly and substantially better safety and side-effect profile. Laserscope estimates that over 125,000 PVP procedures have been performed worldwide since the GreenLight laser system and PVP procedure were made commercially available in 2002. In 2005, the Company sold fiber optic delivery devices to perform approximately 54,000 PVP procedures in the U.S. and over 19,000 internationally.
"Our goal has been and continues to be for the PVP procedure to replace TURP as the standard of care worldwide. We are now also focused on establishing the PVP procedure using the GreenLight PV laser system as a preferable alternative in many cases to other less efficacious surgical solutions as well as pharmaceutical drug therapies, and to begin to take market share from these other therapies currently in use. Our results in 2005 show that we've achieved marked progress toward replacing the TURP," said Reuter. "In the United States, there were about 54,000 PVP procedures performed in 2005, which we believe is somewhere between 20 and 25% of the current TURP market and between 15 and 18% of the overall non-pharmaceutical drug surgical treatment market in the U.S. Although international growth has been strong, we believe penetration of the TURP market remains under 5% in many of the largest markets outside the United States. We are working to obtain regulatory approval in Japan, which we believe is the second largest TURP market outside the United States. We believe Japan represents one of several large untapped market opportunities. Given the significant advantages that the PVP procedure offers the patient, the physician, and healthcare systems, we believe that PVP will continue to be adopted as a replacement for TURP for the foreseeable future.
"We have also recently heard anecdotal accounts from some physicians domestically and internationally of patients who have chosen to stop pharmaceutical drug therapy and instead to seek treatment of their BPH symptoms with the PVP procedure using the GreenLight PV laser system," continued Mr. Reuter. "Although it is not clear whether these anecdotal accounts represent a significant trend, they are consistent with our understanding of the relative merits in many cases of PVP versus pharmaceutical drug therapy. Pharmaceutical drugs usually require daily compliance for the rest of the patient's life, are expensive, can have side effects, and typically offer nowhere near the clinical efficacy of the PVP procedure. Consequently, we believe that when presented with the facts regarding their treatment options -- especially after long-term treatment with pharmaceutical drug therapy -- many men would prefer to have a single, durable, and substantially more clinically efficacious procedure to treat their symptoms rather than be dependent on a lifetime of pharmaceutical drug therapy. We believe the relative merits of the PVP procedure using the GreenLight PV laser system over TURP, other available surgical solutions, and pharmaceutical drug therapy for a wide spectrum of patients enhances the potential long term prospects for the PVP procedure using our GreenLight products both domestically and internationally."
Special Investor Relations Forum in May
Laserscope will be holding a special Investor Relations Forum coinciding with the 2006 American Urological Association Meeting in May, 2006. At this meeting, Laserscope will be discussing current and future key strategic research and development initiatives and additionally will be unveiling the latest new additions to the Laserscope urology product line. Investors are invited to attend in-person or via a web-cast which will be announced prior to the event. Those planning to attend in person should contact Laserscope's IR representatives as attendance will be limited.
Safe Harbor Statement
This press release contains forward-looking information within the meaning of Section 21E of the Securities Exchange Act of 1934, and is subject to the safe harbor created by this section. These forward-looking statements include: statements about Laserscope's future sales, profitability and operating results, competition, expected continued momentum of Laserscope's business and growth including new product offerings, worldwide adoption rates of the PVP procedure using the GreenLight PV® laser system, our ability to compete with similar product offerings and other therapies for the treatment of BPH, market penetration opportunities in international markets such as in Japan. These statements are subject to a number of risks and uncertainties, including: uncertainties regarding introduction of new technologies competitive to Laserscope's products and the degree to which our current and new products are accepted by customers, which could affect the level of demand for our products; uncertainties regarding the impact that competitive products and therapies as well as private and public payer reimbursement levels for the PVP procedure could have on the competitiveness of our current pricing programs, which could adversely impact our financial results; our dependence on sole source providers for key components and products; risk of reductions in government and private insurance reimbursement of hospitals and physicians for health care costs, which may negatively impact hospitals and physicians decisions to purchase our products reducing adoption rates and sales growth; risks that we may be unable to protect adequately the integrity, safety and proper use of our disposable fiber optic delivery device with the GreenLight PV® laser system, which could result in negative patient outcomes and reduce our disposable delivery device recurring revenue stream; risks that patents and licenses that we hold may be challenged, invalidated or circumvented or that we may become the subject of intellectual property litigation; uncertainties regarding our ability to compete with companies that have significantly greater financial, technical, research and development, manufacturing and marketing resources than we have; and uncertainties that new products will receive regulatory approval in applicable jurisdictions. Actual results may differ materially due to these and other factors. The matters discussed in this press release also involve risks and uncertainties described from time to time in Laserscope's filings with the Securities and Exchange Commission. In particular, see the Risk Factors described in Laserscope's most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K. Copies of Laserscope's public disclosure filings with the SEC, including the most recent Annual Report on Form 10-K and the most recent forms 10-Q are available upon request from its Investor Relations Department at its website at www.laserscope.com and at the SEC's website: www.sec.gov. Laserscope assumes no obligation to update the forward-looking information contained in this press release.
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