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BAUSCH & LOMB GETS FDA APPROVAL TO MARKET TECHNOLAS 217 LASER.

Bausch & Lomb (NYSE:BOL), Rochester, N.Y. has announced that the Food and Drug Administration (FDA) has given its approval for U.S. marketing of the company's Technolas 217 Excimer Laser System, which is used by ophthalmic surgeons in performing LASIK (Laser in-situ Keratomileusis), the fastest growing refractive procedure for vision correction.

Using innovative technology that improves surgical accuracy, the Technolas 217 laser far exceeded FDA benchmarks in clinical trials.

With FDA approval in hand, Bausch & Lomb, the preeminent global technology-based healthcare company for the eye, is ready to begin marketing Technolas 217, the world's leading laser, immediately in the U.S.

"Our advanced flying spot Technolas 217 Excimer Laser System is the technology leader around the world, and we intend to make it a leader in the U.S. as well," said Hakan Edstrom, Bausch & Lomb senior vice president and president of Global Surgical. "This technology will provide better surgical outcomes for patients, which is the ultimate goal of Bausch & Lomb's complete approach to vision correction."

Clinical Results

The FDA Pre-Market Approval (PMA) clinical study results show that 99.7 percent of all patients who have undergone surgery with the Technolas 217 see 20/40 or better without glasses or contact lenses; this is 14.7 percent higher than FDA Guidance requires. The results show that 87.3 percent of all patients in the study see 20/20 or better without glasses or contact lenses after the surgery.

Using the latest in laser technology -- the first true scanning/flying spot laser -- the Technolas 217 effectively corrects the refractive error by utilizing its small beam profile to flatten the cornea centrally, and then "polishes" the periphery, or transition zone, to produce an extremely smooth cornea.

The Technolas 217, already widely established outside the U.S. as the market leader for treating both nearsightedness (myopia) and farsightedness (hyperopia), with or without astigmatism, is the only laser designed ergonomically for LASIK. The U.S. approval allows surgeons to treat up to -7.00 diopters of myopia and up to 3.00 diopters of astigmatism (95 percent of people with myopia fall within this range of correction, and approximately 40 percent of this population also have some degree of astigmatism).

Customized Ablation

The Technolas 217 is also the platform for the next generation of LASIK technology -- personalized vision correction -- also referred to as customized ablation. In the first half of 2000, Bausch & Lomb plans to introduce proprietary technology that allows surgeons to prescribe and design personalized laser vision correction treatments with the Technolas 217 laser, in conjunction with its Orbscan(TM)II corneal diagnostic equipment, and new wave-front technology that measures aberrations throughout the eye. Bausch & Lomb will initiate clinical trials for this technology in the U.S. in the next few months. The technology will be marketed outside the U.S. beginning in the second half of 2000.

The introduction of the Technolas 217 laser in the U.S. makes Bausch & Lomb the only company to offer a complete suite of laser surgery products -- lasers, microkeratomes, blades and diagnostic equipment -- illustrating its commitment to providing surgeons and patients with comprehensive vision correction solutions. In addition, Bausch & Lomb sponsors surgeon training on the LASIK procedure; more than 1,500 surgeons benefit from the company's C-LASIK(TM) courses each year.

True Scanning, Flying Spot Technology

The Technolas 217 goes a step beyond the current standard of broad beam (about a 6mm diameter) technology, creating a new therapeutic approach with a scanner-directed 2mm flying spot beam. Following the computer's instructions, this precise spot of laser energy ablates the corneal tissue, allowing each pulse to polish the corneal surface for a smoother result. Unlike broad beam lasers, the Technolas 217 scanner feedback mechanism ensures that every pulse is placed exactly as prescribed, and no laser shots are fired at consecutive locations, or overlap.

"My patients are extremely pleased with the results of their LASIK surgery using the Technolas 217," said Stephen Slade, M.D., an ophthalmic surgeon with a private practice in Houston, who participated in expanded clinical trials. "They've had fewer re-treatments, shorter recovery times and less discomfort after the surgery. The flying spot technology produces an extremely smooth corneal surface, yielding excellent immediate post-surgical results, fewer short-term side effects and overall better vision. And the platform concept means I won't have to buy new equipment every time the technology improves. I can just add software and peripherals as needed."

Platform Technology for Integrated Refractive Solutions

The Technolas 217 laser system was designed as an "evergreen" platform that effortlessly will incorporate software and technology upgrades in the future.

-- Integrated technology: The Technolas 217 is complemented by Bausch & Lomb's Orbscan(TM)II multidimensional diagnostic system and Bausch & Lomb's Hansatome(TM) Microkeratome corneal resection instrument. Together, these Bausch & Lomb products create a complete system for surgical visual correction.

-- Ergonomically superior: Working space was strategically designed especially for the LASIK procedure, to maximize surgeon and patient comfort, and optimize patient accessibility during refractive procedures.

-- Future upgrades: Clinical studies are underway for farsightedness and expanded ranges of nearsightedness.

Marketing Strategy

Technolas 217, the most advanced laser yet to be offered, has a list price of $525,000 per unit. The cost to the eye-care professional will vary according to the laser system design. The company will offer individualized payment programs based on the combination of annual procedures and surgical products used.

With regard to procedural fees, Bausch & Lomb has evaluated the complex issues presented by various patents in the U.S. and believes that it can market the Technolas 217 without obtaining further rights under third-party patents. The company will collect a fee of $100 for each procedure performed with its laser. In light of current patent litigation pending against doctors performing LASIK using certain competitive lasers, the company will indemnify its customers for costs associated with any third-party patent infringement lawsuit, if that becomes necessary.

"We believe the recent developments in the refractive surgery marketplace are consistent with our marketing strategy, which holds that technology will drive the market," said Edstrom. "As the playing field is leveled by the reduction in per-procedure fees, niche players will have minimal impact.

"An increase in procedure volume will not only fuel the demand for advanced technology lasers like the Technolas 217, but will also create even greater awareness among consumers," Edstrom continued. "This change in market dynamics is seen as very positive for Bausch & Lomb, since an increase in procedures should translate into a corresponding increase in demand for our microkeratomes and blades, which have enjoyed more than 100 percent sales growth over the past year."

Bausch & Lomb Incorporated is the preeminent global technology-based healthcare company for the eye, dedicated to helping consumers see, look and feel better through innovative technology and design. Its core businesses include soft and rigid gas permeable contact lenses, lens-care products, ophthalmic surgical and pharmaceutical products. The company is advantaged with some of the most respected brands in the world starting with its name, Bausch & Lomb(R), and including SofLens66(TM), PureVision(TM), Boston(R), ReNu(R), and Storz(R). Founded in 1853 in Rochester, N.Y., where it continues to have its headquarters, the company has pro-forma annual revenues of approximately $1.8 billion and employs approximately 13,000 people in 35 countries. Bausch & Lomb products are available in more than 100 countries around the world.

For more information, call 716/338-8064 or 800/405-5314.
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Title Annotation:217 Excimer Laser System for performing LASIK (Laser in-situ Keratomileusis) surgery
Comment:BAUSCH & LOMB GETS FDA APPROVAL TO MARKET TECHNOLAS 217 LASER.(217 Excimer Laser System for performing LASIK (Laser in-situ Keratomileusis) surgery)
Publication:Biotech Equipment Update
Geographic Code:1USA
Date:Apr 1, 2000
Words:1230
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