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Up Front | May 2005

Wavelight’s Presence in the US

The company is making progress since the FDA's approval of the Allegretto Wave.

Wavelight Laser Technologie AG (Erlangen, Germany) proved to be a stealth fighter when the company entered the US ophthalmic market with the FDA's approval of the Allegretto Wave almost 2 years ago. The demiurgic company stepped up the performance of wavefront technology, an application that several individuals within the ophthalmic arena thought had already achieved its peak. Since the US approval of the wavefront-optimized system, the medium-sized company has achieved nearly a 30% market share of new refractive surgery systems sold internationally, has generated substantial financial growth in a short time, and has been profitable. What's the secret behind 9-year-old Wavelight's accomplishments? Cataract & Refractive Surgery recently spoke with key executives who provided insight into the business, its product, and its future outlook.


Before the first wavefront-guided treatment was ever executed, Professor Theo Seiler, MD, PhD (at the time working with scientists at the University of Dresden) and Wavelight set out to design a laser that would diminish the induction of aberrations to ultimately increase the effectiveness of LASIK treatments.

Katrin Teigeler, global marketing manager at Wavelight, explained that, during the original investigation, researchers quickly recognized that standard laser treatment induced spherical aberrations. Prof. Seiler and colleagues concluded that, in order to perform a wavefront-guided treatment, surgeons first had to make sure that they were not inducing new aberrations. The results of their research led to the development of the unique wavefront-optimized algorithm in the Allegretto Wave. “The wavefront-optimized algorithm takes corneal curvature and refractions into account and adjusts for them in the treatments,” Ms. Teigeler told CRSToday. “There are multiple benefits associated with the Allegretto Wave, including a wide approved treatment range. The system is very tissue friendly, meaning it does not ablate too much centrally, and the FDA trials have shown that patients' postoperative vision in many cases is better than they had ever experienced with their glasses or contact lenses.”

US Approval

When the Allegretto Wave received FDA approval in October 2003, Wavelight became the first European manufacturer of refractive laser surgery equipment to gain US regulatory approval. In the US, the Allegretto is approved for myopic corrections of up to -12.00D with astigmatism of up to -6.00D and for hyperopia of up to +6.00D with astigmatism of up to +5.00D. The Allegretto Wave received the widest range of approvals ever granted to a new laser platform, company representatives said. The Allegretto Wave first became available in Europe in the year 1999 for treating up to -14.00D of myopia with up to -6.00D of astigmatism and up to +6.00D of hyperopia with up to +6.00D astigmatism.

“Overall, the feature of the Allegretto Wave that sets it apart from other refractive lasers is its proprietary wavefront-optimized treatment profile, which allows surgeons to apply wavefront principles to every patient treated,” said Wade Tetsuka, president of US operations at Wavelight. “Today, the industry understands much better the importance of maintaining the natural asphericity of the cornea postoperatively to avoid the induction of spherical aberration. With this feature we are setting a new standard of care in LASIK.”

Market Share
For the past 33 years, Mike Shuler, currently vice president of business development at Wavelight, has worked in the industry with various ophthalmic device companies, including Visx, Incorporated (Santa Clara, CA).

“In Wavelight, I saw an extraordinary opportunity to introduce the US market to a new concept in LASIK treatment, and I knew I had the background and experience to help them become successful,” Mr. Shuler told CRSToday. “Our approach has been to introduce the Allegretto Wave to luminary refractive surgeons, who become proponents of the system and go on to share their enthusiasm with the larger refractive community.”

By the time Wavelight entered the US market, the company had 400 Allegretto Wave lasers installed internationally. In many other countries, Wavelight's Allegretto was leading the market, but it remained relatively unknown here before receiving FDA approval.

According to company estimates and data from Market Scope LLC (Manchester, MO), an information company focusing on the refractive and cataract surgical markets, in the US, the Allegretto Wave has achieved nearly a 5% market share of total LASIK procedural volume since entering the market and more than a 20% market share of new lasers sold. This success is largely due to Wavelight's US subsidiary, Wavelight, Inc. (Sterling, VA). Additionally, close to 70 Allegretto Wave systems have been installed in the US and are being used by high-volume surgeons (average range, 80 to 90 eyes per month). In the last 5 years, the Allegretto Wave has been the only new excimer laser platform approved by the FDA.

Key Features of the Allegretto Wave

The speed of the Allegretto Wave differentiates it substantially from other laser platforms. “The speed enables the procedure to be done faster,” Mr. Tetsuka said. “We are talking about a matter of seconds, but when a surgeon opens a corneal flap, seconds can be critical for the accuracy of the outcome.”

The Allegretto Wave is a small spot-scanning system that operates at a 200-Hz repetition rate and utilizes a 250-Hz eye tracking system, giving the Allegretto the ability to ablate 1.00D of corneal tissue every 4 seconds. Additionally, a time-consuming wavefront-guided workup is eliminated, which translates into surgeons' being able to treat more patients in less time. In terms of ergonomics, the system's built-in slit lamp eliminates the need to move the patient into a different room to check the position of his corneal flap.

“Refractive surgeons like the fact that when they choose a 6.5-mm treatment optical zone, they truly get a 6.5-mm ablation zone” Greg Anderson, vice president of sales and marketing at Wavelight, stated. “Additionally, the Allegretto Wave has demonstrated that it can substantially reduce the amount of enhancements to as little as less than 1% due to the system's precise treatment.”

The Allegretto Wave is creating a paradigm shift in the marketplace as wavefront-optimized procedures achieve equal or better results compared with current customized refractive surgery procedures, according to Mr. Tetsuka. “The company's technology is enabling surgeons to work smarter instead of having to work harder, simultaneously with achieving better outcomes,” he said. “That is the magic behind the Allegretto and behind Wavelight's technology innovation.“

Pricing at a Premium

Wavelight has maintained its premium pricing of the Allegretto Wave “Physicians know going in that the Allegretto is almost a half-million-dollar product, so we'd better be offering an awful lot more value than what they are used to getting with their current system,” Mr. Anderson added. “We do offer a lot in terms of the results, our people, and our services.” Company executives said that they will not tender the Allegretto at a discounted price.

“Our philosophy is to continue technology leadership in the industry,” Mr. Tetsuka said. “For us to do that, we have to re-invest a substantial amount of revenue into our R&D and engineering effort. Therefore, Wavelight cannot, and will not, move down from our premium pricing philosophy.”

According to Mr. Anderson, most physicians are paying an average of $250 for a customized procedure with other systems, whereas the keycard procedure for a wavefront-optimized treatment is $150.

Peer-to-Peer Promotion Wavelight allows its physician base to speak with other surgeons about their experiences with the Allegretto Wave. Additionally, Wavelight has regional sales managers strategically located across the US to consult with ophthalmologists curious about or interested in adopting the Allegretto Wave into their practice.


“WaveLight will move ahead of the competition in the US through the continuous introduction of new technologies,” Mr. Shuler said. “Internationally, we see that our products are making a huge impact, and this excitement is sure to be mirrored in the US once physicians have the technology at their fingertips.”

The company has two active ongoing studies for wavefront-guided technology and mixed astigmatism. Wavelight executives believe that, if and when the customized procedure is approved, it will account for little of the company's bottom line. “Custom, wavefront-guided ablations are going to be applicable to a small percentage of our patient population,” explained Mr. Anderson. “For any given physician using the Allegretto, maybe 5% to 10% of their really sick eyes would be candidates for wavefront-guided treatment with our system.”

At present, Wavelight's Concerto system, which runs at 500Hz, and its 400-Hz Eye-Q system are available in all other parts of the world. Internationally, the company offers four different methods of customization: wavefront-optimized, wavefront-guided, topography-guided, and Q-value–adjusted treatments.

Greg Anderson, vice president of sales and marketing at Wavelight, may be reached at (203) 364-0825; anderson@wavelight-laser.com.
Mike Shuler, vice president of business development at Wavelight, may be reached at (805) 350-0063; shuler@wavelight-laser.com.
Katrin Teigeler, global marketing manager at Wavelight, may be reached at +49 9131 6186 217; teigeler@wavelight-laser.com.
Wade Tetsuka, president of US operations at Wavelight, may be reached at (571) 434-8500 ext. 105; tetsuka@wavelight-laser.com.
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