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(press release from WaveLight Laser Technologie AG)

Erlangen, Germany – March 30, 2005 – WaveLight Laser Technologie AG today announced that a clinical study assessing the innovative cooling handpiece of the company’s MYDON Nd:YAG laser will be the subject of a poster presented at the American Society for Laser Medicine and Surgery (ASLMS) meeting, March 31 -April 3, 2005, in Orlando, FL. The study (Poster #310) was conducted by Dr. Vic Narurkar, Dr. Akhil Wadhera and Dr. Daniel Eisen, dermatologists at the University of California, Davis, School of Medicine. The authors concluded the proprietary cooling device optimized epidermal safety, side effect profile and fluence delivery associated with treatment of hair removal and vascular lesions, especially in patients with darker (Type IV-VI) skin.

"Our study illustrates that clinical efficacy of an Nd:YAG laser can be improved with efficient epidermal cooling, " said Dr. Narurkar. "The innovative design of the MYDON handpiece allowed us to deliver higher therapeutic energy to the target chromophone, whether a hair follicle or blood vessel, with a relatively high degree of comfort and lack of epidermal damage. This benefit was especially significant for darker-skinned patients (Type IV-VI) who require longer pulse durations."

The retrospective clinical study was designed to assess the treatment of lower extremity telangiectasias, hypertrichosis and facial telangiectasias in 30 patients of skin types I to VI with a LP 1064nm laser utilizing a novel cooling tip. According to the authors, most patients reported feeling relatively little pain during the treatment; patients who had treatments with other similar devices reported the pain was much less severe in nature and the application of cold was soothing. None of the patients needed post-procedure analgesia and all were able to resume normal activity immediately after treatment.

"We’re very pleased with the data presented in the Poster that support the unique advantages of the constant contact cooling of the MYDON design," said Kathryn Grant, Director of Sales & Marketing at WaveLight. "The results are particularly exciting in that they present a safe, effective alternative for darker-skinned patients who have historically had few options for treatment of hair removal or vascular lesions."

Although the concept of constant cooling is not entirely new to the industry, according to Dr. Narurkar, the handpiece in this study has two significant advantages over other long-pulsed Nd:YAG systems that offer pre, parallel and post cooling.

"A longer stainless steel plate in the MYDON handpiece provided an extended post-cooling period which we believe led our patients to experience less pain and fewer side effects," he stated. "Also, the ability to remove the sapphire window when treating fine telangiectasias improved the visibility of the operator and avoided application of pressure which typically leads to blanching of the vessel and removal of the targeted chromophore."

A circulating liquid composed of water and ethylene glycol cools the rectangular handpiece of the MYDON, maintaining a temperature of 4ºC in standby mode, dropping to 0ºC when in ready mode. A peltier system (thermoelectric cooling) maintains the cold temperature of the cooling liquid.

Patients were asked to rate pain experienced during and after the treatment on a scale from 1 to 10, 1 being no pain and 10 being the worse pain ever experienced. The mean pain scores were 3.93 for hair removal and 4.38 for vascular lesions. There were no incidences of blistering, pigment alteration, crusting or scarring. The most common side effect reported was temporary erythema lasting a few hours.

For hair removal, 14 patients were treated, predominantly of darker skin type (III-VI). The fluences ranged from 30 to 50 J/cm² with a pulse duration ranging from 15-90 ms, depending on skin type and diameter of hair being treated. The spot size used ranged between 7 and 10 mm, depending on the area being treated. A clear gel was applied to the area to help improve the cooling and mobility of the handpiece.

For vascular lesions, 16 patients were treated and represented a range of all skin types. The fluences ranged between 150 to 250 J/cm² with pulse durations between 20 and 65 ms. The areas to be treated were covered by a clear gel and spot sizes of 1.5, 3 and 5 mm were used, depending on the size and color of the vascular lesion. The maximum size of telangiectasia’s was limited to 3 mm. Frequency of pulses delivered in both arms of the study ranged from 1 to 1.8 Hz.

Because of the limited duration of patient follow-up within the study design, the authors did not report on efficacy. Due to the encouraging preliminary efficacy data, however, they are currently conducting a multi-center IRB-approved study to evaluate efficacy of the MYDON Nd:YAG and its novel constant cooling handpiece for treatment of hair removal and vascular lesions.

The MYDON Nd:YAG is one of four aesthetic laser systems from WaveLight approved for sale in the US market in 2005, including the Sinon Q-switched ruby, Arion alexandrite and, in March 2005, the BURANE XL Er:YAG. Although new to the US market, WaveLight has a dedicated following in Europe and Asia where they are renowned for award-winning product design, speed, reliability and versatility.

For additional information, please visit: www.wavelight-laser.com.

Media Contact:

Fran Kelly

Tel: 732.706.5795

fkelly@comcast.net

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