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First 29 Cases Treated in US Clinical Trial of New Minimally Invasive, All-Femto Laser Vision Correction Method
[November 09, 2012]

First 29 Cases Treated in US Clinical Trial of New Minimally Invasive, All-Femto Laser Vision Correction Method

DUBLIN, Calif. & JENA, Germany --(Business Wire)--

Carl Zeiss Meditec announced that the first 29 subjects in the VisuMax IDE clinical trial in the US have been treated with the ReLEx® smile procedure for the correction of spherical myopia with the VisuMax® femtosecond laser. One month results for the first 15 subjects will be presented at a Carl Zeiss Meditec symposium at the 2012 American Academy of Ophthalmology Annual Meeting in Chicago. The company received conditional approval from the US FDA to initiate the clinical trial in April 2012.

Jon Dishler, MD, the Medical Monitor for the United States VisuMax clinical trial and the first study site to initiate treatments using the ReLEx smile procedure, had the following comment, "My perception is that the ReLEx smile procedure is the first significant innovation in laser vision correction since it became popular almost 20 years ago. Based on positive international experience, we are pleased to have been chosen to lead the US clinical trial of this procedure. We look forward to reporting our results, along with those of the other investigators."

ReLEx smile is laser vision correction by small incision lenticule extraction and was developed by Carl Zeiss Meditec for refractive surgery. The procedure combines femtosecond laser technology and precise lenticule extraction for minimally invasive laser vision correction for the first time - all in a single system: the VisuMax Femtosecond Laser fromCarl Zeiss Meditec. While in LASIK procedures the excimer laser vaporizes tissue, the ReLEx smile method generates a refractive lenticule in the intact cornea with the femtosecond laser. The surgeon then removes the lenticule through a small, less-than-four-millimeter incision without needing to move the patient to an excimer laser. "With the first results of the clinical trial of ReLEx smile in the US, we take further steps to make this procedure available to surgeons in the US," says Dr. Ludwin Monz, President and CEO of Carl Zeiss Meditec AG. "This progress underlines the promising development in the first year after market introduction."

ReLEx smile, which is the first small incision, single-step and all-femto vision correction method, was launched internationally in September 2011. It is already launched in key markets such as Europe, China and India. About 60 clinicians globally perform the procedure today and more than 12,000 eyes have been treated so far.

Brief profile

Carl Zeiss Meditec AG (ISIN: DE0005313704), which is listed on TecDax of the German stock exchange, is one of the world's leading medical technology companies. The company supplies innovative technologies and application-oriented solutions designed to help doctors improve the quality of life of their patients. It provides complete packages of solutions for the diagnosis and treatment of eye diseases, including implants and consumables. The company creates innovative visualization solutions in the field of microsurgery. The medical technology portfolio of Carl Zeiss Meditec is rounded off by promising, future-oriented technologies such as intraoperative radiotherapy. In fiscal year 2010/11 (ended 30 September) the company's around 2,400 employees generated revenue of EUR 759 million.

The head office of Carl Zeiss Meditec is in Jena, Germany. The company has subsidiaries in Germany and abroad; more than 50 percent of its employees are based in the USA, Japan, Spain and France. The Center for Research and Development (CARIn) in Bangalore, India and the Carl Zeiss Innovations Center for Research and Development in Shanghai, China, strengthen the presence in these rapidly developing economies. 35 percent of Carl Zeiss Meditec shares are in free float. The remaining 65 percent are held by Carl Zeiss AG, one of the world's leading groups in the optical and optoelectronic industries. Carl Zeiss offers innovative solutions for the future-oriented markets of Medical and Research Solutions, Industrial Solutions, Eye Care and Lifestyle Products. Carl Zeiss AG, Oberkochen, is fully owned by the Carl Zeiss Foundation.

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