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Growing Body of Clinical Data Validate The Unequaled Performance of OptiMedica’s Catalys In Laser Cataract Surgery

Date Announced: 14 Sep 2012

Results from surgical system presented at key event in Milan.

SUNNYVALE, Calif. — September 14, 2012 — Global ophthalmic company OptiMedica Corp. has announced clinical data presented at ESCRS 2012 in Milan, Sept. 8 – 12, that has confirmed the unparalleled performance of its Catalys Precision Laser System for cataract surgery. The subject of multiple presentations at the meeting, Catalys has been shown to deliver dramatic improvement in the precision, effectiveness and ease of performing cataract surgery.

“We developed Catalys to deliver laser cataract surgery that is without compromise, and I think the data presented at ESCRS clearly indicate the system is performing to this standard,” said Mark J. Forchette, OptiMedica president and chief executive officer. “Once surgeons have a chance to observe a case or use Catalys on their own, the decision-making becomes easy. The differences between Catalys and first generation laser cataract technologies are stark, and it’s these vast improvements that are fueling the rapid adoption of our system around the world.”

Prof. Burkhard Dick, chairman and head of the University Eye Clinic Bochum, Germany, reported at ESCRS on his experience using Catalys in “Femtosecond cataract surgery outcomes: an advance or not?” After performing more than 850 cases in his clinic, he concluded that laser cataract surgery with Catalys is a major advance over manual surgery.

Key metrics supporting the finding include: a 99 percent complete capsulotomy rate; elimination of ultrasound phacoemulsification in 40 percent of his first 850 Catalys cases (with average LOCS III grading of 3.2±09), due to the effectiveness of lens fragmentation; faster visual recovery after surgery1; and, statistically significant superior best corrected visual acuity through seven days post-procedure.2

“Catalys is a breakthrough innovation that has allowed me to dramatically improve my ability to treat a very broad population of cataract patients,” said Prof. Dick. “Its precision and outcomes are unparalleled in the field, and the system’s many unique capabilities have made it the cornerstone of my cataract practice.”

Prof. Dick was the first surgeon in Europe to use Catalys to perform corneal incisions, an indication that was CE mark approved in March 2012 and market cleared by the U.S. Food and Drug Administration in August 2012. At ESCRS, Dr. William W. Culbertson of the Bascom Palmer Eye Institute, Miller School of Medicine, University of Miami, presented data collected by Prof. Dick on corneal arcuate incisions.

Results of the 14-patient study showed that Catalys produced these incisions with exceptional accuracy in size, placement and geometry, with optical zone precision within 0.83 percent of intended; and axis and length precision within 0.22 degrees of intended.

“Catalys delivers extraordinary improvements across the cataract surgery procedure, and corneal incisions are no exception,” said Dr. Culbertson. “I believe that Catalys will eventually change the standard of care in cataract surgery due to the many significant benefits it brings to both surgeons and patients.”

Source: OptiMedica

References
1 Based on an intra-individual, prospective, randomized study of 53 patients and 106 eyes that showed less capsular bag shrinkage through 8 weeks post-op and an intra-individual, prospective, randomized comparative trial of 76 patients and 152 eyes showing 19 percent less inflammation through 1 day post-op.

2 Based on an intra-individual, prospective, randomized study of 73 patients and 146 eyes.

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