Laser Eye Surgery, PRK, LASIK
Favorable FDA Panel Recommendation for LADARVisionx Laser Surgery System |
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Vector analysis showed 96% of the pre-operative astigmatic cylinder was corrected at 6 months while refractive stability was achieved for both spherical and astigmatic patients by 3 months. Commenting on the Panel's announcement, Randy Frey, President and CEO of Autonomous Technologies, stated, "We are delighted that the FDA Ophthalmic Panel has recommended the LADARVisionx System for approval. Our clinical trials team delivered greater than 95% accountability, which I believe helped the panel feel comfortable with their recommendation." The FDA Ophthalmic Advisory Panel reviews a PMA application for approvability. The FDA accepts the advice of the Panel, but is not necessarily bound by its decision. The company's LADARVisionx system (formerly known as T-PRK, tracker-assisted photorefractive keratectomy) is a fully integrated, user-friendly and compact laser surgery system for use by ophthalmologists on an outpatient basis to improve visual quality and clinical outcomes for low to moderate myopia. This high speed, laser radar eye tracking system utilizes a precisely controlled narrow beam shaping technology to form its new and proprietary technology platform. This sophisticated system was designed to track and compensate for the extremely rapid involuntary and random eye movements that occur during surgery and hinder conventional LVC predictability and quality. LADARVisionx provides high accuracy ablation by virtually eliminating the errors resulting from this movement. Additionally, the narrow beam excimer provides for smooth ablation at high speeds, less than 10 seconds per diopter, minimizing surgical duration while retaining the high pointing accuracy required for predictable shaping. The statements in this press release expressing belief, anticipation or expectations, as well as other statements which are not historical fact, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and involve risks and uncertainties that could cause actual results or performance of the Company to differ materially from the results or performance described herein. Specifically, the Company's projection of a final FDA determination or approval of the LADARVisionx product and the marketing of same is subject to continuing FDA audit and review processes which are uncertain in their final outcome and timing. Please see the Company's filings with the Securities and Exchange Commission for a statement of certain risks and uncertainties.
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