ALISO VIEJO, Calif., March 22, 2017 /PRNewswire/ -- ClarVista Medical, Inc. ("ClarVista"), a privately-held ophthalmic device company developing the HARMONI Modular IOL System, a novel intraocular lens (IOL) used to restore vision after cataract surgery, announced today that several feasibility trials of the HARMONI Modular IOL have been fully enrolled with promising follow-up results, as well as the appointment of Paul Yoo, O.D. as VP of Clinical and Regulatory Affairs.
Feasibility Trials of the HARMONI Modular IOL
A series of feasibility trials with more than 175 patients have now been fully enrolled with promising results from preliminary analyses. Longer-term results from these important trials will be analyzed as the HARMONI Modular IOL moves towards a U.S. pivotal trial. In pursuit of FDA approval, the company plans to submit an investigational device exemption (IDE) in the second quarter of 2017. With the completed enrollment of the feasibility trials, ClarVista's body of clinical evidence now consists of more than 250 patients, some with up to three years of follow-up. "Physicians and patients will appreciate the game-changing advantages of the HARMONI System," said Bob Cionni M.D., Medical Director of the Eye Institute of Utah.
Appointment of Paul Yoo O.D.
ClarVista is also pleased to announce that Paul Yoo O.D. has joined the company as Vice President of Clinical and Regulatory Affairs. Paul has a strong track record of clinical leadership in ophthalmology and his work has resulted in several important approvals at both Zeiss and AcuFocus. "Leading a pivotal trial for the HARMONI Modular IOL system will be vital for the company. We are very pleased to have such an accomplished leader as Dr. Yoo join the ClarVista team," said Paul McLean, President and CEO of ClarVista Medical.
About Cataract Surgery
According to the National Eye Institute, cataract disease is one of the leading causes of vision loss and blindness globally with an estimated 150 million people worldwide who suffer from impaired visual acuity due to a cataract in one or both eyes. A cataract is the clouding of the natural lens of the eye, and if left untreated, can lead to blindness. Fortunately, vision can be restored through cataract surgery, a procedure in which the patient's opaque natural lens is removed and replaced with an artificial intraocular lens (IOL).
About ClarVista Medical
ClarVista Medical, Inc., is a clinical and commercial stage ophthalmic device company focused on the development of the HARMONI Modular IOL System. The HARMONI Modular IOL features a base component that acts as a stable platform to receive vision-correcting optics. Optics ranging from monofocal and toric lenses to advanced multifocal and enhanced depth of focus technology can be used to give patients the best chance at reaching their personalized visual needs. Additionally, the modular design gives physicians the confidence to customize outcomes to each individual patient. ClarVista is developing a full range of intraocular lenses to address significant unmet needs in the IOL market. The HARMONI Modular IOL System is not approved for use in the United States.
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SOURCE ClarVista Medical, Inc.