ClarVista Medical, a privately-held ophthalmic device company developing the Harmoni Modular IOL System, a novel IOL used to restore vision after cataract surgery, announced 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, OD, 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 US 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," Bob Cionni, MD, Medical Director of the Eye Institute of Utah, said in a company news release..
Appointment of Paul Yoo, OD
ClarVista has also announced that Paul Yoo, OD, 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.