Cytex implants will require thorough testing to ensure that the products are safe and work as expected. The process for this testing is to conduct clinical trials, in which Cytex implants are placed in actual OA patients who volunteer to participate in the trial. In the trial, Cytex implants will be compared to other forms of treatment for hip OA to see if the Cytex approach provides a better outcome for patients. These trials are conducted under the auspices of the US Food and Drug Administration (the FDA), which must approve details of the trial design and ensure that the company sponsor follows all the appropriate guidelines. Cytex is currently in discussions with the FDA Center for Devices and Radiological Health and expects to file later this year the initial paperwork to begin the clinical trial process.
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