We are also continuing to interact with FDA to make sure the process of filing the documentation supporting the clinical trial is as complete and accurate as possible. This will ensure an efficient path forward to the start of the pilot study.
We expect to file a formal application called an Investigational Device Exemption or IDE, with FDA late next year. If we are able to meet the endpoints of the pilot study, Cytex will conduct advanced clinical trials at clinics around the US. These later-stage trials, termed pivotal studies, will likely enroll 100 to 300 patients.
Typically, the later stage clinical trials at the end of these pivotal studies will be conducted over a period of several years. At the end of the pivotal trials, the results are carefully analyzed and reported to FDA, which will then make a judgement regarding whether the product meets standards of safety and efficacy, and whether it may be marketed.
Current preparation for clinical trials
In the meantime, Cytex is organizing a Clinical Advisory Board consisting of leading orthopaedic surgeons to work with the company. Input from the Clinical Advisory Board will help us identify the most appropriate trial indications, and will keep Cytex focused on the very real challenges these doctors face in treating their OA patients.
The Cytex team very much appreciates the interest shown in its novel products and looks forward to continuing to provide updates on the clinical development process.