Your big questions about our Clinical Trials:
What has Cytex been doing since the last update?
We have already presented results to the FDA while working to define the best clinical development plan for our novel implant. The results we presented to the FDA showed that Cytex implants repaired damaged cartilage and restored joint function in a preclinical model of osteoarthritis (OA). However, at our initial meeting, FDA asked us to complete longer-term preclinical studies, which were already in process at that time. Since then, we have completed the required testing, and the data we have compiled continue to be encouraging.
In our last newsletter, we explained that fundraising is another necessary step before we can start any clinical trials, as these trials are very expensive for a young company. Cytex is very pleased to have been awarded a sizeable grant* by NIH National Institute on Aging this past fall. This grant will fund a small Fist-in-Human trial, which will focus on implant safety and will also gather outcome data on how well patients recover from the surgery. In addition to the grant, Cytex is seeking investment funding to support the company during this exciting phase to potentially expand the size of the trial or the indications we may be able to treat. Qualified investors may contact us via our contact form on our website.
What is Cytex doing now?
The next step for Cytex is to seek regulatory approval from FDA to host our first clinical trial. The results from our preclinical studies are currently helping Cytex identify the best avenue for a pilot clinical trial to treat patients with damaged cartilage in the hip. This will be the subject for another pre-submission meeting with FDA, an important regulatory step on schedule for this summer before a First-in-Human pilot safety study can be started. If all goes according to plan, we will file an application with FDA to start this First-in-Human safety study towards the end of Q4 of this year. Once this study starts, we will enroll a very small number of patients, perhaps 15-20, and will follow up with these patients after surgery for a predetermined period of time to document safety.
For more information on the regulatory process FDA requires for all new medical devices, please refer to our Summer 2019 Newsletter and the explanation provided by FDA on their website, found here.