Summer 2019 Newsletter

Volume 1 | Issue 1
Summer 2019
Cytex employees, advisors, and consultants are working to improve the quality of treatment for patients living with osteoarthritis.
Thank you for signing up to receive updates from Cytex Therapeutics, Inc. Our company was founded to provide solutions for people like you and we’re grateful for your continuing interest in our products. Following is the first edition of our newsletter. Please read below for the latest information and news from Cytex.

                                              – Christine Estes, Director of Business and Finance

When will Cytex clinical trials start?

This is the question we get more often than any other. We get calls and emails almost daily from patients and their families asking about our clinical trials, how can they participate, and when our products will finally be available.

The answer is that we are making good progress, getting closer to the point where we can file the application for the pilot study in late 2020.
 

Product Development Process

Medical product development is a slow process by design, in order to ensure that medical products (i.e. medicines, devices, diagnostics) in the US are safe and work as intended. That is why Cytex and all biomedical products companies go through lengthy and expensive clinical trials.
 

Cytex’s Product Development Process

A quick internet search will reveal a couple of different – and potentially confusing – FDA medical device approval processes. To clarify, Cytex’s initial product candidate falls under FDA’s Class III, premarket approval (PMA) path.

Implanted devices (such as Cytex’s implant) fall under FDA Class III. Cytex’s product is further categorized under the premarket approval (PMA) path for brand new products, in contrast to add-ons to existing products. The PMA route is the most rigorous of FDA’s various pathways to market for medical devices.

We have provided a timeline below outlining the typical PMA stages involved in getting a new device to market to give you an idea of what product development entails from brainstorming to product availability.
Figure 1. Timeline of typical FDA device-to-market process. On average, the approval process takes 5 to 10 years after pilot studies have begun. Cytex is currently in the “Pre-clinical Studies & Advisory Boards” stage.
Cytex products are currently being tested in animal models of osteoarthritis. We completed one such study late last year and reported the results to the Orthopaedic Research Society in February. We have also shared these results with FDA. We are pleased to report that the Cytex implants restored joint function in the animal model of osteoarthritis. 

Planning for clinical trials in osteoarthritis

Based on the efficacy of the implants, Cytex was able to move forward with longer-term animal studies. These results will help Cytex identify the best path forward for the clinical trials (pilot and pivitol studies) in osteoarthritis (OA). 

We are now working with a clinical research organization to help design the pilot study, which will focus on the safety of the Cytex implants in human volunteers with OA.
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For more info on the typical stages of FDA’s device-to-market process, click below.


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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.
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