Newsletter Summer 2021

 

 

 

Volume 3 | Issue 1
Summer 2021

 

Dear Cytex Newsletter Subscribers,
 
We want to thank you for the interest you have shown in Cytex Therapeutics, Inc.  Many of you have contacted us personally to find out more about our technology and with questions about our products and about potential clinical trials.  Many have shared their stories and health concerns.  Please know that each and every one of you is important to us and motivates us to do what we are doing.  We apologize for the length of time that has passed since our last newsletter.  As is the case with most businesses, the current COVID-19 crisis has slowed some of our projects down (including this newsletter!) and stretched us thin.  However, we are continuing to work hard and press forward and are happy to share our progress in the newsletter below.  Please know that our thoughts are with all who are affected by the current health crisis and also with you – the patients and their loved ones who reach out to us.
 
Warmly,
 
The Cytex Team

 

 

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.

 

Regulatory Approval Process

 

                                             We are here.

 

 

Cytex and its Clinical Advisory Board are working together to identify the best path forward to develop products that can treat patients with damaged cartilage in the hip.  After we receive approval from FDA to conduct a pilot clinical trial, a required first step for all new medical devices like the implants we are developing, and assuming the FDA-mandated safety endpoints are met, the next step in our development will then be to conduct large, multi center pivotal studies. The pivotal studies will seek to enroll many more patients with cartilage damage that causes joint pain and is a prominent feature of OA. Typically, the later stage trials will be conducted over a period of several years and will require an additional round of fundraising.

While moving rapidly towards clinical trials, Cytex is continuing to conduct research and hopes to expand its novel technology to treat other joints in the body and other medical conditions, such as using our textile technology for difficult tendon repair in the shoulder. We also plan to continue to apply for grants and raise funds to tackle widespread problems such as cartilagege degradation in the knee and ankle.

The Cytex team very much appreciates the interest shown in its novel products, and we look forward to continuing the conversation on the clinical development process.

 

 

 

Notables: 
  • Laura Tormey joined our team as Manager of Product Development. Laura’s early career involved material science and engineering product development. She is closely involved at Cytex in the design and production of new implants as well as being involved with new material development and implant characterization to support the clinical development programs. We look forward to her continued contributions to our team.

  • Cytex is proud to announce that Dr. Brad Estes, Dr. Farsh Guilak, and Dr. Frank Moutos, Cytex’s co-founders, have received the Kappa Delta award, recognizing their research in musculoskeletal disease or injury with potential to advance patient care. The Kappa Delta Research Fellowship in Orthopaedics was established in 1947 by the Kappa Delta Sorority to honor persons who have performed research in orthopaedic surgery that is of high significance and impact. It is the highest award in the field of Orthopaedic Research. 

 

Click below for Cytex’s homepage to learn more about our company.

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