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We recently visited the CollaMedix headquarters in Cleveland, Ohio, to learn about the company’s innovative collagen-based scaffold, proprietary manufacturing process and potential uses in orthopedics. The company’s first commercial product will be the CollaSleeve® for rotator cuff repair. They expect FDA clearance in 2024. Below is an excerpt from our conversation with CollaMedix CEO Donna Richardson and CTO Subba Shankar, Ph.D.
Let’s start with the core technology: CollaFabric. What is the key innovation?
CollaFabric is a scaffold is that has both strength for load bearing and bio-inductive properties for tissue regeneration without any inflammatory synthetics, making it ideal for soft tissue repair and support.
The device is composed of strong, aligned, pure-collagen threads made through our proprietary electrocompaction process. Because these threads are strong enough to withstand standard textile production methods, we can make macroporous collagen fabrics, allowing for rapid cell integration. The scaffold is strong enough to bear loads on its own. The collagen alignment has bio-inductive properties that support a pro-regenerative effect. New collagen is laid down in parallel with the CollaFabric threads, strengthening the scaffold. CollaFabric resorbs slowly, allowing the host tissue response to stabilize and become permanent.
Can you tell us a little bit about the material’s research history?
The underlying technology behind CollaFabric, collagen thread electrocompaction, has been researched in the laboratories of Ozan Akkus, Ph.D., at Purdue and Case Western Reserve universities since 2009.
Dr. Akkus and his team have refined the electrocompaction process and investigated the material properties of the threads. They conducted animal implant experiments on scaffolds made from the threads in rats, rabbits and sheep in a variety of anatomical locations, including tendon and cartilage repair. There have been 28 peer-reviewed publications on this research and three issued patents.
The first product you’re bringing to market with this technology is CollaSleeve®, for rotator cuff repair. What makes that procedure such a good fit for your collagen fabric?
Orthopedic surgeons specializing in rotator cuff repair seek clinical solutions to address the 25% to 50% retear rate at six months. They express a strong desire for a biological solution to heal the tendon at the bone interface because the suture anchors are strong, and the suture tape used during the speed bridge repair are also strong so that the tendon tears, which they describe as a “cheese slicer” effect on the tendon.
Surgeons need a solution that is fast and does not lengthen surgical procedure time. The CollaSleeve is a pure collagen triple braided sleeve that is placed over the suture tapes during the standard arthroscopic speed bridge repair.
Numerous published studies demonstrate the unique bio-inductive effect of CollaSleeve as new (de novo) collagen is laid down in parallel with the CollaSleeve threads, strengthening the scaffold. The CollaSleeve resorbs slowly, allowing the host tissue response to stabilize and become permanent and neovascularization to develop.
Where are you at on the regulatory path with CollaSleeve?
Numerous discussions with FDA indicate that CollaSleeve is on a 510(k) pathway.
Longer term, are there other areas of orthopedics that could benefit from devices using CollaFabric?
All tendon and ligament surgical repairs will benefit from augmentation with CollaFabric. In addition, CollaFabric has enough strength to be used as a gap-filling, load-bearing material for massive tears, which are presently difficult to address. Orthopedic surgeons seek solutions to these challenging unmet clinical needs.
