“The long-term quantitative MRI data of cartilage repair volume and tissue quality in patients who were treated with ChondroMimetic are extremely attractive,” said the appropriately named Dr Alan Getgood, an orthopaedic surgeon who was involved in ChondroMimetic’s early development.
The developer and manufacturer of medical grade collagen and tissue components for use in regenerative medicine announced successful results from an eight-year extension clinical study of 15 patients who received ChondroMimetic implants as a bone and cartilage scaffold for the repair of cartilage defects in the knee.
The eight-year study found there was an improvement in patients’ clinical symptoms, including alleviation of pain; improved function; and increased activity level.
The ‘Knee Injury and Osteoarthritis Outcome Score’ (KOOS), a well-known and validated patient-reported outcome measure, showed outcomes following the ChondroMimetic procedure were equal to or better than KOOS scores reported in the literature for substantially more expensive two-stage cartilage repair technologies, Collagen observed.
The regenerative medtech said the study leaves ChondroMimetic positioned as “the only minimally invasive, cost-effective, single-stage treatment that fits within surgeons’ current surgical techniques for smaller cartilage defects with eight-year clinical effectiveness and repair quality data”.
With more than a million surgical procedures taking place each year in the US and Europe to treat cartilage defects of the knee, the market for ChondroMimetic is enormous; Collagen reckons at least 30-40% of these operations would be suitable for ChondroMimetic.
“Based on our first-hand clinical experience with ChondroMimetic and these new results confirming the sustainability of both cartilage regeneration and the improvement in patient outcomes, it is my firm belief that this scaffold has an important place in the treatment of focal chondral lesions as an alternative to microfracture,” said László Hangody, the orthopaedic surgeon who was the principal investigator of the study.
Collagen has started the submission process to re-establish the CE mark for ChondroMimetic; the CE mark signifies that the product has passed safety, health and environmental protection requirements.
“This compelling data is a significant achievement in the decades-long effort by clinicians and scientists to develop a cost-effective and clinically effective treatment for these types of cartilage defects. We have illustrated the commercial opportunities with the announcement of an agreement with our South Korean partner in December last year. We look forward to announcing further key milestones including the granting of the CE Mark over the next few months,” said Jamal Rushdy, the chief executive officer of Collagen.
“We are excited by ChondroMimetic’s progress and believe that Collagen Solutions is now in a period of solid progression which will provide future sustainable revenue generation,” he added.
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