Collagen Solutions PLC (LON:COS) is putting together the results of a retrospective, eight-year study of its ‘scaffold’ product that helps fix cartilage defects in the knee.
The 15 patients whose results are being analysed took part in a 2009/10 trial. The original magnetic resonance imaging (MRI) results have been assessed and “full clinical and quantitative MRI data analysis ongoing”, Collagen said.
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A close look at the early scans indicated that the company’s ChondroMimetic scaffold was “virtually indistinguishable” from surrounding cartilage six months following surgery.
Submitting the package
Once the clinical study report is complete, Collagen will submit the information as part of a package to the regulatory authorities.
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It will used for approval and the re-establishment of the CE mark on the product, targeting commercialisation outside the US by mid-next year.
ChondroMimetic has the potential to enable surgeons to treat patients affected by early arthritis and cartilage defects.
Simple & cost effective
It is “a simple, proven, and cost-effective treatment”, said Collagen chief executive Jamal Rushdy.
“To our knowledge, ChondroMimetic will be the only arthroscopically applied cartilage scaffold backed by long-term evidence, significantly differentiating it from competing therapies,” he added.
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He told investors the study extension was a “fundamental step forward” in the company’s programme for developing ChondroMimetic as a product which has the potential to address 450,000 cartilage procedures a year.
This would provide the business access to a market opportunity worth up to US$1bn.