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news.VirtualScopics, a provider of quantitative imaging for clinical trials, has reported that BioSyntech, a medical device company, has reached its enrollment goal in the Canadian-European pivotal clinical trial for its cartilage repair device, BST-CarGel and will now focus on quantitative measures to determine enhanced efficacy compared to the surgical technique called microfracture.
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In the BST-CarGel study, VirtualScopics is providing blinded data analysis of quantitative magnetic resonance imaging which will allow BioSyntech to demonstrate BST-CarGel’s potential for affecting the quantity and quality of the repaired cartilage as their primary endpoint.
Jeff Markin, president and CEO of VirtualScopics, said: “We are very pleased to be working with BioSyntech on this unique Canadian-European pivotal trial. The quantitative nature of these endpoints offers the opportunity to design cartilage repair trials that may be smaller or shorter in comparison to conventional designs which use more qualitative or subjective endpoints. We look forward to providing BioSyntech the critical information they need to demonstrate the effectiveness of their product.”