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ROCHESTER, N.Y., March 12 /PRNewswire-FirstCall/-VirtualScopics, Inc. (Nasdaq: VSCP), a leading provider of quantitative imaging for clinical trials, today announced that BioSyntech Inc., a Canadian medical device company based in Laval, Quebec, has reached its enrollment goal in the Canadian-European pivotal clinical trial for its cartilage repair device (BST-CarGelxAE;) and will now focus on quantitative measures to determine enhanced efficacy compared to the surgical technique called microfracture.
Historically, clinical trials for cartilage-related therapies have used pain as the primary endpoint. In the BST-CarGelxAE; study, however, VirtualScopics is providing blinded data analysis of quantitative magnetic resonance imaging (MRI) which will allow BioSyntech to demonstrate BST-CarGel's potential for affecting the quantity and quality of the repaired cartilage as their primary endpoint.
"We are very pleased to be working with BioSyntech on this unique Canadian-European pivotal trial," said Jeff Markin, VirtualScopics' president and chief executive officer. He further added, "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."
Chief Scientific Officer at BioSyntech, Dr. Matthew Shive, commented, "VirtualScopics' experience in incorporating standardized, yet advanced, imaging into international, multi-center clinical trials has allowed us to conduct what we believe to be the first trial of its kind in cartilage repair. Strategically, their expertise permitted us to focus on the key parameters of repair which are most prominent following treatment with BST-CarGel."
About VirtualScopics, Inc.
VirtualScopics, Inc. is a leading provider of imaging solutions to accelerate drug and medical device development. VirtualScopics has developed a robust software platform for analysis and modeling of both structural and functional medical images. In combination with VirtualScopics' industry-leading experience and expertise in advanced imaging biomarker measurement, this platform provides a uniquely clear window into the biological activity of drugs and devices in clinical trial patients, allowing sponsors to make better decisions faster. For more information about VirtualScopics, visit www.virtualscopics.com.
BioSyntech is a medical device company specialized in the development, manufacturing and commercialization of advanced biotherapeutic thermogels for regenerative medicine (tissue repair) and therapeutic delivery. BioSyntech's platform technology is a family of hydrogels called BST-GelxAE;, some of which are liquid at low temperature and solid at human body temperature. These gels can be injected or applied to a specific local site and offer beneficial properties for the local repair of damaged tissue such as cartilage, bone and chronic wounds and provide the benefit of avoiding invasive surgery. For additional information, visit www.biosyntech.com.
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