ROCHESTER, N.Y., Nov. 22 /PRNewswire-FirstCall/ -- VirtualScopics, Inc. announced today that it has agreed with BioSyntech, Inc., a Canadian biotechnology company, to assist in its clinical trial for BST-CarGel(R). BioSyntech has recently announced that they received approval from Health Canada to conduct the trial for a medical device that repairs cartilage by regenerating it in a process called In Situ ChondroInduction (ICI). BioSyntech plans to commence subject enrollment and surgery immediately and expects that treatment thereafter will proceed according to surgical facility availability.
VirtualScopics, a provider of imaging solutions utilizing biomarkers for product development and clinical trials, has agreed with BioSyntech to conduct the MRI component of this trial. These scans, which include both screening of potential subjects as well as 12 month endpoint assessments, will be carried out at one pre-qualified MRI clinic at each site, followed by blinded data analysis at VirtualScopics.
“Historically, treatment of cartilage damage has been a problematic area for orthopaedics due to a continued lack of technological breakthroughs. This has left many patients without viable options, and many of these patients may eventually require total knee replacement,” said Mr. Claude LeDuc, president and CEO of BioSyntech. “We believe that BST-CarGel is a potential solution to this growing need to repair cartilage damage and, to that end, have retained VirtualScopics to help us conduct this trial more accurately and quickly. Our trial data will not only support Canadian and European approval, but may be instrumental in gaining regulatory approval in the United States.”
The BST-CarGel trial will be a randomized, comparative study of the treatment of focal cartilage lesions located on the medial femoral condyle in 80 subjects from 18 to 50 years of age. Treatment with BST-CarGel applied to a microfractured cartilage lesion varying from 4 to 10 cm2 will be compared to microfracture alone applied to similar lesions. Subjects will be randomized between the BST-CarGel group and the microfracture group, and further stratified to their lesion type, either characterized as acute (i.e. traumatic) or chronic (i.e. degenerative). Following surgery, all subjects will follow the same 12 week physiotherapy regimen, which utilizes assisted passive motion and common strengthening exercises, and calls for a 6 week period of non-weight bearing.
About BioSyntech
BioSyntech is a biotechnology company specializing in the discovery, development and manufacturing of innovative cost-effective and physician- friendly therapeutic thermogels for regenerative medicine and therapeutic delivery. BioSyntech’s Quality Management System is registered to ISO 9001:2000 standards. For additional information, visit www.biosyntech.com.
About VirtualScopics, Inc.
VirtualScopics, Inc. is a provider of advanced medical image analysis services. The company evolved from research first carried out at the University of Rochester Medical Center and School of Engineering. VirtualScopics has created a suite of image analysis tools used in detecting and analyzing specific structures in volumetric medical images, as well as characterizing minute changes in structures over time, providing vital information to support clinical trials and diagnostic applications. The firm’s proprietary software algorithms can assemble hundreds of separate medical images taken during an MRI session into a single, three-dimensional model, bringing a new and previously unobtainable source of data to clinical researchers. For more information about VirtualScopics, visit www.virtualscopics.com.
Forward-Looking Statements
The statements contained in this press release that are not purely historical are forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended, and are intended to be covered by the safe harbors created thereby. Forward-looking statements deal with the Company’s current plans, intentions, beliefs and expectations. Investors are cautioned that all forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, the risk that the Company will not receive the expected benefits from its agreement with BioSyntech, and those discussed from time to time in reports filed by the Company with the Securities and Exchange Commission.
CONTACT: Tracy Bagatelle-Black Bagatelle-Black Public Relations 661/263-1842 tracy@bagatelleblack.com
VirtualScopics, LLC
CONTACT: Tracy Bagatelle-Black of Bagatelle-Black Public Relations,+1-661-263-1842, or tracy@bagatelleblack.com, for VirtualScopics, LLC
