Piramal Healthcare Presents Positive Results of Pivotal Phase III Clinical Trial for BST-CarGel® at the World Congress of the International Cartilage Repair Society (ICRS)
MONTREAL, May 14, 2012 /PRNewswire/ --
- BST-CarGel® treatment results in more repair cartilage of higher quality than microfracture, the current orthopaedic standard of care, with a similar safety profile
- The BST-CarGel® trial met both co-primary endpoints by achieving statistical significance over microfracture in the degree of filling treated lesions and the quality of the new tissue
- The trial represents the first of its kind in cartilage repair using novel, 3-dimensional quantitative MRI techniques that substantially improve comparisons of repair cartilage structure (quantity and quality) through blinded standardized data acquisition and precise analyses
Piramal Healthcare Bio-Orthopaedics, a division of Piramal Healthcare Limited [NSE: PIRHEALTH, BSE: 500302], today announced that positive data from their pivotal (Phase III) clinical trial is being presented in 3 podium presentations as well as during an Industry Symposium at the 10th World Congress of the International Cartilage Repair Society (ICRS), May 12 to 15, in Montreal, Quebec, Canada.
Dr William Stanish, Orthopaedic Surgeon, Professor of Surgery at Dalhousie University in Halifax, Nova Scotia, and Principal Investigator for the trial, commented: "The significant level of evidence from the BST-CarGel® clinical trial, using multiple and independent methodologies, truly supports the positive effect of BST-CarGel® over the standard of care on both the quantity and quality of regenerated cartilage tissue. This represents a cost-effective, off-the-shelf surgical alternative that may dramatically improve cartilage repair over traditional methods in a minimally invasive manner."
This international, multicenter randomized clinical trial was conducted to evaluate BST-CarGel® efficacy at 12 months in repairing cartilage lesions and improving patient clinical symptoms, compared to a surgical control called microfracture, the current standard of care. The trial represents the first of its kind in cartilage repair using novel, 3-dimensional quantitative MRI techniques that substantially improve comparisons of repair cartilage structure (quantity and quality) through standardized data acquisition and precise and blinded analyses.
BST-CarGel® treatment met both co-primary trial endpoints by achieving statistical significance over microfracture in both the degree of filling of treated lesions and the quality of the new tissue.
Overall, this trial demonstrated that cartilage repair structural outcomes resulting from BST-CarGel® treatment were superior at 12 months to microfracture, the current standard of care, with a similar safety profile. This represents a critical finding as cartilage structure (quantity and quality) is believed to translate to longer durability and sustained clinical benefit.
"The 2012 ICRS World Congress is the best venue for Piramal to announce our positive clinical findings for BST-CarGel® as the ICRS membership includes the most renowned international orthopaedic surgeons and researchers in this growing clinical field," remarked Dr. Swati A. Piramal, Director, Piramal Healthcare Limited, "Our Symposium at ICRS represents the next step in our commercialization pathway for this exciting new medical device." Dr. Piramal also serves on the Dean's Advisory Board of the Harvard School of Public Health and Harvard Business School.
About BST-CarGel®
BST-CarGel®: A novel bioscaffold for enhanced tissue regeneration in cartilage repair procedures
BST-CarGel® is a novel chitosan‐based liquid scaffold (EU class III Med. Dev.) that is first mixed with autologous whole blood and then implanted into a debrided cartilage defect prepared with bone marrow stimulation. The BST-CarGel® implant provides a blood clot, which is the physical basis for all wound repair. However, the BST-CarGel® hybrid clot resists the contraction experienced by natural clots and thus provides voluminous and biodegradable scaffolding for cartilage regeneration by stem cells that migrate from the bone marrow. BST‐CarGel® enhances cartilage repair outcomes by stabilizing the implanted active clot and by guiding the repair process.
In April 2012, Piramal received the European CE mark approval which enables the commercialization of BST-CarGel® in all of the countries of the European Union. Piramal Healthcare plans to launch BST-CarGel® for commercial sale in the fourth quarter of the 2012 calendar year.
For further information please visit bst-cargel.piramal.com
About Piramal Group
Piramal Group, led by Ajay G. Piramal, is one of India's foremost business conglomerates. Driven by core values of Knowledge Action Care, the Piramal Group has interests across healthcare, research & drug discovery, diagnostics, glass, real estate and financial services. The Group's turnover exceeded $700 million in FY2012
About Piramal Healthcare
Piramal Healthcare is one of India's largest healthcare companies, with a growth track record of above 29% CAGR since 1988. Piramal Healthcare had consolidated revenues of $450 million in FY2012. With assets across North America, Europe and Asia, it is also one of the largest custom manufacturing companies across the world. It has significant presence in the global critical care space with sales of anesthesia products to over 100 countries. In 2010, Piramal Healthcare sold its domestic formulation business to Abbott for a consideration of US$3.8 billion
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