Phase IV study could present a compelling competitive advantage for heart-valve company
Tuesday, March 28 2006 / Research Triangle Park, NC — Clinipace, Inc., a software company focused on late-stage clinical research studies and patient registries today announced its newest client, Medical Carbon Research Institute, a biomaterials and medical device manufacturer based in Austin, Texas. Medical Carbon Research Institute (MCRI) will use Clinipace’s clinical data capture and trial management technology, Tempo, to run its Phase IV study on the company’s principal product – the On-X® Prosthetic Heart Valve.
The On-X valve is an industry-leading carbon prosthetic heart valve developed and manufactured by MCRI. It is the first mechanical heart valve to receive FDA-approval for a clinical trial exploring associated lower anticoagulation therapy levels. Successful completion of this clinical study could result in the On-X valve becoming the only mechanical heart valve approved for low-dose anticoagulation therapy. Such FDA-approval would not only represent a considerable competitive advantage for MCRI, but would also be advantageous for On-X valve recipients.
Anticoagulation therapy is the use of blood-thinning drugs to slow down or stop the formation of blood clots – a dangerous side effect of having any prosthetic heart valve. Heart valve patients would benefit from a reduction in their anticoagulation therapy because reducing this medication has the potential to reduce or eliminate associated bleeding problems without a corresponding increase in clotting problems. Achieving this careful balance more easily with the On-X valve would make the prosthetic a better long-term choice – a valve designed for the whole life of the patient.
“These post-market anticoagulation trials are a critical element in determining the future of our On-X valve,” explains John Ely, Executive Vice President of MCRI. “We chose Clinipace for the job because their proven web-based solution will allow us to collect and manage intricate data from several sources more simply, and cost-effectively than other vendors.”
Mr. Ely goes on to explain the desire to reduce the administration burden often associated with these kinds of studies, “Our current research sites are already dealing with a complex study protocol, couple that with the coordination that goes into managing several data sources and you can end up depleting your internal resources with the administration of the trial. Because Clinipace’s Tempo is so easy to use, we can better leverage our existing resources and reduce the burden on our research sites, and run the study for a fraction of the cost.”
Jeff Williams, CEO of Clinipace, adds, “The key is to simplify the experience of the investigator and site staff, especially in a complex long term program. Because our product is so intuitive, the site staff can focus on patient care and executing the protocol, rather than how to use the technology.”
Until the completion and analysis of study data, MCRI continues to recommend standard anticoagulation therapy as presently prescribed by various professional societies for the On-X valve.
Clinipace is a clinical research software company providing a single, integrated data capture and study management platform for post-approval research and registries conducted by biopharmaceutical and medical device companies, Clinical Research Organizations (CROs) and Academic Medical Centers (AMCs). Our platform, called Tempo, is delivered via a web-based, on-demand architecture that streamlines the clinical research process by eliminating the integration headaches associated with multiple platforms, reducing project efforts and costs from startup to conclusion, and empowering project stakeholders to make informed real-time decisions regarding their research. For more information on Clinipace, please visit: www.clinipace.com
Medical Carbon Research Institute (MCRI) develops heart valve replacements that significantly improve the quality of life for patients. Jack Bokros, Ph.D., and his associates founded MCRI in 1994 to advance prosthetic heart valve technology by capitalizing on their new form of pyrolytic carbon. The On-X valve design was awarded a 2002 Medical Device Excellence Award in the Implant and Tissue-Replacement Products category. MCRI also provides OEM services utilizing its patented On-X carbon to manufacturers of other medical products, including orthopedic joint and spine implant devices. MCRI is headquartered in Austin, Texas, and maintains a wholly owned subsidiary, MCRI Deutschland GmbH, in Hannover, Germany. More information about the company and valve is located at www.onxvalves.com.