ABPM System Offers Innovative Features for Clinical Trials

April 28, 2009 – Orlando, Florida & Bethesda, Maryland – As part of two important meetings related to clinical trials and cardiovascular safety, Tiba Medical today unveiled enhancements to its Ambulo™ 2400 ambulatory blood pressure monitoring (ABPM) systems to better support the unique needs of the pharmaceutical industry.  These enhancements will enable clinical researchers along with their Clinical Research Organization and Cardiovascular Core Lab partners to better utilize blood pressure as a valuable biomarker during safety or efficacy clinical trials.

The enhancements offered by the Ambulo 2400 device and its Hypertension Diagnostics Suite software enable clinicians and researchers to configure the system to take measurements based on discrete time points as dictated by specific events, such as drug administration and specific timelines before and after administration.  In this way, the Ambulo 2400 adheres to the unique needs of research protocols, including specific pharmacokinetics and pharmacodyamics (PK/PD) of dosing.

“The clinical trial industry came to us with the challenge of offering these unique capabilities to better assess cardiovascular safety and risk.  By integrating them as part of the Ambulo 2400 system, we are enabling clinicians and researchers to have an even more powerful tool to better diagnose safety and efficacy of their therapeutics”, said Merat Bagha, Tiba Medical’s President and Chief Executive Officer.

“Blood Pressure is being recognized as an increasingly important biomarker in assessing cardiovascular risk during both early and late stage clinical trials.  We are enthusiastic about the improvements and enhancements that Tiba Medical is presenting in their Ambulo 2400 monitor that addresses many of the common problems in ABPM safety monitoring” said Adam Steadman, General Manager of Integrium Cardiovascular Core Laboratory.

The enhancements announced today for the Ambulo 2400 will be generally available to customers in the United States, Europe, Canada and beyond in May 2009.  Representatives of Tiba Medical will be available at Partnerships for CRO’s and DIA/FDA’s Cardiovascular Safety conferences next week (see below) to discuss these capabilities with both customers and members of the press.

About Tiba Medical

Based in Portland, Oregon, Tiba Medical offers innovative and affordable hypertension diagnostics solutions.  Tiba Medical is an FDA-registered establishment and certified to be compliant with the ISO 13485:2003, acknowledging that Tiba Medical meets quality system requirements that are recognized across the world.  For more information about Tiba Medical and its products please visit our web site at www.tibamedical.com

About Integrium

Integrium is a full-service Clinical Research Organization (CRO) dedicated to the management of cardiovascular and metabolic disease clinical trials.  Integrium is based in Tustin, California, with offices in Bedminster, New Jersey, and Johannesburg, South Africa. The founders of Integrium are pioneers in the application of ambulatory blood pressure monitoring (ABPM) in drug development.  The Integrium Cardiovascular Core Laboratory provides global on-demand 24/7 provision of blood pressure monitoring in support of clinical trials in all therapeutic areas. Integrium’s Medical Safety Solutions unit provides comprehensive medical safety and pharmacovigilance solutions for local and global clinical trials in all therapeutic areas. For further information, please see http://www.integrium.com/.

About Partnerships for CRO’s

Held at the Rosen Shingle Creek Hotel in Orlando, Florida on April 28-30, 2009, the 18th Annual Partnerships with CRO’s & Other Outsourcing Providers is organized by the Institute for International Research.  The conference provides clinical research associates and investigators, clinical operations and outsourcing managers as well as other pharmaceutical industry executives the chance to discuss partnerships opportunities for better and safer drug discovery.  For further information, please see www.cropartners.com.

About Cardiovascular Safety Conference

Held at the Hyatt Regency in Bethesda, Maryland on April 30 and May 1, 200, the Cardiovascular Safety, QT and Arrhythmia in Drug Development is organized by the Drug Industry Association and co-sponsored the US Food & Drug Administration and the Heart Rhythm Society.  This open forum brings together academic scientists, pharmaceutical industry participants, regulatory oversight agencies, clinical project physicians, safety assessment personnel as well as ECG/blood pressure central lab service and equipment vendors.   The forum provides opportunities to discuss new directions in the development of pharmaceutical agents, associated safety biomarkers, practical challenges and possible solutions to manage cardiovascular safety including challenging the current science and regulatory approaches.  The forum specifically includes a session titled “CV Safety Beyond QT/Torsade” where Dr. Michael Weber, MD, FACP and Dr. Diane Jorkasky, MD, FACP will debate whether the routine assessment of a thorough blood pressure study should be part of clinical development.  For further information, please see http://www.diahome.org/DIAHome/resources/content.aspx?type=eopdf&file=%2fproductfiles%2f18335%2f09009.pdf

PHOTOS: High resolution and low resolution pictures of the Ambulo 2400 are available online, in the Tiba Medical Image Bank.


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