Catalyst Pharma Group (Pasadena, California) has entered into a strategic partnership with Spacelabs Medical Data (Issaquah, Washington). The Medical Data division of Spacelabs provides regulatory-compliant core ECG, Holter and other cardiac research services for Phase I-IV clinical drug trials. Catalyst is a contract research organization focused on helping Asian- and European-based pharmaceutical companies with limited presence in the U.S. develop their products and navigate regulatory channels in obtaining FDA approval. Spacelabs Medical Data will provide core ECG services for Catalyst's clients at its Healthcare Discoveries (HD) Phase I research unit in San Antonio, as well as supporting Catalyst Pharmaceutical Research (CPR), its Phase II-IV clinical trial division, for cardiac and blood pressure safety and efficacy. HD will not only be the Phase I testing site for Medical Data's sponsors, but through CPR also will provide full-service CRO assistance as part of its offering. Spacelabs Medical Data has performed extensive cardiovascular procedures for virtually all of the major pharmaceutical companies, as well as biotech firms, universities, clinical research organizations and device manufacturers. The company provides centralized monitoring, collection and analysis of data from ECG, Holter (ambulatory ECG), ABP (ambulatory blood pressure) and event monitors.
CTI PET Systems (CPS; Knoxville, Tennessee), a unit of CTI Molecular Imaging, and Toshiba America Medical Systems (TAMS; Tustin, California), have signed an agreement to jointly develop a line of integrated positron emission tomography(PET)/computed tomography (CT) systems for Toshiba to distribute in Japan. The development agreement serves to formalize the collaborative work that has taken place between the two companies for more than a year and expands the relationship of the companies under which Toshiba is presently a distributor in Japan for dedicated PET units manufactured by CPS. PET/CT is used most frequently in the detection and treatment of cancer, neurological disorders and cardiac disease. The first prototype PET/CT developed between CPS and Toshiba was unveiled in Japan at the Congress of the Japan Radiological Society in April. CPS and Toshiba anticipate that the new PET/CT will be commercially available during the first half of 2005.
IT&E International Group (San Diego) reported that it has signed a long-term, multi-country agreement with Cordis (Miami Lakes, Florida), a business of Johnson & Johnson (New Brunswick, New Jersey), for expanded FDA regulatory compliance services. The multi-country contract calls for IT&E to validate trial results and provide a variety of other regulatory compliance services for Cordis as it tests new medical devices. IT&E will supply these services to Cordis's laboratories in Miami, Puerto Rico and Mexico. Cordis develops devices for circulatory disease management, including stents, balloons, vena cava filters and catheters used in treating cardiovascular disease and related conditions. IT&E focuses on providing medical device, biotech and pharmaceutical companies with project-based consulting services and business process outsourcing in the areas of FDA regulatory affairs, clinical data management, clinical programming, biostatistics and clinical validation.
Merit Medical Systems (South Jordan, Utah), a maker of disposable products used primarily in cardiology and radiology procedures, has signed a supplier agreement with Premier Purchasing Partners, the group purchasing organization of Premier (San Diego), an alliance of hospitals and health care organizations. The agreement covers much of Merit's line of cardiology products, including diagnostic catheters, diagnostic guide wires, inflation devices and angioplasty accessories. It will run through Aug. 31, 2006. Premier is owned by 200 not-for-profit hospital and health care systems. These systems operate or are affiliated with 1,500 hospital facilities in 50 states and hundreds of other non-acute care sites.
Neoprobe (Dublin, Ohio), a diversified developer of oncology and cardiovascular surgical and diagnostic products, reported the extension of its current distribution arrangement with Century Medical (Tokyo) to provide sales coverage for the Quantix products in Japan in addition to the neo2000 gamma detection system. Century Medical is a wholly owned subsidiary of Itochu (Tokyo) Yasuo Kyotani, president and CEO of Century Medical, said, "This expanded agreement with the Quantix product line will further solidify our commitment to the cardiovascular marketplace in Japan and our relationship with Neoprobe."
Siemens Medical Solutions (Malvern, Pennsylvania) has signed a two-year research collaboration agreement with The Heart Center of Indiana (THCI; Indianapolis). Through the agreement, THCI will leverage Siemens' most advanced MRI technologies to discover innovative uses of MRI in cardiac care, potentially reducing, it said, the need for invasive procedures and providing more efficient patient care. As part of the research agreement, THCI, a specialized all-digital facility focused on cardiovascular disease, will work in unison with Siemens as a development site in cardiac MRI, assisting to develop new software and testing imaging sequences and clinical protocols. The Cardiovascular MRI center at THCI will work with Siemens experts to optimize ways to evaluate patients with coronary artery disease with MRI.