HITACHI RECEIVES FDA CLEARANCE FOR PROBEAT PROTON BEAM THERAPY SYSTEM
TARRYTOWN, New York, March 21, 2006 - Hitachi America, Ltd., a subsidiary of Hitachi, Ltd., (NYSE: HIT) today announced that it has obtained FDA (U.S. Food & Drug Administration) clearance for commercialization of Hitachi’s PROBEAT Proton Beam Therapy System in the United States. FDA clearance comes after a staged filing process that began in 2002 and within three months after Hitachi America submitted its final and complete FDA 510(k) filing in December 2005. The FDA’s finding of substantial equivalence allows Hitachi America, Ltd to begin marketing its PROBEAT system throughout the United States.
Hitachi’s first U.S. PROBEAT system is in its final stages of construction at The University of Texas M. D. Anderson Cancer Center Proton Therapy Center in Houston. Receipt of FDA clearance comes in time for M. D. Anderson to begin patient treatments as planned in May 2006.
In announcing the FDA’s clearance, Masahide Tanigaki, president and CEO of Hitachi America, Ltd., said, “Hitachi is very gratified by the FDA’s clearance of this important new technology. We are very enthusiastic about the opportunity to bring proven Hitachi technology to this great medical center for the benefit of society, and in particular, to help in the fight against cancer. We developed the Hitachi proton beam therapy system in 1998, which was an important technological achievement in R&D and engineering in nuclear fusion and particle accelerator fields. In the M. D. Anderson project we are not only a clinical partner by supplying equipment but also a business partner. We look forward to the start up of the facility in May 2006, and are pleased to be a collaborator with Dr. James Cox and his oncology team at M. D. Anderson.”
“Proton therapy was a natural ‘next step’ for the Division of Radiation Oncology at M. D. Anderson which has a long history of moving the discipline forward,” said Dr. Cox, professor and head of the Division of Radiation Oncology at M. D. Anderson. “This proton therapy center, one of only three such hospital-based centers in the nation, has been innovative on so many levels from the business model to the technology itself and we are proud to call Hitachi a partner.”
PROBEAT is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. PROBEAT is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose and dose distribution to the prescribed patient treatment site. The equipment is comprised of two main components. One is a beam delivery system whose primary responsibility is to ensure that the above listed prescription parameters are properly delivered. The other is the equipment necessary to generate the proton beam and direct it to the beam delivery system. For further information, please visit, http://www.mdanderson.org/care_centers/radiationonco/ptc/.
Hitachi America, Ltd., a subsidiary of Hitachi, Ltd., markets and manufactures a broad range of electronics, computer systems and products, and consumer electronics, and provides industrial equipment and services throughout North America. For more information, visit http://www.hitachi.us.
Hitachi, Ltd., (NYSE: HIT / TSE: 6501), headquartered in Tokyo, Japan, is a leading global electronics company with approximately 347,000 employees worldwide. Fiscal 2004 (ended March 31, 2005) consolidated sales totaled 9,027.0 billion yen ($84.4 billion). The company offers a wide range of systems, products and services in market sectors including information systems, electronic devices, power and industrial systems, consumer products, materials and financial services. For more information on Hitachi, please visit the company’s website at http://www.hitachi.com.