• Cepheid (Sunnyvale, California) reported that it has been issued U.S. patent No. 6,818,185 for a “Cartridge for conducting a chemical reaction.“ The patent covers a sample preparation cartridge having a reaction vessel extending from the cartridge body for receiving the prepared sample for chemical reaction and/or optical detection. The company said the cartridge provides several advantages for conducting a test on a sample, including automated preparation of the sample in the cartridge body; convenient loading of the prepared sample into the reaction vessel extending from the cartridge body so that the sample may be chemically reacted and optically detected in the vessel; and a closed system which substantially eliminates the risk of contamination.

• Miravant Medical Technologies (Santa Barbara, California), which specializes in PhotoPoint photodynamic therapy, said it would conduct a Phase III confirmatory clinical trial of Photrex (rostaporfin, formerly known as SnET2) for wet age-related macular degeneration (AMD), based on a special protocol assessment by the FDA. The placebo-controlled trial, to be conducted outside of the U.S., will enroll a broad range of wet AMD patients. According to the protocol, each study patient will receive Photrex (or placebo) treatments over the course of nine months. The company said it currently plans to conduct a primary efficacy endpoint analysis at one year after initial treatment, which, pending positive results, will be submitted for FDA review and subsequent marketing approval. Patients will continue to be evaluated for a second year to confirm the longer-term results established in previous Photrex Phase III studies. Miravant said it expects to begin patient enrollment in mid-2005.

• R2 Technology (Sunnyvale, California) reported the introduction of the ImageChecker LS CAD (computer aided detection) system, designed for low volume film-based mammography sites. The ImageChecker LS is a flexible, component-based system featuring R2's CAD technology in a tabletop package. Described by the company as a cost-effective option for low-volume sites, the ImageChecker LS processes a case of four mammogram films in just a few minutes and the results of the CAD analysis can be viewed on any of R2's display solutions, including the CheckMate Ultra flat-panel monitor, or be sent to a printer. The system also will be able to leverage all of R2's advanced workflow and display features, such as connection to mammography reporting systems and PeerView software. The software features are fully upgradeable, the company said.

• ThermoGenesis (Rancho Cordova, California) said that Erhan Basad, MD, an orthopedic surgeon, and Detlef Kuhn, MD, an anesthesiologist, studied the use of the company's CryoSeal autologous fibrin sealant in total knee arthroplasty (TKA) at University Hospital (Giessen, Germany). The results of the study were published in the December 2004 issue of the German orthopedic journal, Orthopadische Praxis. The 21-patient pilot study measured blood loss, cardiovascular stability, pain score, range of motion and wound healing. According to Basad, “the total blood loss in TKA was reduced by 50% when using CryoSeal fibrin sealant. The CryoSeal patients also had better cardiovascular stability, a higher range of motion, less pain and better wound healing than the control group.“ The CryoSeal FS System is used to prepare hemostatic and adhesive surgical sealants from patient blood in about an hour.

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