• Breg (Vista, California), a division of Orthofix International specializing in orthopedic, rehabilitative and post-operative products, reported the availability of its full line of Fusion functional knee braces, including Fusion, Fusion XT, Fusion Women's and Fusion OA, in custom and off-the-shelf versions. Unlike traditional functional knee braces, Fusion works in tandem with the knee to provide optimum protection of the ACL, PCL and collateral ligaments, without hindering mobility. By incorporating Breg's ProForm technology, which uses Zytel, a strong yet flexible polymer, each Fusion brace conforms intimately with the leg for a low profile, contoured fit. This allows the brace to remain in place through all levels of activity, permitting unhindered motion and enhanced protection while also providing superior comfort and suspension.

• Clearant (Los Angeles) said findings from a multicenter study by nine orthopedic surgeons concluded that there is now clear evidence for strongly recommending sterile implants treated with the Clearant Process. The results, presented at the recent American Academy of Orthopaedic Surgeons convention, demonstrate the comparability, at six-month post-operative examinations, of a knee reconstructed using a Clearant Process-treated allograft with the patients' non-operated knee. The Clearant Process substantially reduces all types of pathogens in biological products while maintaining a high degree of the underlying protein, the company said.

• Fujifilm Life Science (Stamford, Connecticut), a developer of imaging technology, reported the availability of the LAS-3000mini, a compact, super CCD luminescent image analyzer. Based on the LAS-3000, the mini offers researchers a high-performance desktop solution for luminescence applications. The compact image analysis system is designed for chemiluminescence and bioluminescence analysis, specifically for Western blotting applications. It incorporates Fuji's super CCD chip, which allows for resolution of 3.2 to 6.3 million pixels. The LAS-3000mini also uses the newly designed F0.85 Fujinon high-sensitivity lens to capture the faintest images. The low-noise design captures images at minus 30 degrees Celsius, allowing for increased exposure times. In addition, the compact body incorporates the modular darkroom and non-parallax tray.

• IsoTis OrthoBiologics (Irvine, California) reported that it received 510(k) clearances from the FDA for the use of Accell Connexus and OrthoBlast II in dental indications. Accell Connexus is a highly osteoinductive bone graft substitute that the company said provides exceptional handling and graft containment. The putty includes growth factors TGF- Beta-1 and various natural human bone morphogenetic proteins (nhBMPs). Compared to first generation demineralized bone matrix particles (DBM) products, the AccellRx process on which Accell Connexus is based yields a higher level of TGF- Beta-1 and nhBMPs, which act synergistically to stimulate new bone formation. Employing a reverse phase medium (RPM), Accell Connexus thickens at body temperature and resists irrigation so the nhBMPs are delivered at the surgical site where they are needed. OrthoBlast II is a combination of DBM with cancellous bone chips delivered in RPM. The product is malleable at operating room temperatures, but thickens when placed in the operative site. This allows the DBM particles and bone chips to be contained at the graft site with minimal loss through irrigation and suction.

• Mediscience Technology (Cherry Hill, New Jersey), which is developing a fluorescence-based optical biopsy platform system that uses the properties of light and its molecular interaction with tissue to aid in the diagnosis of physiological change and cancer, said that it has been notified by the FDA that its optical biopsy device (CD-R) has been classified as a non-significant risk device, and that it can commence a multicenter pilot study of CD-R for cancer detection of the cervix. The main objectives of the pilot study are to determine efficacy; the clinical sensitivity and clinical specificity by comparing the device's real-time results to the Pap test and biopsy; and assess any adverse events.