• Bausch & Lomb (Rochester, New York) reported that the FDA has approved the company's 100 Hertz excimer laser, the 217z100, for use as part of its Zyoptix Personalized Laser Vision Correction System for refractive surgery. The combination of beam diameters and laser speed of the 217z100 makes it among the fastest laser vision correction treatment times available in the U.S. The 217z100 laser operates at twice the speed of the Bausch & Lomb system currently on the U.S. market in both standard and custom treatment modes. The laser is expected to be commercially available in the U.S. by July, along with an upgrade path to allow current users of the Zyoptix laser to access the faster technology.

• OrthoHelix Surgical Designs (Akron, Ohio), developing a line of implants and instruments for use in hand and foot reconstructive surgery, reported that it received FDA clearance for its DRLock Volar Plate and Screw System. The DRLock System is a series of implantable bone fixation plates, pegs and screws intended to stabilize and aid in the fusion of fractures and osteotomies involving the distal radius. The system includes plates for both the left and right hand in standard and long lengths. The anatomic design of the plate allows for multi-planar fixation.

• OrthoLogic (Tempe, Arizona) reported results of an analysis of topline data from its Phase III clinical trial of the novel synthetic peptide Chrysalin (TP508) in unstable, displaced distal radius (wrist) fractures. Treatment with 10ug Chrysalin did not demonstrate a statistically significant benefit compared to placebo in the primary efficacy endpoint of time to removal of immobilization. A secondary endpoint, radiographic evidence of time to radial cortical bridging, showed a statistically significant benefit for Chrysalin-treated subjects (p = 0.049). No difference was observed between Chrysalin treatment and placebo in the other secondary endpoints. The company expects to communicate results of its interim analysis of prospective, double-blind, randomized, placebo-controlled trial during 3Q06.