The FDA has cleared Osteotech Inc.’s Plexur P biocomposite for use in spinal applications as a bone void filler and graft extender. Osteotech has already received FDA clearance for Plexur P for use in filling bony voids of the pelvis and extremities. The biocomposite has been used in tibial plateau fractures, tibial osteotomies and foot and ankle procedures. The company aims to immediately offer our Plexur P(TM) product to spine surgeons.

 Genta Incorporated’s patent application covering novel pharmaceutical gallium compositions and complexes, including the company’s franchise of oral gallium-containing products intended as potential treatment for diseases associated with accelerated bone loss, has been allowed by the U.S. Patent Office. The company has completed its initial Phase 1 dose-ranging study of its lead compound in this investigational pipeline, G4544, and is seeking a buyer for the intravenous formulation of its on-market product from this franchise, Ganite(R).

The Orthopaedic Reconstruction business of Smith & Nephew Inc. announced the global launch of the R3 Acetabular System, an advanced multi-bearing acetabular cup system used in total hip replacement procedures. The R3 Acetabular Cup is engineered for multiple bearing options and features a STIKTITE porous coating that is designed to enhance fixation and bony in-growth.

Kyocera Industrial Ceramics Corporation has been appointed the official North American representative for Japan Medical Materials Corporation (JMM) for the sales of biocompatible ceramic structural components used in orthopedic systems. JMM components are immediately available from Kyocera to manufacturers of medical implant products, including “total hip” and “total knee” joint-replacement systems. The components include a wide range of biocompatible ceramics, including alumina and zirconia; bioactive coatings, such as hydroxyapatite; medical-grade alloys, such as titanium and vanadium-free titanium; and medical-grade ultra-high-molecular-weight polyethylene (UHMWPE).

Amgen Inc announced positive results of its pivotal Phase III trial for its denosumab drug for the treatment of osteoporosis. The results demonstrated that bone density at several skeletal sites improved for women in the early- and late-stage postmenopausal phase. Osteoporosis patients taking denosumab showed a drastic increase in lumbar spine bone mineral density (BMD) after 24 months, as compared to placebo, Amgen added.