Merck & Co., Inc. and Japan Tobacco Inc. have entered into a worldwide licensing agreement for the development and commercialization of JTT-305, an oral osteoanabolic (bone growth stimulating) agent to be used in the treatment of osteoporosis. JTT-305 is in its investigational stage at the moment. Under the agreement, Japan Tobacco will be receiving an upfront payment, along with additional milestone payments and royalties from sales. Currently in Phase II of its clinical trial, the oral calcium sensing receptor (CaSR) antagonist is being tested in Japan for its potential to increase bone density.

Bayer HealthCare’s anticoagulant Xarelto® (rivaroxaban) has been granted marketing authorization by Health Canada. Taken as a once-daily tablet, Xarelto prevents venous thromboembolic events (VTE) in patients who have undergone elective total hip or total knee replacement surgery. With the product receiving its first approval, Bayer will be starting with its commercialization immediately. Xarelto is one of the most extensively researched product that has brought about an advancement in therapeutics of antithrombosis. The European Committee for Medicinal Products for Human Use (CHMP) has also received recommendations for approving Xarelto.

StemCor Systems, Inc., has received the CE (Conformite European) Mark for its MarrowMiner System, a minimally invasive device which is used to harvest adult stem cells from the pelvis. The next-generation technology is brought in use for bone marrow transplants, to accelerate bone healing in orthopedic procedures such as spinal fusions, and in a number of clinical applications that utilize bone marrow-derived cells. The CE Mark confirms the appropriate quality and safety that StemCor’s systems are known to follow.

The US Food and Drug Administration has expanded Titan Spine‘s ENDOSKELTON® TA Vertebral Body Replacement Device (VBR) 510k to include an Interbody Fusion Device indication. The expanded 510K indication, means that the device is approve for the use in skeletally mature patients with Degenerative Disc Disease (DDD). Patients should have received six months of non-operative treatment prior to treatment with the devices. The device may be used with supplemental fixation. It will enable the surgeon to utilize the Endoskeleton TA as an Interbody Device while taking off the VBR label. The device will make the surgeons comfortable by providing them the option to use the device in a stand-alone setting.

ApaTech has come up with a new product called Actifuse MIS that will be of crucial importance in the procedures that are minimally invasive. The surgeons often perform such open procedures and need an artificial bone graft ready to use immediately. In this case, the unique product from the table of ApaTech serves as a purpose designed applicator to provide the surgeon an easy and accurate access to the graft site. Designed for a single patient use only, Actifuse MIS will enable controlled bone graft delivery with flexible, replacement cartridges for faster and more accurate placement of graft.