A Medical Device Daily
DJO (San Diego) reported that its surgical division, DJO Surgical, has signed an agreement with the implant company, Lima (Udine, Italy). The strategic partnership will allow Lima to distribute select DJO Surgical products in several countries in Europe, while Lima will provide products for sale in the U.S. through DJO Surgical.
As a starting point, Lima will distribute DJO Surgical's 3DKnee and Foundation Total Knee Systems in selected European markets. The result of more than a decade of research, the 3DKnee is the first knee implant specifically engineered to accommodate the important changes in contact, movement, and pressure that occur in the knee joint after total knee replacement.
DJO said not only is the 3DKnee designed to provide a wider range of motion and greater stability than other knee prostheses, "its revolutionary design is also intended to minimize the stresses that have traditionally led to the premature deterioration of most available implants. As a result, the 3DKnee should have a longer life expectancy than other devices, making ideal for younger patients."
Also, as part of this first phase, DJO Surgical will pursue FDA clearance to bring to the U.S. Lima's Revision Hip Stem and Acetabular Cups System, including Trabecular Titanium.
Trabecular Titanium is a multi-planar hexagonal cell structure imitating the cell structure of the trabecular bone. Its morphology and dimensions have been optimized to improve vascularization and therefore maximize osteointegration.
The companies said the low rigidity of the Trabecular Titanium structure fosters the transmission of physiological loads from implant to bone. "It is far more resistant compared to trabecular bone, therefore it can be used as the ideal filler/support structure for bone in growth," they said.
Clinical studies have demonstrated excellent osteointegration and a bone implant contact of 95% in 26 weeks. Trabecular Titanium can be applied in the most diverse prosthetic implants, DJO said, from initial and revision Acetabular cups to cemented cup and glenoid cages.
"It would be difficult to find a better match between two total joint companies," said Les Cross, president/CEO of DJO. "Our product lines and geographic strengths are quite complementary. We are excited to be able to provide each other products that will allow both companies to grow in their respective market spaces."
In other agreements/contracts news:
• BD (Becton, Dickinson; Franklin Lakes, New Jersey) and Fujirebio Diagnostics reported the signing of a worldwide development and supply agreement for oncology diagnostic assays.
Under the agreement, the two companies will develop diagnostic products that incorporate Fujirebio Diagnostics' cancer biomarkers for use on BD's multiplex testing platform. The initial products will be directed to the ovarian cancer biomarker, HE4, which is FDA-cleared for monitoring the progression or recurrence of epithelial ovarian cancer. Fujirebio Diagnostics also grants BD, through its BD Diagnostics - TriPath platform, access to its other cancer biomarkers for inclusion in future multiplex diagnostic products.
• PGxHealth, a division of Clinical Data (Newton, Massachusetts), said that it has begun a broad research collaboration with the University of Pittsburgh to discover and further validate the application of genetic variants in FCGR (Fc gamma receptor) genes, including FCGR3A, for predicting response to monoclonal antibodies (mAbs) in cancer treatment. The strategic collaboration aims to conduct a series of clinical programs to evaluate the response to mAb-based therapies, such as Erbitux (cetuximab), Rituxan (rituximab) and Herceptin (trastuzumab) and potentially other mAbs of the IgG1 subclass in treating a variety of cancers.
• Simbionix USA (Cleveland) and B-Line Medical (Washington) said the companies have signed a strategic agreement enabling the data integration of Simbionix Mentor simulation systems with B-Line Medical's SimCapture product.
The collaboration will combine Simbionix' unique data collected during a simulation session with video streams into the SimCapture system for debriefing, assessing and centralizing multiple types of simulated encounters.