A Medical Device Daily

Biomet (Warsaw, Indiana) reported that its orthopedics unit has formed a strategic research alliance with Massachusetts General Hospital (Boston) to collaborate on clinical outcome research for Biomet's recently introduced Regenerex and E-Poly technologies.

Massachusetts General will manage the global multi-center prospective clinical studies sponsored by Biomet to provide documented outcomes for the products.

Biomet said that U.S. and European researchers have been invited to participate in the clinical outcome studies, including surgeons from the U.S., Sweden, UK, Denmark, Germany and the Netherlands. Henrik Malchau, MD, co-director of The Harris Orthopaedic Biomechanics and Biomaterials Laboratory at Massachusetts General is managing the research. He and Andrew Freiberg, MD, vice chair of the Department of Orthopaedic Surgery, will be the lead researchers at Massachusetts General.

"We believe these clinical studies will provide the long-term clinical results to validate Biomet's Regenerex and E-Poly products as important improvements in total hip reconstruction, said Biomet's president/CEO, Jeffrey Binder.

The separate non-randomized clinical outcome studies are designed to enroll 500 patients each to collect post-market data on Biomet's Regenerex Ringloc+ Acetabular System and E-Poly highly crosslinked polyethylene acetabular liners. The Regenerex Ringloc+ acetabular system is made of Biomet's internally-developed Regenerex porous titanium construct, a highly porous structural material engineered for optimal biological fixation.

In other agreements:

• Axiomed Spine (Cleveland) reported an agreement to add a second manufacturing site for its spinal disc replacement products at the company's new facility in Garfield Heights, Ohio.

The Polymer Technology Group (PTG; Berkeley, California) will provide business continuity by maintaining manufacturing capability at its Berkeley facility.

Axiomed said that the material characteristics of PTG's polymer, in combination with its implant design, may provide a type of 3D motion that closely matches the natural biomechanics of the spine.

Axiomed has established manufacturing processes for the artificial discs, as well as an exclusive license for PTG's patented polymer for applications in the lumbar and cervical spine. Axiomed's first product, the Freedom lumbar total disc replacement, is currently in pilot clinical studies in Europe.

Scale-up of manufacturing at Axiomed's facility will begin immediately, and funds advanced by the Ohio Department of Development under its Innovation Ohio Loan Fund Program will be used for equipment purchases. The company said it expects to manufacture the devices in its new facility by year's end.

• Rosetta Genomics (Rehovot, Israel), a microRNA company, reported a research agreement with Columbia University Medical Center (CUMC; New York) to advance its lead cancer diagnostic. CUMC will utilize its CLIA-certified laboratory to perform validation of the company's lead diagnostics program for cancer of unknown primary (CUP).

Rosetta said that this is its first agreement for clinical validation of one of its cancer diagnostics. The company is developing several microRNA-based diagnostics at its R&D facilities in Israel and the U.S.

The company's CUP diagnostic, currently in the final development stages, is designed to assist clinicians in identifying the origin of tumors which have metastasized throughout the body.

Rosetta will provide CUMC with its protocol for diagnosing the primary origin of metastatic cancers, which will then be tested and validated using unknown (blinded) samples provided by the medical center.

• BioE (St. Paul, Minnesota) a biomedical company that provides human stem cells for drug discovery and therapeutic research, and Phillips Plastics (Prescott, Wisconsin), a custom injection molder they entered into a collaborative agreement to develop and commercialize stem cell therapeutics for orthopedic applications.

The stem cell therapeutics will consist of BioE's Multi-Lineage Progenitor Cell (MLPC) stem cell derived from human umbilical cord blood and Phillips Plastics' growth structures.

In early development studies, the MLPC has differentiated into bone (osteoblasts) and cartilage (chondrocytes) progenitor cells, along with numerous other cell and tissue precursors. Phillips Plastics is developing custom structures to enhance the growth of these cells from the MLPC.

Michael Haider, president/CEO for BioE, said, "These therapeutics could lead to treatments for osteoporosis and bone fractures of the hip, spine, wrist, arm and leg, as well as remedies for injured or deteriorated joints throughout the body."

• Broadlane (Dallas) reported that Cirrus Health (Dallas) has selected it to provide an array of supply chain services under an exclusive agreement. Financial terms were not disclosed. Broadlane will provide Cirrus Health with its national supply chain services for consumable supplies and equipment, pharmaceuticals and purchased services and technology to help them manage their supply spend.

Cirrus, a healthcare development and management company specializing in ambulatory surgery centers and hospitals, has 11 facilities throughout California, Louisiana and Texas.

Broadlane is a supply chain services company serving acute care hospitals, ambulatory care facilities, physician practices and other providers throughout the U.S.