Musculoskeletal News Roundup 26-May-11
BY LAUREN UZDIENSKI, MAY 26, 2011
Earnings
Medtronic reported F4Q:11 revenue of $4.3 billion, flat over the year-ago period and in line with estimates. Spine sales were $875.0 million during the quarter, down 2% over F4Q:10. The company said that strong performances from the Solera posterior fixation system, Atlantis Vision Elite cervical plate and the Osteotech acquisition were offset by declines in Interspinous Process Decompressions Systems and balloon kyphoplasty. Net earnings were $776.0 million, and adjusted EPS of $0.90 missed estimates by $0.03.
M&A
Integra LifeSciences acquired SeaSpine, a Vista, California-based manufacturer of a range of anterior and posterior fusion implants, for $89.0 million in cash. The company says the transaction offers scale in spine and doubles Integra's distribution footprint and customer base in the U.S. spine hardware market.
Kensey Nash paid $22.0 million to acquire the assets of Synthes' Norian subsidiary. The deal includes an R&D agreement, a supply agreement and the acquisition of a manufacturing facility. The divestiture was a condition of Synthes' settlement with the government over allegations that the company facilitated unauthorized clinical studies of Norian XR, a bone graft substitute.
Regulatory
Stryker Orthopaedics received 510(k) clearance for their ShapeMatch Cutting Guides, which are intended for use with the company's Triathlon Total Knee System. The single-use guides are designed and manufactured from patient-specific 3D imaging data.
Product Introduction and Update
DFINE announced two product enhancements to its StabiliT Vertebral Augmentation System, consisting of the introduction of the VertecoR Bone Drill 3.0 as well as the StabiliT First Fracture Kit, which allows consolidation of StabiliT System components into a single package. The company says the kit now features a single tray for easy access to product components and a pre-filled cement syringe.
Interventional Spine announced the first use of its innovative Percutaneous Transforaminal Lumbar Interbody Fusion System, the PerX360 System, for the treatment of lumbar discogenic pain and instability. The procedure was performed at the Teknon Medical Center in Barcelona, Spain. The company says the system is the "first and only system in the world capable of providing surgeons the ability to perform a complete 360 lumbar interbody fusion via two 15mm percutaneous incisions."
MEDMIX announced that they have developed a range of syringes with integrated mixing device for the preparation of PMMA or calcium phosphate bone cements as well as pastes and gels. This company says the device allows for pre-filled storage of the powder component and the safe transfer of the liquid.
Tornier launched the Porous Coated Affiniti Stem for shoulder joint replacement surgery. The Porous Coated Stem facilitates device fixation to bone without bone cement.
Intellectual Property
Omeros Corporation announced the allowance of a new patent by the USPTO claiming the composition of OMS103HP, the company's PharmacoSurgery product for arthroscopic procedures, including meniscectomy. OMS103HP is described as a proprietary combination of anti-inflammatory/analgesic active pharmaceutical ingredients (APIs) designed to reduce pain and improve function following arthroscopic surgery. The patent will have a term extending into January 2020.
Distribution
Smith & Nephew Orthopaedics signed a distribution agreement with Graftys, whereby Smith & Nephew was granted distribution rights for Graftys' fast-setting, macroporous calcium phosphate bone void filler in the U.S. and potentially in additional countries around the world.
Appointments
Olympus Biotech appointed Oliver Burckhardt to the position of president of Olympus Biotech Corporation. He will also join the company's Board of Directors.
