Musculoskeletal News Roundup 23-Jun-11
BY LAUREN UZDIENSKI, JUNE 22, 2011
M&A
Smith & Nephew acquired Calgary-based Tenet Medical Engineering, which manufactures equipment for patient positioning during arthoscopic surgery. Financial terms were not disclosed.
Funding
NuVasive priced a $350.0 million offering of convertible senior notes in a transaction co-managed by BofA Merrill Lynch and Goldman, Sachs & Co. The offering, which is scheduled to close on June 28th, includes an over-allotment option valued at $52.5 million. The company plans to use the proceeds for general corporate purposes, to repurchase a portion of its existing notes and potentially for acquisitions.
Regulatory
MedShape Solutions received expanded 510(k) clearance for new, larger sizes of its ExoShape CL, which the company describes as a two-part PEEK Altera interference fixation device that "simplifies and improves soft tissue graft fixation" in ACL procedures.
MiMedx received 510(k) clearance for its HydroFix Ortho Shield device, which is described as a "biocompatible polyvinyl alcohol polymer (PVA) membrane" designed to "minimize tissue attachment to the device in case of direct contact with the tissues" in tendon repair cases.
X-spine received CE mark certification for its AXLE Interspinous Fusion System, which consists of a modular system indicated for the treatment of DDD, tumors and trauma. The device was launched in the U.S. earlier this year.
Product Introduction and Update
lluminOss Medical announced that the first forearm case utilizing the company's IlluminOss Medical Photodynamic Bone Stabilization System was performed in Germany. The company reports that "Within two hours of the procedure, the patient was able to move her entire arm without a motion-limiting external cast."
Tornier launched the Aequalis Ascend Convertible Shoulder System, which features a modular and convertible design that can be "converted to a 'reversed' configuration without the requirement for the surgical removal of implant components."
Intellectual Property
Kuros received an allowance of European Patent Application 00910049 by the European Patent Office, which will support the company's synthetic matrix technology platform.
Investigations
In a letter to Medtronic, Senators Max Baucus and Charles Grassley requested documentation relating to Infuse consultants, adverse events, FDA reporting and journal articles. The investigation follows recent news concerning a link between Infuse and male sterility
Legal
Smith & Nephew was awarded $85.0 million in a patent infringement case against Arthrex. The jury found that Arthrex's Bio-SutureTak, PEEK SutureTak, PushLock and Bio-PushLock suture anchors infringe a Smith & Nephew patent. In another case against Arthrex earlier this week, an appeals court reversed a prior $4.7 million award to Smith & Nephew. The court found that Smith & Nephew "presented insufficient evidence at trial to support" an infringement claim.
