Orthofix Set To Accelerate Advent Cervical Disc Trial Enrollment In Early 2009
This article was originally published in The Gray Sheet
Executive Summary
Orthofix plans to accelerate a clinical study of its Advent artificial cervical disc in early 2009, the firm said during its first investor day Sept. 8 in New York
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Next-generation Trinity Evolution stem cell-based bone growth matrix will launch in June 2009, ahead of schedule, the firm announces Dec. 15. Orthofix inked a deal with the Musculoskeletal Transplant Foundation in August to develop Trinity Evolution, which is designed to mimic an autograft in spinal and orthopedic surgeries and is sourced from cadaver tissue (1"The Gray Sheet" Sept. 15, 2008, p. 11). The product will be the second stem cell-based allograft on the market after NuVasive's Osteocel, which Orthofix currently distributes as Trinity. NuVasive purchased Osteocel from Osiris Therapeutics in May, prompting Orthofix to pursue a replacement allograft
Orthofix allograft
Next-generation Trinity Evolution stem cell-based bone growth matrix will launch in June 2009, ahead of schedule, the firm announces Dec. 15. Orthofix inked a deal with the Musculoskeletal Transplant Foundation in August to develop Trinity Evolution, which is designed to mimic an autograft in spinal and orthopedic surgeries and is sourced from cadaver tissue (1"The Gray Sheet" Sept. 15, 2008, p. 11). The product will be the second stem cell-based allograft on the market after NuVasive's Osteocel, which Orthofix currently distributes as Trinity. NuVasive purchased Osteocel from Osiris Therapeutics in May, prompting Orthofix to pursue a replacement allograft
People In Brief
Device matrix leader: Jonathan Sackner-Bernstein assumes the role of associate director for post-market operations Sept. 2, tasked with overseeing CDRH's recently launched matrix organization, FDA announces Aug. 29. Sackner-Bernstein is the program's first permanent director, after acting heads Diane Mitchell and Don St. Pierre helped to set up the program (1"The Gray Sheet" July 21, 2008, p. 7). Prior to joining FDA, Sackner-Bernstein was chief medical officer at New York City-based contract research organization Clinilabs. Previously, he served on the faculty at Columbia University and was associate chief of cardiology at St. Luke's-Roosevelt Hospital. In addition, Sackner-Bernstein has sat on the cardiovascular and renal drugs advisory panel for FDA's drug center and the device center's dispute resolution panel