Julie A. Vetalice, Author at ORTHOWORLD

Premia Spine Secures FDA Approval for IDE Study of TOPS

Premia Spine secured FDA approval for a pivotal IDE study of TOPS™, a posterior arthroplasty device for the treatment of spondylolisthesis and spinal stenosis. The study seeks to establish the superiority of TOPS vs. traditional lumbar spinal fusion.

May 08, 2017

iFuse SI Fusion Implant Covered by TRICARE

ORTHOFLASH Spine

TRICARE, a managed healthcare program for active duty and retired members of the U.S. military, established a written coverage policy for minimally invasive SI joint fusion such as is provided with SI-BONE’s iFuse™ implant.

May 08, 2017

Histogenics Update: Agreement with Japan PMDA on NeoCart Regulatory Path

Orthobiologics ORTHOFLASH

Histogenics successfully completed consultations with Japan’s PMDA regarding the regulatory path for NeoCart® autologous cell therapy for the treatment of knee cartilage defects.

May 08, 2017

Inspired Spine Presents OLLIF Procedure Study Results

ORTHOFLASH Spine

Results from a 124-patient study indicate that Inspired Spine’s OLLIF procedure was completed at ~2x the speed of an open TLIF, and reduced blood loss by >80% vs. TLIF.

May 08, 2017

Stryker Orthopaedics 2016 Settlement Program Reaches Milestone

Company Updates Competitive Landscape

Stryker Howmedica Osteonics/Stryker Orthopaedics informed courts that 95% of additional registered eligible patients have enrolled in its Settlement Program relative to revisions of the Rejuvenate Modular-Neck hip stem and/or ABG II Modular-Neck hip stem.

May 08, 2017

CurveBeam Receives FDA Clearance for InReach Cone Beam CT Imaging for Upper Extremities

ORTHOFLASH Robotics/Tech

CurveBeam received FDA 510(k) clearance for InReach, a Cone Beam CT imaging system designed for the hand, wrist/elbow and lower extremities in non-weight bearing positions.

May 08, 2017

Globus Medical Reports 1Q17 Revenue

Company Revenue The Numbers

Globus Medical reported 1Q17 revenue of US $155.8MM, +11.9% vs. 1Q16. (U.S. $129.7MM, +1.6%; ex-U.S. $26.1MM, +123.4%)

May 04, 2017

TheraCell Issued U.S. Patent for Enhanced Cancellous Bone

Orthobiologics ORTHOFLASH

TheraCell was issued U.S. Patent No. 9,636,436, "Compositions of and Methods for Cancellous Bone Matrix," addressing its ECS™ enhanced cancellous demineralized bone technology.

May 04, 2017