Julie A. Vetalice, Author at ORTHOWORLD

Histogenics Update: Agreement with Japan PMDA on NeoCart Regulatory Path

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

Medikon to Distribute InterFuse in Turkey

Company Updates Competitive Landscape

Vertebral Technologies partnered with Medikon for distribution of InterFuse® spinal fusion products in Turkey.

May 04, 2017

Exactech Posts 1Q17 Revenue

Company Revenue The Numbers

Exactech posted 1Q17 revenue of US $69.5MM, +6.5% vs. 1Q16. (U.S. $47.6MM, +7.0%; ex-U.S. $21.8MM, +5.2%)

May 04, 2017

K2M Posts 1Q17 Revenue, Announces Product Approvals in Japan

Company Revenue The Numbers

K2M posted 1Q17 revenue of US $61.9MM, +9.9% vs. 1Q16. (U.S. $46.2MM, +9.5%; ex-U.S. $15.7MM, +11.1%) Following 1Q, the company received key product registrations from Japan’s Pharmaceuticals and Medical Devices Agency, and can now implement a new distribution strategy in that region.

May 03, 2017

Implanet Receives CE Mark Approval for JAZZ Standalone Implant

ORTHOFLASH Spine

Implanet received approval under the CE Mark for the JAZZ™ Standalone implant for posterior spinal fixation.

May 03, 2017

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