Julie A. Vetalice, Author at ORTHOWORLD

Carmell Therapeutics to Launch Phase III Study of Bone Healing Accelerant

Carmell Therapeutics will launch a Phase III clinical study for Bone Healing Accelerant, its first Plasma-based Bioactive Material product/indication, designed to treat fractures.

May 09, 2017

Aesculap Implant Systems Presents Long-term activL Study Data

ORTHOFLASH Spine

Studies indicate that, at 5 years, the activ-L® Artificial Disc from Aesculap Implant Systems had a protective effect on the progression of degenerative disc disease at adjacent levels in 91.2% of patients.

May 09, 2017

ZipLine Medical Receives India Regulatory Approval for Zip Skin Closure System

Joint Replacement ORTHOFLASH

ZipLine Medical received regulatory approval of the Zip® Surgical Skin Closure device in India.

May 09, 2017

CartiHeal Raises $18.3 Million

Investments The Numbers

CartiHeal closed a US $18.3MM financing round, supporting the recently-approved IDE clinical trial of the Agili-C™ implant.

May 08, 2017

Premia Spine Secures FDA Approval for IDE Study of TOPS

ORTHOFLASH Spine

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

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