Julie A. Vetalice, Author at ORTHOWORLD

Results from 6-month ActiPatch Product Observation Study

Results from a 6-month study observing BioElectronics’ ActiPatch® musculoskeletal pain therapy device indicated an average 61% reduction in pain for >90% of participants, a decrease in doctor visits, etc.

Mar 29, 2016

Anika Therapeutics Obtains CE Mark Approval for Cingal to Treat Knee OA Pain

Orthobiologics ORTHOFLASH

Anika Therapeutics received CE Mark approval for CINGAL® as a medical device to treat knee osteoarthritis pain.

Mar 29, 2016

Bone Therapeutics Reports Initial Efficacy from PREOB® Phase IIA Trial

Orthobiologics ORTHOFLASH

Initial 12-month efficacy results from a Phase IIA trial demonstrate positive effects on pain and osteoporosis blood markers from a single administration of Bone Therapeutics’ PREOB® autologous osteoblastic cell therapy.

Mar 29, 2016

U.S. Government Extends Biomet’s Deferred Prosecution Agreement

Company Updates Competitive Landscape

Zimmer Biomet announced that the U.S. DOJ and SEC are continuing evaluation of the company’s past conduct in Brazil and Mexico, regarding possible violations of the Foreign Corrupt Practices Act.

Mar 29, 2016

Tenex Receives FDA Clearance for TX2 MicroTip to Treat Chronic Tendinosis

ORTHOFLASH Sports Medicine

Tenex Health received FDA 510(k) clearance to market the TX2 MicroTip, with application to treat tendinosis of the shoulder and hip in an outpatient procedure. Launch is slated for mid-2016.

Mar 29, 2016

Xtant Medical Enters Distribution Agreement with Vivex Biomedical for OsteoVive Cellular Allograft

Company Updates Competitive Landscape

Xtant Medical entered into a distribution relationship with Vivex Biomedical to commercialize OsteoVive™ viable cell allograft.

Mar 24, 2016

Carestream Submits FDA 510(k) Application for OnSight 3D Extremity Diagnostic System

ORTHOFLASH Sports Medicine

Carestream Health filed its FDA 510(k) application for the CARESTREAM OnSight 3D system for weight-bearing extremity imaging.

Mar 24, 2016

Amedica to 3D Print Silicon Nitride for Medical Applications

ORTHOFLASH Spine

Amedica has fabricated its first silicon nitride structures with a 3D printing process called robotic deposition, or robocasting.

Mar 23, 2016

aap Implantate Divests Biomaterials Unit

Competitive Landscape Mergers & Acquisitions

aap Implantate sold its biomaterials unit to an undisclosed private equity firm for 36MM (~US $40.3MM). Upon closing, aap will proceed as a pure-play trauma entity.

Mar 22, 2016

EOS imaging Receives China Regulatory Clearance for Orthopaedic Imaging System

ORTHOFLASH Robotics/Tech

EOS imaging received regulatory approval to market the EOS 2D/3D orthopaedic imaging system in China.

Mar 21, 2016

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