Julie A. Vetalice, Author at ORTHOWORLD

Strategic Orthopaedic-related 510(k)s issued in December 2015

Strategic orthopaedic-related 510(k)s issued in December 2015 include: Fusion Implant System (Bio2 Technologies), Spinal Fixation System (Changzhou Dingjian Medical), Metallic Intramedullary Nail (Changzhou Waston Medical), Latitude-C Cervical Interbody Spacer (DeGen Medical), V-Steady and V-Fast Bone Cements (G21), Firefly Pedicle Screw Navigational Guide (Mighty Oak Medical), Apex Revision Knee (OMNIlife sciences), Remedy Shoulder Spacer (Osteoremedies), Internal Joint Stabilizer, Elbow (Skeletal Dynamics)

Jan 13, 2016

DeGen Medical Launches Hyper-C Anterior Cervical Plate

ORTHOFLASH Spine

DeGen Medical launched the Hyper-C™ Anterior Cervical Plate and announced its first implantation.

Jan 13, 2016

Smith & Nephew Acquires BST-CarGel from Piramal

Competitive Landscape Mergers & Acquisitions

Smith & Nephew acquired BST-CarGel® cartilage repair product and IP assets from Piramal. Transaction terms were not disclosed.

Jan 12, 2016

VEXIM Initiates New Clinical Study of SpineJack vs. Conservative Treatment of VCFs

ORTHOFLASH Spine

Vexim initiated a new clinical study in France to compare 1-year and 2-year follow-up of SpineJack® vs. bracing in 100 acute traumatic vertebral compression fracture patients.

Jan 12, 2016

BioPoly Receives U.S. Patent for Partial Resurfacing Implant

Joint Replacement ORTHOFLASH

BioPoly was issued an additional U.S. patent pertaining to partial resurfacing implant designs and method of implantation.

Jan 11, 2016

Bio2 Technologies Receives FDA Clearance for Extremities Fusion Implant

ORTHOFLASH Trauma

Bio2 Technologies received FDA 510(k) clearance to market a fusion system for interphalangeal fusion, fracture repair and osteotomies of toes, fingers and other small bones. Limited product launch is slated for 2Q16.

Jan 11, 2016

MiMedx to Acquire Stability Biologics

Competitive Landscape Mergers & Acquisitions

MiMedx signed a definitive agreement to acquire Stability Biologics for US $10MM in cash and stock. Stability Biologics provides human tissue products for the surgical, spine and orthopaedic industries. The transaction is expected to close in early 1Q16.

Jan 11, 2016

CartiHeal Raises $15 Million

Investments The Numbers

CartiHeal completed a US $15MM financing round. Funds will support ongoing manufacturing scale-up, EU product commercialization in 2017 and clinical studies in new therapeutic areas for Agili-C™ cartilage regeneration technology.

Jan 11, 2016