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superior augment baseplate or posterior augment baseplates versus allograft or autograft) due to insufficient sample sizes; instead, the graft and augment subgroups were combined.
The decision is a vindication of sorts for the company, which had its PMA for Augment rejected in August 2013.
Augment revenue to be in the range of $10 million to $12 million in the first seven to eight months post-approval.
Sundin said it's not easy for the Operations Center, or any organization, to voluntarily let their people go for any period of time to augment in the field, especially when everyone these days is doing more with less.
Results show that augment use began at 7[degrees] retroversion with 100% use at 14[degrees].
The same size of each posterior augment glenoid implant design type was then seated in each corresponding glenoid defect size; cortical and cancellous bone were removed from the bone model to restore the retroversion of the original scapula and permit fully-seating of each glenoid implant.
Built on the Salesforce1 Platform, the social, mobile and cloud customer platform built to transform sales, service and marketing, Augment for Salesforce is currently available on the AppExchange at www.
The following presentations highlighted the clinical and pharmaco-economic need and biologic rationale for Augment Bone Graft as an alternative to autograft.
Approval of Augment Bone Graft by another major regulatory agency, such as the TGA, marks a significant achievement in BioMimetic's global product development program and further validates our technology, clinical data and ability to gain regulatory approvals," said Dr.
If approved by the FDA, Augment Bone Graft would be the first, new recombinant protein technology for orthopedics introduced to the market in nearly a decade and the first and onlycost effective fully synthetic bone growth factor replacement for autograft with Level 1 data supporting its safety and efficacy.
The Augment Bone Graft treated specimens demonstrated the highest fusion scores of all groups evaluated.
The Company recently received a determination letter from the FDA's Office of Combination Products (OCP) indicating that the Augment Injectable review will follow a medical device pathway and accordingly has been assigned to the FDA's Center for Devices and Radiologic Health (CDRH) Division of Surgical, Orthopedic and Restorative Devices for lead review.
Positive EU Augment Trial Results Consistent with Canadian, North American Studies
It is a combination of the real scene viewed by the user and a virtual scene generated by the computer that augments the scene with additional information.
In the most general sense, the term "augmented reality" refers to mobile technology that enhances, or augments, the physical environment around the user with digital information.