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We have completed post-marketing human clinical studies of CORTOSS in Europe for its use in hip compression screw augmentation.
We are conducting clinical studies of RHAKOSS in Europe required to obtain a CE Mark for its use as an interbody fusion device.
There can be no assurance that any product in our product pipeline will be successfully developed or manufactured, or that final results of clinical studies will be supportive of regulatory approvals required to market licensed products.
These early results in our current Phase I/II clinical studies are an important step forward, but because they are preliminary, we will need to complete additional clinical studies with larger numbers of patients to demonstrate efficacy and establish the roles of I-Mel- 1 and I-Mel-2 in the management of melanoma," said Dr.
Data from six clinical studies, which further establish the safety and efficacy of the Pillar Procedure, were presented by several of the foremost otolaryngologists from the U.
Among other things, the University of Washington's intention to use the animal test results to apply for the Investigational Device Exemption for FDA clinical studies contain forward-looking statements.
In addition, readers are cautioned that results from preclinical studies and early-stage clinical studies of bevirimat may not be replicated in larger, later-stage clinical studies of that product candidate.
Jonas Salk and indicated to be safe and immunogenic in extensive clinical studies of REMUNE(R), the Company's first generation HIV product candidate.
Based on the established biology of rhPDGF as a wound healing factor and the demonstrated clinical benefit of the combination of rhPDGF and B-TCP to stimulate new bone formation, as shown in the Company's clinical studies with their product GEM 21S(R), I am optimistic about the potential for GEM OS1 to accelerate healing in foot and ankle applications," said Christopher W.

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