Intellijoint Surgical, a medical technology company, is pleased to announce that it has received FDA Clearance for Revision Total Hip Arthroplasty (THA) with its intelligent HIP System. A 3D Mini-Optical Navigation System, intelligent HIP provides surgeons with precise measurements for cup position, leg length and offset for THA. Requiring no pre-operative or intra-operative imaging, the intelligent HIP can be used with any implant manufacturer, and for any primary or revision THA.
"Our goal is to develop a new class of immunotherapeutics for the treatment of neurological disease," commented Mei Mei Hu, chief executive officer of UNS. "These data from trials of UB-311, an active vaccine we believe to be the most advanced in clinical development for Alzheimer's disease, support the ongoing development of UB-311 as a targeted therapeutic autoantibody, or 'endobody,' approach. We look forward to results from the phase 2 trial in the second half of 2018."
"These analyses build on previously announced phase 1 safety data and provide evidence in support of potential activity for UB-311 across age groups as an immunotherapy that can specifically target toxic oligomers and fibrils of amyloid," said Ajay Verma, M.D., Ph.D., chief medical officer of UNS. "In addition, the baseline PET imaging results from our ongoing phase 2 trial show the level of amyloid burden that we would hope to see in a trial targeting patients in the early stages of disease. Both imaging data and cognition assessments provide comfort in the safety profile of UB-311."
The analyses, presented today in late breaking poster presentations at the 10th Clinical Trials on Alzheimer's Disease (CTAD) meeting included results from the completed phase 1 study as well as data from 43 patients in the ongoing phase 2 study of UB-311 for AD. A review of cases by the study safety group identified no signs of an adverse CNS event, including no evidence of brain edema (amyloid-related imaging abnormalities, ARIA-E) as assessed by MRI, in blinded data in phase 2. The UNS ongoing phase 2 active immunotherapy trial of UB-311 in patients with early-to-mild AD is fully enrolled.
Intellijoint receives fda clearance, revision tha with intellijoint hip
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