NVIV
Resumen del comunicado de hoy
INSPIRE: Encouraging clinical data. In December 2015, we unveiled our plan for the INSPIRE study, including the conversion of our pilot study into a pivotal probable benefit study. Expand the number of patients to the full 20 in 2016. We hope to be approaching full enrollment by the end of the year. We are now running a pivotal trial with planned international expansion and the potential to file an application for HDE approval in just two years.
We also expect to make significant progress in 2016 with our programs dedicated to cervical and chronic SCI. To that end, we recently announced our plans to initiate in mid-2016 a study for acute, neurologically complete cervical SCI. The importance of moving higher in the spinal cord cannot be overemphasized, as cervical SCI represents a higher-risk/higher-reward condition than thoracic SCI. In general, gaining or losing a single neurological level in patients with thoracic injuries may have minimal impact on the patient’s overall function and quality of life. However, in the cervical cord, a single level often makes a dramatic difference. We are highly encouraged by the safety profile of the Neuro-Spinal Scaffold in the INSPIRE study to date, and we look forward to testing the Neuro-Spinal Scaffold in injuries where small changes in neuronal preservation or regrowth may have substantial impact on function.
We are also devoting significant resources to advancing our Bioengineered Neural Trails program for the 276,000 patients in the U.S. currently living with chronic SCI. We are targeting a pre-IND (Investigational New Drug) meeting with the FDA by the end of 2016
«Después de nada, o después de todo/ supe que todo no era más que nada.»