Stimulating Peripheral Activity to Relieve Conditions (SPARC): Pre-clinical Development of Existing Market-approved Devices to Support New Market Indications (U18) - 0 views
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MiamiOH OARS on 26 Feb 16This FOA relates to one of the initiatives of the SPARC (Stimulating Peripheral Activity to Relieve Conditions) Common Fund program titled: Use of Existing Market-Approved Technology for New Market Indications. By establishing effective public-private partnerships, this SPARC initiative allows supported investigators to have access to existing neuromodulation Technology to explore new indications. A number of device manufacturers have entered into partnership agreements with the NIH to make their neuromodulation Technology, consisting of implantable devices with recording and/or stimulation capabilities, available to SPARC's supported clinical investigators (see Device Portal for a list of companies and available technologies). The specific goal of this FOA is to promote the pre-clinical development of these technologies, in support of a new market indication, towards enabling an Investigational Device Exemption (IDE) submission for a future pilot clinical study. Awarded projects of this FOA that fully reach their pre-clinical testing milestones will be eligible for further support, subject to a subsequent FOA, to conduct a pilot clinical study. The expectation is that these pilot clinical studies will provide the initial proof-of-principle demonstrations in humans that will motivate the additional studies needed in pursuing FDA approval as a labeled indication.
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MiamiOH OARS on 26 Feb 16This FOA relates to one of the initiatives of the SPARC (Stimulating Peripheral Activity to Relieve Conditions) Common Fund program titled: Use of Existing Market-Approved Technology for New Market Indications. By establishing effective public-private partnerships, this SPARC initiative allows supported investigators to have access to existing neuromodulation Technology to explore new indications. A number of device manufacturers have entered into partnership agreements with the NIH to make their neuromodulation Technology, consisting of implantable devices with recording and/or stimulation capabilities, available to SPARC's supported clinical investigators (see Device Portal for a list of companies and available technologies). The specific goal of this FOA is to promote the pre-clinical development of these technologies, in support of a new market indication, towards enabling an Investigational Device Exemption (IDE) submission for a future pilot clinical study. Awarded projects of this FOA that fully reach their pre-clinical testing milestones will be eligible for further support, subject to a subsequent FOA, to conduct a pilot clinical study. The expectation is that these pilot clinical studies will provide the initial proof-of-principle demonstrations in humans that will motivate the additional studies needed in pursuing FDA approval as a labeled indication.