The goal of this Phase II SBIR proposal is to expand upon the research and development efforts, begun in Phase I, with new enhancements and product offerings, while also taking the initial steps to position the Company for a multi-center clinical trial, planned for Phase III. Phase I efforts have led to the development and commercialization of the Company's first product, IB NeuroTM 1.0, which received FDA 510K clearance for indications of brain tumors and stroke. This product uses perfusion analysis algorithms, which were proven to be the most robust in a multi-year comparison study performed in patients with brain tumors. A key element of the product is the leakage correction algorithms, critical for the accurate evaluation of brain tumors. Currently no other perfusion analysis software product with FDA clearance incorporates leakage correction algorithms. Therefore, the IB Neuro 1.0 product makes available, for the first time, advanced and proven algorithms for the analysis of MRI perfusion data in a robust and easy-to-use fashion. Given this early success, the specific objectives of this Phase II proposal are to extend the functionality of IB NeuroTM in three important ways. First, additional tools will be added to enable comparison of imaging data across studies. This capability is especially important for the most efficient and accurate evaluation of both standard treatments (such as chemotherapy and radiation therapy) and for the newly available and promising biologic agents that target a tumor's new blood vessel growth (angiogenesis). Second, the Company's patented dual-echo perfusion technology will be developed as part of IB Neuro 1.1. With this proprietary technology DSC (dynamic susceptibility contrast) and DCE (dynamic contrast enhanced) perfusion data can be simultaneously collected while using only a single dose of contrast agent. IB Neuro 1.1. will incorporate the tools to generate relevant perfusion parameters including CBV (cerebral blood volume), CBF (cerebral blood flow) as well as Ktrans, a marker of vascular permeability. A third objective is to incorporate the functionality necessary to more specifically support the evaluation of perfusion data for the evaluation of stroke. Each of these product development objectives will be accomplished in the context of receiving frequent feedback from the Company's luminary sites. This will position the Company for the multi-center trials planned for Phase III. Overall the technological niche of IB, which is to develop advanced imaging analysis tools that plug into existing vendors'systems, will enable advanced imaging options to become more widely available to clinics and therefore patients in a cost-effective manner. The result will be to provide the best and most state-of-the- art patient care on a more widespread basis. This has the potential to shift current clinical practice paradigms with regard to how treatments are planned and monitored, as none of these proven advanced technologies have been previously available on a wide-spread basis.
The goal of this Phase II SBIR proposal is to enable the Company, Imaging Biometrics LLC, to continue its development and distribution of innovative and proven perfusion and diffusion analysis software for the evaluation of brain tumors and stroke. While stand-alone options are available, the primary approach is to develop the software to plug into existing vendors'systems. With this approach the best and most up-to-date image analysis software can be made available on a widespread and cost-effective basis, which has the potential to shift current clinical practice paradigms for treatment planning and monitoring.