SBIR-STTR Award

Currently, there are over 10,000 MRI scanners used in the US alone. US citizens today are mobile and many times medical treatments may require MRI scans from several different facilities. Images from MRI scanners can also drift over time. There is a tremendous need for all medical imaging scanners to be on the same level. Sigma-K will develop the commercialization of the ISMRM/NIST MRI Calibration Phantom. Sigma-K will develop a manufacturing technique that will produce a phantom that is consistent and accurate over the phantom life of five years. Our production system will allow these phantoms to be sold at the target price of $2000 with a minimal annual sales of 100 units. Sigma-K will also provide a software package to accompany the phantom that will allow the user to easily make quantitative measurements of the scanned data. Commercial Applications: Sigma-K will work to make this calibration phantom a standard. These phantoms will be needed for all MRI scanner systems. The 10,000 MRIs scanners in the US alone may require 5000 phantoms. With a five year calibration life for the phantom, the US market is 1000 phantoms per year and growing. The market potential is $2 million in sales annually for the US market. Globally, the total potential market is $20 million annually

Magnetic Resonance Imaging data needs to be calibrated using a universal standard. NIST and the ISMRM SQRM committee have developed the NIST/NIST MR phantom. The group had two phantoms manufactured to their specifications and these phantoms have been imaged at numerous imaging facilities. Sigma-K now proposes to develop a complete manufacturing method that will produce 50 MRI phantoms. These phantoms will be sent to numerous imaging facilities for research and testing. The phantom design proposed by Sigma-K will ensure measurement traceability of all of parameters in the phantom. These include 100 contrast and fiducial spheres, resolution inset(s), and slice profile wedges. The work performed by Sigma-K during the Phase 2 Work Plan, will allow Sigma-K to immediately begin a production process that will allow this phantom to be purchased for less than $2500. Commercial Applications: The work performed during the Phase 2 Work Plan will have allowed Sigma-K to develop a complete manufacturing process as well as a quality control system for the ISMRM/NIST phantom. At the commencement of the Phase 2 efforts, Sigma-K will go directly into full scale production of this phantom. The results of the Phase 2 efforts will be the development of a proprietary manufacturing process for this phantom. This fully automated assembly system will be a subset of the complete assembly method that will ensure measurement traceability throughout the five year life of the phantom.