Advanced NMR wins support for dedicated MR breast imager project

Advanced NMR Systems was awarded a National Cancer Institute grantlast month to develop a specialized MRI breast imager that maysell at a price equivalent to high-end mammography systems.

The MRI technology offers the prospect of $50 to $100 breastscreening exams, performed in real time without the need for compressionor ionizing radiation. MRI techniques could also be used to performspectroscopic analysis of the breast tissue, said Paul D. Bullinger,president and CEO of Advanced NMR.

The company hopes to have a prototype system completed by theend of next year, he said. Initial research on the MRI techniquehas been performed on a modified whole-body scanner, but the finalizedmachine will be compact and require no cryogen maintenance. Thepatient will sit in front of the machine and insert her breastinto the machine.

While declining to discuss specifics of the technology, Bullingersaid the system will not operate at a high field strength. Itwill use Advanced NMR's proprietary Instascan echo-planar imagingtechnology, however.

"The intent of this program is to develop a stand-alone,dedicated mammography machine. The goal is to develop this machineto sell for under $150,000," he said.

Extensive clinical work is under way on the use of MR spectroscopyto analyze the composition of tissue. Contrast agents are underdevelopment that show promise in enhancing MR spectroscopic analysis.

"Hopefully, by the time we are ready to market this product,we will be in a position to use those new contrast agents,"Bullinger said.

The MRI breast imager would be used at first as a back-upprocedure to standard mammograms when there is concern about thetissue. Eventually, the technique could take on a screening roleof its own. First, however, the design must be refined and theprice of the magnet and other hardware reduced, Bullinger said.

The company hopes to sell this system direct to customerswith its own sales force in three years, he said.

Advanced NMR expects to submit a 510(k) application this monthfor its Instascan upgrade to GE's 1.5-tesla Signa MRI scanner,Bullinger said.

GE has not decided whether to incorporate this technologypermanently into its product line, but has authorized the smallerfirm to sell 50 of the machines to its end users, he said.

Advanced NMR will make use of GE representatives in sellingthe Instascan upgrade, which will be priced at about $535,000,he said.

The company is preparing for the extra business. It movedinto a new 35,000-square-foot facility three months ago and isgearing up manufacturing of the Instascan product. Advanced NMRhas increased its staff from 15 to 70 employees in the process,Bullinger said.