Advanced NMR gains FDA clearancefor dedicated MRI breast scanner

Sales efforts to focus on women's health services

A year and a day after filing its 510(k) application with theFood and Drug Administration, Advanced NMR of Wilmington, MA,gained regulatory clearance to commence U.S. marketing effortsfor Aurora, the first MRI scanner designed exclusively for breastimaging.

Advanced NMR officials have experienced highs and lows on theAurora project since it was announced as an R&D goal for thesmall, publicly traded company in 1992. Funding demands associatedwith its development contributed to Advanced NMR's close encounterwith possible financial disaster in 1993 and led directly to theformation of Advanced Mammography Systems to raise cash that allowedthe project to continue.

Advanced NMR proposed a merger with Advanced Mammography Systemsin mid-February and was promptly hit with a stockholders' lawsuitrelated to the move (SCAN 2/28/96).

That development, however, did not diminish the importanceof the Aurora product launch for Advanced NMR officials.

"This is a momentous occasion for us," said Bob Kwolyk,vice president of marketing.

Aurora is designed to capitalize on MRI's star status as themodality of choice for soft-tissue imaging, while addressing challengingcost and patient-comfort issues unique to mammography.

By optimizing the scanner's electronics for breast imaging,Advanced NMR is bringing the 0.5-tesla Aurora to market for slightlyunder $500,000, an essential requirement for addressing the lowreimbursement rate for diagnostic mammography, according to Kwolyk.

The configuration is built around a superconducting magnetthat is installed in the examination suite wall. The scanner featuresa 60-cm bore flaring out to 75 cm. Patients are slid into themachine feet first, and lie on their stomachs during the procedurewith breasts suspended through a cutout that is surrounded bybilateral radio-frequency coils. Exams take about 20 to 30 minutes.

The setup is designed to minimize claustrophobia, Kwolyk said,while providing extra resolution gained by concentrating the scanner'simaging power to a 36-cm field-of-view for bilateral acquisitionsand 18 cm for procedures involving a single breast. A fat-suppressionimaging technique was developed by ANMR engineers to operate at0.5-tesla field strength.

Comparisons between Aurora's diagnostic prowess and the sensitivityto breast cancer attainable with 1.5-tesla supercons will be animportant part of Advanced NMR's sales pitch, according to EileenKirrane, vice president of corporate communications. The claimis based on comparisons between images of breast disease acquiredby Aurora and a high-field GE Signa, she said.

"You're buying a 0.5-tesla state-of-the-art system thathas 1.5-tesla performance parameters for $500,000," Kwolyksaid.

The marketing effort for Aurora will initially be directedat women's health and breast imaging centers. Medical Diagnostics(MDI), a New England imaging services company acquired by ANMRlast year, will also investigate possible deployment of Aurorain either fixed or mobile configurations, Kwolyk said.

The scanner will be touted as a powerful alternative to diagnosticx-ray mammography for equivocal cases, women with dense breasts,and the search for recurrent disease after surgery and radiationtherapy, Kwolyk said. An add-on biopsy unit is in development.

Advanced NMR's dedicated sales force will sell Aurora in theU.S. The company is in the market for partners to handle overseassales and distribution, he said.

More effort this year will also be devoted to clinical testsof Aurora, Kirrane noted. The first unit is being installed thismonth at a breast imaging center associated with the Universityof Texas Medical Branch in Galveston. Dr. Sandra Rhoden will bethe principal researcher.

Comparative studies conducted by Rhoden and others to measurethe clinical and economic outcomes possible with Aurora will stronglyinfluence its commercial success, Kirrane said.

"If this technology is to be successful, it will haveto do more than the current armamentarium driven by mammography.It's got to provide more information and make an impact from anoutcomes point of view," she said.