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Fischer Imaging filed suit against competitor Lorad last weekalleging that the latter's StereoGuide stereotactic breast biopsysystem violates a patent covering features of its Mammotest stereotacticbiopsy system. Lorad received Food and Drug
Fischer Imaging filed suit against competitor Lorad last weekalleging that the latter's StereoGuide stereotactic breast biopsysystem violates a patent covering features of its Mammotest stereotacticbiopsy system. Lorad received Food and Drug Administration approvalto sell StereoGuide in February.
The Lorad and Fischer units are the only prone stereotacticbiopsy systems on the market. This type of design enables thebreast to hang freely through an aperture as the patient lieson a table. Stereoscopic x-ray images are then taken of the breastto localize the lesion for needle biopsy.
Lorad talked with about 12 potential luminary sites for StereoGuidesince showing the system as a works-in-progress product at the1991 Radiological Society of North America meeting. The companyhas geared up production of its stereotactic table and plannedto begin regular manufacturing by this month, said Hal Kirshner,president. Kirshner spoke with SCAN prior to Fischer's filingof the patent infringement lawsuit.
Denver-based Fischer, in announcing the suit filed in U.S.federal court in Colorado, said it had notified Lorad of the company'spatent claims in February but that "despite such notice,Lorad has continued to sell its system." Fischer is seekingto enjoin Lorad and its officers from manufacturing, using orselling StereoGuide.
Fischer maintains that Mammotest is safer and permits moreaccurate needle placement than upright biopsy systems. It is alsoless invasive and about a third of the cost of surgical biopsywith equivalent accuracy, the company said.
Lorad of Danbury, CT, has sold an upright stereotactic biopsysystem for over four years, according to Kirshner. Other vendorswith upright units include Siemens, GE and Philips.
Originally a U.S. distributor of Mammotest for Tekniska RÕontgencentralenAB (TRC) of Stockholm, Fischer signed an exclusive license withTRC four years ago to manufacture the system in this country.This was part of Fischer's strategy to diversify out of more competitiveand mature x-ray markets (SCAN 11/11/87).
Demand for Mammotest started slowly, however. Only four unitswere sold by Fischer in 1988, according to the company's prospectusfor its initial public stock offering last year. Meanwhile, Fischermodified the system to meet U.S. clinical needs and developedits own proprietary technology for the unit. Mammotest startedto catch on last year. 30 systems were sold in the first six monthsof 1991 (SCAN 7/31/91).
Fischer took over full control of Mammotest from TRC late lastyear. The U.S. company was granted worldwide marketing rightsand assumed all related trademarks and patents from the Swedishfirm (SCAN 10/9/91).
Increased sales of Mammotest last year were a major reasonfor Fischer's improved financial performance in 1991. Revenuesrose 30%, from $44.2 million in 1990 to $57.6 million in 1991.Fischer earned a profit of $2.8 million last year, compared toa loss of $487,393 in 1990 (see graph, previous page).
The Lorad stereotactic table has a number of features thatdifferentiate it from the Fischer unit, Kirshner said. StereoGuideprovides full 360´ needle access to the breast, which Mammotestdoes not. Stereoguide also uses a Cartesian coordinate systemfor localization, which improves accuracy, stability and easeof use, he said.
Lorad is developing a digital spot mammography system, labeledDSM, which can be used with StereoGuide. The digital system hasnot yet received FDA approval. Digital guidance of the biopsyresults in faster procedures and lower radiation exposure, Kirshnersaid.
"We have had clinical studies that show it (DSM) cutsthe procedure time in half. It also reduces patient dose and providesgreater diagnostic accuracy," he said.