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Company takes on segment dominated by NorlandThe peripheral densitometry market will soon have a new competitor. Densitometry firm Lunar, which has built its reputation largely through the sale of premium axial scanners, plans to introduce a
Company takes on segment dominated by Norland
The peripheral densitometry market will soon have a new competitor. Densitometry firm Lunar, which has built its reputation largely through the sale of premium axial scanners, plans to introduce a peripheral densitometer later this month. The new product, called PIXI (peripheral instantaneous x-ray imager), will be able to scan both the heel and forearm and will compete directly with products being sold by Norland Medical Systems of White Plains, NY.
Lunar of Madison, WI, plans to officially unveil PIXI on April 28 at the annual meeting of the American College of Obstetricians and Gynecologists (ACOG), with international distribution starting next month. Sales in the U.S. depend on the Food and Drug Administration completing its review, which is now under way. Lunar president Richard Mazess expects PIXI to expand Lunar's revenues, while boosting the number of patients who can be assessed for bone loss.
Lunar's strategy is to place PIXI in outpatient medical sites, including clinics and physicians' offices, so that patients likely to have bone loss can be referred to another, perhaps central facility for an axial scan. Axial systems that perform such scans examine the hip and spine for bone loss likely to lead to debilitating fractures.
"PIXI will be a way to classify patients who need further testing and then definitively identify those who need drug therapy," Mazess said.
PIXI will be targeted at patients at risk of developing osteoporosis, such as postmenopausal women or patients with a family history of osteoporosis, who might otherwise forgo an examination due to cost. The product is not intended for screening, which Mazess defines as studying patients who have no signs, indications, or symptoms.
About eight million to 10 million women in the U.S. alone are at high risk of developing osteoporosis, Mazess said, yet only 5% to 10% of the people with indications are being examined with densitometry. PIXI is expected to help Lunar tap this market.
PIXI uses dual-energy x-ray absorptiometry (DEXA), the same technology employed by axial scanners. Collimators focus the x-ray beam into a cone that passes through the heel or forearm and onto a scintillation screen. An optical lens then focuses the image onto a charge-coupled device (CCD).
Lunar may be just the first of several companies to introduce this CCD-based technology into the bone densitometry marketplace. The technology has been licensed from the University of Massachusetts, not only by Lunar but by competitors Hologic and CompuMed as well. CCDs are in demand because of their high sensitivity, which allows the use of an x-ray generator driven by electrical current found in standard wall outlets.
A major appeal of the system is its ease of use and speed. A single push of a button and just five seconds are needed to complete a scan. A PC generates a quantitative analysis of the bone and a digital image, which can be displayed by pushing a button or clicking a mouse. The measurements or image can then be printed on a laser printer hooked up to the PC, again with a single push or click.
PIXI is just one of two approaches that Lunar is exploring for accessing the peripheral densitometry marketplace. The other is an ultrasound-based heel assessment system, called Achilles. That system, however, is at least a year away from marketing in the U.S. because of the need to file a premarket approval (PMA) application. Because PIXI is substantially equivalent to other x-ray densitometers on the market, Lunar is following the much less rigorous and time-consuming 510(k) route for this product.
Lunar has not been daunted by the recent decision of the Health Care Financing Administration to establish a reimbursement code for peripheral densitometry that is less than one-third that of axial exams (SCAN 1/8/97). David Weissburg, marketing director at the company, views the Medicare decision as an opportunity rather than an impediment to sales. The break-even point on the low-cost PIXI will be just three to four patients per week, he said. The price of PIXI has not yet been set, but Weissburg expects it to be in the low $30,000 range.