Rather than consolidate, as industries often do under economic pressure, the industry that makes bone densitometry equipment is expanding in a few ways. Two companies, Pronosco and Sunlight Ultrasound Technologies, exhibited bone density products for the first time at the 1999 RSNA meeting. They joined such veterans as Hologic, Lunar, and Norland Medical, which are seeking to broaden their markets beyond the traditional bounds of patients at risk for developing osteoporosis. Driving this activity is saturation in the market for bone mineral densitometers.
“Today’s challenge is to make money in a mature marketplace,” said Brad Herrington, director of marketing at Lunar of Madison, WI.
Novel attempts to do just that were apparent on the RSNA exhibit floor. Newcomer Pronosco, whose U.S. office is in Pittsburgh, advocated the use of x-ray equipment in combination with its X-Posure system to measure bone density.
“The precision is very high, because it’s a fully automated system,” said Paul Lucas, vice president of sales and marketing for the U.S. “You just put the x-ray on the scanner and the system does everything else.”
A standard radiograph of the hand and forearm is digitized with an off-the-shelf PC scanner and fed into a desktop computer, where Pronosco software automatically identifies regions of interest, calculates bone density, and compares the measurements to a reference database to assist in the assessment of possible osteoporosis. The turnkey system, comprising computer, scanner, and software, lists for $25,000. Sales of the Food and Drug Administration-cleared product began in the U.S. in October.
Israel-based Sunlight showed a work-in-progress ultrasound system, called Omnisense, that measures bone density at up to four different sites, including the fingers, wrist, and heel. The system, which is expected to list below $25,000 and is pending FDA clearance, uses a hand-held probe rather than the heel-based approach used by most other companies. The probe includes both the ultrasound transmitter and the receiver.
“Omnisense is just as accurate as the gold standard, DEXA (dual-energy x-ray absorptiometry),” said Jeff Freilich, director of marketing for Sunlight. “We don’t want to compare ourselves to other ultrasound machines. We want to compare ourselves to DEXA as an alternative (to x-ray) for the primary-care market.”
Among the leading DEXA companies at the RSNA was Hologic, which earlier in 1999 bought Direct Radiography Corp., a developer of digital x-ray products, as a way to diversify its product line (SCAN 5/12/99). The Bedford, MA-based Hologic underscored its commitment to bone densitometry at the RSNA show, introducing Delphi QDR. The new product, which uses high-resolution fan-beam technology, allows the simultaneous assessment of existing vertebral fractures and low bone density. The system features Instant Vertebral Assessment, which allows a morphometric assessment of vertebral deformities.
“If you don’t do a full-fledged morphometric assessment, you are missing a big piece of diagnostic information,” said Hologic chairman David Ellenbogen.
The Delphi also offers a new Windows-based operating system; an auto-analysis feature for assessing spine and hip bones; and a capability called Dual Hip that automatically assesses dominant and nondominant femur BMD, leading to identification of the site with the lowest bone density.
Lunar of Madison, WI, showed DPX-NT, designed as an economical yet high-performance scanner that delivers bone density measurements of the spine, femur, and total body. The Dual Femur mode measures both femurs in a single, automated sequence.
The pencil-beam system is built around Lunar’s proprietary enCore software, which is based on Windows NT. An intuitive user interface reduces training time while increasing reproducibility. The SmartScan feature automatically locates the bone. By eliminating the need for scout scans, procedure time and dose are reduced.
The company is hoping to extend its market beyond patients at risk for weakened bones due to osteoporosis, a strategy reflected in Lunar’s positioning of the DPX-NT for sales to sports medicine and wellness programs, as well as for the assessment of patients with eating, growth, and metabolic disorders.
Exemplifying the interest in diversification was Norland Medical. Having decided that the BMD market has little opportunity for growth in the near term, the company launched several new product lines addressing market segments described by executives as musculoskeletal in nature. These include sports medicine, pain management, and rehabilitation.
Exhibited by Norland for the first time at the RSNA show was Galileo, a patent-pending exercise system designed to rebuild ailing muscles as part of rehabilitation and sports medicine programs. Also shown was Leonardo, a device intended to monitor patient progress. The company unveiled a third product, Orbasone, an “orthotripter” that fires sound waves to massage sore joints, muscles, and ligaments. Norland is distributing these products from Bionix, a limited liability company controlled by Norland chairman, Reynald G. Bonmati.
“We’re expanding our business and we intend to expand our markets,” said Ralph Cozzolino, vice president of U.S. sales and marketing for Norland.
Norland also continues to evolve its BMD products. The XL Plus, a small-footprint axial scanning unit, was upgraded to allow lateral spine and forearm measurement, as well as the hip scans that were standard when the system was released at the 1998 RSNA meeting. Also featured this year was a new high-end release, the XR 46, and a second-generation peripheral scanning system, Discovery, which can scan the forearm in less than two minutes. In development is an ultrasonometer that measures bone density in the heel, featuring self-calibration and an adjustable heel fitting.
Two other veterans of the BMD industry, Mindways Software and Image Analysis, showed improved technologies. Mindways of San Francisco upgraded its 3-D QCT (quantitative CT) technology to allow advanced volumetric scanning. Called QCT Pro, the software system uses a 3-D data set from a CT scanner to achieve increased precision. The Windows-based system runs on a desktop PC, integrating application management, quality control, scanner interface and image translation, and a patient database.
Image Analysis put its own twist on desktop systems, showcasing the Index, which measures BMD of the fingers using four different x-ray energies rather than the two commonly applied by manufacturers. The system, which has not yet received FDA clearance, will be marketed to primary-care physicians.
The Columbia, KY, company’s main business, like that of Mindways, is hospital- and clinic-based quantitative CT systems. And, like Mindways, Image Analysis focused on 3-D QCT at the RSNA. A vertebral data set, obtained with a spiral CT, is reformatted to create quantitative measurements in different planes and at different regions of interest. The goal is to achieve the precision needed to gauge patient response to treatment after six months or less.
“With modern DEXA (dual-energy x-ray absorptiometry) systems you might have to wait two years to see a response to therapy,” said Ben Arnold, president of Image Analysis. “That’s a long time to be taking a drug to find out if it works.”
While DEXA has its drawbacks, Arnold notes that it has become the de facto standard for patient assessment. As a result, the company this year released DXAView, which converts the CT image data into 2-D, DEXA-like measurements.
Marketing-driven product development appears to be the new trend in the bone densitometry industry, as it attempts to adapt to changing times. Market acceptance has become paramount, whether that acceptance comes in the traditional segments of the BMD industry or not.
