FDA nod for Sahara densitometer helps Hologic target new markets

Company to focus on physician offices through PSS

Bone measurement companies are hoping that a new wave of ultrasound-based densitometers will help lead their market out of the doldrums. Hologic of Waltham, MA, will become the first densitometry vendor to test whether these hopes are justified, after receiving Food and Drug Administration approval on March 12 for its Sahara clinical bone sonometer.

Sahara uses ultrasound to measure bone density in the heel, and produces data that can be used as an aid in the diagnosis of osteoporosis and in estimating a patient's risk for future fracture. Ultrasound-based densitometers are smaller, more portable, and lower priced than x-ray-based systems, and are more suited to small physician offices that haven't yet acquired bone measurement technology.

Bone densitometry companies are in serious need of new markets such as physician offices. The spurt of growth linked to the commercialization in 1995 of Merck's Fosamax osteoporosis drug appears to have run its course, and most densitometry companies have been reporting lower sales and net income numbers for the past several quarters (SCAN 1/21/98). Nearly every major bone densitometry company has an ultrasound-based product in development.

The 22-lb Sahara assesses the os calcis, or heel bone, using ultrasound gel as the interface between the patient's skin and its dual transducers, one for transmitting ultrasound waves and the other for receiving echoes. The attenuation of these waves indicates the density of the bone in the heel.

Exams require only about one minute. Results are interpreted in the context of family history, lifestyle, diet, and age. On those bases, the physician may decide to begin drug therapy to prevent or treat osteoporosis, according to Hologic.

Although Sahara is the first such system to reach the market, for a time it was questionable whether Hologic would earn this distinction. Sahara appeared to be on a fast track to market after an FDA advisory panel recommended approval of the device's premarket approval (PMA) application last August. But an FDA inspection of Hologic's manufacturing plant late last year turned up problems related to the company's record-keeping practices that required correction before final approval could be granted. One week after receiving a thumbs-up from inspectors in early March, the company got final approval on its bone densitometer.

Sahara has met with lackluster sales in Europe and Asia, but positive conditions in the U.S. are likely to support a stronger performance. Efforts by the National Osteoporosis Foundation and pharmaceutical companies, which target primary-care physicians and end users, have been steadily building interest in osteoporosis screening, said Mark Duerst, Hologic's vice president of sales and marketing.

Growing interest. About a half-dozen vendors hope to benefit from the growing interest in ultrasound bone densitometers. Executives with Hologic's arch-rival, Lunar of Madison, WI, believe that their company's Achilles bone densitometer could be the next to pass FDA muster, and are hoping for a positive announcement in the next few months. Among the other companies with similar products are Norland of Fort Atkinson, WI, and Diagnostic Medical Systems (DMS) of Montpellier, France. Another company, Metra Biosystems of Mountain View, CA, announced March 17 that it had received a patent three weeks earlier covering a transducer and an algorithm that the company hopes will give its QUS-2 ultrasound product an advantage over those of its competitors.

The surge in interest in ultrasound bone densitometers could not have come at a better time. The bone densitometry industry is floundering after several years of booming growth, and the stagnant market may be related to improved productivity of densitometers installed in the most recent growth wave. Whereas typical throughput on a new machine two years ago was just four or five patients per day, the machines have been handling a dozen or more patients daily. Increasing the productivity of installed systems has dampened demand for new products among traditional buyers in rheumatology, endocrinology, and radiology.

Ultrasound densitometers, however, promise to rejuvenate sales by addressing new markets, specifically the individual and group practices of primary-care physicians. Hologic is well positioned to penetrate these markets, having signed up Physician Sales and Service (PSS), a Jacksonville, FL, distributor with more than 1000 sales representatives that focuses on selling medical products to private physician practices in the U.S.

"PSS was recruited two years ago specifically for this product," Duerst said.

Hologic will use its own sales force to approach traditional markets, he said.

Sahara users will be advised by Hologic to employ a CPT code for unlisted ultrasound procedures when seeking reimbursement. The code allows physicians to request reimbursement at a reasonable rate, according to Duerst. Hologic will suggest $40, the amount now allowed for peripheral x-ray exams. Duerst hopes a specific CPT code for ultrasound-based bone densitometry will be in effect by January 1999.

Ultrasound-based products have an advantage over the premium dual-energy x-ray absorptiometers (DEXA) that sell for $70,000 and more. This price advantage dissipates, however, when compared with DEXA systems that measure bone in peripheral regions, such as the forearm. The new Sahara is list-priced at $30,000, which is comparable to many peripheral DEXA scanners.

Ultrasound units have an indisputable regulatory edge over x-ray systems, however. About half the states in the U.S. have regulations for x-ray units and the technicians who operate them. Duerst expects the lack of such regulations for ultrasound systems to help spur Sahara sales.