Myriad Seeking Distributor For SoundScan Bone Sonometer Approved By FDA

Myriad Ultrasound currently is negotiating with a number of potential U.S. distributors for its SoundScan family of bone sonometers following FDA approval, announced June 3.

The SoundScan ultrasound system, intended for use as an aid in diagnosing osteoporosis and estimating a patient's risk for bone fracture, is the second bone sonometer to gain FDA approval. Hologic's Sahara bone sonometer, FDA approved March 12 for diagnosing osteoporosis and estimating fracture risk, is being distributed directly in the U.S. by Hologic and through distributor Physician Sales and Service ("The Gray Sheet" March 16, p. 3).

Myriad's marketing efforts likely will benefit from clinical data, included in the firm's premarket approval application and presented at a November 1997 meeting of FDA's Radiological Devices Panel, that demonstrate the SoundScan provides more precise measurement of skeletal bone strength than the Sahara ("The Gray Sheet" Nov. 24, 1997, p. 3). The panel recommended that FDA approve the device, which has the ability to exclude "the surrounding soft tissue" during bone analysis, the firm explains.

In addition, the SoundScan Compact version is the "smallest and lightest bone sonometer on the U.S. market, weighing less than 10 lbs.," Myriad states. The Compact is designed for "single-users, small clinics and private offices," while the larger SoundScan 2000 version is aimed at the hospital market and higher-end clinics.

The "waterless" SoundScan system uses standard ultrasound gel and is passed longitudinally over the tibia to collect a series of transducer readings in a two to three-minute procedure. The SoundScan "provides a measure of skeletal fragility and can be used in conjunction with other risk factors as an aid in the diagnosis of osteoporosis and fracture risk," the firm states.

Rehovot, Israel-based Myriad first introduced SoundScan 2000 outside the U.S. in 1994, and a network of distributors already markets the system in Europe, Asia and South America. The Compact debuted outside the U.S. in 1997. In addition to Hologic, Myriad's competition in the U.S. bone sonometer market will include Lunar, which has a PMA pending at FDA for its Achilles system.