Swedish manufacturer Demetech plans to begin marketing a peripheral bone densitometer in the U.S. by year end. The DXL Calscan is based on technology the company believes will substantially improve the ability of clinicians to accurately diagnose
Swedish manufacturer Demetech plans to begin marketing a peripheral bone densitometer in the U.S. by year end. The DXL Calscan is based on technology the company believes will substantially improve the ability of clinicians to accurately diagnose osteoporosis.
Unlike competing densitometers that use dual-energy x-ray absorptiometry (DXA), DXL Calscan, which the FDA cleared in May, combines DXA with a laser measurement technique to determine bone density. This method eliminates what Demetech executives perceive as a shortcoming in existing DXA-only technology.
"DXA measures more than just bone-it measures bone and bone marrow fat combined," said David Weissburg, vice president for Demetech North America. "For most women, about half the bone marrow is filled with fat. If an individual's bone marrow fat deviates from that average, then the result measured with the DXA-only technology is inaccurate."
The technology, which Stockholm-based Demetech developed in the late 1990s, distinguishes between bone and bone marrow fat to deliver a more accurate measure of bone density. Weissburg claims that DXL is 97% accurate, compared with 80% to 85% for competing products.
"We believe that at least one of 10 patients is misdiagnosed using DXA and that those initial diagnoses would be different if physicians had a measure of the individual's fat-corrected bone density rather than the bone density result obtained using an average fat value for a population," Weissburg said.
DXL Calscan is already available in selected European markets. It was first launched in Sweden two years ago and in Germany and the U.K. the following year. The product is the third densitometer developed by eight-year-old Demetech. The other two, both DXL-based systems, were developed but not brought to market, although one still might get there. The hip/spine densitometer is being groomed as a commercial complement to the DXL Calscan, which will lead the company's charge into this arena.
Demetech will be battling only two major competitors, Hologic and GE Lunar, whose technology has not changed much over the past decade, Weissburg said. Company strategists plan to match the DXL Calscan primarily against GE's Pixi, a peripheral bone densitometer that first entered the market nearly a decade ago.
They hope to leverage the increased accuracy of the DXL Calscan and the system's enhanced x-ray design, which exposes the patient to a lower radiation dose. They will be using money from investors, including the Karolinska Investment Fund and Scandinavian Life Science Venture, to convince U.S. hospitals and clinics that the DXL Calscan is something new.
"Will it be difficult to compete with a GE? Absolutely," said Weissburg, a former executive at GE Lunar. "But we look at the lack of technical innovation in this area and see that it is ripe for something significantly and measurably better."