Our Product: CBMT Instruments
Enables scientists to measure what they could not: accurate, non-invasive, direct functional measurements of the structural mechanical properties of cortical bone in ulnas of living people.
Our Cortical Bone Mechanics Technology Instrument™
Integer Scientific Instrument Model SI-001 is now commercially available. Contact us to learn more or place an advance order.
Funded by National Institute of Aging to develop CBMT Medical Device
CBMT reveals bone quality information that BMD cannot provide.
We measure the kind of bone most likely to fracture with osteoporosis.
The mission of OsteoDx is to develop and commercialize novel technology that enables the mechanical properties of cortical bone to be measured in living people. By pursuing this mission, we expect our customers to increase knowledge about factors causing bone fragility, and to better identify individuals in need of medical care to prevent fragility fractures. To better serve the different needs of these scientific and medical markets, OsteoDx operates two divisions, the Scientific Instruments division and the Medical Devices division.
Osteoporosis affects 54 million Americans and 325 million people worldwide. In women, the resulting low trauma fractures cause pain, disability and a higher rate of death than heart disease, stroke and breast cancer combined. The associated annual medical expenses will reach $25 billion in the US and €35 billion in Europe by 2025. Physicians use two methods to decide who to treat to prevent fractures. One is to diagnose osteoporosis by measuring Bone Mineral Density (BMD) at sites of predominantly trabecular bone in the spine and hip. The other is to estimate fracture risk by assessing clinical risk factors. However, in prospective studies of post-menopausal women, most diagnosed with osteoporosis or high fracture risk, or both, did not fracture, and most fractures occurred in women diagnosed without osteoporosis or at low risk Measurement of cortical porosity has been proposed to improve decisions to treat, because after age 60, most bone loss is cortical and most fractures occur at predominantly cortical sites. Yet again, prospective research has found most patients with high cortical porosity did not fracture and most fractures occurred in patients with low cortical porosity. Missing from all these methods is a direct functional measure of cortical bone strength.
Caution: Investigational device, limited by United States Law to investigational use.
OsteoDx is manufacturing and marketing scientific instruments using the patent-pending Cortical Bone Mechanics Technology™. CBMT instruments perform a noninvasive 3-point bending test on the forearms of living humans to deliver a direct, functional measurement of the mechanical properties of cortical bone.
A Critical Barrier to Progress
Osteoporosis is characterized by reduced bone strength, but no current medical device measures bone strength. Instead, since 1993 physicians have been advised to diagnose osteoporosis by measuring BMD at sites of predominantly trabecular bone in the spine and hip. However, subsequent research has found that BMD does not predict fractures well. In a study of 160,000 post-menopausal women, 11,397 (96%) of 11,806 women diagnosed with osteoporosis did not fracture, while 1757 (81%) of 2166 fractures occurred in those diagnosed without osteoporosis. Consequently, since 2011, many physicians decide who to treat by assessing clinical risk factors for fracture using the web-based questionnaire FRAX®. The FRAX® web page records 8000 assessments per day. Yet, a recent prospective study of post-menopausal women found that 74% of those identified by FRAX® as high risk did not fracture, while 81% of fractures occurred in women identified as low risk. Combining BMD and FRAX® only reduced these errors to 69% and 62%. As a result, preventive care is administered to millions of patients who do not fracture, and withheld from millions who do. These diagnostic errors drive healthcare costs.
OsteoDx is poised to overcome that barrier with new CBM technology that measures cortical bone strength more accurately. We are currently marketing a CBMT scientific laboratory device for scientific research use. In parallel, we are working under NIH and other funding to develop CBMT as a separate product for future use as a medical device. (This device is not cleared by the FDA for commercial distribution in the United States - Caution: Investigational device, limited by United States Law to investigational use).