The mission of AEIOU Scientific, LLC is to improve the targeting of medical care for the prevention of low-trauma fractures. In America, 1 in 2 women and 1 in 4 men over age 50 suffer such a fracture. A quarter of hip fracture patients die within a year and half are disabled in walking. The primary cause of these low-trauma fractures is osteoporosis.
AEIOU Scientific, LLC, (AEIOU) is developing and commercializing Ohio University’s patent-pending Cortical Bone Mechanics Technology™ (CBMT) to enable better measurement of bone strength. The first product is a scientific laboratory instrument for researchers. This instrument is for scientific use only, and not for use in diagnostic procedures. AEIOU will also develop CBMT as a non-invasive medical device to be submitted for approval by the FDA for improving the diagnosis and monitoring of osteoporosis and other bone diseases (this device is not cleared by the FDA for distribution in the United States).
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.
Results indistinguishable from Quasistatic Mechanical Testing (QMT)
Rapid reproducible results
CBMT devices well suited for research studies because of ease of operation and consistency of results
Non-Invasive and Non-Significant Risk
Planned for eventual FDA submission of a CBMT medical device
Our Cortical Bone Mechanics Technology™
A scientific lab instrument developed for laboratory bone research studies. We are also developing a CBMT medical device (for FDA approval).
Ohio University IRB approved CBMT device for use in human subjects research
Measures cortical bone stiffness including bone protein and surrounding tissue
Mechanical Bending Test
CBMT device performs a non-invasive mechanical bending test of the mid-shaft of the ulna
CBMT utilizes improved Mechanical Response Tissue Analysis (iMRTA™) methods
Frequency response in skin-bone
Direct functional measures of the mass, stiffness, and damping of cortical bone in living persons
CBMT has been tested extensively on human volunteers and cadaveric arms
Osteoporosis is characterized by reduced bone strength leading to an increased risk of fracture. It causes pain, disability and more deaths among women than heart disease, stroke and breast cancer combined. In the US, 1 in 2 women and 1 in 4 men over age 50 will suffer an osteoporotic fracture with annual medical costs expected to reach $25 billion by 2025. Since 1993, physicians have diagnosed osteoporosis by measuring bone mineral density (BMD) at spine and hip sites where most bone tissue is trabecular (i.e., spongy) bone. Since 2001, however, a series of studies have shown that BMD does not predict fractures well. In one study of 160,000 postmenopausal American women, for example, 11,397 (96%) of 11,806 women diagnosed with osteoporosis did not fracture, while 1,757 (81%) of 2,166 fractures occurred in women diagnosed without osteoporosis. Thus, the high cost of osteoporosis is driven by (1) unnecessary preventive care administered to most patients diagnosed with osteoporosis, and (2) fracture treatment for non-osteoporotic patients who were denied preventive care that they did need.
BMD fails to predict who will fracture because (a) BMD is only one of several factors that affect bone strength; (b) BMD measurements are not accurate (4-6); and (c) after age 60, most bone loss is cortical (i.e., dense) bone tissue. About 80% of fractures after age 60 occur at non-spine, mainly cortical sites, and 50% percent occur in the arm. Thus, a new diagnostic tool is needed to assess cortical bone.
Measurement Repeatability of CBMT. We measured ulna EI in 70 healthy human subjects. Measurement repeatability was determined in 6 subjects by 3 technicians with coefficients of variation within subjects and between technicians of 3.6% and 4.5%, respectively. By comparison, the repeatability of bone stiffness measurements by QMT in 3-point bending and of stress-strain index measurements by peripheral quantitative computed tomography (pQCT) have been reported as 10% (24) and 7% (25), respectively.