SBIR-STTR Award

AEIOU Scientific, LLC. (AEIOU) aims to develop and commercialize Ohio University's (OHIO's) patent-pending Cortical Bone Mechanics Technology (CBMT) as a non-invasive medical device for improving the diagnosis and monitoring of osteoporosis and other bone diseases. Osteoporosis and low bone mass affect 54 million Americans and 325 million people worldwide. In women, the resulting fragility fractures cause pain, disability and a higher death rate 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. While osteoporosis is characterized by a decline in bone strength leading to an increased risk of fracture, no commercially available medical device measures bone strength. Instead, physicians decide who to treat to prevent fragility fractures based on bone mineral density (BMD) measured by dual energy X-ray absorptiometry (DXA), or based on clinical risk factors assessed by FRAX (a World Health Organization questionnaire). Unfortunately, repeated and consistent prospective studies have found that neither of these methods predicts fractures well. Bone stiffness accurately predicts bone strength, but the current method for measuring bone stiffness, Quasistatic Mechanical Testing (QMT), can only be performed on excised bones. OHIO's novel CBMT enables, for the first time, noninvasive measurements of bone stiffness that are indistinguishable from QMT measurements (R2 = 0.99). AEIOU's long term goal is to develop a commercial medical device based on this technology. High demand for a CBMT-based medical device has been confirmed through interviews of 188 potential customers in the 2016 iCorps@Ohio program. In Phase I of this SBIR project, we will conduct human factors engineering studies in Aim 1 to guide the design, fabrication and validation of a CBMT medical device in Aim 2. In Aim 3, we will conduct a controlled experiment to confirm that CBMT can detect effects of changes in bone protein on bone mechanics that are unique and independent of BMD. In Phase II of this SBIR project, AEIOU and clinical collaborators will conduct studies of patients with age-related and secondary osteoporosis and low bone mass to study the effectiveness of CBMT for predicting fragility fractures and for monitoring disease progression and treatment, and to document adverse events associated with the use of CBMT in these populations.

Project Terms:
Adverse event; Affect; Age; age related; American; arm; base; Biotechnology; bone; Bone Density; Bone Diseases; bone loss; bone mass; bone strength; Cadaver; Clinical; clinical risk; Computer software; cortical bone; data acquisition; Data Analyses; Death Rate; design; Development; Device or Instrument Development; Devices; Diagnosis; disability; Disease Progression; Doctor of Philosophy; Documentation; Dual-Energy X-Ray Absorptiometry; Effectiveness; Engineering; Error Sources; Europe; Event; Excision; experience; experimental study; Fracture; fracture risk; fragility fracture; Goals; hazard; Heart Diseases; Hip region structure; Human; human subject; Immersion Investigative Technique; improved; in vivo; Institutes; instrument; Interview; Investigation; Laboratories; laboratory equipment; Legal patent; malignant breast neoplasm; Manuals; Measurement; Measures; mechanical properties; Mechanics; Medical; Medical Device; Medical Device Designs; Medical Technology; Methods; Monitor; Musculoskeletal; Needles; Neurologic; novel; Ohio; Osteopenia; Osteoporosis; Outcome; Pain; patient safety; Patients; Performance; Phase; Physicians; Platelet Factor 4; Population; Porosity; Postmenopause; Potassium Hydroxide; prevent; programs; prospective; Prospective Studies; Proteins; prototype; Questionnaires; Relative Risks; Reporting; Reproducibility; Research; Research Personnel; Residual state; response; Risk; Risk Factors; Safety; Site; Skin; Small Business Innovation Research Grant; Speed; stroke; substantia spongiosa; success; Technology; Test Result; Testing; Time; Tissues; Trauma; ulna; Universities; Validation; Vertebral column; vibration; Woman; World Health Organization

AEIOU Scientific, LLC is currently in the process of converting to a C-Corp under the name of OsteoDx. This Phase 2 SBIR grant application proposes to continue development and commercialization ofOsteoDx's Cortical Bone Mechanics Technology™ (CBMT), a novel osteoporosis related diagnostic device thatnon-invasively measures the mechanical properties of cortical bone and provides direct information about bonestrength and quality that is not accessible by other diagnostic modalities. Phase 1 successfully illustratedcommercial feasibility and demonstrated that CBMT can accurately and efficiently estimate ulna bone bendingstrength (R2=0.99). We also generated strong evidence that CBMT provides information about cortical bone thatis unique and independent of bone mineral density (BMD), which suggests CBMT may yield clinically significantinformation about osteoporotic fracture potential. Osteoporosis is a common, chronic medical condition causingprogressive weakening of bones, eventually leading to nontraumatic or fragility fractures. These fractures arepainful and, in many cases, cause prolonged or life-long disability, and dramatically increases mortality rates upto 8x within 3 months post fracture. Numerous treatments with varying mechanisms of action exist forosteoporosis and, if given to high risk individuals, could dramatically reduce the risk of fracture. However, currentosteoporosis treatment decisions are heavily driven by X-ray based measurements of BMD and risk surveys.Unfortunately, these tools lack sufficient discriminatory sensitivity and accuracy to identify many individuals athigh risk of experiencing a fragility fracture. There is a large unmet need to better diagnose patients who are atrisk of fracture so that physicians can accurately identify individuals who would benefit from osteoporosismedications and to better monitor the effectiveness of treatment. OsteoDx CBMT technology has the potentialto meet these needs. OsteoDx's market research, interviews with key opinion leaders, and an initial meeting withthe FDA identified the most important and immediate commercialization milestones necessary for FDA approvaland market adoption, and resulted in the development of two Specific Aims: Aim 1) Complete device design tomeet specific clinical needs, and Aim 2) Conduct a clinical study assessing CBMT's fracture discriminationcapability. To achieve the aims of this proposal and the other commercialization objectives of OsteoDx, thecompany has assembled a team with broad experience and relevant expertise. The team includes seniorindividuals with mechanical design, biomedical engineering, aging and fracture risk assessment expertise, anda CEO and Board of Directors with successful medical device commercialization experience. The team also hasextensive experience conducting clinical studies.

Public Health Relevance Statement:
AEIOU Scientific's CBMT technology is intended to remedy the highly significant unmet need for an improved diagnostic identifying persons at high risk of suffering an osteoporosis related fragility fracture. If successful, CBMT will enable much more efficient delivery of anti-osteoporosis medication, greatly reducing the number of fragility fractures and their enormous healthcare cost burden. CBMT can also accelerate the development of new and better anti-osteoporosis therapies.

Project Terms: