# Development of Cortical Bone Mechanics Technology for Enhancing the Diagnosis of Osteoporosis

> **NIH NIH R44** · OSTEODX INC. · 2024 · $827,361

## Abstract

ABSTRACT
This Phase IIB SBIR grant application proposes to continue development and commercialization of OsteoDx’s
Cortical Bone Mechanics Technology™ (CBMT™), a novel osteoporosis related diagnostic device that non-
invasively measures the mechanical properties of cortical bone and provides direct information about bone
strength and quality that is not accessible by other diagnostic modalities. OsteoDx has already successfully
illustrated commercial feasibility and demonstrated that CBMT can accurately and efficiently estimate ulna bone
bending strength (R2=0.99). OsteoDx also established that CBMT is sensitive to detecting change in bone
strength and provides information about cortical bone that is unique and independent of Bone Mineral Density
(BMD), which suggests CBMT may yield clinically significant information about osteoporotic fracture potential.
Osteoporosis is a common medical condition causing progressive weakening of bones, eventually leading to
nontraumatic or fragility fractures. These fractures are painful and, in many cases, cause prolonged or life-long
disability, and dramatically increases mortality rates up to 8x within 3 months post fracture. The Bone Health and
Osteoporosis Foundation projects that by 2025, there will be 3 million osteoporosis related fractures every year
in the US, resulting in healthcare costs of more than $57 billion. Numerous treatments with varying mechanisms
of action exist for osteoporosis and, if given to high-risk individuals, could dramatically reduce the risk of fracture.
However, current osteoporosis 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 at high risk of experiencing a fragility fracture. For instance, <50% of the variation in whole-bone
strength is attributable to variations in BMD, and the vast majority of patients who sustain fragility fractures do
not have low BMD (i.e., they have T-score’s above −2.5). Thus, there is a large unmet need to better diagnose
patients who are at risk of fracture, so that physicians can accurately identify individuals who would benefit from
osteoporosis medications and to better monitor the effectiveness of treatment. OsteoDx’s market research,
interviews with key opinion leaders, and prior meetings with the FDA have identified the most important and
immediate commercialization milestones necessary for FDA approval and market adoption: a study that
demonstrates the accuracy (aim 1) and clinical precision (aim 2) of the final design production version of the
medical device, and advances safety and regulatory compliance (aim 3). Thus, in this Phase II application we
propose a series of experiments, tests, and approaches to accomplish the above-mentioned aims. Upon
successful achievement of these aims, OsteoDx will be positioned to submit a Class II de novo medical device
application to the FDA for noninv...

## Key facts

- **NIH application ID:** 10876493
- **Project number:** 5R44AG058312-05
- **Recipient organization:** OSTEODX INC.
- **Principal Investigator:** Brian C Clark
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $827,361
- **Award type:** 5
- **Project period:** 2017-12-01 → 2026-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10876493

## Citation

> US National Institutes of Health, RePORTER application 10876493, Development of Cortical Bone Mechanics Technology for Enhancing the Diagnosis of Osteoporosis (5R44AG058312-05). Retrieved via AI Analytics 2026-05-31 from https://api.ai-analytics.org/grant/nih/10876493. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*