# Development of a Photoacoustic Quantitative Ultrasound (PAQUS) device for clinical use

> **NIH NIH R44** · IF, LLC · 2021 · $942,730

## Abstract

TITLE: DEVELOPMENT OF A PHOTOACOUSTIC QUANTITATIVE ULTRASOUND (PAQUS)
DEVICE FOR CLINICAL USE
Abstract:
Osteoporosis is a major public health threat with significant physical, psychosocial, and financial consequences.
Technologies that can facilitate population screening, early diagnosis and, more importantly, highly sensitive
therapeutic assessment are crucial for achieving optimal management of osteoporosis. Clinically available diagnostic
technologies for osteoporosis rely on either X-rays or ultrasound (US) to assess bone mass. Although representing
the integrated effects of osteoclast and osteoblast activity and the appearance of altered skeletal structure, these
standard clinical techniques have no or limited sensitivity to the real-time cellular activities and physiological properties
in bone, resulting in a delay of information relayed to the clinician. Therefore, there is a clear and urgent need to
develop alternate methodologies that add diagnostic imaging power using instruments that are cost-effective and
accessible for wide-spread use.
To fill this long-standing gap in technology, the objective of this program is to develop and commercialize an innovative
and cost-effective device for early and accurate diagnosis and treatment monitoring of human osteoporosis. By
combining our recently invented photoacoustic (PA) bone assessment techniques with more established quantitative
ultrasound (QUS), the proposed PAQUS device can measure a group of biomarkers, including bone mass and bone
microstructure, as well as chemical and functional properties which can then be combined with established biomarkers
from QUS, such as speed of sound (SOS), broadband ultrasonic attenuation (BUA), and stiffness, to achieve more
comprehensive assessment of bone health.
In the last two years, sponsored by the Phase I SBIR project, the feasibility of PA assessment of human bone health
has been rigorously validated. Experiments conducted in vivo on the calcaneus bones of 20 females (10 healthy
volunteers and 10 subjects with osteoporosis) demonstrated that by performing spectral analysis of light-induced
acoustic signals from a calcaneus bone over a broad optical spectrum, both chemical and micro-structural information
in the bone can be obtained in a non-invasive and non-ionizing manner. Encouraged by the successful Phase I study,
we now propose to further develop and commercialize this highly translational PAQUS technique in Phase II, aiming
at a comprehensive and objective validation of the overall performance of PAQUS, and to prepare the device for FDA
approval. To achieve this goal, three Specific Aims are proposed. Aim 1: Refine and optimize PAQUS method and
establish testing phantoms; Aim 2: Develop clinical PAQUS system; and Aim 3: Perform pre-market field evaluation
and collect reference data on a minimum of 150 individuals as a representative sampling based on the FDA’s
publication “Bone Sonometers - Class II Special Controls Guidance for Industry and ...

## Key facts

- **NIH application ID:** 10258569
- **Project number:** 2R44AR070071-02A1
- **Recipient organization:** IF, LLC
- **Principal Investigator:** Richard Franklin Morris
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $942,730
- **Award type:** 2
- **Project period:** 2017-09-15 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10258569

## Citation

> US National Institutes of Health, RePORTER application 10258569, Development of a Photoacoustic Quantitative Ultrasound (PAQUS) device for clinical use (2R44AR070071-02A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10258569. Licensed CC0.

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