# Bedside ultrasound system for 3D guidance of bone marrow aspiration and biopsy procedures

> **NIH NIH R44** · RIVANNA MEDICAL, INC. · 2020 · $670,777

## Abstract

PROJECT SUMMARY/ABSTRACT
 Bone marrow and trephine biopsy (BMTB) is the gold standard for diagnosing and monitoring
hematological disorders and malignancies. Although BMTB procedures rarely cause serious adverse events,
the number of non-diagnostic biopsies should be minimized because repeated testing delays diagnosis and
treatment, consumes additional healthcare resources, and causes unnecessary patient anxiety and discomfort.
World Health Organization guidelines recommend that bone marrow biopsy cores exceed 1.5 cm in length,
however multiple clinical trials have reported that 20 – 50 % of core lengths are ≤ 1.0 cm, suggesting that these
clinical recommendations are not regularly met. This conclusion is further supported by the finding that
between 5 – 25 % of BMTB specimens are deemed non-diagnostic by pathology, often necessitating a repeat
BMTB procedure, referral for radiographic guidance of the BMTB procedure, or ultimately resulting in an
ambiguous or false negative diagnosis.
 The goal of this Phase II project is to finalize the design and fabrication of a clinical-trial-ready imaging
system (Accuro 3S) for real-time 3D image guidance of bone marrow trephine biopsy procedures at the
bedside. The key technological innovations of this project include: (i) the design of a miniaturized 3D
ultrasound imaging probe, (ii) the development of advanced bone-specific imaging and 3D rendering
technologies for generating volumetric reconstructions of the patient's iliac crest in real-time, and (iii) the
implementation of an image processing algorithm that automatically detects the posterior iliac crest and assists
with automated needle guidance to the target anatomy to facilitate biopsy acquisition. The intent of these
technologies is to provide an intuitive visualization of the iliac crest and to avoid difficulties associated with
ultrasound image interpretation when conducting an image-guided interventional procedure. Core technologies
will be developed and tested via extensive in vitro imaging studies of anatomically correct phantoms prior to
pre-clinical validation in a human cadaveric specimens.
 The impact of the proposed solution is a significant improvement in BMTB success rates and a reduced
rate of referral for radiographic guidance. These effects are expected to reduce delays in BMTB acquisition,
reduce patient exposure to ionizing radiation, and reduce costs due to the need for fewer repeat biopsies and
fewer referrals for radiographic guidance. Together, the annual costs due to referral for radiographic guidance,
repeat BMTB procedures, and costs stemming from diagnostic errors exceed $480M/yr. For these reasons,
BMTB specimen retrieval at the bedside in the hematology clinic is the preferred biopsy technique. The
technological solutions proposed in this Phase II application seek to enable improved outcomes of BMTB
procedures performed at the bedside. Finally, the total US market size for this device is estimated to be
$230M/yr, supporti...

## Key facts

- **NIH application ID:** 10005652
- **Project number:** 1R44CA246854-01A1
- **Recipient organization:** RIVANNA MEDICAL, INC.
- **Principal Investigator:** Frank William Mauldin
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $670,777
- **Award type:** 1
- **Project period:** 2020-05-01 → 2022-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10005652

## Citation

> US National Institutes of Health, RePORTER application 10005652, Bedside ultrasound system for 3D guidance of bone marrow aspiration and biopsy procedures (1R44CA246854-01A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10005652. Licensed CC0.

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