SBIR Success Story – QalibreMD, Inc. (QMD) (previously dba High Precision Devices, Inc. (HPD))

4601 Nautilus Ct. South, Suite 100
Boulder, CO 8030

Contact: Kevin Miller
Phone: 303-447-2558
E-Mail: kmiller [at] qalibre-md.com (kmiller[at]qalibre-md[dot]com)
Website: www.qalibre-md.com

Project Title: Optimization of the NIST/UCSF Breast Phantom for Quantitative MRI

NIST Award: 70NANB14H297

Technology Developed: QMD/HPD created a new breast phantom designed to (a) universally fit in all current breast coils, (b) simulate the heterogeneous distribution of fat and fibroglandular tissue, and (c) enable the evaluation of standard breast MRI protocols including quantitative T1, T2 and diffusion. This work provides a traceable calibration standard to substantially reduce measurement uncertainty in quantitative magnetic resonance evaluation of disease in breast tissues.

Key Words: Quantitative MRI calibration breast diagnosis cancer necrotic healthy

Uses of Technology/Products/Service: QMD/HPD quantitative MRI technology hardware products, including the focus of this SBIR, the breast phantom and supports non-invasive quantitative imaging of diseases such as cancer and neurological disorders enable the harmonization of imaging data across all MRI scanners and longitudinally over time. In today’s MRI, which is qualitative by nature, one can identify a suspicious lesion, but an invasive biopsy is usually necessary for confirmation, and there is no quantitative method to determine the effectiveness of treatment. QMD’s products are revolutionizing this by enabling qMRI. Our qMRI products consist of physical ground truth standards that are designed as a reference to support diagnostic imagery of specific organs and anatomical features. These standards, including the breast phantom, incorporate carefully designed «mimics» of the span of human tissue characteristics ranging from healthy to diseased. The phantoms are traceable to NIST-defined standards for tissue response to magnetic resonance. In conjunction with software tools and guidance documents that are under development for characterization or correction of MRI scanners and images, this system enables clinicians to perform specific diagnostic or treatment monitoring techniques such as staging cancer or evaluating the effectiveness of neoadjuvant breast cancer therapies.

Benefit to Company: The NIST SBIR has enabled High Precision Devices and QalibreMD to conduct the research, design and protoyping of the breast phantom. The breast phantom is a critical element of establishing quantitative MRI technology because of the relatively high rate of occurrence of disease, and potential benefits in diagnostic effectiveness and patient outcome. QalibreMD is a startup spinoff from High Precision Devices, structured to commercialize quantitative MRI technology. This SBIR provided critical grant funds for advancement of this high payoff technology. Additionally, and also of great value to commercialization, the SBIR provided a basis for collaboration with subject matter experts from NIST. Additionally, the SBIR provided opportunity for collaboration with experts at UCSF who brought forth the operational expertise and many of the unique design objectives for the breast phantom. QalibreMD has established an excellent revenue stream from its quantitative MRI technology, including the breast phantom, in support of hospital researchers. We project even stronger growth as we expand the technology tool set in support of MRI physicists and technicians, as well as radiologists and others in the medical community.

Technology’s Impact on Company’s Growth: Strategic

How Product was Commercialized: QalibreMD has had a very successful commercialization effort thus far, principally focused on sales and technical support to MR researchers in hospitals, academia, government agencies and commercial MR OEM supplier organizations. QalibreMD approaches the commercialization effort on multiple fronts, as described herein: a) One aspect of this is to establish a reproducible, affordable product. This product has to offer a commensurate level of accuracy, life and repeatability necessary for the utility functionality of quantitative evaluation of MRI, as well as preserve the traceability to NIST-defined and vetted performance. In the broader market of medical imaging phantoms, the levels of quality, traceability and repeatability provided by QMD products is unique. B) A second aspect of our commercialization efforts is to make the technology readily available and accessible. This is through a combination of advertising, web presence and visibility to relevant professional communities through conferences and other technical interchange forums. C) A third aspect of commercialization efforts is to make the technology easy to apply. QMD has a concerted development effort underway to generate software platforms that can be used in conjunction with the breast phantom and our other hardware products. The software is used to provide rapid analysis of MR imaging results in specific parameter spaces.

The addressable markets include: 1) medical physicists and researchers who are evaluating and refining existing MR and medical protocols, as well as developing new protocols to improve effectiveness. QMD’s breast phantom provides a tissue emulator and performance reference tool to support evaluation of these efforts. 2) There are also unique markets for MR technicians and physicists who are responsible for machine performance and readiness in a clinical environment. QMD’s breast phantom provides a calibration reference traceable to NIST – analogous to having a reliable measure of weight or length – that can be used to evaluate machine performance on a routine basis and provide a quantitative measure of how errors in machine performance can be compensated. 3) In addition, there is a market for diagnostic support of scans of human patients. The value of having a reliable, traceable breast phantom in this environment is that, with an appropriate software “wrapper”, the phantom can be used as a tool to account for machine error, a basis for assessing nonuniformity in tissues, imaging biomarkers and staging of disease, statistical support and as a means of rapidly identifying regions of greatest interest to the radiologist.

QalibreMD has been recognized by a variety of medical professional, business and investment organizations for its work on advancing this paradigm-shifting technology.

Past R&D and/or Sales from this Project: Breast phantom R&D and sales are not available as a separate product line item. However, QalibreMD revenue and sales exceed $500k per year. Breast phantom sales are one of four standard products that comprise the majority of revenue. Furthermore, the National Cancer Institute has provided a $1.72M FastTrack award to QMD to further breast phantom qMRI technology by validating the phantom performance and reliability on a wide range of machines in different settings, and creating an open source software product for rapid evaluation of scan imaging results.  Based on the NIST Phase II effort, internal investment, the NCI award and our commercialization efforts, we project year over year  market growth of 50% or higher.

Estimated Future Annual R&D and/or Sales from this Project: With over 12,000 MRI installations in the US, and more than 30,000 installations worldwide, and the potential that quantitative MRI technology offers in terms of improved patient outcome and hospital productivity, market opportunities for the breast phantom and other quantitative MRI technology products is very promising.