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Scanner INVESTOR PRESENTATION April 2024
Disclaimer ABOUT THIS PRESENTATION This investor presentation (this
"Presentation") is provided for informational purposes only. The information contained herein does not purport to be all-inclusive and neither QT Imaging Holdings, Inc. (the "Company", "QT Imaging Holdings",
"QTI"), nor its respective directors, officers, employees, agents, advisors or affiliates, including QT Imaging, Inc. ("QT Imaging"), makes any representation or warranty, express or implied, as to the accuracy, completeness
or reliability of the information contained in this Presentation, which has not been verified and is subject to change at any time. Viewers of this Presentation should each make their own evaluation of QT Imaging Holdings and of the relevance and
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employees, agents, advisors or affiliates for any loss howsoever arising, directly or indirectly, from any use of this Presentation or such information or opinions contained herein or otherwise arising in connection herewith. This Presentation does
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affiliates, nor shall there be any sale, issuance or transfer of securities in any jurisdiction where, or to any person to whom, such offer, solicitation or sale would be unlawful. You should not construe the contents of this Presentation as legal,
tax, accounting or investment advice or a recommendation. You should consult your own counsel and tax and financial advisors as to legal and related matters concerning the matters described herein, and, by accepting this Presentation, you confirm
that you are not relying upon the information contained herein to make any decision. On June 6, 2017, the U.S. Food and Drug Administration ( FDA ) in response to QT Imaging's Section 510(k) Summary of Safety and Effectiveness premarket
notification under the Food, Drug and Cosmetic Act, determined that the QT Breast Scanner is substantially equivalent to the predicate device. Our use of the words "safe", "safety", "effectiveness", and
"efficacy" in relation to the QT Breast Scanner in this Presentation and all other QT Imaging related documents is limited to the context of the Section 510(K) Summary of Safety and Effectiveness that was reviewed and responded to by the
FDA. TRADEMARKS AND INTELLECTUAL PROPERTY All trademarks, service marks, and trade names of QT Imaging Holdings or its affiliates used herein are trademarks, service marks, or registered trade names of QT Imaging Holdings or its affiliates, as noted
herein. Any other product, company names, or logos mentioned herein are the trademarks and/or intellectual property of their respective owners, and their use is not intended to, and does not imply, a relationship with QT Imaging Holdings or its
affiliates, or an endorsement or sponsorship by or of QT Imaging Holdings or its affiliates. Solely for convenience, the trademarks, service marks and trade names referred to in this presentation may appear without the , TM or SM symbols, but
such references are not intended to indicate, in any way, that QT Imaging Holdings or its affiliates will not assert, to the fullest extent under applicable law, their rights or the right of the applicable licensor to these trademarks, service marks
Disclaimer FORWARD LOOKING STATEMENTS Certain statements included in
this Presentation that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied
by words such as "has the potential to", "believe", "may", "will", "estimate", "continue", "anticipate", "intend", "expect",
"should", "would", "plan", "predict", "potential", "seem", "seek", "future", "outlook", and similar expressions that indicate or predict
future events or trends that are not statements of historical matters. These forward looking statements include, but are not limited to, the potential impact on existing medical technology, the company's technology, products, business
prospects, revenue, client adoptions, commercialization, projections of market opportunity and statements regarding estimates and forecasts of other financial and performance metrics. These statements are based on various assumptions, whether or not
identified in this Presentation, and on the current expectations of QT Imaging Holdings' management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not
circumstances intended to serve as, and must not be relied on by any investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. In addition, statements regarding the Company's products, technology,
and market opportunity reflect the beliefs and opinions of QT Imaging Holdings' management on the relevant subject as of this Presentation. Actual events and circumstances are difficult or impossible to predict and will differ from
assumptions. Many actual events and circumstances are beyond the control of QT Imaging Holdings. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market,
financial, political and legal conditions; risks related to the rollout of QT Imaging Holdings' business and the timing of expected business milestones; the demand for QT Imaging Holdings' products and services; the ability of QT Imaging
Holdings to increase sales of its output products in accordance with its plans; issues that could arise during the course of the acquisition of QT scanners by CMSC or the Feasibility Study; the desire of customers and service recipients to continue
engaging QT Imaging Holdings; the effects of competition on QT Imaging Holdings' future business, changes in the Company's strategy, future operations, financial positions, and product development timeline. If any of these risks
materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that QT Imaging Holdings presently does not know or believes is
immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect QT Imaging Holdings' expectations, plans or forecasts of future events and views
as of the date of this Presentation. QT Imaging Holdings anticipates that subsequent events and developments will cause its assessments to change. However, while QT Imaging Holdings may elect to update these forward-looking statements at some point
in the future, its specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing QT Imaging Holdings' assessments as of any date subsequent to the date of this Presentation.
QT Imaging Holdings (QTI) Has the Potential to Transform Medical Imaging
QTI is a medical device company with imaging technology that has the potential to transform the industry QTI Scanner is the only 3D imaging device to receive FDA clearance for use as a transmission and reflection ultrasonic imaging
system of a patient's breast QTI's patent-protected technology provides a relatively low-cost, comprehensive, no radiation, no discomfort medical imaging solution QTI's technology yields superior performance
compared to traditional mammogram with regard to specificity (false positives) and has similar imaging quality and diagnostic value compared to MRI but is a lower cost and more accessible solution. Copyright 2024 QT Imaging Holdings, Inc. All
QT Imaging Holdings (QTI) Has the Potential to Transform Medical Imaging
This sub-millimeter, high-definition, image resolution enables the identification of normal and abnormal breast structures and the accurate depiction and measurement of the precise shape and location of findings, as well as being suitable
for full body imaging and other applications QTI was founded by John Klock, MD, who is recognized globally as a successful co-founder of multiple companies, including one that successfully commercialized five FDA-approved drugs A
Introduction to the QT Imaging Holdings Management Team Nasser C. Bilal
Malik, Dr. Raluca Dinu Stas Budagov Steve Choate Pirshafiey, MBA Ph.D. CHIEF EXECUTIVE CHIEF FINANCIAL CHIEF OPERATING CHIEF PRODUCT CHIEF SCIENCE OFFICER OFFICER OFFICER OFFICER OFFICER Dr. Raluca Dinu is a global Mr. Budagov is serving as Mr.
Steve Choate, appointed Mr. Pirshafiey has been with Dr. Bilal Malik has over ten business executive, with long CFO of QTI since December as Chief Operations Officer at QTI since 2017. Previously, he years of experience in 2023. He has more than 15
QTI in April 2024, is public companies' governance founded and managed a research, development, and experience, offering over 22 years of accounting and responsible for managing the consulting firm providing translation of medical years of
achievements in the consulting experience, operations organization, sustainable practices to devices, both in academia including consulting public ensuring quality, and industries including medical high-tech industry, with an and industry. He is an
expert established track record of and private clients. fostering collaboration with device, high-tech, and in leading and directing Additionally, he has 3 years of internal, domestic, and driving increased revenue and consumer products for giants
efforts in image and data profitability, delivering strong audit experience at Ernst & international manufacturing such as Johnson & Johnson science and has a track results in turnaround or M&A Young. partners. and Siemens. He has 14
record of successfully leading inventions filed with the US situations, leading strategic innovation for medical growth, and consolidation in patent office. imaging products. fast-paced business environments. Copyright 2024 QT Imaging
Our Mission Create disruptive innovation-a dedication to
using technology (software, artificial intelligence, and smart physics) to improve medical imaging and thus health care quality and access. NIH has awarded QT Imaging about Continue to improve our FDA-cleared, high quality, high resolution,
native 3D, reproducible image quality regardless of operator or breast size/tissue $18M type breast imaging technology, as well as the techniques for quantifiable analysis, comparison, and training. for new women's imaging solution
Introduce the first comprehensive body-safe imaging technology into the marketplace, enabling for the first-time well-person body imaging health screening, and the first health screening medical imaging for infants. Expand the market
opportunities beyond hospitals, imaging centers and health centers by supporting additional direct to consumer (DTC) and direct to provider (DTP) approaches to enable the ability to lower health care costs and increase access via personal medical
Executive Summary Patent-protected technology: Low-cost,
comprehensive, quantitative, no radiation 14 granted US/Europe medical imaging solution yielding sub-millimeter, high-definition, image resolution: application in areas Software platform protected by trade secrets such as breast
infant body full body Sales Agent Agreement signed with NXC (1) Imaging (A Subsidiary of Canon Medical Commercial stage, FDA-cleared breast scanner Systems) for dense breast imaging, with better sensitivity and specificity
than mammography and potential for: Feasibility Study Agreement signed with Applicability to determine a measure of breast density Canon Medical Systems and measure mass size and growth Improved compliance with screening
guidelines Go-to-market strategy: US: Distributor network with strategic partners Expanded FDA clearances to increase access to medical imaging in multiple applications, including Developed roadmap for additional FDA
preventative screening clearances, product development, clinical adoption, and commercialization Breakthrough Device Designation awarded by the FDA provides fast track to unique CPT codes and future clearances (1) FDA Labels: K162372,
QTI's Technology Has the Opportunity to Transform Several Large
Markets (1) 2022 GLOBAL MEDICAL IMAGING MARKET SIZE: $29B Current Market Future Markets - Body Scanner Platform Development IMAGE-GUIDED PROCEDURES: (3) (4) (2) BREAST: $5B MARKET ORTHO: $9B MARKET INFANT: $8B MARKET (5) $5B MARKET FDA
approved as Target replacing MRI New market opportunity Commenced feasibility supplementary screening examinations given limitations of current study device for breast imaging imaging modalities for Primary focus on
Variety of image-guided infants orthopedic practices procedures including Aim to revolutionize current biopsies, injections and imaging paradigm, replacing cryoablation mammography, ultrasound (handheld and automated), and freeing
MRI scanners time (1) Medical Imaging Market Size, Share & Trends Analysis Report by Products (X-Ray, Ultrasound, Computed Tomography, Magnetic Resonance Imaging (MRI), Nuclear Imaging), by End Users (Hospitals, Diagnostic Imaging Centers, Other
End Users), by Region (North America, Europe, Asia Pacific, Latin America, Middle East & Africa) - Global Industry Assessment (2016 - 2021) & Forecast (2022 - 2028), Vantage Market Research (2) Coherent Market Insights (3) Global Orthopedic
Medical Imaging Systems Market Analysis Report 2022: Market to Reach $10.6 Billion by 2026 - The US Corners Orthopedic Medical Imaging Market with Adoption of Innovative Systems, Research and Markets. (4) Pediatric Imaging Market Size, Share &
Trends Analysis Report By Modality (X-ray, Ultrasound, MRI, CT), By Application (Gastroenterology, Cardiology, Oncology), By End User, By Region, And Segment Forecasts, 2020 - 2027, Grandview Research. (5) Image-guided Therapy Systems Market
Size, Share & Trends Analysis Report By Product (Ultrasound Systems, Computed Tomography Scanners), By Application, By End-use, And Segment Forecasts, 2022 - 2030, Grandview Research. 9 Copyright 2024 QT Imaging, Holdings, Inc. All
Agreement Signed with NXC Imaging A Subsidiary of Canon Medical Systems
Sales Agent Agreement signed with NXC Imaging marks a major milestone for QTI Accessing NXC Imaging's distribution channel in the US and the US territories, this agreement provides potential to accelerate the commercial roll-out of
Feasibility Study Agreement Signed with Canon Medical Systems
Canon to initiate studies to evaluate the business, technical, and clinical values of QTI's ultrasound breast scanner including: product quality validation development and manufacturing studies clinical evaluation
regulatory investigation, and market validation. QTI shall provide support for the feasibility study with Canon and shall use its commercially reasonable efforts to facilitate the feasibility study. All know-how and
intellectual property embodied in the QT Scanner are owned by QTI. During the term of the Feasibility Study Agreement, the QTI shall give Canon first priority in any negotiations for collaborations, including joint development, contract
Current Ultrasound Technologies Have Major Deficiencies (2) Shortfalls
of Commercial Current, Rival Systems : Reflection images have speckle; compounding without refraction correction No valid true "transmission" mode - use "shear wave" (low resolution) data (ABUS, AVUS,
etc. are not transmission) Data yielded is compounded 2D - not true "3D" - Transmission images have artifacts. Low contrast-to-noise ratios (speckle) Specificity for masses is relatively poor (1)
Unable to view consistently calcifications - misses 20% of cancers No "functional" imaging features for most(doubling time, tissue identification and specific tissue volume segmentations) Poor reproducibility of
measurement and volume data Operator dependence (HHUS) (1) A Multireader Multicase (MRMC) Receiver Operating Characteristic (ROC) Study Evaluating Noninferiority of Quantitative Transmission (QT) Ultrasound to Digital Breast Tomosynthesis
(DBT) on Detection and Recall of Breast Lesions Jiang, Yulei et al., Academic Radiology, in press. (2) Based on opinion of QTI management. QTI believes necessary data has been obtained through 18 separate clinical trials 13 Copyright 2024 QT
(1) Critical Modality Advantages of QTI's Breast Acoustic CT
Clinically useful sensitivity and specificity Presence of comparative clinical trials Proven success in head-to-head trials against mammography for primary screening Ability to determine doubling times - can
identify slow growing cancers and help prevent cancer deaths Enhanced volume measurements - can follow cancer treatments and provide breast density measurements Patented technology opens the door for potential future growth in
Why QTI Scan Generates Better Resolution Compared to MRI: More Data!
MRI QTI (3D UT) Spiral data Planar Volumetric acquisition 20mm for speed of overlapping acquisition detectors 2mm gap Receiver Array Receiver Array ~200,000 Data points per voxel Data points per voxel (1) times more data ~180 thousand data points
~36 billion data points per voxel than (N ) QT redundancy of data means: 22 million voxels MRI Similar collection time and resolution Higher detection capability Higher Signal-to-Noise (without Gadolinium or other contrast)
Repeatable quantitative measurements (1) Y. Gao and S. L. Heller, Abbreviated and Ultrafast Breast MRI in Clinical Practice, RadioGraphics, vol. 40, pp. 1507-1527, 2020 Quantitative and morphological biomarkers Note: Voxel is a 3D
Market Positioning of Breast Acoustic CT Scanner Not intended to
compete with mammography for screening, although many patients may find it preferrable for: Dense breasts Implants Post therapy screening where breasts can be very sensitive to compression When concerned about
radiation dose Diagnostic alternative to MRI Lower cost, faster, more accessible Similar image quality and diagnostic value More tolerable for patient (claustrophobia, noise, time, no contrast) Images are inherently
quantitative and repeatable, and hence serve as an imaging biomarker (helps following a patient) Scanner is easily deployable (<2 days) and frees MRI scanners for other non-breast imaging studies Diagnostic alternative to Hand-held
Ultrasound Native 3D imaging (like MRI and CT) Quantifiable image analysis No need for specialized technologist training Consistent and reproducible image quality regardless of operator Copyright 2024 QT
Technical Capabilities (1) Resolution of ~600 microns in
reflection compared to 800 microns for MRI (depends on field strength, homogeneity etc) Contrast to noise ratio of 23:1 at 100 microns ( in reflection; can detect small calcifications) Contrast to noise ratio of 15:1 (at resolution
in transmission - speed of sound) 0 Speckle-free because of 360 compounding and refraction correction for reflection image Volumetric data acquisition (3D), not stacked 2D slices Volumetric reproducibility 0.2% for
fibro glandular volume Volumetric accuracy better than 3% extrapolated from linear accuracy ~1% ( vertical < 2%) (1) Y. Gao and S. L. Heller, Abbreviated and Ultrafast Breast MRI in Clinical Practice, RadioGraphics, vol. 40, pp.
Enhanced Clinical Capabilities and Value High-quality and
high-resolution native 3D Imaging Quantifiable images enables accurate analysis, comparison and trending Consistent and reproduceable image quality regardless of operator or breast size/tissue type. Clinical feature detection
of 50-100 microns including microcalcifications Functional imaging capability - determine tissue type from the speed of sound Allows tissue doubling time assessments - similar to MRI and CT Highly accurate measurements,