Qt Imaging Holdings, Inc. · NASDAQ:QTI
Qt Imaging — Investor Presentation (May 2025)
70 slides from Qt Imaging's investor presentation, May 2025
Slide 1: Quantitative Transmission Imaging Investor Presentation
Quantitative Transmission Imaging Breast Acoustic CT Scanner INVESTOR PRESENTATION May 2025
Slide 2: Disclaimer
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 respecti
Slide 3: Disclaimer: Forward Looking Statements
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 generall
Slide 4: Disclaimer: Non-GAAP Financial Measures
Disclaimer NON-GAAP FINANCIAL MEASURES This presentation includes references to EBITDA and Adjusted EBITDA, financial measures that have not been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”). EBITDA is defined as loss before interest expense, inc
Slide 5: QT Imaging Holdings Has the Potential to Transform Medical Imaging
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
Slide 6: Our Mission
Our Mission NIH has awarded • Create disruptive innovation using technology (software, QT Imaging machine learning, and smart physics) to improve medical about imaging and thus, healthcare quality and access $18M • Continue to build upon our FDA clearances to offer QTI for new women’s as a breast sc
Slide 7: Our Management Team
Our 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 Copyright ©2025 QT Imaging Holdings, Inc. All Rights Reserved. 7
Slide 8: Executive Summary
Executive Summary Patent-protected technology: 14 granted patents in US/Europe + 2 new patent applications TECHNOLOGICAL CONSIDERATIONS PATIENT CONSIDERATIONS • FDA cleared for breast Imaging • Safe, no radiation, no contrast ➢ Breakthrough Device Designation awarded by the FDA • No discomfort, pain
Slide 9: Business Partnerships
Business Partnerships • Under Distribution Agreement with • Under Contract Manufacturing NXC Imaging (Subsidiary of Canon Agreement with Canon Medical Medical Systems) for U.S.A. market Systems − Committed quarterly minimum order − In the process of bringing up large scale quantities (MOQs) for scan
Slide 10: Breast Health
gy QT IMAGING Breast Health
Slide 11: QTI's Technology Has the Opportunity to Transform Several Large Markets
QTI’s Technology Has the Opportunity to Transform Several Large Markets 2023 Global Medical Imaging Market Size: $40B(1) CURRENT MARKET FUTURE MARKETS – BODY SCANNER PLATFORM DEVELOPMENT IMAGE-GUIDED PROCEDURES: BREAST: $5B MARKET (2) ORTHO: $9B MARKET (3) INFANT: $8B MARKET (4) $5B MARKET (5) • FDA
Slide 12: QT Imaging's FDA-cleared Solution for Dense Breasts
QT Imaging’s FDA-cleared Solution for Dense Breasts Many Women Have Dense Breasts, The FDA Has Recognized the Which Mammograms are Inefficient Importance of Breast Density in Screening for Cancer in Breast Cancer Screening 50% of women between 50% 50% the ages of 40-74 in the US have dense breasts(1
Slide 13: Clinical Evidence: Non-Inferiority to DBT
Clinical Evidence: Non-Inferiority to DBT Non-inferiority to DBT ROC curves Individual reader AUC • Breast Abnormalities The line closer to 1.0 is The line closer to 1.0 is indicative of higher accuracy indicative of higher accuracy • Benign, non-cancer, normal without biopsy • Cancer, abnormal with
Slide 14: Sensitivity and Specificity
Sensitivity and Specificity • Sensitivity − Lower for QT (70.6%) compared to DBT (85.2%) − Potentially attributable to reader unfamiliarity with QT imaging, suggesting a need for enhanced training • Specificity − Significantly higher for QT (60.1%) compared to DBT (37.2%) − Indicates QT's ability to
Slide 15: Subgroup Analysis: Dense Breasts
Subgroup Analysis: Dense Breasts MRMC Analysis Results by Breast Density of 24 Readers and 177 Cases (66 Abnormal, 111 Normal) BI-RADS Density N AUC ± SE 95% CI Abnormal/Normal QT DBT QT-DBT c, d 28/53 0.6852 ± 0.0457 0.5987 ± 0.0447 0.0865 ± 0.0557 [-0.0227, 0.1956] a, b 38/58 0.7912 ± 0.0335 0.779
Slide 16: Anatomic & Visual Grade with Comparative Modality
Clinical Evidence Anatomic & Visual Grade with Comparative Modality Normal Anatomic Comparison X-Ray Mammography (XRM) Handheld Ultrasound (HHUS) • Visual Graded Analysis • 4 readers • 5 readers • Compared QTI vs • 22 breast, 20 subjects • 17 breast, 17 subjects HHUS, XRM • Lower score means better
Slide 17: The Current Breast Imaging Paradigm Leads to Unnecessary Concern and Costs
The Current Breast Imaging Paradigm Leads to Unnecessary Concern and Costs Screening compliance is low For every 1,000 screening mammograms: 35% of women aged 40–70 do not get screened.(1) CALL BACK 35% RATES 98% of 65% Do not follow guidelines ~15% call-backs rates with 150 Recalls are Avoidable Fo
Slide 18: Recall Rate
Clinical Evidence Recall Rate • Recall Rates: 10% Approximately 150 women out of Combined Recall Rate every 1,000 screened are recalled for more tests. Out of those 150, • Adherence to screening only three or four will be diagnosed with cancer. compliance: Unnecessary recalls create stress − 16% Dec
Slide 19: Standard of Care Today and How QTI Fits In
Competitive Landscape Standard of Care Today and How QTI Fits In
Slide 20: Standard of Care Today, How QT Scan Fits In
Standard of Care Today 1, 2 How QT Scan Fits In Patient under the Patient age and risk Patient over the age of age of 40 undergoes assessment 40 undergoes routine risk assessment determines mammographic screening the screening pathway Patient is above- average risk Patient Patient is average or is h
Slide 21: Current Standard of Care in Breast Imaging
Current Standard of Care in Breast Imaging Risk Lifetime Breast Recommended Category Risk Density Imaging Modalities Guideline Recommendations NCCN(4): Annual mammography for women aged 40 and older. Screening Mammography Fatty ACR/SBI(1,2): Annual mammography starting at age 40. Average Risk ≤12–15
Slide 22: QTI's Current Indications For Use
QTI’s Current Indications For Use Broad intended use to allow breast imaging of any subject of age 18 or older First FDA clearance for an ultrasound-based device to be able to quantify breast tissue volume QT Scanner 2000 Model A 510(k) Summary (link) Copyright ©2025 QT Imaging Holdings, Inc. All Ri
Slide 23: How QTI Potentially Fits Into the Current Paradigm
How QTI Potentially Fits Into the Current Paradigm Risk Category Potential Role of QTI Device QTI offers a non-ionizing, high-resolution alternative for supplemental imaging, Average Risk especially useful in patients with dense breasts where mammography is limited. (≤12–15%) Ideal for frequent moni
Slide 24: QTI Technology vs HHUS, DBT, MRI, CT
QTI Technology vs HHUS, DBT, MRI, CT
Slide 25: Imaging Modalities
Imaging Modalities Breast Imaging Modality Acronym Underlying Technology QT Scan QT Scan Ultrasound Mammography XRM X-Ray Digital Breast Tomosynthesis DBT X-Ray Magnetic Resonance Imaging MRI Magnetic Resonance Contrast Enhanced Magnetic Resonance Imaging CE-MRI Magnetic Resonance + Contrast Compute
Slide 26: The QT Scanner Delivers a Better Experience for Patients than Traditional Systems
The QT Scanner Delivers a Better Experience for Patients than Traditional Systems QT Scan HHUS CE-MRI XRM/DBT CT Underlying Technology Ultrasound Ultrasound Magnetic Resonance X-Ray X-Ray Image Quality Safety(1) Speed 40-45 min 10-30 min 40-45 min 5-10 minutes 5 minutes Cost Efficiency Patient Exper
Slide 27: Other Ultrasound Products Use 2D Imaging for Dense Breast Imaging
Other Ultrasound Products Use 2D Imaging for Dense Breast Imaging DELPHINUS BREAST INVENIA ABUS ACUSON S2000 ABVS AWBUS SOFIA 3D SOFTVUE ACOUSTIC CT DESIGN TYPE Articulating Arm Articulating Arm Articulating Arm Rotating Armature Water Bath Water Bath Guided Handheld OUTPUT Stacked 2D Stacked 2D Sta
Slide 28: Current Ultrasound Technologies Have Major Deficiencies
Current Ultrasound Technologies Have Major Deficiencies Shortfalls of Commercial Current, Rival Systems (2) • Reflection images suffer from speckle; compounding is done without refraction correction • No true “transmission” mode available – instead use low resolution “shear wave” data (e.g. ABUS, AV
Slide 29: QTI Technology vs XRM/DBT
QTI Technology vs XRM/DBT • Projection overlap in mammography: overlapping tissues in 2D Screening Mammogram Diagnostic Mammogram mammograms can obscure or mimic lesions(3) (DBT improves this, but not completely eliminates it) • Reduced sensitivity to dense breasts: Mammography and DBT can miss canc
Slide 30: QTI Technology vs MRI: Shortfalls of Breast MRI
QTI Technology vs MRI: Shortfalls of Breast MRI • High cost and limited availability: Breast MRI is expensive and not Non-fat sat Pre-contrast widely accessible compared other imaging modalities • Limited specificity: While highly sensitive, breast MRI often produces false positives, leading to unne
Slide 31: Quantitative Transmission (QT) Imaging
Quantitative Transmission (QT) Imaging • What is QT Imaging? − Inherently 3D volumetric ultrasound modality due to 3D data acquisition and image reconstruction − Uses CT-like configuration with ultrasound to acquire and reconstruct transmission images which map the speed-of-sound across the tissue v
Slide 32: Optimized Patient Experience
Optimized Patient Experience PerfeQTion Imaging Center Haverford, PA • No ionized radiation. Acoustic source only • No breast compression and associated discomfort • 10-12 minutes per breast exam time • Quiet and comfortable (as compared to MRI - claustrophobia, coil pressure, noise and lengthy exam
Slide 33: Clinical Results Comparison
Clinical Results Comparison
Slide 34: Imaging Accuracy in Breast Mass Diagnosis
Imaging Accuracy in Breast Mass Diagnosis(1) QT Scan XRM/DBT HHUS CE-MRI CT Normal Breast Dense Breast Cyst Tumor Solid Tumor Calcification Quantitative Tissue / Density Characterization Implant Visualization (1) Based on opinion of QT Imaging Holdings team. (2) Quantitaitve tissue/density character
Slide 35: Technology & Clinical Overview
Technology & Clinical Overview
Slide 36: Technical Capabilities
Technical Capabilities • Resolution of ~600 microns in reflection compared to 800 microns(1) 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 tra
Slide 37: QTI Provides High Resolution, Similar to MRI
QTI Provides High Resolution, Similar to MRI MRI Spiral data QTI (3D UT) Planar acquisition Volumetric 20mm for speed of overlapping acquisition detectors 2mm gap Receiver Array Receiver ~200,000 Array times more data Data points per voxel per voxel than Data points per voxel ~180 thousand data poin
Slide 38: Enhanced Clinical Capabilities and Value
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
Slide 39: QT Speed of Sound and Reflection Images
QT Speed of Sound and Reflection Images Copyright ©2025 QT Imaging Holdings, Inc. All Rights Reserved. 39
Slide 40: Modality Comparison – FFDM and HHUS
Modality Comparison – FFDM and HHUS Mammogram - (left) CC and (right) MLO views. Arrows mark a region of spiculated focal asymmetry. HHUS images across the lesion Copyright ©2025 QT Imaging Holdings, Inc. All Rights Reserved. 40
Slide 41: Modality Comparison – MRI Images
Modality Comparison – MRI Images Non-fat sat Pre-contrast Fast low angle Post-contrast shot 3D (FL3D) Copyright ©2025 QT Imaging Holdings, Inc. All Rights Reserved. 41
Slide 42: Modality Comparison – QT Image
Modality Comparison – QT Image QT speed of sound image showing the mass (marked by arrows) as a region of high-speed IDC in lower outer quadrant of the left breast, 4 o’clock in the coronal view. Copyright ©2025 QT Imaging Holdings, Inc. All Rights Reserved. 42
Slide 43: QTI Scans Image Quality
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Slide 44: Normal Dense Breast
Normal Dense Breast CORONAL AXIAL SAGITTAL Chest wall Transmission Reflection click on image for video Dense breast – no high-speed lesion, mass, or cancer Copyright ©2025 QT Imaging Holdings, Inc. All Rights Reserved. 44
Slide 45: Cyst Identification Using Speed of Sound
Cyst Identification Using Speed of Sound Cystic mass seen in speed of sound (top 3 panels) and anechoic in reflection (bottom 3 panels) in 3 planes – coronal, axial, and sagittal Copyright ©2025 QT Imaging Holdings, Inc. All Rights Reserved. 45
Slide 46: Solid Identification Using Speed of Sound
Solid Identification Using Speed of Sound Solid mass seen in speed of sound (top 3 panels) and hypoecoic in reflection (bottom 3 panels) in 3 planes – coronal, axial and sagittal Copyright ©2025 QT Imaging Holdings, Inc. All Rights Reserved. 46
Slide 47: Case 1: Invasive Ductal Carcinoma
Case 1: Invasive Ductal Carcinoma Mammogram - (left) CC and (right) MLO views Arrows mark a region of spiculated focal asymmetry HHUS images across the lesion Copyright ©2025 QT Imaging Holdings, Inc. All Rights Reserved. 47
Slide 48: Case 1: MRI
Case 1: MRI Non-fat sat Pre-contrast FL3D Post-contrast Copyright ©2025 QT Imaging Holdings, Inc. All Rights Reserved. 48
Slide 49: Case 1: QTI Scan
Case 1: QTI Scan QT speed of sound image showing the mass (marked by arrows) as a region of high-speed IDC in lower outer quadrant of the left breast, 4 o’clock in the coronal view. Copyright ©2025 QT Imaging Holdings, Inc. All Rights Reserved. 49
Slide 50: Case 2: MRI – Invasive Ductal Carcinoma
Case 2: MRI – Invasive Ductal Carcinoma Non-fat sat Pre-contrast FL3D Post-contrast Copyright ©2025 QT Imaging Holdings, Inc. All Rights Reserved. 50
Slide 51: Case 2: QTI Speed of Sound
Case 2: QTI Speed of Sound QT speed of sound image showing the mass (marked by arrows) as a region of high-speed. In coronal view at 8 o’clock. Relatively posterior mass but still all visible in the QT image. Copyright ©2025 QT Imaging Holdings, Inc. All Rights Reserved. 51
Slide 52: Case 3: MRI – Invasive Ductal Carcinoma
Case 3: MRI – Invasive Ductal Carcinoma Non-fat sat Pre-contrast FL3D Post-contrast Copyright ©2025 QT Imaging Holdings, Inc. All Rights Reserved. 52
Slide 53: Case 3: QTI Speed of Sound
Case 3: QTI Speed of Sound QT speed of sound image showing the mass (marked by arrows) as a region of high-speed. In coronal view, at 6 o’clock, near the center. Copyright ©2025 QT Imaging Holdings, Inc. All Rights Reserved. 53
Slide 54: Calcifications Detected with Better Visibility Than XRM
Calcifications Detected with Better Visibility Than XRM Digital Mammography QT Reflection Tomogram Detectability of calcifications in QT Acoustic CT is superior to XRM (1) (1) Sensitivity of Quantitative Transmission ultrasound to detection of microcalcifications. SPIE (International Society for Opt
Slide 55: Market Positioning & QT Scanner Locations In USA
Market Positioning & QT Scanner Locations In USA
Slide 56: Market Positioning of Breast Acoustic CT Scanner
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 sensitive to compression • When concerned about radiation dose Diagnos
Slide 57: QT Scanner Locations Map
QT Scanner Locations Map COMMERCIAL CENTERS CLINICAL TRIAL SITES Center For New Medicine PerfeQtion Imaging Qlarity Breast Imaging Keio U niversity Dr. Leigh Erin Connealy Dr. Jenn Si mmons Dr. Yvonne Karney 2 Chome-15-45 Mita 6 Hughes, Suite 100 346 W Lancaster Ave, Vitality Renewal Functional Medi
Slide 58: Open Angle Scanner
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Slide 59: Developing an Open Angle Scanner Will Expand the Technology to New Markets
Developing an Open Angle Scanner Will Expand the Technology to New Markets …providing significant potential to access new markets and applications • The Open Angle Scanner uses an open, partial angle configuration which reduces the viewing field from 3600 to 3250 and provides additional capabilities
Slide 60: Financials
gy QT IMAGING Financials
Slide 61: Financial Highlights for Q1'25
Financial Highlights for Q1’25 • Shipped six scanners and generated revenue of $2.8 Million with 65% gross margin in the first quarter of 2025 • Closed $10.1 million Lynrock Lake term loan to: − Retire Prior Debt and − $5.4 million for Working Capital Purposes • Entered into Contract Manufacturing A
Slide 62: Financial Highlights for Q1'25 QTD and YTD
Financial Highlights for Q1’25 QTD and YTD • Commercial revenue was $2.8 million during the first quarter of 2025, compared to $0.8 million during the fourth quarter of 2024 and $1.4 million during the first quarter of 2024 • Gross margin of 65% in the first quarter of 2025, compared to gross margin
Slide 63: Financial Highlights for Q1'25 QTD and YTD
Financial Highlights for Q1’25 QTD and YTD • Non-GAAP Adjusted EBITDA of $(0.9) million for the first quarter of 2025, compared to $(1.2) million for the first quarter in 2024 and $(1.9) million for the fourth quarter of 2024. • Ended Q1’25 with $3.0M in cash, compared to end of Q4’24 with $1.2M in
Slide 64: Summary of Q1'25 QTD and YTD GAAP Results
Summary of Q1’25 QTD and YTD GAAP Results Copyright ©2025 QT Imaging Holdings, Inc. All Rights Reserved. 64
Slide 65: Summary of Q1'25 QTD and YTD Non-GAAP Results
Summary of Q1’25 QTD and YTD Non-GAAP Results Copyright ©2025 QT Imaging Holdings, Inc. All Rights Reserved. 65
Slide 66: Balance sheets as of Q1'25 and Q4'24
Balance sheets as of Q1’25 and Q4’24 Copyright ©2025 QT Imaging Holdings, Inc. All Rights Reserved. 66
Slide 67: Cash flow statements for Q1'25 YTD and Q1'24 YTD
Cash flow statements for Q1’25 YTD and Q1’24 YTD Copyright ©2025 QT Imaging Holdings, Inc. All Rights Reserved. 67
Slide 68: Adjustments to EBITDA
Adjustments to EBITDA (1) The Company recorded debt modification expense of $0.1 million related to its modification of the Cable Car Note on January 9, 2025 and debt extinguishment expense of $2.0 million related to the extinguishment of the Yorkville Note and Cable Car Note on February 26, 2025 in
Slide 69: Investment Highlights
Investment Highlights Cutting-edge imaging technology with multiple potential applications creates a tremendous opportunity to transform the imaging market NXC Imaging Distribution Industry-Transforming, FDA Cleared Agreement to Drive Accelerated (Breakthrough Device Designation) Commercial Roll-out
Slide 70: Thank You!
gy QT IMAGING Thank You!
QT Imaging Holdings — Investor Presentation (May 2025) on 6ix