Revenue of $6.5 Million, Up 133% Year-Over-Year with 13 Scanners Shipped
Two Year Extension of the Maturity Date of the Senior Secured Term Loan to March 31, 2029
Secured a Category III CPT Code Specific to QT Imaging, Paving the Way to U.S. Reimbursement
Conference Call Begins Today at 4:30 p.m. Eastern Time
NOVATO, Calif.--(BUSINESS WIRE)--May 13, 2026--
QT Imaging Holdings, Inc. (Nasdaq: QTI) ("QT Imaging" or the "Company"), a medical device company dedicated to transforming breast health management through innovative, radiation-free imaging technology, today reported financial results for the three months ended March 31, 2026 and provided a business update.
"We continued to execute during the first quarter, making meaningful progress across commercialization, regulatory execution, and clinical validation," said Dr. Raluca Dinu, Chief Executive Officer of QT Imaging. "During the quarter, we shipped 13 QT Breast Acoustic CT$(TM)$ systems, in line with our commercial distribution commitments, secured a dedicated Category III CPT code for our technology that becomes effective as of January 2027, and received FDA 510(k) clearance for enhancements that improve visualization of posterior breast tissue.
"Recently, the maturity date of our senior secured term loan with our lender was extended by two years from March 31, 2027 to March 31, 2029. This extension provides the Company with additional financial flexibility as we continue executing on our commercial, clinical, and strategic growth initiatives.
"Importantly, we also expanded internationally with regulatory clearance in the United Arab Emirates, supporting a previously established multiyear commercial agreement in the region. At the same time, we advanced our technology platform through the launch of the QT Imaging-Olea Viewer and released a meaningful software improvement focused on reflection image quality, workflow, and quantitative analysis.
"Our clinical strategy continues to gain momentum through investigator studies at leading institutions that demonstrate strong concordance between QTscan and MRI. We believe QTscan is uniquely positioned as a radiation-free, compression-free, true 3D breast-imaging platform capable of providing quantitative information meant to improve clinical decision making, particularly for women with dense breasts. We remain focused on disciplined execution as we expand adoption of the platform globally," she added.
First Quarter and Recent Business Highlights
-- Shipped 13 Breast Acoustic CT scanners in the first quarter of 2026
through our Amended NXC Distribution Agreement.
-- Generated additional clinical evidence supporting agreement of the
QTscan with MRI through investigator studies. A prospective pilot study
at the Mayo Clinic evaluated QTscan as a supplemental screening tool in
high-risk women and demonstrated absolute agreement between QT Imaging
and MRI, suggesting comparable effectiveness of QT Imaging and MRI in
identifying positive findings.
-- Secured American Medical Association $(AMA)$ approval of a new Category
III CPT code, X579T, for 3D quantitative transmission volumetric
ultrasound tomography of the breast. This code recognizes the distinct
clinical service enabled by QTI's Breast Acoustic CT system's
radiation-free, compression-free, 3D breast-imaging platform, and becomes
effective January 1, 2027.
-- Received U.S. Food and Drug Administration (FDA) 510(k) clearance for
an updated configuration of QTI's Breast Acoustic CT scanner, which is
designed to enhance visualization and expand imaging coverage of the
posterior breast tissue, a region that is challenging to capture.
-- Received official classification and clearance from the United Arab
Emirates $(UAE)$ Emirates Drug Establishment for use of QTI's Breast
Acoustic CT scanners and the QT Imaging's Cloud SaaS Platform
subscription. QT Imaging has an exclusive distribution agreement for the
UAE with Al Naghi Medical Co., a leading regional distributor of medical
devices in the Gulf region. The agreement provides for committed minimum
order quantities (MOQs) of seven scanners in 2026, increasing to 16
scanners in 2027 and 20 scanners in 2028, for a total minimum of 43
scanners representing revenue of more than $24 million.
-- Launched the QT Imaging-Olea Viewer, which provides a unified platform
for viewing multiple breast imaging modalities, enabling clinicians to
efficiently correlate findings across multi-imaging sources and monitor
patients longitudinally to streamline workflow. The viewer is designed to
enhance clinical efficiency and support more informed patient
management.
-- Released software update version 4.5.0, a next-generation image
reconstruction that improves spatial resolution in reflection imaging,
resulting in more accurate image representation while maintaining
efficient processing time.
-- Uplisted to The Nasdaq Capital Market after having met all listing
requirements, including financial, corporate governance, and regulatory
criteria.
-- Named renowned breast cancer researcher Dr. Mary W. Yamashita as
Medical Advisor to provide strategic advisory and development support
across several key areas, including optimizing clinical integration and
user experience, and ensuring the Company's technologies meets and
exceeds the expectations of clinicians and patients.
-- Welcomed Dr. Barry Roseman, a breast surgical oncologist with more than
25 years of experience treating breast cancer and breast disease, as
Senior Medical Advisor. Dr. Roseman's engagement includes clinical
implementation of the QT Imaging technology in his diagnostic and
screening center to support physician training, workflow integration,
patient access, and ongoing collection of real-world clinical,
operational, financial, patient, and provider experiences.
-- Subsequent to the close of the quarter, the Company amended the Lynrock
Lake Credit Agreement, extending the maturity date of the senior secured
term loan by two years to March 31, 2029, and increasing the interest
rate to 12.0% per annum from 10.0% previously.
First Quarter Financial Results
-- Revenue for the first quarter of 2026 was $6.5 million, an increase of
133% from $2.8 million for the first quarter of 2025. The increase was
primarily attributable to the shipment of 13 Breast Acoustic CT scanners
in the 2026 quarter compared with six scanners in the prior-year period.
-- Gross margin for the first quarter of 2026 was 41% compared with 65%
for the first quarter of 2025. The higher gross margin in the first
quarter of 2025 was primarily due to the sale of two majorly depreciated
scanners, hence with a lower cost basis.
-- Total operating expenses for the first quarter of 2026 were $5.0
million compared with $2.9 million for the same period of 2025. The
increase was primarily attributable to employee compensation and
professional and outside service costs.
-- Total interest and other expense, net for the first quarter of 2026 was
$1.1 million compared with $10.1 million for the first quarter of 2025.
The decrease was primarily due to $8.8 million in nonrecurring charges
recorded in the prior-year period, including noncash expense related to
the issuance of the Lynrock Lake Term Loan and the extinguishment and
modification charges associated with the Yorkville and Cable Car Notes.
The decrease was partially offset by higher interest expense driven by
accrued interest and debt discount amortization on the Lynrock Lake Term
Loan.
-- Net loss for the first quarter of 2026 of $3.4 million, or $0.25 per
share, compared with a net loss of $11.1 million, or $1.21 per share, for
the first quarter of 2025.
-- Non-GAAP adjusted EBITDA* for the first quarter of 2026 of $(1.9)
million compared with $(0.9) million for the first quarter of 2025.
-- Net cash used in operating activities during the first quarter of 2026
was $3.7 million compared with $3.5 million during the first quarter of
2025.
-- Cash, restricted cash, and cash equivalents were $7.0 million as of
March 31, 2026 compared with $10.5 million as of December 31, 2025.
2026 Revenue Guidance
The Company reaffirms guidance for 2026 revenue to be approximately $39 million, reflecting scanner shipments in the U.S. and world-wide, and initial revenue from the QT Imaging Cloud Platform. These expectations are in accordance with the MOQs per its Amended Distribution Agreement with its U.S. strategic business and distribution partner, NXC Imaging, Inc., a wholly owned subsidiary of Canon Medical Systems USA, as well as its new distribution partners in the Gulf region, Gulf Medical and Al Naghi Medical.
Conference Call and Webcast
QT Imaging management will host an investment community conference call today beginning at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss the Company's financial and operational results and answer questions. Participants can pre-register for the conference call here. Callers who pre-register will be given a conference passcode and unique PIN to gain immediate access to the call and bypass the live operator. Participants may pre-register at any time, including up to and after the call start time.
Those who choose not to pre-register can access the live conference call by dialing 866-777-2509 from within the U.S. and 412-317-5413 from outside the U.S. and requesting the QT Imaging call.
A live and archived webcast of the conference call will be available on the IR Calendar section of the Company website.
Non-GAAP Financial Measures
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