QTI News & Events

QT Imaging Holdings announced that its Breast Acoustic CT scanner has received official classification and clearance from the Kingdom of Saudi Arabia, KSA, for use as a medical device in that country. The Saudi Food and Drug Authority, SFDA, approval allows QT Imaging's Breast Acoustic CT scanner to be marketed, sold, and deployed throughout Saudi Arabia, one of the largest healthcare markets in the Middle East. The approval marks a significant milestone in the Company's international expansion strategy and further strengthens its growing commercial presence across the Gulf region.

QT Imaging Holdings announced the pricing of an underwritten public offering of 2,000,000 shares of common stock for gross proceeds of $10M. Ladenburg Thalmann & Co. Inc. is acting as sole book-running manager and Northland Capital Markets is acting as co-manager for the offering. Each share of common stock is being sold to the public at a public offering price of $5.00 per share and each pre-funded warrant is being sold to the public at the public offering price of each share of common stock less the $0.0001 per share nominal exercise price for each pre-funded warrant. Gross proceeds to the Company from this offering are expected to be approximately $10M, before deducting underwriting discounts and commissions and other offering expenses. Each pre-funded warrant will be immediately exercisable, will entitle the holder to purchase one share of common stock, and may be exercised at any time until exercised in full. This offering is expected to close on or about May 18, 2026, subject to the satisfaction of customary closing conditions.

Reports Q1 revenue $6.5M vs. $2.8M last year. "We continued to execute during the first quarter, making meaningful progress across commercialization, regulatory execution, and clinical validation," said Dr. Raluca Dinu, CEO. "During the quarter, we shipped 13 QT Breast Acoustic CT 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.