QT Imaging Holdings, Inc. (NASDAQ: QTI) filed a Current Report on Form 8-K on November 11, 2026, to disclose supplemental product and operational information. The filing includes an updated investor presentation dated November 2026, which is furnished as Exhibit 99.1.
The presentation highlights the company’s mission to transform breast health through a scalable 3D safe imaging platform. QT Imaging states its goal is to replace fragmented workflows with a solution that offers accurate diagnosis for dense breasts without compression or radiation exposure. The company notes that its product is validated and FDA cleared.
According to the presentation, the company was founded in 2012 by Dr. John Klock. In 2012, the company received FDA clearance. On June 6, 2017, the U.S. Food and Drug Administration (FDA) determined that the QT Breast Scanner is substantially equivalent to a predicate device in response to a Section 510(k) Summary of Safety and Effectiveness.
The document outlines a timeline of key events, including the receipt of $18 million from the National Institutes of Health (NIH) from 2012 to 2026 to develop a supplemental imaging modality. It notes that the company raised $18 million through a PIPE in October 2017 and completed a $10 million underwritten public offering in March 2024.
The presentation also details recent commercial and regulatory progress. In October 2025, the company received approval for a Category III CPT billing code. It states that QTI became a public company on the NASDAQ in March 2024. The company indicates that Medicare hospital outpatient payment will begin in January 2027. Additionally, the filing mentions regulatory approvals in Saudi Arabia, the UAE, Israel, Bahrain, and Qatar during the period from March to November 2026.
The presentation includes forward-looking statements regarding the potential impact on existing medical technology, the evolution of the company into a scalable imaging platform, and the performance of software enhancements. It also lists risk factors, including that the company is a development-stage company with limited operating history and significant losses since inception. The company cautions that it may never be able to effectuate its business plan or achieve meaningful revenue.
