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On April 23, the U.S. ultrasound company QT Imaging will be listed on the NASDAQ. The company completed its merger with special purpose acquisition firm GigCapital5 (NASDAQ: GIA, GIAFW) on March 4, valuing the combined company at $151 million under the new ticker symbol "QTI."
QT Imaging focuses on the research and development of low-energy ultrasound systems, and its first product, the QT Imaging Breast Acoustic CT™ System, has been approved by the FDA. This is a unique 3D breast ultrasound diagnostic system, and the results of studies have shown that the system's screening effect on breast cancer is not inferior to that of traditional gold standard mammography.
At present, breast cancer has jumped to the "world's number one cancer", ultrasound has no radiation and no pain compared with mammography, and has advantages in screening dense breasts, and its technical means of research and development have important value, so QT Imaging has received more than $15.5 million in funding from the National Institutes of Health (NIH).
QT Imaging's ultimate goal is to extend its QTscan technology beyond breast cancer screening to scan the entire body, providing a less risky and costly alternative to CT and MRI scans.
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Innovative 3D breast ultrasound system
Mammography (MG, also known as mammography) has been a mainstay of breast cancer screening for more than 50 years, but mammography still faces many challenges. For example, pain, overdiagnosis, and low positive predictive value, especially in people with dense breasts, have significantly lower sensitivity.
Other mammography modalities such as traditional handheld ultrasound (HHUS) and breast magnetic resonance imaging (MRI) have certain advantages to these challenges.
Handheld ultrasound is radiation-free and easy to access, which has generally improved the cancer detection rate in women with dense breasts. However, this increase in detection rate is usually accompanied by a decrease in the specificity of benign masses. Handheld ultrasound also relies on the operator's manipulation and is more time-consuming than automated ultrasound.
Masses of the same patient observed by different imaging modalities
DYNAMIC CONTRAST-ENHANCED MRI (DCE-MRI) IS A WIDELY USED IMAGING TECHNIQUE IN BREAST CANCER BECAUSE IT CAN PROVIDE HIGH SPATIAL RESOLUTION AND PROVIDE TUMOR ANATOMICAL AND HEMODYNAMIC INFORMATION. However, low specificity, relatively long scan times, and high cost have hindered the use of MRI as a primary screening tool in at-risk populations and those with extremely dense breasts.
Therefore, we urgently need a radiation-free, low-cost, and accurate screening tool to complement it. QT Imaging's QTscan was developed for this purpose, using a curved package of transmitter/receiver consisting of three low-frequency reflective transceivers and a transmitter-receiver pair.
The transmitter rotates around the patient, allowing for multi-angle signal acquisition, generating volumetric images without the need for contrast and radiation irradiation, providing more information than traditional HHUS, while overcoming the reliance on sonographers to achieve standardized ultrasound scans with an average imaging time of 10 minutes per mammary.
Invasive lobular carcinoma observed by different imaging modalities
Recently, QT Imaging is proud to announce the positive results of its second blinded multi-reader, multi-case study, published online in Academic Radiology in January 2024.
Twenty-four breast radiologists were involved in the study of 177 selected cases (66 were cancerous, atypia, or solid masses, and 111 were normal or non-solid benign abnormalities). QTscan for QTI has been found to be as effective as digital breast tomosynthesis (DBT, also known as 3D mammography). The area under the receiver operating characteristic curve (AUC) of the QTI scan was statistically non-inferior to DBT compared to DBT, with an AUC difference of -0.05. This means that QTI technology is not inferior to DBT in detecting whole breast lesions. Statistical analysis was performed by Dr. Yulei Jiang from the Department of Radiology, University of Chicago.
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Actively enter China
The characteristics of breast cancer in mainland China are quite different from those in Europe and the United States, and mammography has certain limitations in the application of breast cancer screening in China. Compared with European and American women, mainland women have the characteristics of small breast size, high gland density, and early age of breast cancer, and mammography is less sensitive to Chinese women.
The official website of QT Imaging also shows that about 50% of women in the United States and more than 75% of women in Asia have dense breasts.
Due to the high cost of screening, it is difficult for mammography to be widely carried out in grassroots areas in mainland China. Screening breast ultrasound has a better cost-effectiveness ratio than mammography. At present, the proportion of breast cancer screening in mainland women is only 23.5%~40%, the delay rate of breast cancer patients is as high as 35%, and only 15.7% of patients are in stage I at the time of diagnosis.
QT Imaging is also aware of this and is actively deploying in the Chinese market.
In September 2020, the company entered into a partnership with TCL Medical to promote QTscan's entry into China and other Asian markets. In September 2021, the company and Shanghai Huiying Medical Technology Co., Ltd., a shareholding subsidiary of TCL Medical, jointly invested to establish Kedi Yunying Medical Technology (Shanghai) Co., Ltd., which will develop and produce 3D breast tumor diagnostic ultrasound systems, and plan to sell them in more than 19 countries and regions in Asia.
Dr. John Klock, Founder of QT, said, "QT Ultrasound is excited to partner with TCL Healthcare to bring our safe and innovative breast imaging technology to China. This team has the knowledge, experience and relationships to move the QT phacomammography scanner from approval to commercialization. We couldn't have found a better partner. ”
George Chan, Chairman of TCL Medical Group, said: "The QT Ultrasound Mammography Scanner technology comes at the right time to facilitate our screening for common cancers, especially for women's cancers – quickly, safely, and affordably. ”
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Domestic and foreign giants have made efforts to screen breast cancer
In 2021, female breast cancer became the most common cancer in the world, accounting for about 11.7% of new cancer cases. The number of new cases of breast cancer among Chinese women in 2021 was 420,000, making it the largest number of new cases of breast cancer among women in mainland China. But thankfully, most types of breast cancer are detected and treated early, and the prognosis is very ideal. Therefore, reasonable screening and early detection are one of the most effective measures to prevent and treat breast cancer.
Ultrasound, as one of the preferred technologies for breast cancer screening, especially the emergence of automatic breast full volume ultrasound (ABUS), provides new solutions and opportunities for the diagnosis and screening of breast cancer. In addition to QT Imaging, companies such as GE Healthcare and Jurong Healthcare from China are making efforts in this area.
GE Healthcare ABUS
GE Healthcare ABUS was launched in the U.S. in 2012 and subsequently introduced in China. ABUS can be simply understood as breast ultrasound "CT", which can provide standardized tomographic images, and further obtain coronal and full-volume images of the breast with the help of 3D image reconstruction technology. The coronal image of breast lesions is comparable to the intraoperative field of view, which provides important reference information for the formulation of preoperative surgical plans.
Jurong Medical Cygnus (Swan Star)
As the latest third-generation automatic breast ultrasound diagnostic system, Jurong Medical Cygnus was approved by the NMPA for marketing in February 2022.
Its crescent probe can cover all aspects of breast tissue, automatically complete layer-by-layer scanning and create a 3D full-volume image, and can complete the examination of a patient in an average of 5 minutes. This all-in-one ultrasound machine is equipped with a number of domestic pioneering technologies, such as relying on the company's original BTM probe technology to develop a special probe for Cygnus - crescent probe, equipped with the world's first special probe acoustic window accessories instead of traditional ultrasound couplant, and equipped with a new mirror platform for Cygnus on the self-developed Hi platform, etc., to provide solutions for the whole process of breast cancer "screening and supervision" disease management.
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According to a report on the breast imaging market published by Exactitude Consultancy, the global breast imaging market is expected to grow at a CAGR of more than 8.2% from 2020 to 2029. It is expected to grow from $3.6 billion in 2020 to more than $7.32 billion by 2029. With the efforts of giants at home and abroad, breast volumetric ultrasound is expected to occupy a large share in the future, and the instrument home will continue to pay attention to the latest developments in this field.