Delphinus Medical Technologies Files for IPO Following $109.1M Raised and FDA-Cleared SoftVue™ Breast Cancer Screening System

Breast cancer has become the “number one killer” of women’s health.

According to data released by the International Agency for Research on Cancer (IARC), in 2020, female breast cancer cases accounted for 11.7% of all new cancer cases globally (approximately 2.3 million), surpassing lung cancer (approximately 2.2 million) for the first time to become the most commonly diagnosed cancer. In terms of mortality, female breast cancer has become the fifth leading cause of cancer death worldwide, with a high fatality rate of 6.9%. In 2020, a total of 685,000 people died from breast cancer globally, making it the leading cause of cancer-related deaths among women.

Although breast cancer incidence rates are similar worldwide, patients in less developed countries exhibit significantly higher mortality rates and lower survival rates. The primary reason is that patients are often diagnosed at an advanced stage; therefore, access to early diagnosis and timely treatment is a critical factor contributing to the disparities in survival outcomes among breast cancer patients.

Delphinus Medical Technologies (hereinafter referred to as “Delphinus”) is an innovative medical device company dedicated to developing solutions for breast cancer screening. Founded in 2010 and headquartered in Michigan, USA, Delphinus is a spin-off from the Barbara Ann Karmanos Cancer Institute.

Since its inception, Delphinus has been dedicated to developing innovative technologies that overcome barriers to the early detection of breast cancer. Its independently developed SoftVue™ 3D Whole-Breast Ultrasound Tomography system has directly transformed the diagnostic approach for breast cancer in women with dense breast tissue.

Delphinus raised a total of $109.1 million across its previous six financing rounds. The latest round, an undisclosed-risk financing completed on August 22, 2023, saw Delphinus secure $12 million in growth capital from Trinity Capital. Delphinus will use these funds to further expand its operational scale and business scope, driving the continued commercialization of the SoftVue™ system. Additionally, the company has added Corewell Health to its network of clinical sites, where a robust dense breast screening program is being established to benefit more women with dense breasts.

Breast tissue consists of glandular tissue, milk ducts, supportive tissue (dense breast tissue), and fatty tissue (non-dense breast tissue). Mammography reveals that women with dense breasts have more dense tissue than fatty tissue. On mammographic images, both dense breast tissue and cancer appear as solid white areas, making them difficult to distinguish and increasing the difficulty of detecting cancers, such as masses, hidden within dense breast tissue.

Data released by Delphinus shows that dense breast tissue is common among women in the United States, with 40% of women having dense breasts. Compared to women with excessive fatty breast tissue, those with dense breasts have a 4-6 times higher risk of developing breast cancer. Mammography fails to meet the screening needs of patients with dense breasts. A study conducted by Thomas M. Kolb, MD, Jacob Lichy, and colleagues analyzed 11,130 asymptomatic women in the United States who underwent mammography. The results revealed that in women with dense breasts, the sensitivity of mammography dropped to 48%, meaning approximately 50% of breast cancers were missed.

Delphinus Medical Technologies’ SoftVue™ 3D Whole-Breast Ultrasound Tomography System is designed for breast cancer screening in asymptomatic women with dense breast tissue. This imaging technology is not affected by breast density and can identify masses beyond dense tissue based on varying acoustic properties, thereby helping physicians detect more cancers. SoftVue™ can be used as an adjunct to digital mammography to enhance screening efficacy. It offers higher screening accuracy compared to full-field digital mammography (FFDM) alone.

SoftVue™ received FDA 510(k) clearance in October 2021 and is the only FDA-approved device indicated as an adjunct to mammography. According to the FDA clearance documents, SoftVue™ can be performed on the same day as screening mammography, allowing women with dense breast tissue to undergo two cancer screening tests during a single appointment. This approach helps ensure detection accuracy while also improving patient compliance.

Compared with traditional breast ultrasound equipment, the innovation of SoftVue™ lies in its unique circular ultrasound transducer. SoftVue™ incorporates a circular ultrasound transducer into its sensor design; this configuration integrates 2,048 sensor elements, features 14-bit data resolution, and employs the proprietary TriAD™ (Triple Acoustic Detection) technology exclusive to medical imaging. It is the first and only circular array sensor to utilize TriAD™ technology.

TriAD™ technology not only captures reflected echoes that define anatomical details, but also captures transmission signals passing through tissue, thereby quantifying speed of sound and signal attenuation.

During the examination, a circular transducer encircles the entire breast. Upon initiation of the scan, it automatically scans the patient’s nipple and chest wall. The sensor elements on the transducer employ electronic 360-degree sequencing to capture transmitted and reflected signals, acquiring images of various tissue layers of the breast in 2-mm increments. Subsequently, the acquired data are processed by algorithms into a stack of coronal plane images, wherein three signal types—reflection, speed of sound, and attenuation—are reconstructed into four image sequences that collectively constitute a view of the patient’s breast architecture. Because the speed of sound and attenuation signals exhibit distinct transmission characteristics when passing through different tissues, quantification and imaging of these two signals can reflect varying tissue characteristics of the breast. Upon completion of the scan, a tomographic coronal image clearly delineating the characteristics of breast tissue is ultimately obtained.

A clinical study by Delphinus involving breast cancer screening in 8,500 patients in the United States demonstrated that when used in conjunction with mammography, SoftVue™ increased cancer detection accuracy by 20% and improved specificity by 8% at the BI-RADS 3 threshold. This reduced the probability of “false-positive” results (i.e., suspicious lesions identified on screening but confirmed benign by biopsy), thereby decreasing unnecessary patient follow-up visits and biopsies.

This is because merging reflection images, sound speed images, and attenuation soft-view images allows for an accurate depiction of the anatomical and physiological characteristics of tissues. By examining such tomographic coronal images, physicians can more clearly visualize breast tissue properties, thereby differentiating between cancerous tissues, normal tissues, and areas affected by benign conditions, which ultimately enhances the accuracy of diagnostic results.

In terms of patient comfort during testing, “pain and discomfort,” “breast exposure,” and “radiation” are currently existing problems with breast cancer screening methods.

SoftVue™ effectively addresses the aforementioned issues. The Sequr™ breast interface guide is a core component of SoftVue™; it is soft in texture and conforms to the shape of the breast. During the examination, it engages with the anterior aspect of the patient’s breast, centering the breast to form a stable, semi-elliptical pendant shape. By shaping and stabilizing breast tissue, Sequr™ facilitates proper breast positioning, thereby improving the efficiency of image acquisition. Furthermore, as a single-patient-use disposable, it ensures procedural safety and reduces the risk of transmitting certain infectious diseases.

During the specific examination, the physician will first align the Sequr™ device on the platform inside the imaging chamber with the patient’s breast. Once positioned, the imaging chamber is gradually filled with warm water. At this time, the patient, wearing a garment that fully covers the upper body, lies prone on the padded platform table and immerses one breast into the warm water. After confirming the positions of the breast, the Sequr™ device, and the circular transducer, the machine is activated to begin scanning, during which the circular transducer moves along the breast. Upon completion of the scan, the Sequr™ device is detached from the breast, and the imaging chamber is prepared for scanning the contralateral breast. The patient then places the second breast into the warm-water imaging chamber to repeat the scanning procedure. Each breast is scanned within 2–3 minutes, and the entire examination process takes approximately 8–10 minutes.

The entire procedure is conducted in a room staffed by a single female attendant. During the exam, the patient lies prone on a cushioned table, ensuring that the breasts are neither compressed nor exposed. Additionally, SoftVue™ utilizes sound waves, warm water, a guide ring, and a circular transducer as media for acquiring breast data. The examination is radiation-free, providing a comfortable experience for the patient.

Among patients who underwent breast cancer screening at Delphinus, 95% of women who used SoftVue™ stated that they would recommend the examination to other women.

Breast cancer has become the most common malignant tumor among Chinese women. According to data released by the International Agency for Research on Cancer (IARC), there were 416,000 new cases and 117,000 deaths from breast cancer in China in 2020, ranking it among the top three cancers in terms of incidence and within the top ten in terms of mortality.

Clinical practice has demonstrated that screening for early-stage breast cancer enables earlier diagnosis and treatment, resulting in higher rates of breast-conserving surgery, faster postoperative recovery, and fewer complications. Furthermore, the likelihood of requiring chemotherapy decreases with earlier disease stages, allowing patients to avoid a range of adverse effects associated with chemotherapy, such as cardiotoxicity and myelosuppression. With appropriate treatment, the 5-year survival rate for breast cancer patients can reach 50%–90%.

However, the early symptoms of breast cancer are often subtle, and its etiology is complex. As a secondary prevention measure, breast cancer screening has become a critical tool for detecting early-stage disease, improving treatment outcomes, and reducing mortality. “Early screening, early diagnosis, and early treatment” are key to the prevention and control of breast cancer.

Currently, mammography is the primary method for breast cancer screening in European and American countries. It has a sensitivity of approximately 85% for breast cancer screening in women; however, its sensitivity is lower for dense breast tissue, ranging from 47.8% to 64.4%. Asian women generally have dense and smaller breasts, resulting in lower sensitivity and accuracy of mammographic examination. Both clinical research and practice indicate that screening guidelines primarily based on mammography are not suitable for Chinese women.

According to the "Guidelines for Breast Cancer Screening in Chinese Women (2022 Edition)" led by Professor Sun Qiang's team from the Department of Breast Surgery at Peking Union Medical College Hospital, breast ultrasound is the preferred screening method for breast cancer in Chinese women. However, traditional handheld ultrasound examination results are highly dependent on the operator's experience and skill level, and ultrasound is difficult to detect microcalcifications and spiculated changes, which can easily lead to missed or misdiagnoses.

Technological innovation in the breast cancer screening market is urgently needed. According to the “In-Depth Report on the Early Cancer Screening Industry: Early Cancer Screening, Leveraging a Hundred-Billion-Yuan Market and Sparking a Revolutionary Era – Overweight (Maintained)” published by Soochow Securities, the potential terminal market size for early breast cancer screening in China is projected to reach RMB 51.496 billion by 2030.

Currently, China already has companies such as Shenbo Medical and Delphinus Medical Technologies that specialize in the field of breast cancer screening. However, the Chinese breast cancer screening market still requires the entry of more innovative enterprises to provide patients with more effective screening solutions.

Reference Article:

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