Pioneering painless, accurate breast cancer screening and AI-assisted diagnosis
In recent decades, many developed countries have adopted routine, population-wide screening programs for the detection of breast cancer, benefiting millions of women around the world. In the United States, the American Cancer Society estimates that the breast cancer screening program there has contributed to the 42 percent drop in breast cancer mortality from 1989 to 2019. Similarly, estimates suggest the National Health Service Breast Screening Programme in England saves around 1,300 lives per year among women aged 50 to 70.
However, all programs currently in operation use X-ray mammography, which has several drawbacks. The procedure involves compressing the breast between plates to get a clear image, which can be painful or uncomfortable for many women. Although the radiation dose is low, mammography does involve cumulative X-ray exposure over many years of a woman’s life.
Lastly, mammography is not as accurate at spotting cancer in dense breast tissue, which is more commonly found in younger women and those from Asia. Alongside cultural factors, this is perhaps one reason why breast screening is less common in Asia, even higher-income nations like Japan.
A Focus on Early Breast Cancer Detection
Japanese entrepreneur Azuma Shiho and CEO of Lily MedTech saw an opportunity to change the status quo, motivated in part by the loss of her own mother to cancer and the desire to catch tumors in women earlier. In 2016, she established Lily MedTech alongside her co-founder, husband and University of Tokyo Professor Azuma Takashi, who is involved in research into ultrasound computed tomography techniques at the Graduate School of Medicine and the Graduate School of Engineering.
Mrs. Azuma comments: “Unlike many other cancers, breast cancer affects a larger percentage of younger adults. If the cancer is found at an early stage, the survival rate is actually quite high, and I realized that the earlier we could detect breast cancer, the further we could reduce the mortality rate and shorten the treatment period.”
COCOLY Breast Ultrasound Machine
Based on the latest research from Professor Azuma’s lab, Lily MedTech began developing an entirely new breast imaging system called COCOLY, which uses ultrasound rather than X-rays. It consists of a bed-like table that patients lie on, face down, with the breast placed in a cavity, partially filled with warm water. Inside the cavity, a ring-shaped ultrasonic transducer moves up and down without touching the breast, building up a high-resolution three-dimensional scan of the breast. This removes the need for breast compression and the associated pain that many women experience as well as eliminating X-ray exposure.
Using AI to advance breast cancer detection
Since its formation, Lily MedTech has attracted ongoing investment, including from venture capital firms specializing in ‘deep tech’ – a term for technology promising significant advances over current scientific or engineering standards. Since its founding, Lily MedTech has raised over 3.3 billion yen ($21.5 million) across various seed rounds.
After securing medical regulatory approval in Japan, the company officially launched the COCOLY system to the domestic Japanese market in May 2021, forging partnerships with pharmaceutical and medical device companies and entering into sales agreements.
Crucially, Lily MedTech has maintained strong working relationships with medical institutions.
This has allowed the company to gain feedback and trust from clinicians as well as participate in clinical trials, which provide a vital source of anonymous patient data. This data has been used to train artificial intelligence (AI) models to aid diagnosis by learning to identify breast tumors in patterns of data that a busy clinician might potentially miss.
IP Protection Key in Lily MedTech’s Global Expansion
A joined-up approach to care and IP
Lily MedTech has been granted three patents in Japan and six in the United States – and has filed ten international applications under WIPO’s Patent Cooperation Treaty related to COCOLY. As a team, they have actively used the support and subsidy systems offered by the JPO and Tokyo Metropolitan Government with respect to intellectual property (IP) issues. Particularly helpful was their support and advice regarding patent applications, preliminary research and portfolio construction.
“The patent rights cover a wide range of technologies, including breast imaging methods, user interfaces for image interpretation and image diagnostic support software such as AI processing,” explains Mrs. Azuma. “There are many existing technologies related to ultrasound in this field, making it difficult to claim novelty or an inventive step, which is needed to obtain strong patents for medical devices alone. So the value of patents may increase if new technologies such as AI diagnosis are added.”
The team is currently gearing up for overseas expansion, including in the United States where there are several companies developing ultrasound breast screening solutions, making IP protection particularly important. They are also scoping potential opportunities in Islamic regions and China, where breast cancer screening is not widely used. In both regions, IP protection will be the foundation of their business strategy and plans.
Even greater than the anticipated geographic expansion of COCOLY is Lily MedTech’s ultimate vision for the future: the company hopes one day to develop of an AI-supported all-in-one device that incorporates all aspects of breast cancer care, from screening and diagnosis and even to treatment. As the company states, they are ultimately striving “toward a world without a need to fight against breast cancer.”
