Japanese Startups Are Pioneering New Cancer Tools With AI And Focused Ultrasound

In early 2024, the World Health Organization predicted that by 2050 there will be more than 35 million new cancer cases worldwide, an increase of 77% from 20 million in 2022. Driven by aging and growing populations as well as lifestyle factors, the cancer burden will strongly impact countries around the world. In Japan, doctors and engineers are harnessing artificial intelligence (AI) and other technologies to help meet a massive demand for tools that can help diagnose and treat cancer and related diseases. Two innovative medical startups in Tokyo are commercializing their innovations to improve the health of people everywhere.

Using AI to spot early signs of cancer

Early, proper diagnosis is key in fighting diseases like cancer. One recent study, however, found that in the U.S. nearly 800,000 people die or are permanently disabled each year due to misdiagnosis and cancers not being detected early enough. Mainly because they are detected too late, gastrointestinal (GI) cancers account for the biggest cause of cancer mortality in Japan and worldwide. Even though an endoscopic exam can catch early-stage GI cancers, about 20% are overlooked by doctors when viewing patients’ upper GI tract.

But what if AI could double-check gastroscopy images and pick up any missed problem spots? That’s exactly what AI Medical Service Inc.’s gastroAI model-G does. It’s an AI system that views gastroscopy imagery in real time along with doctors, and makes suggestions about examining potential areas of concern. As an endoscopist feeds a gastroscope into a patient’s stomach and performs the usual procedure, gastroAI instantaneously reviews the imagery. If it detects a problem spot, within seconds the software highlights the area and displays a warning notice: “Consider biopsy.” The endoscopist makes the diagnosis and is free to consider the need for a biopsy and make a diagnosis based on the system's suggestions.

“Endoscopic examination is basically an image-recognition process,” says Tada Tomohiro, CEO of AI Medical Service. “Doctors look into the stomach or colon and see if there is a lesion or not. The system acts like an assistant, asking the doctor to double-check potential problem areas. Even if doctors’ accuracy wanes from morning to afternoon, the AI system does not tire.”

After working at various hospitals in Tokyo, in 2006 Tada opened a gastroenterology and proctology clinic in Saitama Prefecture, where he and other staff went on to perform 8,000 to 9,000 endoscopic examinations per year, making it one of the top GI medicine centers in the country. Even as he opened other clinics, Tada began researching new means to reduce missed diagnoses. He realized that AI could exceed human abilities in image recognition, which is a crucial part of finding GI cancers.

In 2016, he began applying AI tools to endoscopic medicine. He trained a deep-learning AI system, collecting about 200,000 high-definition GI medicine videos and developed what he describes as the world’s first AI system for early gastric cancer and esophageal cancer detection. In 2017, Tada founded AI Medical Service and later established subsidiaries in the U.S. and Singapore. One of the company’s advantages is a robust research network giving it access to data from more than 100 medical centers in Japan, including the University of Tokyo Hospital, Keio University Hospital and Osaka International Cancer Institute. Another asset is its links to manufacturers. AI Medical Service has been focused on developing software that can be used with most endoscopes.

“Japan is a top producer of endoscopes,” Tada notes. “Working with manufacturers is part of a strategy to make Japan No. 1 in the world for medical technology.”

AI Medical Service’s diagnostic support system has been approved by regulators in Japan, Brazil, and Singapore, and the company has raised some 14.5 billion yen (US$93.4 million) in funding from venture capital firms and government subsidies. In 2024, AI Medical Service was included in Forbes Asia’s 100 to Watch list of small companies and startups grabbing investors’ attention. Tada is now focused on rolling out his product in Singapore, updating the system along with the evolution of AI, getting approval from U.S. regulators and targeting other forms of cancer for AI detection, even as he continues his clinical work.

“Regardless of whether I am working as a doctor, clinic director or a startup CEO, my goal does not change,” says Tada. “My motivation is to improve medical practice. Ultimately, we want to reduce the rate of missed cancer detection to zero.”

Bringing A Future Full Of Hope To Pancreatic Cancer Patients

Across town at Tokyo Medical University Hospital, a cancer patient lies down while a cone-shaped device on a robotic arm is positioned over his abdomen. The device delivers ultrasound energy to the patient’s pancreas and generates localized heat of up to 100 degrees Celsius that destroys cancer cells in the organ. Other types of ultrasound waves allow doctors to monitor exactly the location of the heated region. The procedure is minimally invasive, does not involve any surgery or anesthesia, and only lasts about half an hour.

This technique employs high-intensity focused ultrasound (HIFU). In conventional radiotherapy, radiation damages both cancer cells and the surrounding healthy cells that it passes through. In contrast, HIFU waves can be focused on a small region inside the body and do not damage the healthy cells they pass through. While the focal energy decreases with the depth below the skin, it can be used repeatedly in cases where cancers recur frequently.

In studies around the world, focused ultrasound has been used to attack cancers of the brain, breast, prostate and other organs. In Japan, HIFU is already used to treat prostate enlargement, Parkinson’s disease and essential tremor. Clinicians in Japan are now hoping HIFU will become a standard treatment for pancreatic cancer, one of the deadliest of all cancers and one that recurs often. In addition, some 70% of pancreatic cancer cases are detected after the disease has progressed too far for surgical removal, resulting in a three-year survival rate of only 3.2%. Even after surgery, the cancer recurs in about 80% of patients.

Pancreatic cancer is difficult to treat in part because the organ moves up and down while a patient is breathing, causing therapeutic radiation to impact the surrounding gastrointestinal tract.

“The pancreas is resistant to radiation, so it requires high doses during radiotherapy, which can involve daily sessions for six weeks,” says Satoh Tohru, CEO of SONIRE Therapeutics Inc., a Tokyo startup developing next-generation HIFU technology for cancer treatment. “With SONIRE’s HIFU, patients are expected to be treated with only two sessions on an outpatient basis.”

The unique part about SONIRE’s technology is that it makes use of cavitation. Often seen around underwater propellers, cavitation is the formation of gas bubbles in a liquid due to pressure changes. Using cavitation allows doctors to precisely visualize the treatment region to ensure effective treatment and increase heating efficiency, which shortens treatment time.

Results suggest HIFU can be effective when used with conventional treatment. The median survival time of patients with inoperable pancreatic cancer after treatment with chemotherapy alone was 288 days, but when combined with HIFU it was 648 days, according to a 2021 study in the journal Current Oncology.

Satoh cofounded SONIRE in 2020 based on research that began some 12 years earlier at Tokyo Medical University, Tokyo Women’s Medical University and Tohoku University. With support from Japanese venture capital companies, SONIRE soon raised 730 million yen (US$4.7 million) in funding. The backing enabled it to develop its own HIFU therapy system as a next-generation focused ultrasound.

SONIRE’s innovation has earned it recognition at home and abroad. In 2023, it was selected for the Ministry of Economy, Trade and Industry’s J-Startup support program for new businesses. The following year, its HIFU therapy system was designated as a breakthrough device for pancreatic cancer by the U.S. Food and Drug Administration. These distinctions have opened up doors.

With its research and clinical partners, SONIRE is now conducting the world’s first randomized, controlled trial of HIFU therapy for pancreatic cancer. The study at six hospitals across Japan is designed to give hope to patients, their families and healthcare professionals, and will follow the survival outcomes of 90 patients with inoperable pancreatic cancer, with 30 undergoing chemotherapy alone and 60 undergoing chemotherapy and HIFU therapy.

SONIRE aims to complete enrollment in early 2025 and obtain regulatory approval for HIFU therapy in Japan in 2027. Meanwhile, a U.S. study is also being prepared, with the aim of obtaining U.S. approval in 2028. From there, the company hopes to expand not only into other markets, but other types of cancer.

“We want to offer a more effective and safer cancer treatment to as many patients as possible as soon as possible,” says Satoh. “We want to go beyond the boundaries between pharmaceuticals and medical devices, and one way to do this is through HIFU treatment for cancer patients.”

Note: All Japanese names in this article are given in the traditional Japanese order, with surname first.

To learn more about AI Medical Service Inc., click here.

To learn more about SONIRE Therapeutics Inc., click here.