AI Medical Service Inc. Completes First Pharmaceutical Registration of Gastric AI-based Endoscopic Diagnosis Support System from Brazil’s ANVISA

TOKYO–(BUSINESS WIRE)–AI MEDICAL SERVICE INC. (hereinafter AIM), a medical start-up specializing in the development of diagnostic endoscopic AI, is excited to announce the first instance of Brazilian pharmaceutical registration of an AI-based endoscopic diagnostic support device that operates within the stomach (product name: gastroAI, model name: model G). The regulatory registration was conducted by Brazil’s National Health Supervisory Agency under the Brazilian Ministry of Health (Agência Nacional de Vigilância Sanitária, hereinafter ANVISA) on April 1, 2024. The endoscopic AI assists the physician in diagnosis of neoplasia during endoscopy by detecting lesion candidates for biopsy^(*1) or other additional diagnostic steps based on gross visual features. AIM has confirmed that this is the first case of pharmaceutical registration in Brazil for an endoscopic support software that operates within the upper gastrointestinal tract^(*2).

^*1 “Biopsy” refers to taking a piece of tissue and examining it under a microscope when a lesion is found.

^*2 As of April 3, 2024, according to AIM’s research.

Background of our efforts to complete pharmaceutical registration in Brazil

Gastric cancer is the fifth most common cancer in the world, with more than 1 million people contracting gastric cancer and approximately 770,000 people dying from the disease each year^(*3).

Gastric cancer is characterized by a mortality rate that increases significantly with disease progression. However, gastric cancer is very often treatable if detected at an early stage; the 5-year relative survival rate is approximately 95% if detected at stage I, but less than 50% if detected at stage III or later. Nevertheless, early-stage gastric cancer is difficult to detect and is said to be missed in 4.5 to 25.8% of cases. In Brazil, the difference between the number of gastric cancer cases and gastric cancer deaths is small, suggesting that the failure to detect gastric cancer at an early stage is directly linked to the loss of life.

Brazil’s population has already exceeded 210 million, and as a member of the “Global South,” the country’s economic development is attracting increasing attention. However, Brazil also has a noticeable trend toward low birthrates and is noteworthy for an aging population, projected to reach super-aged demographic status by 2050^(*4). With a land area equivalent to approximately 23 times that of Japan, a further shortage of endoscopists within certain regions is expected in the future.

Considering these circumstances, AIM has been convinced that adopting AI to clinical practice in Brazil to support the diagnosis of gastric cancer utilizing Japan’s world-leading endoscopic medical technology will help solve the problem of a shortage of endoscopists and reduce the number of deaths from gastric cancer in the future.

^*3 Source: WHO “GLOBOCAN 2022” (https://gco.iarc.who.int/media/globocan/factsheets/populations/76-brazil-fact-sheet.pdf)
^*4 Reference (Japanese Only): https://www2.jiia.or.jp/kokusaimondai_archive/2020/2022-08_005.pdf

About gastric cancer diagnosis support AI “gastroAI-model G -BR”

The software was developed based on training data provided by world-class medical institutions, utilizing deep learning technology and the support of more than 100 institutes for collaborative research.

The AI works by scanning for candidate lesions using a general-purpose computer, using images extracted from the endoscopy system’s video processor. When the program calculates that a lesion is suspicious for early gastric cancer and warrants further workup, it alerts the physician and provides diagnostic assistance by displaying a rectangle inside the endoscopic display area.

Product Information

Product name: gastroAI

Model name: model G

Medical device certification number: 80102513219

Classification: II

Future Developments

AIM had signed a business contract with Allm Inc. (hereinafter Allm), a medical tech company providing cloud-based technologies and secure communication platforms for the healthcare industry in August 2022. Allm is providing multiple communication apps for medical professionals, including “Join”, which is used by over 16,000 medical professionals in Brazil.

AIM will release and introduce our AI system to Brazilian medical fields with the support of Allm who has deep knowledge of the Brazilian market.

About AI Medical Service Inc.

AI Medical Service (AIM) is a Tokyo-based med-tech company established with the mission to “Save Lives All Over the World.” Japan leads the world in endoscopic diagnosis and treatment, providing firms and researchers with access to large amounts of high-quality data. AIM is the leading player in the field of endoscopic AI, engaging in joint research with more than 100 medical institutions. By bringing endoscopic AI to the real-world clinical setting as soon as possible, AIM aims to reduce the number of missed cancer diagnoses and save lives around the world.

About CEO of AIM, Dr. Tomohiro Tada

Tomohiro TADA, M.D., Ph.D.

Dr. Tomohiro TADA is the CEO of AI Medical Service Inc., the chairperson of Tada Tomohiro The Institute of Gastroenterology & Proctology as well as Visiting Lecturer, Department of Surgical Oncology, Graduate School of Medicine, the University of Tokyo Hospital.

Dr. TADA received his M.D. of school of medicine in 1996 and Ph.D. of department of surgery in 2005 from the University of Tokyo. He trained in Colorectal Surgery at the University of Tokyo Hospital.

Company: AI Medical Service Inc.

Address: Hareza Tower 11F, 1-18-1 Higashiikebukuro, Toshima-ku, Tokyo 170-0013, Japan

CEO: Tomohiro Tada

Founding: September 1, 2017

Business: Development of Endoscopic AI

Contacts

AI Medical Service Inc.

Manami Taniguchi

pr@ai-ms.com