Amidst Unicorn Valuation, Anheng Medical Submits IPO Filing for Its CE-Certified NaviCam Magnetic Capsule Gastroscope Deployed Across 29 Chinese Provinces

Anhan NaviCam’s “Magnetic-Controlled Capsule Gastroscopy” robot has been hailed as a “revolutionary innovation in the examination of digestive diseases and endoscopic development in the 21st century” and has received the “Top Ten Medical Advances Award in China.” To date, this product has been clinically applied in over 100 Grade A tertiary hospitals and more than 500 health checkup centers across 29 provinces and municipalities in China.

In 2014, Anhan’s “Magnetic-Controlled Capsule Gastroscopy” robot obtained CE certification from the European Union and was included in the UK’s Innovative Medical Services Directory; the product has also been widely used in clinical practice in several European countries.

Recently, VCBeat (WeChat official account: vcbeat) interviewed Dr. Huan Dandan, Vice President of AnHan Medical. Dr. Huan shared with us the journey of AnHan Medical, as well as the research and development, clinical application, and commercialization process of its flagship product, the AnHan NaviCam “Magnetic-Controlled Capsule Gastroscopy” robot.

Anhan is primarily engaged in the detection and analysis of gastrointestinal diseases. Since 2009, the team has spent approximately nine years independently developing and commercializing the world’s only capsule endoscopy robot capable of precise gastric examination.

Anhan’s “Magnetic-Controlled Capsule Gastroscope” robot has realized the long-held dream of undergoing gastroscopy without intubation. By simply swallowing a capsule-sized device with water, patients can complete a painless, non-invasive, anesthesia-free, comprehensive, and cross-infection-free gastric examination in just 15 minutes. Offering comfort, precision, and safety, it has become the clinically recommended standard for gastroscopy in China and holds significant importance for the early screening of gastric cancer.

Why did Anhan consider developing such a product?

Huan Dandan told us that gastrointestinal diseases are highly prevalent worldwide, with gastric cancer ranking fourth in global cancer incidence. In China, the saying “nine out of ten people suffer from stomach ailments” reflects the extremely high prevalence of gastrointestinal disorders, with approximately 680,000 new cases of gastric cancer diagnosed each year.

If gastric cancer is detected early, nearly 90% of cases are curable with endoscopic submucosal dissection (ESD) performed via conventional gastroscopy. However, approximately 90% of gastric cancer cases in China are diagnosed at an advanced stage, with a survival rate of less than 30%.

Japan and South Korea, both located in Asia, share genetic factors with the Chinese population, including dietary habits. Gastric cancer is also highly prevalent in these two countries. However, Japan and South Korea implemented mandatory, nationwide gastric cancer screening programs at an early stage. After years of development in early screening, their current rates of early diagnosis exceed 50%, and the five-year survival rate surpasses 60%, extending patients’ lives by 10 to 20 years.

So why has China not conducted large-scale gastric cancer screening? Huan Dandan explained that, first, gastrointestinal diseases are not symptomatic enough to prompt proactive action; without mandatory national screening programs, few people feel the need to undergo gastric cancer testing when experiencing stomach discomfort. Moreover, even in advanced stages, many gastric cancer cases present with no significant subjective symptoms.

Moreover, traditional gastroscopy is extremely painful, often deterring patients from undergoing the procedure. The discomfort associated with traditional gastroscopy is a primary reason why many patients are reluctant to undergo gastric examinations. Huan Dandan once tried searching for “gastroscopy” on Baidu, and the first results that popped up were common questions from the public: Is traditional gastroscopy painful? Is anesthesia harmful?

Secondly, compared with the 10% screening rate in Japan and South Korea, China does not have sufficient physician resources to support large-scale population screening for gastrointestinal diseases. Statistics show that only 6,218 medical institutions in China are equipped to perform digestive endoscopy. Moreover, as this is a traditional intubation-based examination, it carries significant risks and must be performed by experienced physicians. Currently, there are only slightly more than 20,000 doctors in China qualified to conduct intubation-based gastroscopy. Even if these physicians work at full capacity throughout the year, they can collectively perform just over 22 million gastroscopies. Consequently, scheduling a gastroscopy at a tertiary Grade A hospital may require a waiting period of one to two months, or even up to three months.

In light of these clinical pain points, Anhan began to explore how to transform its technology into a miniature robot capable of performing examinations via an orally ingested capsule. Given the vast market potential for this condition, Anhan initially chose to enter the market through medical robotics, expanding from disease-specific diagnostics to the broader health screening market, thereby further enlarging its addressable market.

After deciding to develop the capsule gastroscopy product, Anhan’s primary challenge was how to achieve precise control.

The stomach is a large hollow organ. Without control, inserting a wireless camera would only allow for non-targeted observation, lacking precision and thus losing clinical significance. Therefore, Anhan decided to develop the capsule endoscope as an active, controllable robotic device.

Robots have several control methods. If a handheld external magnet is used for control, complex synchronized coordinated control cannot be achieved due to limitations in operating distance and human operational accuracy. Magnetic resonance imaging (MRI)-based approaches also suffer from magnetic field instability, and their high power consumption leads to elevated costs for power supply and heat dissipation.

After continuous experimentation, Anhan ultimately decided to adopt a method involving precise multi-dimensional rotational movement of the magnetic field via an external robotic arm’s magnetic field, with adaptive matching. Success was finally achieved after thousands of trials. Huan Dandan stated that for every product, Anhan conducted extensive preliminary testing.

Compared with traditional gastroscopy, Anhan’s “Magnetic-Controlled Capsule Gastroscopy” robot represents a disruptive innovation. Huan Dandan stated that it serves as an excellent example addressing the “impossible triangle of healthcare.”

Within the “impossible triangle of healthcare,” the accessibility of medical resources, the quality of medical services, and the overall reduction of healthcare costs constitute an intractable triangular dilemma under the existing system. The only solution is to introduce a new technological increment to trigger an expansionary adjustment of the production network.

Anhan’s “Magnetic-Controlled Capsule Gastroscope” robot represents such a technological increment, achieving a breakthrough in size reduction from 1 meter to 27 millimeters, thereby creating a robot nearly the size of a clinically used oral capsule. This stark contrast highlights that the tube-free procedure is very low-risk, enabling the separation of diagnostic assessment from operational execution and thus alleviating constraints on medical resources.

How does the accuracy of magnetic-controlled capsule gastroscopy screening compare to that of conventional gastroscopy? Anhan insists on answering this question through data-driven evidence. They selected five top-tier Grade A tertiary hospitals across different regions in China, including Shanghai Changhai Hospital, Beijing 301 Hospital, and Guangzhou Nanfang Hospital. Led by Changhai Hospital, a double-blind controlled trial involving 350 cases was conducted to compare magnetic-controlled capsule gastroscopy with conventional gastroscopy.

Patients first underwent AnHan capsule gastroscopy, followed by conventional gastroscopy performed by different physicians, after which the results were compared. The comparison focused on focal lesions, as diffuse lesions involve the entire stomach and are readily identifiable. The comparative analysis demonstrated that the diagnostic accuracy of AnHan capsule gastroscopy reached 93.4% relative to conventional gastroscopy. The conclusion was that AnHan magnetically controlled capsule gastroscopy exhibits diagnostic accuracy consistent with that of conventional gastroscopy and is suitable for gastric cancer screening.

Having resolved the issue of accuracy, Anhan encountered a second question: Can magnetically controlled capsule gastroscopy be used for large-scale population screening?

To address this issue, Anhan also chose to let the data speak. They selected 3,182 patients from 99 health checkup centers, with an average age of 44.8 years. Using magnetically controlled capsule gastroscopy, gastric cancer was detected in 0.22% of the asymptomatic screening population.

Anhan’s “Magnet-Controlled Capsule Gastroscopy” robot has gained recognition from the international academic community for its diagnostic accuracy. In September 2016, the prestigious international journal Clinical Gastroenterology and Hepatology (CGH) featured a cover article titled “Accuracy Comparison Between Magnet-Controlled Capsule Gastroscopy and Electronic Gastroscopy in Diagnosing Gastric Diseases.” This study systematically compared the diagnostic accuracy of magnet-controlled capsule gastroscopy and electronic gastroscopy for gastric diseases, demonstrating that Anhan’s “Magnet-Controlled Capsule Gastroscopy” robot exhibits exceptionally high accuracy, with results consistent with those of the “gold standard” electronic gastroscopy.

Anhan is not limited to these aspects; it has expanded the application of its magnetically controlled capsule gastroscope robot across a broader spectrum through internet and artificial intelligence technologies.

Anhan empowers primary care physicians through medical consortiums, creating an integrated structure that spans from primary care facilities and health examination centers to community hospitals and tertiary Grade A hospitals. Quality control measures, including two-way referrals, are managed within the framework of these medical consortiums. Currently, multiple regions, including Shandong, Tianjin, and Fujian, have established medical consortiums linked by Anhan’s “Magnetic-Controlled Capsule Gastroscopy” robot system and have set up “Magnetic-Controlled Capsule Gastroscopy Collaboration Centers.” These initiatives aim to build rigorous medical quality control systems and conduct screening for gastrointestinal tumors. Through this medical consortium model, Anhan seeks to integrate more primary healthcare institutions and empower grassroots medical services.

The Internet offers the highest efficiency. Anhan connects all examinees, examination institutions, and physicians on a cloud platform to facilitate information sharing. Regardless of time or location, as long as there is internet access, physicians can perform remote diagnosis and consultation based on examination data, requiring only one local technician to operate the equipment.

Anhan further liberates physician resources and addresses image interpretation challenges through artificial intelligence. Powered by AI, the magnetically controlled capsule gastroscope robot can perform real-time diagnostics, conduct automated cruising examinations akin to drones, and prioritize observation of lesion sites, ensuring no lesions are missed. After completing the small intestine examination, the capsule is excreted naturally with bodily waste. As a single-use device that is not retrieved, it eliminates the risk of cross-infection.

To expand the scope of widespread application, Anhan has also established a comprehensive quality control and training system. Traditionally, “end-to-end” refers solely to the stages from production to distribution. However, for Anhan’s capsule robot, it encompasses every link from production and personnel training to operational inspection, data processing, and expert image interpretation, ensuring rigorous quality control throughout the entire examination process.

Furthermore, Huan Dandan informed us that Anhan’s products are manufactured on self-built production lines, with all automation equipment on these lines independently developed. The production line in Hubei Province was also recognized as a Hubei Provincial Demonstration Base for Intelligent Manufacturing. Led by the Chinese Medical Doctor Association, Anhan established the Capsule Gastroscopy Training Academy. Operators can easily master the entire operational technique after approximately one week of training, significantly improving efficiency.

Huan Dandan stated that while artificial intelligence and big data are frequently discussed in the current healthcare industry, for Anhan, these technologies effectively address clinical needs arising during large-scale screening programs.

A magnetically controlled capsule gastroscopy costs over 3,000 yuan at health checkup centers and approximately 4,000–5,000 yuan at hospitals. As hospitals set their own prices, costs vary across different institutions. Moreover, this product has been included in the medical insurance scheme in certain regions, such as Shanghai. Huan Dandan stated that with the continuous expansion of sales volume, the cost of this product will continue to decrease.

It is reported that Anhan has also partnered with an insurance institution in Munich, Germany, to develop an insurance product specifically designed for the “magnetically controlled capsule gastroscope” robot. This product has been filed with the China Banking and Insurance Regulatory Commission (CBIRC). If a patient is diagnosed with a malignant gastrointestinal tumor through examination using this device, the insurance will provide corresponding coverage for treatment.

Huan Dandan stated that AnHan was very fortunate to have gained widespread recognition in the capital markets. In August 2017, AnHan secured $100 million in joint investment from SoftBank China Capital, Dazhong Investment, Qiansheng Investment, Houxin Health Investment, Tongsheng Capital, and other institutional investors, becoming a unicorn enterprise with a valuation exceeding $1 billion. In selecting investors, AnHan seeks to partner with those who can offer synergies in terms of industry chain integration and shared business philosophy.

After achieving certain milestones, Anhan expanded its operations along two dimensions. First, it broadened the indications for its existing capsule gastroscopy robot. While this product was primarily used in gastrointestinal examinations, Anhan extended its applications to health check-ups, cardiology, geriatrics, pediatrics, and healthcare services for cadres, among other areas. Huan Dandan specifically explained why this product can be applied in the cardiovascular field, facilitating cross-departmental collaboration.

Because patients with stents need to take antiplatelet drugs after surgery, and these drugs can cause damage and bleeding of the gastrointestinal mucosa, a gastroscopy is required at this time to observe the extent of gastrointestinal damage in the patient. If traditional gastroscopy is used, its scope body is prone to causing further bleeding, making it impossible to perform the examination. The "magnetically controlled capsule endoscopy" by Anhan precisely addresses this need. Huan Dandan stated that there are many patients undergoing percutaneous coronary intervention (PCI) with stent placement in China, so this also represents a vast market space.

According to Xun Dandan, Anhan has now entered the green channel for innovative medical devices and plans to launch a vibrating capsule product next year, primarily targeting the highly prevalent issue of gastrointestinal constipation.

Gastrointestinal disorders are highly prevalent among the elderly and pregnant women; however, this population is generally unsuitable for chemical pharmaceuticals, which can also lead to drug resistance. Anhan’s vibrating capsule treats constipation by physically massaging the nerve endings in the gastrointestinal tract. It allows for personalized adjustments through a handheld device that regulates vibration frequency and intensity. This product does not require administration in a medical institution and is poised to become a consumer healthcare item available for purchase at pharmacies.

Anhan has also expanded its product portfolio, with more than a dozen products currently under development, primarily focusing on the gastrointestinal tract. All these products will be integrated into Anhan’s artificial intelligence and big data platform. Huan Dandan introduced us to several other products in Anhan’s pipeline:

1. Dual-lens colon capsule. Colorectal disease is highly prevalent in China, and in Europe and the United States, colorectal disorders are also more common than gastric diseases. Therefore, this product represents a key strategic initiative for Anhan’s expansion into overseas markets;

2. Robots for targeted drug delivery. Capsule robots can serve as carriers to transport drugs and release them at specific locations;

3. Another direction for capsule robots is targeted microbiota sampling. With this capsule robot, targeted microbiota samples can be collected from different locations within the human body without being affected by environmental changes during transmission. Anhan has also expanded the positioning capabilities of its capsules to enable motility analysis across different segments of the gastrointestinal tract;

4. Robotic products for surgical assistance. This product is primarily designed for mucosal dissection. Since endoscopic submucosal dissection (ESD) requires highly experienced physicians to perform, and the physician can effectively operate with only one hand after the endoscope is inserted, the capsule robot serves as an additional hand, assisting the physician in performing mucosal dissection.

Huan Dandan summarized Anhan’s development over the years, noting that Anhan possesses world-leading technological advantages and barriers, and has consistently addressed significant unmet clinical needs.

Secondly, Anhan has established authoritative endorsements both domestically and internationally by focusing on academic rigor, leveraging clinical data and clinical systems.

Furthermore, Anhan has established a comprehensive quality control and training system, expanded into the blue-ocean market of multidisciplinary integration, and developed an accessible business model through technological innovation.

Finally, Anhan continues to engage in product research and development and innovation, integrating technologies such as artificial intelligence and big data with clinical needs to continuously expand their applications.

Huan Dandan stated that these are the key factors that have enabled Anhan to reach its current position.