Founded in 2015, we are one of the first to provide AI-empowered retina-based non-invasive, fast, effective and scalable early detection, diagnosis and health risk assessment solutions in China, according to Frost & Sullivan. We have three versions of Airdoc-AIFUNDUS, our in-house developed Core Product, in our portfolio. Our Airdoc-AIFUNDUS (1.0), an AI-based Software as a Medical Device (“SaMD”) approved for auxiliary diagnosis of diabetic retinopathy to assist physicians with medical diagnosis, was the first of its kind to obtain the Class III medical device certificate from the NMPA. We began to generate revenue from our Airdoc-AIFUNDUS (1.0) since the first quarter of 2021. Airdoc-AIFUNDUS (2.0) is indicated for the auxiliary diagnosis of hypertensive retinopathy, retinal vein occlusion and AMD. Airdoc-AIFUNDUS (3.0) is indicated for the auxiliary diagnosis of pathological myopia and retinal detachment. As of the Latest Practicable Date, we had not commenced clinical trials of Airdoc-AIFUNDUS (2.0) and Airdoc-AIFUNDUS (3.0), and had not received any objection notice from the NMPA to the commencement of the clinical trials of Airdoc-AIFUNDUS (2.0). We offer health risk assessment solutions with the ability to detect risk indicators in a wide range of healthcare environments, including health checkup centers, community clinics, insurance companies, optometry centers and pharmacies. In addition, we have a pipeline of seven other in-house developed SaMDs and health risk assessment solutions to address various healthcare needs for the wider population. As of the Latest Practicable Date, we owned 158 patents, patent applications and published PCT applications, among which 24 are related to our Core Product.
WE MAY NOT BE ABLE TO ULTIMATELY DEVELOP AND MARKET OUR CORE PRODUCT, AIRDOC-AIFUNDUS, OR OUR OTHER PRODUCTS
Airdoc-AIFUNDUS — Our Core Product
Airdoc-AIFUNDUS (1.0)
Our Airdoc-AIFUNDUS (1.0), an AI-based SaMD approved for auxiliary diagnosis of diabetic retinopathy, was the first AI-empowered retina-based auxiliary diagnosis product to obtain the Class III medical device certificate from the NMPA according to Frost & Sullivan, enabling it to be used in hospitals in China to assist physicians with medical diagnosis. Diabetic retinopathy is the most common complication for patients with diabetes. With the increasing prevalence of diabetes in China, the diabetic retinopathy patient population in China was 37.3 million in 2020 and is forecasted to reach 50.6 million in 2030 at a CAGR of 3.1% from 2020 to 2030. Because early stage diabetic retinopathy is often asymptomatic, approximately 90% diabetic retinopathy cases, or 33.6 million people, remain undiagnosed with a screening rate of less than 10% in China in 2020. We face fierce market competition in relation to Airdoc-AIFUNDUS (1.0). To date, we were one of the three NMPA-approved Class III AI-based SaMDs for the auxiliar
Airdoc-AIFUNDUS (2.0)
Our Airdoc-AIFUNDUS (2.0) is designed for the auxiliary diagnosis of hypertensive retinopathy, retinal vein occlusion and AMD. According to Frost & Sullivan, 13% hypertensive patients have hypertensive retinopathy in China. The hypertensive retinopathy patient population in China was 42.2 million in 2020 and is forecasted to reach 62.1 million in 2030. The retinal vein occlusion patient population in China was 6.7 million in 2020 and is forecasted to reach 9.5 million in 2030. The age-related macular degeneration patient population in China is forecasted to reach 52.3 million in 2030. As of the Latest Practicable Date, there were no NMPA-approved products similar to our Airdoc-AIFUNDUS (2.0). As of the same date, we were preparing for the clinical trial for our Airdoc-AIFUNDUS (2.0). We were in the process of communicating with the NMPA about our detailed clinical trial plan and protocols. We plan to commence our multi-center clinical trial in October 2021 and apply for a registration approval of new indicati
Airdoc-AIFUNDUS (3.0)
Our Airdoc-AIFUNDUS (3.0) is designed for the auxiliary diagnosis of pathological myopia and retinal detachment. The pathological myopia patient population in China was 22.6 million in 2020 and is forecasted to reach 32.3 million in 2030. The retinal detachment patient population in China reached 0.14 million in 2020 and is forecasted to reach 0.15 million in 2030. To date, there were no NMPA-approved products similar to our Airdoc-AIFUNDUS (3.0) which is designed for the auxiliary diagnosis of pathological myopia and retinal detachment. As of the Latest Practicable Date, we had finished the initial development of our Airdoc-AIFUNDUS (3.0). We plan to commence our multi-center clinical trial in October 2022 and apply for a registration approval of new indications with the NMPA in the first half of 2024. As of the Latest Practicable Date, there has not been any material communication between us and the NMPA. For details, see “Business — Our portfolio — SaMDs for Detection and Diagnosis — Airdoc-AIFUNDUS —
Individual Products
Glaucoma Detection SaMD
Our glaucoma detection SaMD is used to process and analyze fundus images to detect glaucoma by measuring the cup to disc ratio (the “CDR”) of the optic disc. The number of patients with glaucoma in China was 20.0 million in 2020 and is expected to reach approximately 23.0 million in 2030. With satisfactory results from clinical evaluation, we have obtained a Class II medical device registration certificate in June 2020 from the Shanghai branch of the NMPA. We have started commercialization of glaucoma detection SaMD for a short period of time and began to generate revenue from our glaucoma detection SaMD since February 2021.
Cataracts Detection SaMD
Our cataracts detection SaMD is designed to detect early symptoms of cataracts by measuring the density of the lens of the eye. With the aging population in China, the number of cataracts patients is expected to increase to 237.6 million in 2030 in China. We had submitted the Class II medical device registration certificate application for our cataracts detection SaMD in April 2021.We aim to market our cataracts detection SaMD to ophthalmology departments of hospitals, ophthalmology specialist hospitals and community clinics.
Other SaMDs for Detection and Diagnosis
We are developing five other SaMDs for detection and auxiliary diagnosis, covering ICVD and ASCVD, gestational diabetic retinopathy, gestational hypertensive retinopathy, papilledema intracranial hypertension retinopathy and anemia based on our AI-empowered retina-based early detection, diagnosis and health risk assessment technology platform. We plan to apply for separate medical device registration certificate from relevant authorities for each of our SaMDs for detection and diagnosis.
As advised by our PRC Legal Advisors, medical institutions, rather than us, will be liable for misdiagnose or misuse of the medical institutions, as long as we fulfill the product specifications stated on individual registration certificate and regulated by applicable laws and regulations, such as the Good Manufacturing Practice for Medical Devices (《醫療器械生產管理規範》) and the Regulations on Supervision and Administration of Medical Devices (《醫療器械監督管理條例》), because our SaMDs are used for auxiliary diagnosis to help physicians make diagnosis rather than diagnosis. As confirmed by our PRC Legal Advisors, during the Track Record Period and up to the Latest Practicable Date, we were in compliance with the Good Manufacturing Practice for Medical Devices and the Regulations on Supervision and Administration of Medical Devices.
Health Risk Assessment Solutions
Our health risk assessment solutions aim to provide basic health assessment to users and enable detection of risk indicators, including retinal abnormalities, retinal vascular diseases, vitreous abnormalities, retinal tumors, optic nerve pathologies, macular diseases, congenital anomalies of the retina, cardiovascular diseases and anemia. Our health risk assessment solutions have an average AUC of 0.968, measured on large-scale real-world user data, demonstrating accuracy compared to ground truth established by real-life medical experts’ diagnoses. Our health risk assessment solutions are different from our SaMDs for detection and diagnosis in terms of indications as well as sales and marketing strategies. As advised by our PRC Legal Advisors, unlike our SaMDs for detection and diagnosis, our health risk assessment solutions are not regulated as medical devices and no clinical trial, clinical evaluation or regulatory approval is required before commercialization of our health risk assessment solutions. During the Track Record Period, we marketed AI-based health risk assessment solutions to a wide range of customers, including health checkup centers, community clinics, insurance companies, optometry centers and pharmacies, and generated revenues of RMB21.9 million, RMB42.8 million, RMB6.0 million and RMB39.1 million, respectively for the years ended December 31, 2019 and 2020 and the six months ended June 30, 2020 and 2021. For details, see “Business — Our Portfolio — Health Risk Assessment Solutions.”
As advised by our PRC Legal Advisors, we are not liable for misuse of the customers because our health risk assessment solutions are used for detecting risk indicators associated with a wide range of diseases and lesions.
Proprietary Hardware Devices
We also have three in-house developed fundus cameras, which received a Class II medical device certificate or expect to receive Class II medical device certificate, compatible with our auxiliary diagnosis SaMDs and health risk assessment solutions and enabling us to provide integrated healthcare solutions that combine hardware and software. No clinical trial is required for the Class II medical device certificate of such hardware devices. For details, see “Business — Our Portfolio — Proprietary Hardware Devices.”
Source: Airdoc-B (02251) Prospectus (IPO Date : 2021/10/26) |