Vistel Files IPO Prospectus Following Global Launch of EyeWisdom®MCS, the World’s First Multi-Disease AI Diagnostic Software for Ophthalmology

Jun 22, 2024 00:15 CST Updated 00:15

Vistel

Artificial Intelligence Eye Health Product Developer

Source: Eye Future; Editor: Bai Xiaofei

Reprint requirements: Can be reprinted 24 hours after the first publication, source must be credited.

Recently, information released on the official website of the National Medical Products Administration shows,VistelInnovative Products Produced"Fundus Lesion Fundus Image Auxiliary Diagnosis Software" (EyeWisdom®MCS）Passed the review of the National Medical Products Administration,FormalApproved by NMPA for Class III Medical Device Registration Certificate (Registration No. 20243211109)。So far,A total of 273 innovative medical devices have been approved for marketing in China.。Previously, EyeWisdom®MCSCE MDR Certification Obtained, and has landed in the markets of EU developed countries such as France and Germany.

EyeWisdom®MCS isWorld's First Technology，ForThe FirstBased onMulti-disease AlgorithmFundus Image Analysis Software. Compared with the single disease algorithm, this product can determine whether there is any fundus abnormality by using a single network model, and thenIdentify a variety of common fundus diseases。Currently, Vistel's multi-disease fundus image auxiliary diagnosis softwareIs the first AI-assisted diagnostic software to pass the "Special Review Procedure for Innovative Medical Devices" (Class III) approval.。

Compared with single-disease AI products, multi-disease AI products canTruly adapt to the complexity of populations in real clinical environments，Further enhance the diagnostic capabilities of primary healthcare institutions for common fundus diseases,Enable a broader population to access early screening and treatment., reduce the occurrence of vision impairment and blinding diseases, and alleviate the social burden caused by related diseases.

# AI Fundus Screening Market

Fundus Diseases IncludeNeovascular Age-Related Macular Degeneration (nAMD), diabetic macular edema (DME), retinal vein occlusion (RVO), dry eye disease, glaucoma, etc., with nAMD being predominant in the elderly.

According to Evaluate Pharma statistics,Fundus diseases are the fastest-growing market in the field of ophthalmology., the market size in 2021 was approximately 21.8 billion US dollars. Among this,nAMD, DME, RVO account for the largest market share., accounting for 63%. In 2020, nAMD, DME, and RVO were approximately USD 12.928 billion, contributing USD 7.8 billion, USD 3.12 billion, and USD 2 billion respectively.It is expected to increase to 8.76, 3.86, and 2.4 billion US dollars respectively by 2025.。

For ophthalmic diseases,Early screening and regular check-ups are crucial throughout the entire treatment process.For example, diabetic retinopathy is the leading cause of blindness among working-age individuals (18-65 years old). Over 80% of people with diabetes will develop diabetic retinopathy, and their risk of blindness is 25 times higher than that of healthy individuals; however,As long as regular fundus examinations are performed in the early stage of diabetes, the risk of blindness from diabetic retinopathy can be reduced by 94.4%.. In fact,The Screening Rate for Diabetic Retinopathy in China is Less Than 10%The vast majority of patients with diabetic retinopathy have not been diagnosed and are unaware of its dangers, even ignoring the existence of this serious complication.

China currently has about 35,000 ophthalmologists, with an average of only 22 ophthalmologists per million people, far behind the average level of developed countries. Moreover, there is a significant disparity in the expertise of ophthalmologists across different regions and levels of hospitals.The realities of an aging population, a growing number of eye disease patients, the long training cycle for ophthalmologists, and a severe shortage of ophthalmologists are important reasons for the very low rate of diabetic retinopathy screening in China.。The development and application of artificial intelligence can solve this problem perfectly.。

AI fundus screening is one of the fastest areas where image recognition technology has been implemented in the medical field.Since the fundus is the only part of the human body where arteries, veins, and capillaries can be directly and clearly observed with the naked eye, these blood vessels can reflect the dynamics of the body's overall blood circulation and health condition. Fundus examination is not only an important method for detecting retinal, choroidal, and optic nerve diseases, but also a "window" for monitoring many systemic diseases.Using machine vision technology to analyze fundus photographs for assessing potential disease risks, is an application scenario where image recognition technology can shine in the medical field.

"The Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2020 Edition)" points out that artificial intelligence (AI) has shown great potential in the screening and grading diagnosis of DR.The automatic fundus screening technology using AI has an accuracy of 90%~98% for diagnosing DR, with high sensitivity and specificity.. This not only provides guidance and recommendations from a professional diagnostic perspective but also makes the market prospects for AI fundus screening clearer.

In recent years, many leading Internet companies and startups have recognized the potential of this scenario, and have joined the competitive track. In fact, since the end of 2019,AI Fundus Screening is Called the "King of Implementation" in the Ophthalmology Sector。

In fact,EyeDepartment Diseases and Artificial Intelligence Technology Have a Natural FitThis is because the photography of fundus images is more convenient, more universal, and easier to promote on a large scale, which provides AI companies with more data to improve the intelligence of their algorithms.

# EyeWisdom®MCS Introduction

EyeWisdom®MCS Software Interface

EyeWisdom®MCS: Fundus Lesion Diagnosis Aid SoftwareForWorld's First Technology，It took 7 years from the R&D project initiation to obtaining the registration certificate.，It solves the challenge of identifying complex fundus lesions through proprietary patented technology and is adaptable to various models and different photo qualities.

The product is able to process a single color fundus photograph,YesDetectedIncluding glaucoma, epiretinal membrane, macular hole, age-related macular degeneration, etc.More Than Ten Common Blinding Eye Diseases, with excellent clinical outcomes,The sensitivity of the clinical trial results reached 92.96%, and the specificity reached 93.32%.。

This fundus lesion fundus image auxiliary diagnosis software containsClient and Server, including user registration and login module, patient information management module, image automatic analysis module based on deep learning algorithm (including image quality assessment module and fundus multi-disease recognition module), report generation and management module, and system management module.

According to the official introduction,EyeWisdom®MCS can be widely used in health examination centers, primary medical institutions, and even ophthalmology., significantly improving the current situation of the lack of grassroots ophthalmology professionals and insufficient disease diagnostic capabilities,Promote the realization of hierarchical diagnosis and treatment，Improve the diagnostic and treatment efficiency of fundus diseases in large medical institutions at the same time。

# Vistel

Vistel was founded in 2016 and is aFocus on artificial intelligence in the medical industry, especially in the field of ophthalmologyApplicationA national high-tech enterprise dedicated to empowering medical institutions at all levels with advanced technology, enhancing diagnostic capabilities and efficiency.

Vistel for All Scenarios in Ophthalmic HealthcareProvide integrated hardware and software artificial intelligence solutions，Has been applied in more than 1,800 medical institutions at all levels across China, supporting various common blinding fundus diseases in grassroots screening, auxiliary diagnosis, treatment and other medical procedures,Served more than 1 million patients cumulatively。

The company has a complete, independent intellectual property rights-based innovative R&D system and profound technical accumulation, with more than 60 software copyrights and 22 patents obtained. Independently developedDiabetic Retinopathy Fundus Image Auxiliary Diagnosis Software, the first to obtain China's NMPA Class III medical device certification and EU CE certification.Multi-Disease Fundus Image Assisted Diagnosis SoftwareApproved for marketing by the NMPA. Currently, the product has been commercially applied on a large scale in France, Germany, Spain, Italy, and other countries.

As of the date of publication, the company's financing history is as follows:

KPMG

United Imaging HealthcareUnitedImaging

Editor-in-Chief | Zhao Qing Reviewed by | Yi He