Big Vision Medical's BVB2000 Series Ophthalmic Biometer Receives Class II Medical Device Approval in China

Jul 26, 2024 09:28 CST Updated 09:28

Big Vision

Developer of Artificial Intelligence Analysis and Diagnosis Products for Ophthalmic Imaging

Source: Eye Future; Editor: Bai Xiaofei

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Recently,Suzhou Big Vision Medical Technology Co., Ltd. (Abbreviation: Big Vision)Wholly-owned subsidiary ——JiangXi Big Vision Medical Technology Co., Ltd.Independently DevelopedBVB2000 Series Ophthalmic Optical BiometerObtained byJiangxi Provincial Drug AdministrationIssued byPeople's Republic of China Class II Medical Device Registration Certificate (Gan Standard 20242160119)。

The deviceRelying on cutting-edge frequency-domain OCT technology`, achieved`Combination of Biometry and OCT Functions, providing ophthalmologists with comprehensive, accurate, and efficient diagnostic and treatment support.

This is also what Big Vision Medical has obtainedThe Fifth Medical Device Registration Certificate，Further enhancing the company's comprehensive market competitivenessBig Vision Medical Technology will continue to innovate,Relying on its technical advantages in the field of ophthalmic AI,Continuously Improve the Layout of Ophthalmic Intelligent Products。

# Market Overview

Ophthalmic Optical BiometerCapable of accurately measuring corneal curvature, corneal thickness, pupil diameter, and calculating intraocular lens power,Widely used in fields such as cataract surgery and myopia prevention and control, throughProvide Multi-dimensional Ocular Biometric Data, providing doctors with repeatable, timely, and accurate diagnostic evidence.

According to the research data from YH Research,Global Ophthalmic Optical Biometer MarketReached approximately 1.42 billion yuan in 2023, and is expected to maintain a steady growth trend in the coming years.The market size is expected to approach 2.27 billion yuan by 2030.。

There are various types of optical biometers available in the market, which can be divided into two categories based on usage scenarios and functions. One category isProfessional-grade products used in hospitals, such as the Zeiss IOL-MASTER series products, while the other category is forProducts used in optometry stores to meet myopia prevention and control needs, mainly composed of domestic brands such as Moptim, Sowei, and New Vision.In terms of sales revenue, the Zeiss IOL-MASTER series holds an absolute advantage in the market, accounting for a staggering 57.5% of sales revenue.。

▲ZEISS Optical Biometer MASTER 500 ((Source: Company official website)

According to research, in 2021 and 2022, the number of optical biometers listed for sale in public hospitals (on the procurement websites of Zhejiang Province and Guangdong Province) were 46 and 72 units respectively, with total winning bid prices of approximately 28 million yuan and 36 million yuan respectively.An increase of 28%, demonstrating good growth potential.。In the field of myopia prevention and control, the下沉 market space for biometric devices is even broader.However, the technical barriers and competitive thresholds in this field are relatively low, and price competition among domestically produced manufacturers is fierce.

According to incomplete statistics,In the field of myopia prevention and control, more than 1,000 optical biometry devices are sold each year.`, and the growth rate is very fast,`Expected to reach ten thousand units per year in the futureHowever, in this field, the average sales price of many domestically produced biometers is about 80,000 yuan per unit, with a price range of approximately 60,000 to 150,000 yuan per unit. Compared with products like the Zeiss Master biometer, which has an average sales price of 500,000 yuan in public hospitals and a price range of 400,000 to 1.8 million yuan, there is a difference of an order of magnitude.

Since the specific sales data of biometric devices in the field of myopia prevention and control cannot be verified, it is impossible to provide a relatively accurate prediction of the sales revenue growth trend. However, according to incomplete statistics,The total market sales scale of this product is currently around 500 million to 800 million yuan per year.. For ophthalmic biometry products,The high-end market of public hospitals is still in a state of import monopoly, with significant opportunities for domestic substitution.。

With the continuous intensification of global aging trends, the number of ophthalmic diseases and patients requiring ophthalmic surgery will continue to increase, further driving the market demand for optical biometers. Optical biometers, with their precise and rapid eye examination and diagnostic capabilities, effectively reduce missed diagnoses and misdiagnoses, bringing greater convenience to patients.Whether in ophthalmic diagnosis, surgical planning, or fields such as cataract surgery and myopia prevention and control, ophthalmic optical biometers have demonstrated their unique advantages and indispensable value.。

# Product Introduction

▲BVB2000 Series Ophthalmic Optical Biometer

AI Optical Biometer (BVB2000 Series)Based on Frequency Domain OCT Design, is a brand-new 2nd generationBiometer+OCT Combination Device, with advantages such as fully automatic intelligent convenience, multi-parameter comprehensive accuracy, and AI-powered efficiency.

This device not only canApplied to the myopia prevention and control market, achieving visualized axial length measurement, simultaneouslyComprehensive Eye Health Management, which can monitor the changes in choroidal thickness and the condition of macular diseases in real time.

Product Features:

(1) Comprehensive parameter measurement，Multiple Data from a Single Measurement, Axial Length (AL), Central Corneal Thickness (CCT), Pupil Diameter (PD),Limbal White-to-White DistanceWTW, Corneal Curvature Radius (CR), Astigmatism Axis, Anterior Chamber Depth (ACD), Lens Thickness (LT), while also capturing corneal OCT images and fundus OCT images.

(2) Visual Measurement, which can dynamically observe the corneal structure diagram and fundus structure diagram, supporting the measurement of retinal thickness and choroidal thickness (5mm).

(3) AI Fundus Disease AnalysisEquipped with an advanced artificial intelligence imaging-assisted diagnosis system in the industry, it can conduct in-depth analysis of OCT images of the macular region, enabling the detection of macular diseases such as macular holes, diabetic macular edema, and epiretinal membranes.

(4) Fully automatic operation, achieving automatic pupil positioning, focusing, and shooting.; AI intelligent analysis, judgment of refractive errors, axial ratio/axial growth exceeding the alert line, risk of myopia, etc., prediction of myopia status at age 18, simulation of eye development process, improvement of patient education communication efficiency, and realization of precise myopia prevention and control.

# About Big Vision Medical

Big Vision Medical Technology was founded in 2015 by the National 973 Program's Young Chief Scientist.JiangXi Big Vision Medical Technology Co., Ltd. was established in 2018 and is located in Ganzhou City, Jiangxi Province.

Big Vision Medical Technology Co., Ltd. with leading technology in ChinaOphthalmology AI-Assisted Diagnosis System-Based, toOphthalmic OCT Hardware Integrated with Artificial IntelligenceAs the market entry point, providing intelligent system solutions for grassroots hospitals, physical examination centers, optometry centers and other eye health medical and service units; and aroundImage-Centric Eye Health Data，Provide comprehensive one-stop eye health management services for individual users。

The company has obtained more than forty innovative achievements and patents, and has taken the lead in developing the multi-modal artificial intelligence analysis and diagnosis software system MIAS, which has obtained the Class II medical device registration certificate. The company has also developed a fully automatic artificial intelligence ophthalmic Optical Coherence Tomography (OCT) scanner.BV1000, forThe First ProductAI OCT with Fully Independent Intellectual Property Rights, Integrating Software and Hardware, meeting the diagnostic and screening needs of ophthalmic hospitals at all levels, and has received high praise from experts and users.Obtained the Class II Medical Device Registration Certificate and License in August 2020.。The company simultaneouslyDeveloped the "Bright Lemon" Eye Health Management System for optometry., highly favored by optometry centers, eyewear stores, grassroots ophthalmology departments, and ophthalmology clinics.

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