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Recently,Fuhan Medical(abbreviation: Fuhan Medical) announced that its latest iterative productCreighton Ophthalmology Wide-field Imaging System (CorrettoUltra）Obtained the registration certificate for medical device products in China，Upgrade the Retinal Vessel Angiography Function, will be inScreening and Diagnosis of Childhood Blinding Eye DiseasesPlay an important role in China.Fuhan Medical's self-developed Kiretem (Coreiton) ophthalmic wide-field imaging system, isThe World's FirstPediatric Ophthalmic Product with 160° Ultra-Wide Angle Lens, with 13 million high-definition images, enabling more accurate and rapid detection of pediatric fundus lesions. It is equipped with7mm lens, the smallest diameter in the industry currently, more suitable for newborns with small palpebral fissures, especially preterm infants.Fundus angiography is an important diagnostic technique that primarily reflects the condition of retinal blood vessels and perfusion in the fundus.Fuhan Medical, building on the superior optical performance of its previous-generation products, has launched a brand-new product — the CreoTone Ophthalmic Wide-Field Imaging System Ultra.DepartmentRetina Ultra has upgraded the retinal angiography function, which is an important advancement for the screening and diagnosis of childhood blinding eye diseases.。As of the date of publication,Fuhan Medical has three different models of ophthalmic wide-field imaging systems on the market.。It is reported that,The company alsoPreparing for registration and listingThe First Product in ChinaOCT Equipment for Posterior Segment Imaging in Infants and Toddlers, suitable for two major scenarios: intraoperative and routine examination, and combined with fundus color photography and FFA to provide doctors with a comprehensively upgraded imaging combination; integrating the entire Corretro product series,Build an integrated platform including fundus color photography, FFA, OCT, and multispectral imaging.。
Function Upgrade：Upgrade Retinal Angiography Function, Independent contrast light source design with one machine and two handles, higher fluorescein excitation efficiency.Free Adjustment: During the filming processCan achieve free adjustment of 90°, 130°, and 160° field of view., Owns13 Million HD Imaging and 7mm Minimum Lens Diameter, which can detect pediatric fundus lesions more accurately and quickly.Creighton Three Field-of-View One-Touch SwitchingScreen can be deflected:Deflectable ScreenMore suitable for bedside examination in the Neonatal Intensive Care Unit (NICU), which can be flexibly switched between trolley mode and laptop mode, meeting clinical needs across departments and hospital zones in various scenarios.Deflectable Examination Handle ScreenRich Software:The intelligent software is even more abundant, such asArtificial intelligence capture, intelligent lesion recognition and measurement systems, etc.- FFA Imaging:Improved the contrast and visibility of blood vessels, enabling the recognition of some subtle vascular changes.
- Image Enhancement Technology:Combining algorithms such as image enhancement, filtering, denoising, and deep learning, further improving the quality of fundus images.
- Hemorrhage Detection and Quantitative Analysis of Hemorrhage Area:Self-developed AI AlgorithmAutomatic Segmentation and Quantitative Measurement of Fundus Lesions, providing doctors with more objective and precise data support through in-depth data mining.
- Automatically obtain key data indicators:Creighton Ultra PassedAutomatic Macular Localization, Automatic CDR CalculationThe objective fundus data obtained is of great guiding significance for the diagnosis of fundus diseases.
- Panoramic Stitching:Creiton Ultra is based on LoFTR stitching technology,Intelligently stitching multiple fundus images from different perspectives，Can display full-eye fundus images, allowing doctors to obtain more complete fundus information, making the diagnosis through image reading more intuitive and accurate, and providing assistance for the zoning of Retinopathy of Prematurity (ROP).
# Product Iteration and UpgradeSince 2020, Fuhan Medical officially launched the research and development of ophthalmic wide-field imaging systems,Thus, the Creton Ophthalmology Wide-field Imaging System has completed the iterative upgrade of three products.。These products provide important technical support in the field of pediatric ophthalmology, especially in neonatal fundus screening.Keruitong KRS-01:This is launched by Fuhan MedicalThe First Ophthalmic Wide-field Imaging System, withWorld's first 160° ultra-wide-angle shooting lens, with a wider shooting range than traditional lenses, a lens diameter of only 7mm, and a wireless handle weighing just 400 grams.Creighton Mini: Mini, while retaining the excellent optical characteristics of the Keratop series, has undergone a comprehensive upgrade in portability and cost-effectiveness.The handle weighs only 200g.。# Overview of the Global MarketCurrentlyContact systems in the global market are still inIntroduction PeriodIn 2022, statistics from projects supported by the United Nations Children's Fund (UNICEF) showed that globally,50% of Doctors Use Only Indirect Ophthalmoscopy for Neonatal Fundus Disease Diagnosis，67% of doctors do not have access to fundus imaging systems.，20% of doctors simply take fundus photographs using mobile phones and other imaging recording systems.。
Mobile phones and other imaging recording systems generally have an imaging field of view within 65 degrees, making it more difficult to clearly observe the peripheral areas of the fundus that are prone to lesions compared to current professional contact-based fundus imaging systems (such as Retcam, Phoenix, and Forus in the figure below), which offer 130-degree imaging. Moreover, these systems cannot be integrated with cutting-edge optical examination technologies such as Optical Coherence Tomography (OCT).
▲Statistical Results of UNICEF-Supported Projects in 2022The number of newborns in China who need fundus examination each yearMore Than a Million CasesThis includes preterm infants accounting for about 10% of the birth population and high-risk newborns triggered by abnormal oxygen inhalation as required by national screening, as well as infants with abnormal fundus development caused by genetic disease risks or other factor risks that are not included in the screening requirements.According to the U.S. statistical data on preterm infants published in May 2023,After using a precise contact fundus camera for examination, the incidence of fundus diseases in premature infants has been increasing year by year, butThe incidence of blindness, amblyopia, and strabismus has been effectively controlled.. On the one hand, it indicatesContact-based fundus imaging systems are also in the introductory phase in the United States.，With the promotion of advanced equipment, more pediatric fundus diseases can be effectively detected and intervened in the early stage; on the other hand, it alsoReflecting the demand for contact-based fundus imaging systems, thereby achieving the goals of disease treatment and control in pediatric ophthalmology.▲ The incidence of Retinopathy of Prematurity (ROP) in the United States continues to rise (due toJAMA ophthalmology）In 2022,Global sales of contact imaging systems for newborns (wide-field fundus cameras for newborns) reached $1.535 billion, and the global market is expected to reach $2.535 billion by 2030, showing relatively rapid growth.。Contact-based fundus imaging systems are dominated by American companies Natus and Phoenix, nearly monopolizing the market in China., the product's high price and complex lens assembly have made the promotion of this diagnostic tool in developing countries extremely difficult. However, developing countries have a significant demand for high-quality, cost-effective contact fundus imaging systems.The demand is growing day by day., the success of India's local brand Forus Camera in the Indian market is sufficient to demonstrateHuge Market Space in Developing Countries。▲ Products from the U.S. Natus company and India's Forus company (from official website)From the development of fundus cameras, contact-based fundus imaging systems will also undergo a process of iterative integration of advanced optical functions into products. In 2021, about half of the market consisted of standard fundus cameras, followed by fundus cameras with fluorescein angiography functionality, and those with OCT functionality were the least used.By 2028,The usage of OCT functional fundus cameras will increase rapidly., the market for ordinary fundus cameras will be compressed, and it is expected to formOrdinary Fundus Camera, Fluorescein Angiography Fundus Camera, OCT Fundus Camera"A Tripartite Market Structure"From a clinical perspective, 60% of fundus diseases require angiography for assessment, and 30% of fundus diseases can only be diagnosed with OCT technology. This is the intrinsic driving force behind the technological transformation of fundus cameras.▲ Sales Share of Different Products in Fundus Imaging Systems(Source: Grand View Research)# Overview of the Domestic MarketContact Fundus CameraBecause the physical optics part has significant design differences from non-contact fundus cameras (e.g., desktop or handheld devices for adults),Increased Difficulty in OCT Localization, currentlyThe overseas developer under research is Leica.，The developer in China is Fuhan Medical.。In January 2024, the Jiangsu Provincial Drug Administration released the review results announcement for the registration application of innovative Class II medical device products, approving Fuhan Medical'sOphthalmologyOptical Coherence Tomography Scanner(Specifications and Model: Kiretem-OCT) Enters the Innovative Product Registration Process，Fuhan Medical has also becomeOne of the Two GloballyThe R&D and production enterprise of contact-type OCT ophthalmic systems。▲Image source: Jiangsu Provincial Drug AdministrationKiretem-OCT is suitable for occasions requiring tomographic imaging of the fundus. The product consists of a main unit, imaging client software (Kiretem-OCT, release version V1), and a foot pedal.Is currently the only OCT device in China and abroad suitable for infant fundus imaging., self-developed contact optical lens, meets the clinical needs of pediatric ophthalmologists for OCT imaging.▲ Kiretem-OCT (from the official website)Network communication and network intelligence are crucial for the development of image-based medical devices. How to achieve high-definition, lossless, and low-latency transmission of medical images, and how to ensure interference-free and fast wireless transmission are at the forefront of research and development in this field.Fuhan Medical has complete independent intellectual property rightsKNT image transmission technology specifically addresses the aforementioned issues.。▲Two Communication Transmission Methods of Contact Fundus Imaging System ((Source: Official Website)Clinically, the use ofWireless Detection System, avoiding the hassle of doctors having to push carts to the patient's side for testing, and avoiding the secondary risks of removing critically ill infants from incubators.Achieving Bedside Diagnosis of Contact Fundus Imaging Systems (POCT）。This wireless communication technology can also be applied to other medical devices that require high-speed, stable transmission of high-quality images.This wireless communication technology also serves as the cornerstone for subsequent deep processing of medical images by artificial intelligence, enabling automated or semi-automated, quantitative or semi-quantitative intelligent disease diagnosis.。Literature research found that deep learning technology providesRetinopathy of Prematurity (ROP) ofThe diagnostic accuracy is equivalent to that of a doctor, and with the application of telemedicine technology, the sophisticated field of ophthalmology can benefit pediatrics and under-resourced areas. With advancements in antibody drugs and gene therapy medications, more and more complex ophthalmic conditions now have treatment options.Early detection of diseases and effective tracking and subsequent treatment require more accessible testing methods in various scenarios.。In addition to being more portable, how to facilitate doctors' use in different scenarios and how to develop intelligent quantitative diagnostic assistance tools for different disease types are all questions that provide R&D directions for new products.。Fuhan Medical was founded in 2018 and is committed toProducts in the field of children's eye healthAnd service development-oriented technology SMEs, with headquarters and R&D base located in Nanjing's Jiangbei New Area.Since its establishment, it has focused on independent research and development, forming a research and development team in various fields from hardware to software, and from application to research. Under its umbrella,Creighton Ophthalmology Wide-field Imaging System has obtained more than 30 national patents., including more than 20 utility model and invention patents, and over 10 software copyrights. In the future, Fuhan Medical will continue to focus on the field of pediatric ophthalmology, developing innovative products such as portable pediatric OCT, using technological innovation to support children's eye care.As of the date of this report, the company's financing history is as follows:
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