Fude Medphotonic Files IPO Prospectus: Pioneering Aspheric Lens LED Surgical Headlights to Fill Domestic High-End Market Gap

From kerosene lamps and oil lamps without any clean protective features, to Edison’s first incandescent light bulb, and then to energy-saving lamps and LED lights.

The Evolution of Lighting: A Footnote to the History of Human Medicine, Quietly Yet Brightly Illuminating Human Life and the Future.

High-quality medical lighting and imaging systems not only safeguard the health of healthcare professionals, prevent visual impairment, and extend surgeons’ career longevity—thereby benefiting more patients—but also minimize operational errors caused by color-induced dizziness, enhance procedural precision, and ensure the smooth execution of surgical procedures.

Along with the trend towards minimally invasive and refined surgical procedures, the application disciplines of wearable intraoperative auxiliary imaging and illumination systems have gradually expanded from traditional cardiac surgery and biliary tract surgery to many emerging fields such as dentistry and plastic surgery. The market demand for professional medical surgical headlamps has also increased accordingly.

According to relevant data, the global demand for surgical headlamps was approximately $47.69 billion in 2018. Calculated at a compound annual growth rate (CAGR) of 6.1%, the market is projected to reach a cumulative value of $72.22 billion by the end of 2025.

However, the domestic mid-to-high-end surgical headlight market is dominated by imports, which are expensive, suffer from slow product updates, and have certain performance deficiencies that may pose surgical risks, creating a strong demand for domestic alternatives.Zhejiang Fude Medical Optoelectronics Co., Ltd.(abbreviation“Fude Medical”) emerged as the times required.

Founded in November 2019, Fude Medical is located at the foot of Moganshan, a renowned summer resort. As a domestic medical device enterprise with independent capabilities in R&D, design, and manufacturing, the company operates across multiple new material fields, including medical optics, and is committed to serving clinicians and hospitals. The company has been honored as a Leading Entrepreneurial Team (Category B) under the 2020 “Nan Taihu Elite Plan” of Huzhou City, Zhejiang Province; recognized as one of the Top 10 Emerging Enterprises in the 2021 “Shanghai Pudong New Area Cloud+ Entrepreneurship Hub”; and shortlisted for the 4th Qipu Awards for Medical Device Innovation in 2022.

The company currently has operations in both Shanghai and Zhejiang, with its Pudong branch responsible for research and development and its Zhejiang branch handling mass production. At present, it offers the Aspholight series of professional medical surgical headlights and the Kepler series of surgical loupes, while also developing a professional medical surgical headlight equipped with intraoperative 4K wireless video transmission (4K camera headlight).

Fude Medical Corporate Environment

The Aspholight series of professional medical surgical headlamps is an advanced medical surgical headlamp independently developed by Fude Medical, and it is also the company’s flagship product.The product was approved for market launch in 2021.

The headlamp system employs optimized design technology for aspherical LED lens arrays and the concept of Köhler illumination. By utilizing high-performance optical materials and aspherical injection molding technology, it effectively reduces the number of optical lenses while significantly enhancing illumination performance, thereby successfully achieving lightweight and miniaturized production applications.

This productColor Rendering Index > 95(The higher the color rendering, the closer the color rendering index (CRI) value is to 100, the stronger the ability to restore the colors of objects, and the easier it is for the human eye to distinguish object colors), enabling high-definition restoration of the observed surface.The lens design angle has reached8°, exceeding existing products on the market3~5°,Illumination diameter at a distance of 60 cm reaches18cm, significantly expanding the surgeon's field of view. The LED utilizes a 3W high-luminous-efficiency imported light source, achieving an illuminance at 40 cm of70000lx. Features stepless dimming, allowing adjustment of light intensity to suit different environments; provides comfortable illumination brightness and effectively prevents glare. Net weight of the headlamp10g, it is currently the lightest among similar brands both domestically and internationally, offering comfortable wear and effectively avoiding obstruction of the field of vision.Applicable toCardiology, Neurosurgery, Ophthalmology, Stomatology, Plastic Surgery, Otorhinolaryngology, Urology, Obstetrics and Gynecology, Surgeryand other departments.

Comparison of Color Rendering Between Fude Medical Headlamp and Natural Light

Among these, the design and manufacturing of aspheric doublet lenses constitute the core technology in Fude Medical’s headlight production, effectively eliminating distortion and delivering superior illumination quality.

Excellent products are inseparable from a research and development team with outstanding capabilities.

Founder: Ji MinbiaoAfter graduating from the Department of Physics at Peking University, he pursued his Ph.D. at Stanford University in the United States, followed by postdoctoral research in biophotonics at Harvard University. He is currently a Professor and Doctoral Supervisor at Fudan University in Shanghai. He was selected for the National Overseas High-Level Talent Introduction Program organized by the Organization Department of the CPC Central Committee in 2015, and for the Shanghai “Young Science and Technology Star” Program in 2015. He serves as the Chief Expert for the Ministry of Science and Technology’s Key R&D Program on “Digital Diagnostic and Therapeutic Equipment.” He has published more than 70 papers in high-impact academic journals such as *Science* and *Science Translational Medicine*, which have been cited over 3,000 times. He has delivered invited talks at international conferences, including those organized by the International Society for Optics and Photonics (SPIE) and the Gordon Research Conferences. His work has been featured by BBC News, the National Institutes of Health (NIH), the Harvard Gazette, and Medical News Today.

Professor Ji Minbiao has been deeply engaged in optoelectronics for over a decade, commanding a strategic overview of the field with a solid technical foundation and forward-looking innovative spirit.

Ji Minbiao, Founder of Fude Medical

Leveraging his position as a professor and doctoral supervisor at Fudan University, Ji Minbiao assembled a core team of R&D and management professionals with expertise in optoelectronics, medicine, and management from Fudan University.

Chief Medical Officer, Yao Lie, Ph.D. from Fudan University, Deputy Director of the Department of Pancreatic Surgery at Huashan Hospital Affiliated to Fudan University, with extensive clinical experience and a broad medical perspective. He is adept at identifying clinical needs and pain points, playing a pivotal role in quality control and product promotion for the medical devices developed under this project.

CEO He Ruoyu, Ph.D. from Fudan University, with many years of experience in R&D of optical technologies and product management. Possesses solid professional expertise and excels in communication and strategic planning, demonstrating unique insights and systematic approaches to user training, feedback collection, and marketing for products.

Chief Scientist Ma Jiong,Ph.D. from Fudan University; Researcher in Optoelectronics at the School of Information Science and Engineering, Fudan University; recipient of the “National Overseas High-Level Talent Introduction Program” (organized by the Organization Department of the CPC Central Committee) and the “Shanghai Rising-Star Program for Young Sci-Tech Talents.” Expertise in the development and application of super-resolution microscopy technologies, providing high-end imaging technical support for this project.

The image shows Dr. Yao performing a surgical procedure using the Fude Medical surgical headlight.

The company currently has 12 full-time employees. The team possesses a solid foundation in basic science and R&D, is well-versed in the global landscape of process development, has an in-depth understanding of the current state of the surgical lighting industry, and maintains keen insights into future technological trends within the sector.

Furthermore, the company also collaborates withDepartment of Cardiac Surgery, Zhongshan HospitalandDepartment of Physics and Institute of Engineering and Applied Technology, Fudan UniversityCollaboration to bridge the innovation chain across industry, academia, and research has not only enabled full mastery of independent intellectual property rights at the foundational technological level, but also established a robust capacity for continuous and sustainable innovation.

Leveraging internationally leading technology and product performance, Fude Medical’s professional surgical headlamps have enteredHuashan Hospital of Fudan University, Zhongshan Hospital of Fudan University, Renji Hospital of Shanghai Jiao Tong University School of Medicine, Beijing 304 Hospitalin the operating rooms of numerous Grade 3A hospitals.

In minimally invasive mitral valve repair surgeries performed by the Department of Cardiac Surgery at Zhongshan Hospital, Fudan University, Fude Medical’s surgical headlamps demonstrated a larger illumination area, higher irradiance, and superior color rendering compared to foreign competing products.

Fude Medical Headlamps vs. U.S. CompetitorsActual MeasurementData Comparison

Furthermore, the company offers the Kepler series of portable surgical loupes, which surpass the resolution limits of the naked eye, enabling surgeons to visualize fine anatomical structures and perform precise surgeries.

Fude Medical Kepler Aspheric Loupe 3.5x Actual Photo

Looking to the future, founder Ji Minbiao stated that Fude Medical will adopt a “three-step” strategy.

First, regarding regulatory approvals, simultaneous submissions are being made in China and the United States. The Aspholight series of professional medical surgical headlamps received NMPA approval for market launch last year. This year, the regulatory submission and review process for the Kepler series of surgical loupes is underway. Meanwhile, both product lines are concurrently pursuing FDA and CE certifications.

Second is the reserve of technological products. Adhering to the R&D strategy of “producing one generation, developing one generation, and reserving one generation,” Fude Medical has currently reserved a medical professional surgical headlight with a 4K intraoperative recording system based on wireless transmission technology, namely the Fude Medical 4K Camera Headlight. The product features automatic center focusing and dynamic light sensitivity, achieving the industry’s highest 4K resolution to meet the needs of surgeons for operative documentation and live broadcasting at major conferences.

Third, in terms of market promotion, simultaneous efforts are being made in both domestic and international markets. Domestically, the focus is on top-tier (Grade 3A) hospitals, while overseas expansion leverages the advantage of high cost-performance ratio. According to Ji Minbiao, Fude’s aspheric lens LED surgical headlamps have also attracted significant attention from a large number of Japanese physicians. The company is currently engaged in active negotiations with the Japanese market to discuss future models of cooperation.