Global First: 3N Eyecare’s Active Rigid Contact Lens Care Device Enters NMPA Innovative Medical Device Review Program

On January 9, 2024, with the conclusion of the public announcement period for the special review of innovative medical device applications (No. 9 of 2023), a domestic Chinese medical device innovation companySuzhou 3n Biological Technology Co., Ltd. (referred to as 3N Tech)Relying on innovative technologyElectrophoresis-Dissociation Elepy^®The world's first rigid contact lens cleaning and disinfection device, developed by 3N Tech, has officially entered the special review process for innovative medical devices by the National Medical Products Administration.

Corneal hypoxia, corneal epithelial staining, corneal pigment ring, corneal deformation, glare, decreased visual quality, and even corneal pathogenic microbial infections... All of these are potential corneal complications associated with wearing contact lenses.

With the increase in the number of people with myopia, the popularity of OK lenses, and the launch of rigid scleral contact lenses, a series of issues arising from wearing rigid contact lens products have gradually begun to attract widespread attention.

Apart from the mechanical friction between the lens and the cornea caused by wearing issues, protein deposition is also a major cause of corneal complications. When lens care is poor and the lens is not cleaned properly, protein substances accumulate, which not only reduces visual acuity and the oxygen permeability of the lens, affecting oxygen transmission, but also interferes with the disinfection effect of the lens. Therefore, maintaining the cleanliness and oxygen permeability of the lens is crucial to reducing corneal hypoxia and physical and chemical damage.^[1]The participation of contact lens care products is necessary to maintain the cleanliness and breathability of the lenses.

With So Many Contact Lens Care Products, What Should Patients Do?

Current rigid contact lens care products on the market can be divided into multipurpose solutions, hydrogen peroxide solutions, specialized enzymatic tablets/liquids, chlorine-containing solutions, and others based on their functions, all of which are non-powered care products. Care products are categorized by usage frequency into daily routine care and intensive protein removal care performed every 1-2 weeks. However, currently available products have limitations such as single functionality, incomplete cleaning, and time-consuming processes. 3N Tech's rigid contact lens protein remover and sterilization device, as the first innovative medical device to pass special application review, will provide a new option for contact lens wearers in the future with its excellent safety performance and innovative technology.

Protein Removal and Sterilization Device for Rigid Contact Lenses is exclusively used with 0.9% sterile sodium chloride solution, achieving protein removal and sterilization effects on rigid contact lenses through electrophoresis-dissociation (electrophoresis and electrochemical dissociation). The lens is placed in the electrophoresis-dissociation chamber containing 0.9% sterile sodium chloride solution, where a direct current applied to the electrodes inside the chamber by the instrument base creates an electric field. Utilizing the characteristic of proteins being charged and able to move within an electric field, tear proteins located in the interstitial spaces or on the surface of the lens material are physically moved directionally—a novel application of "protein electrophoresis" in biology. "Electrochemical dissociation," on the other hand, involves electrolyzing the 0.9% sterile sodium chloride solution to produce chlorine-containing saline solutions that efficiently eliminate microorganisms attached to the lenses.

Compared with traditional rigid contact lens care solutions, the 3N Rigid Contact Lens Protein Remover and Sterilizer features "simple composition, easy operation, dual effects combined, and high safety acceptability."

● In terms of composition, the 3N Rigid Contact Lens Deproteinizing and Sterilizing Care Instrument is only used with 0.9% sterile sodium chloride solution. Both the added liquid and the rinsing liquid are 0.9% sterile sodium chloride solution, which is safe and non-irritating, and contains no preservatives.

● In operation, simply rub the lens with 0.9% sterile sodium chloride solution, place the lens in the lens holder, follow the instrument prompts, and thoroughly rinse with 0.9% sterile sodium chloride solution before wearing. This effectively liberates both hands and enhances patient compliance.

● In terms of effectiveness, the 3N Rigid Contact Lens Protein Remover and Sterilization Device enhances 0.9% sterile sodium chloride solution with cleaning and disinfection capabilities for rigid contact lenses that the solution does not inherently possess, and its performance is comparable to existing rigid contact lens care solutions.^[2]。

● In terms of safety, the 3N Rigid Contact Lens Deproteinization and Sterilization Care Device has successively conducted pre-market clinical trials in multiple authoritative ophthalmology hospitals in China. This research was led by Tianjin Ophthalmology Hospital, with top optometry expert Director Li Lihua serving as the Principal Investigator (PI), alongside Director Liu Jun from Changzhi People's Hospital and Director Jin Wanqing from the Eye Optometry Hospital affiliated with Wenzhou Medical University. Currently, the 3N Rigid Contact Lens Deproteinization and Sterilization Care Device has achieved excellent clinical data, with a high level of acceptance among participants, positive comfort evaluations, and better satisfaction of patient needs."As a new type of rigid contact lens care method, it can further reduce the infection risk for teenage myopia patients who use rigid contact lenses," this is the high praise given by Director Li Lihua to this device.

In summary, as a completely new technology that distinguishes itself from existing rigid contact lens care products,OperationElectrophoresis-Dissociation Elepy^®The rigid contact lens cleaning and disinfection device, born out of advanced technology, has successfully brought the care of rigid contact lenses into the powered era. It integrates daily care and deep care in one machine, addressing current industry challenges and pain points. Its performance in all aspects has been fully validated, offering contact lens wearers a revolutionary new choice.

Innovative medical devices are one of the important driving forces for promoting the development of the medical industry. Only by focusing on clinical value can we unleash the vitality of innovation in the medical device industry, enhance the safety, effectiveness, and accessibility of medical device products, improve the quality of medical devices, and steadily advance China's transformation from a "major medical device country" to a "strong medical device country."

As of now, the National Medical Products Administration (NMPA) has approved a total of 250 innovative medical devices, of which 13 are related to ophthalmology (involving 11 companies and 9 types of products). Currently, those that have passed the special review for innovative medical device applications...Ophthalmic instruments related to rigid contact lens care only include 3N Tech's "Rigid Contact Lens Cleaning and Disinfection Equipment"., the birth of this device has achieved a leap from "0" to "1" and from "passive" to "active", filling the gap in the domestic market.

 Table 1. Ophthalmic Innovative Medical Devices Approved by the National Medical Products Administration

Whether it can effectively meet the people's demand for high-quality medical devices is an important criterion to measure the innovative development of the medical device industry.

3N Tech pioneered the field of rigid contact lens cleaning and disinfection devices, creating a care system independent of traditional care solutions. It is the only domestically produced active care Class III medical device that can technically surpass imported rigid contact lens care products, significantly stimulating new market demands and promoting the healthy growth of China's innovative industry.

According to data from the National Health Commission of China, China has over 700 million myopia patients, among which the overall myopia rate for children and adolescents is 52.7%. The myopia rate among Chinese children and adolescents now ranks first in the world. Various products have emerged around myopia prevention and control. Currently, orthokeratology lenses (OK lenses) remain the most recognized product in the optometry industry, but rigid contact lenses such as scleral lenses are gradually appearing as well.

The potential of 3N Tech's rigid contact lens deproteinization and sterilization care device is not limited to the application scope of orthokeratology lenses or the Chinese market.

In terms of materials, whether it is RGP lenses, orthokeratology lenses, or scleral contact lenses, the base materials of the lenses are almost the same. Based on current clinical data and research materials,3N Tech Rigid Contact Lens Deproteinization and Sterilization Care Instrument is highly likely to expand its application scope to a broader range.

On January 13, 2022, 3N Contact Lens Care Device was approved by the FDA certification, belonging to 3N Tech.Electrophoresis-DissociationThe First Encounter of the Product Series with Overseas Markets, for3N Tech's Rigid Contact Lens De-Protein and Sterilization Care Device Lays the Foundation for Entering the Global Market in the Future.

3N Tech is located in the Biomedical Industry Park of Suzhou Industrial Park, focusing on the research, production, and sales of contact lens care solutions. The team has spent years deeply engaged in the ophthalmology field, directly addressing the pain points of contact lens care. Based on the principle of protein electrophoresis in biomedicine and combined with electrolysis technology, they have developed a new electrophoresis-dissociation technology called Elepy.^®Technology, and globally pioneered the application of this technology in contact lens protein removal, sterilization, and cleaning care. 3N Tech continuously enhances the wearing experience of contact lens users with disruptive innovative technology, while minimizing the risk of complications such as corneal infections and dry eyes caused by improper contact lens care. To date, 3N Tech hasHolding more than 150 patents domestically and internationally。

The successful approval of this rigid contact lens cleaning and disinfection device into the innovative medical device review process has introduced a highly competitive product to the current market of contact lens care products. It will jointly safeguard the eye safety of lens wearers and promote the healthy and orderly development of contact lens care technology, benefiting the sustained, healthy, and standardized growth of China's contact lens industry.

In the future, as 3N Tech continues to expand into the international market, it may introduce this innovative product and other series to more countries and regions, fully aligning with the global market and bringing China's innovative strength to the world.

References:

[1] E K, PK A, EK A, et al. Contact lens complications among wearers in Ghana.[J]. Contact lens & anterior eye : the journal of the British Contact Lens Association, 2021,44(1): 67-71.

[2] ZHOU Y, JIN W, YANG J, et al. The efficacy of a device-based approach to microorganism disinfection and protein removal for orthokeratology lenses in varied clinical circumstances.[J]. Contact lens & anterior eye : the journal of the British Contact Lens Association, 2023: 102106.