World's First Rigid Contact Lens Care Device Enters China's Innovative Medical Device Green Channel

Jan 09, 2024 18:04 CST Updated 18:04

3N Tech

Manufacturer and R&D of Corneal Contact Lens Care Technology and Products

On January 9, 2024, with the conclusion of the public review period for the special examination application of innovative medical devices (Announcement No. 9 of 2023), a domestically produced medical device innovation company in ChinaSuzhou 3n Biological Technology Co., Ltd. (referred to as 3N Tech)Relying on innovative technologyElectrophoresis-Dissociation Elepy®3N Tech's globally pioneering rigid contact lens cleaning and disinfection device officially enters the NMPA innovative medical device green channel.

Corneal Complications Require More Attention

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 orthokeratology lenses (OK lenses), and the market 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 deposits are also a major cause of corneal complications. When lens care is poor and the lenses are not cleaned properly, protein substances accumulate, which not only reduces visual acuity and the oxygen permeability of the lenses, affecting oxygen transmission, but also interferes with the disinfection effectiveness of the lenses. Therefore, maintaining the cleanliness and oxygen permeability of the lenses is crucial to reducing corneal hypoxia and physical and chemical damage [1]. Maintaining the cleanliness and oxygen permeability of the lenses requires the use of contact lens care products.

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

Currently, rigid contact lens care products on the market can be divided into multipurpose solutions, hydrogen peroxide solutions, dedicated enzymatic tablets/liquids, chlorine-based solutions, and others, 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. The rigid contact lens protein removal and sterilization device developed by 3N Tech, as the first Class III medical device approved through the innovative medical device special review process for contact lens cleaning and disinfection, will provide a new option for contact lens wearers in the future with its excellent safety performance and innovative technology.

New Electrophoresis Dissociation Technology

A New Experience in Ocular Surface Health

Rigid Contact Lens De-Protein and Sterilization Care Device is used exclusively with 0.9% sterile sodium chloride solution. It achieves de-protein and sterilization effects on rigid contact lenses through electrophoresis-dissociation (electrophoresis and electrochemical dissociation). The lens is placed in an electrophoresis dissociation chamber containing 0.9% sterile sodium chloride solution. A direct current is applied to the electrodes inside the chamber via the device base, creating an electric field. Utilizing the characteristic that proteins are charged and can move within an electric field, tear proteins 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" involves electrolyzing the 0.9% sterile sodium chloride solution to produce chlorine-containing saline solution that efficiently eliminates microorganisms attached to the lens.

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

Ingredients

3N Rigid Contact Lens Deproteinization and Sterilization Care Device is only used with 0.9% sterile sodium chloride solution. Both the added liquid and the flushing 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 saline solution, place the lens in the lens holder, follow the instrument's prompts for operation, and thoroughly rinse it with 0.9% sterile saline solution before wearing. This effectively frees up both hands and improves patient compliance.

In terms of effectiveness

The 3N Rigid Contact Lens Deproteinization and Sterilization Care Device endows 0.9% sterile sodium chloride solution with cleaning and disinfection effects for rigid contact lenses that the solution itself does not possess, and the effects are comparable to existing rigid contact lens care solutions [2].

In terms of safety

3N Rigid Contact Lens De-Protein and Sterilization Care Device Conducts Pre-Market Clinical Trials in Multiple Authoritative Ophthalmic Hospitals in China"As a new type of rigid contact lens care method, it can further reduce the infection risk for teenage myopia patients using rigid contact lenses," said Director Li Lihua in her high praise for this device.

In summary, as a completely new technology that distinguishes itself from existing rigid contact lens care productsElectrophoresis-Dissociation Elepy®The rigid contact lens cleaning and disinfection device, born from 3N Tech's innovation, has successfully brought the care of rigid contact lenses into the powered era. Integrating daily and deep care in one machine, it addresses current industry challenges and pain points. Its performance in all aspects has been fully validated, offering contact lens wearers a revolutionary new choice.

3N Tech Boosts the Development of Innovative Medical Devices

Safeguarding Healthy China

Innovative medical devices are one of the important driving forces for promoting the development of the medical industry. Guided by clinical value, the innovation and development vitality of the medical device industry can be unleashed, enhancing the safety, effectiveness, and accessibility of medical device products, improving the quality of medical devices, and steadily advancing 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 devices...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 marks a leap from "0" to "1" and from "passive" to "active," filling a gap in the Chinese market.

Table 1. Ophthalmic innovative medical devices approved by the National Medical Products Administration (NMPA)

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, establishing a care system independent of traditional care solutions. It is the only Class III active medical device for contact lens care produced in China that can technically surpass imported rigid contact lens care products, greatly stimulating new market demands and promoting the healthy growth of China's innovative industry.

More Possibilities & Bigger Market

Rigid Contact Lens Cleaning and Disinfection Equipment Has Broad Prospects

According to data from the National Health Commission, China has over 700 million patients with myopia, 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 primary recognized product in the optometry industry, but rigid contact lens products such as scleral lenses are gradually emerging.

The potential of 3N Tech's Rigid Contact Lens De-Protein 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 identical. Based on current clinical data and research information,3N Rigid Contact Lens De-Protein and Sterilization Care Instrument is highly likely to expand its application scope to a wider range.

On January 13, 2022, the 3N contact lens care device received FDA certification, marking the first introduction of 3N Tech's electrophoresis-dissociation series to the overseas market. This milestone lays the foundation for the global expansion of the 3N rigid contact lens protein-removal and sterilization care device.

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 working 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 completely new solution.Electrophoresis-Dissociation Elepy® Technology, and is the world's first to apply this technology to protein removal, sterilization, and cleaning care for contact lenses. 3N Tech continuously enhances the wearing experience of contact lens users with its disruptive innovative technology, while minimizing the risk of complications such as corneal infections and dry eyes caused by improper contact lens care. As of now,3N Tech has more than 150 patents in China and overseas.

This rigid contact lens cleaning and disinfection device has been successfully approved for entry into the Chinese market.Green Channel for Innovative Medical Devices, providing a highly competitive product in the current contact lens care market, jointly safeguarding the eye safety of wearers and the healthy and orderly development of contact lens care technology, which is beneficial to the continuous, healthy, and standardized development 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.