One innovative medical device approved for market launch

January 14, 2025  Source: drugdu 34

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Recently, the National Medical Products Administration approved the registration application for the innovative product "intraocular lens with crystalline lens" of Abonod (Beijing) Medical Technology Co., Ltd. (hereinafter referred to as Abonod).

Heavy product, breakthrough innovation
Established in 2010, iBonod is an innovation driven manufacturer of ophthalmic medical devices, covering three major areas: ophthalmic surgical treatment, myopia prevention and control, and vision health care. We strive to provide one-stop solutions for cataract surgery, refractive error correction, and optical consumption.

It is worth mentioning that iBonod successfully listed on the Science and Technology Innovation Board on July 29, 2020, becoming the first ophthalmic medical device company in China to complete the listing on the board. The company is based on three core products: artificial intraocular lenses, corneal reshaping lenses, and contact lenses. The company has strategically expanded its coverage of the entire lifecycle product pipeline for eye health.

After years of development, Ebono has harvested many products. In 2014, the company launched the first foldable non spherical artificial lens in China, breaking the monopoly of international manufacturers in high-end artificial lens technology and market.

This product is made of hydrophobic acrylic ester material that has been recognized by clinical physicians for many years. It has good biocompatibility and biological viscosity, and can bond more tightly with the lens capsule, reducing the proliferation of lens epithelial cells (LEC), reducing the incidence of anterior capsule opacity (ACO), posterior capsule opacity (PCO), and YAG laser posterior capsule incision rate.

Longjing, which has been approved for listing this time ® PR type crystalline intraocular lens is used for the treatment of adult crystalline eyes, correcting/reducing myopia degree from -3.25D to -18.00D. The product adopts a stable arch height design with zero spherical aberration large aperture and double concave surface, which can improve visual quality and bring a wider surrounding arch height.

Moreover, the product adopts the patented Balacrystalline technology ™ Balanced acrylic ester material with excellent comprehensive performance. Balacrylic ™ Balanced acrylic materials can increase the optical zone diameter, reduce thickness, and decrease crystal volume with high refractive index; Excellent elastic modulus, good mechanical resistance and support, excellent implant deployment performance, and long-term stability of arch height; Moderate moisture content is relatively more resistant to sedimentation and calcification, ensuring long-term material stability for intraocular implantation.

In addition, Longjing ® PR type intraocular lenses with crystalline lenses also have multiple product advantages:
 The arch height is more open: the artificial lens of the crystalline eye is accommodated in the limited space in front of the natural lens in the eye, and the thin volume helps to reduce the burden on the anterior chamber to a certain extent; Dragon Crystal ® PR benefits from Balacrystalline ™ The material has a high refractive index, increasing the diameter of the optical part while achieving a slim volume. Combined with a non spherical double concave surface design, the dragon crystal ® After PR, the surface is flatter and the surrounding arches are wider.
 Higher visual quality: Insufficient diameter of the optical zone of the intraocular lens in crystalline eyes can cause adverse visual phenomena such as glare and halo; Dragon Crystal ® The PR 6.0mm large optical zone combined with high-order non spherical zero spherical aberration optical design does not introduce additional aberrations, achieving high-quality visual performance. Clinical trial results have confirmed that it significantly reduces the probability of postoperative glare.
 The choice of personalized refractive surgery: The diameter of the ciliary sulcus in the human eye varies, and finer size division is beneficial for matching different eye shapes; Dragon Crystal ® PR offers 10 models with 0.3mm intervals, providing more personalized and refined choices for clinical use.
 Long term stable intraocular state: The decrease in arch height after intraocular lens surgery in crystalline eyes increases the risk of contact between the artificial lens and the natural lens, as well as the involvement in refractive error; Dragon Crystal ® PR benefits from Balacrystalline ™ The mechanical stability of the material, clinical trial results show that there is less change in central and peripheral arch height after surgery, and residual refractive power is also more stable.
Dragon Crystal ® PR has achieved breakthroughs and innovations in materials and design. The approval of this product for market launch is not only another enrichment of Abonod's product pipeline in safeguarding eye health throughout the entire life cycle, but also provides a new and advantageous option for refractive surgery for the majority of myopic people.

Domestic substitution acceleration
At present, the field of ophthalmology has a huge patient population, and the incidence rate is gradually increasing. The demand is rigid and strong, making it a golden track with broad development space. The number of myopic people in China ranks first in the world, reaching 630 million, and the number of patients with dry eye syndrome has also reached 360 million. In addition, the market size of retinal diseases is also growing rapidly.

The number of ophthalmic patients in China continues to increase, and the ophthalmic medical industry presents a blue ocean of demand. According to Frost&Sullivan data, the overall market size of ophthalmic medical devices in China will exceed 20 billion yuan in 2023 (excluding contact lenses, orthokeratology lenses, etc.), with ophthalmic diagnostic and therapeutic equipment accounting for the largest proportion, reaching 50.3%; The proportion of ophthalmic consumables is 44.5%; The proportion of ophthalmic technical services is 5.2%. Among them, it is expected that diagnostic equipment will cost about 3.4 billion yuan, and therapeutic equipment will cost about 6.9 billion yuan.

From the perspective of the domestic market, the diagnosis and treatment rates of ophthalmology in China have always been at a low level, and the development of ophthalmic drugs and equipment in China is also in a very early stage, still dominated by imports. Compared with the United States, although China has a wider patient base, the market size of ophthalmic devices and drugs is only one eighth to one-fifth of it.

However, in recent years, with the further rise of domestic substitution forces, the process of domestic substitution in the ophthalmology market has accelerated. In the field of ophthalmic diagnostic equipment, domestic production has achieved breakthroughs, with basic detection equipment mainly domestically produced. The high-end ophthalmic OCT (Optical Coherence Tomography, the gold standard for ophthalmic diagnosis) equipment has been certified and registered by multiple domestic companies in recent years, and has begun to compete with imported brands for the market.

However, in the field of ophthalmic treatment equipment and ophthalmic consumables, there is still a long way to go before domestic substitution. The former mainly relies on imports, such as the phacoemulsification machine for cataract and vitrectomy surgeries, and femtosecond laser surgical instruments for refractive surgery, mostly relying on imported brands such as Zeiss, Alcon, and Topcon. The latter domestic manufacturers are gradually achieving technological breakthroughs and winning more and more market share, but in the fields of intraocular fillers, glass cutting consumables, etc., they basically rely on imports.

Conclusion
With the support of policies and the promotion of continuous technological development, the "gold content" of domestic medical devices is becoming increasingly high, and local medical devices are continuously shining with new brilliance.

Source: https://news.yaozh.com/archive/44798.html

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