Xianwei Medical's iMoist® Meibomian Gland Thermal Pulsation System Receives Regulatory Approval and Files for IPO

Dec 03, 2024 16:41 CST Updated 16:41

Legding Micros

Ophthalmic Surgical Robot Developer

Source: Eye Future; Editor: Seven Kite

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Recently,Legding MicrosSelf-developedAimust^TMiMoist^®Meibomian Gland Thermal Pulsation Treatment DeviceOfficially Obtain Medical Device Registration Certificate, used for local heating and pressing treatment of the eyelids in adult patients with meibomian gland dysfunction. ItWith “Heating the meibomian glands, softening the meibum, and massaging to express the meibum"Method,"Unclogging Meibomian Glands, Alleviating Dry Eye Syndrome。

According to Ma Weimin, founder of Legding Micros, this self-developed thermal pulsation meibomian gland treatment deviceAlso took into account the issue of treatment comfort.:"There are significant differences in eye shape and eyeball size between Europeans/Americans and Asians. The consumables and designs in imported equipment that come into contact with the eyeball are not very suitable for Asian eye shapes, so we have made adjustments accordingly."

Legding Micros' Meibomian Gland Thermal Pulsation Treatment DeviceApproved for Class II Certification，Expected to reduce the cost of a single treatment to 1/3 of similar imported products.。

iMoist^®Meibomian Gland Thermal Pulsation Treatment Device

# Meibomian Gland Dysfunction and Dry Eye Syndrome

In recent years, with the popularity of electronic products, changes in people's living environment and lifestyle, as well as the extension of life expectancy,The Prevalence of Dry Eye Continues to RiseBy 2021, the number of dry eye patients in China approached 300 million, andIncreasing at a rate of 10% per year。In ophthalmology clinics, the proportion of dry eye patients can be as high as 30%.Dry eye has become one of the important issues affecting the eye health of the Chinese population.

The factors that cause dry eye are numerous and complex. Research shows:Meibomian Gland Dysfunction (MGD) is one of the leading causes of dry eye.。MGD It is a group of chronic, diffuse meibomian gland abnormalities, characterized by obstruction of the meibomian gland ducts or abnormal meibomian gland secretions, and is the most common cause of evaporative dry eye.Mainly manifested as dry eyes, eye pain, blurred vision, and increased eye discharge.

Research shows,86% of dry eye patients have signs of meibomian gland dysfunction.If meibomian gland dysfunction remains untreated for a long time, it can worsen symptoms and potentially lead to more severe complications, even causing atrophy and loss of function in the meibomian glands. Timely treatment of meibomian gland dysfunction is crucial for maintaining ocular surface health.

Alleviate meibomian gland blockage, restore meibomian gland function, and improve symptoms.Is one of the main goals of MGD treatment. Current treatment methods include physical therapy and medication, among whichPhysical therapy is the main treatment method for MGD.。

With the development of technology, advancements have been made on traditional physical therapies such as hot compress and fumigation.It has appeared.Intense Pulsed Light and Thermal PulsationNew treatment technologies. A course of intense pulsed light treatment requires 3-4 sessions at the hospital, with an interval of 2-4 weeks between each session, thus a full course takes 2-4 months. In contrast,The treatment course of the Thermopulse device is relatively short., typically once per treatment course, repeated every six months to one year.

At the beginning of 2024, the American Academy of Ophthalmology JournalOphthalmologyThe published review article states: Compared with the untreated group,Within 1-12 months after receiving thermal pulsation treatment, both subjective and objective indicators of meibomian gland dysfunction or dry eye disease in patients improved.。

# Aimu Shi^TMMeibomian Gland Thermal Pulsation Treatment Device

Legding Micros' Aimsure^TMMeibomian Gland Thermal Pulsation Treatment DevicePerforming on the meibomian glands42.5°C Constant Temperature Heat Therapy`, and possesses`Automatic Temperature Regulation Capability, ensuring the treatment process is safe and effective. While heating,Apply Constant-Pressure Pulsatile Massage to the Meibomian Glands, achieving rapid and effective unclogging of the meibomian gland area.

Registration Details

Registration Certificate Number：E Medical Device Registration Certificate No. 20242165279

Product Name：Meibomian Gland Thermal Pulsation Treatment Device

Management Category：Class II

Model Specifications:XWRM-01

Structure and Composition/Main Components：

This device consists of a main unit (Model: XWRM-01) and a disposable treatment head (Model: XWT-01). The main unit includes a touch display screen, treatment head interface components, and a trolley. The disposable treatment head includes the treatment head, connecting cable, and plug. The treatment head is for single-use only.

Product Features

This therapeutic instrument is able to achieveEffectively melt and drain the hardened meibum obstructing the meibomian glands, ultimately completing the treatment to unblock the meibomian glands., helping dry eye patients with meibomian gland dysfunction (MGD) quickly and effectively improve dry eye symptoms,And maintain effective relief for one year。

Effective and safe meibomian gland expression depends onPrecise Control of Temperature and Massage Pressure"An outer temperature of 42.5°C and an inner temperature of 40°C that can effectively melt meibomian gland lipids while ensuring the safety of the anterior chamber of the eyeball and the surrounding eye area," Legding Micros hasAchieved constant temperature by optimizing sensors and heating modules through self-developed control programs.，"The sensitivity of the instrument is 0.5°C, and when it fluctuates up or down to this value, it will quickly auto-regulate to bring the temperature back to the set value."

# Product Market Prospects

Heating the eyelids using warm towels or commercially available eye masks/eye patches, as well as Thermal Pulsation and Intense Pulsed Light (IPL) therapy, are the most common methods for treating Meibomian Gland Dysfunction (MGD), utilizing heat as part of the treatment.

Efficacy and cost are the most concerning issues for patients with meibomian gland dysfunction.. For a long time, the main physical therapy for MGD has been manual meibomian gland massage, which generally results in poor patient experience and low treatment efficiency. Meanwhile,For intense pulsed light devices and thermal pulsation devices,Currently, the instruments introduced in hospitals in China are still dominated by foreign-funded products, and the equipment and consumables are relatively expensive.The cost of a single thermopulse instrument treatment is generally around 10,000 yuan; the cost of intense pulsed light treatment varies significantly, with a single course of treatment ranging from a few thousand to nearly 10,000 yuan.。

In an expert consensus released in 2022, it was mentioned: Intense Pulsed Light (IPL) treatment for dry eye syndrome, if improperly performed, may lead to adverse reactions such as local skin crusting, edema, and pigmentation. Therefore, in terms of regulatory access,Currently, intense pulsed light therapy devices are managed as Class III medical devices, while thermal pulsation therapy devices only need to obtain Class II medical device certification to be marketed.。

NowSeveral medical device manufacturers are developing dry eye treatment instruments using the thermal pulsation technology pathway.Previously, there were a total of 5 thermal pulsation treatment devices approved for marketing in China (2 imported and 3 domestically produced)., includingJohnson & Johnson Vision's Lipiflow Thermal Pulsation System for Meibomian Gland, Alcon's SYSTANE iLux Thermal and Light Pulsation Composite Treatment System for Meibomian Gland, Zhenfu Medical's Tearmaestro Liquid Pulsation Dry Eye Treatment Device, Dingshi Bio's DisionEyemore Meibomian Gland Treatment Device, Aishiyah's Handheld Thermal Pulsation Device for Meibomian Gland。

In October 2021, the Ministry of Finance and the Ministry of Industry and Information Technology issued relevant policies explicitly stipulating the proportion requirements for government institutions to procure domestically produced medical devices and instruments.Including dry eye detectors among 137 types of medical devices, all are required to be 100% domestically produced.。As the number of manufacturers increases, patients may receive treatment at a lower cost in the future.Thermal PulsationInstrumentTreatment.

It should be noted that, due to the relatively lower technical barriers of these two devices, and the first-mover effect of imported brands is already in play,It is difficult to penetrate the in-hospital channel solely based on low prices., and gain market share,Manufacturers may face homogeneous competition.At this timeThe biggest challenge for manufacturers may lie in marketing., making doctors and patients more willing to accept this treatment plan, we can refer to the promotion strategies of products that focus more on consumer healthcare scenarios, such as orthokeratology lenses (OK lenses) and medical aesthetics.

Moreover, according to industry insiders, while unblocking the meibomian glands is an essential need, not everyone is willing to spend a lot of time going in and out of the hospital. In the future,Miniaturization, lightweight, and home-use instruments may be a trend in the development of such devices.。

# About Legding Micros

Legding Micros was founded in June 2022 in Beijing, and is committed to becoming internationally influential.Provider of Innovative Medical Solutions for Ophthalmology and Microsurgery, leveraging technological innovation to advance the development of ophthalmology and microsurgery healthcare and benefit patients.

The current products under development include a master-slave dual-arm surgical robot platform with micrometer-level precision for ophthalmic and microsurgical procedures, meibomian gland thermal pulsation treatment devices for dry eye therapy (including both clinical and home-use models), and ultra-thin injector needles with force feedback functionality for intravitreal and cosmetic injections.

In June 2024, the company completed a new round of financing, which will be used for team building, advancing the development and clinical registration of meibomian gland devices and ophthalmic surgical robots. Prior to this, Legding Micros had undergone a total of three rounds of financing. As of the publication date, the company's financing history is as follows:

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