Targeting 9 Million Patients: Three Domestic Innovative Neurosurgical Devices Receive NMPA Approval

Focus on Non-Invasive Neurosurgery

China-Made Innovative Medical Device System Approved for Marketing

Recently, according to the National Medical Products Administration (NMPA) Message,Hangzhou Genlight Medical Technology Co., Ltd. (referred to as "Genlight Medical")Its three products——MRI-guided semiconductor laser therapy device, disposable laser fiber optic kit, stereotactic surgical planning software, has officially passed China's special review process for innovative medical devices and has been formally launched on the market.

The information shows that the magnetic resonance-guided semiconductor laser treatment device is used in conjunction with a single-use laser fiber optic kit.Mainly used for laser ablation treatment of local lesions in patients with drug-resistant epilepsy (focal seizures, with a clear epileptogenic zone or conduction pathway).; while the stereotactic surgical planning software works in conjunction with the equipment to plan and formulate the pathway for head stereotactic surgery.Three ModelsThe product will constitute GenLight Medical's LaserRO™ MRI-guided laser ablation minimally invasive surgical system.

Unlike traditional craniotomy surgeries that involve large openings,LaserRO™ Magnetic Resonance-guided Laser Ablation System (MRgLITT) requires only a small hole to be drilled in the skull with an incision of just 2-3 millimeters. After the procedure, only one suture is needed. Under real-time monitoring via magnetic resonance imaging (MRI), a tiny laser fiber is inserted into the lesion. Thermal energy is precisely delivered to the lesion area through the laser fiber, achieving ablation treatment of intracranial tissue.It is an advanced minimally invasive surgical technique, and more importantly,One of the most cutting-edge technologies in the field of neurosurgery today.

The Special Review Procedure for Innovative Medical Devices is a special approval channel established by the National Medical Products Administration to encourage technological innovation and the transformation of achievements in medical devices, commonly known as the "Green Channel."

Products that can enter this channel,Must meet stringent criteria such as being a domestic first, internationally leading technology, and having significant clinical application value.Genlight Neurotech's approval of three products at the same time is a testament to its strength.

It is reported that the LaserRO™ system innovatively introduces magnetic resonance temperature imaging in ablation procedures.Achieved "visualized" precise thermal ablation under magnetic resonance imaging (MRI) guidance., which can significantly reduce the damage of surgical access to normal brain tissue and better protect patients' advanced cognitive functions such as memory and language.

It is worth mentioning that the global Magnetic Resonance-guided Laser Induced Thermal Therapy (MRgLITT) field has long been monopolized by a few American companies such as Medtronic (Visualase) and Monteris (NeuroBlate).ItsThe equipment and consumables required are extremely expensive.

Moreover, LITT surgery must be performed in an intraoperative magnetic resonance imaging (iMRI) operating room or a hybrid operating room. The infrastructure for this "gold standard" requires substantial investment.Only a few top hospitals in China have the capability, these two major factors greatly limit the penetration of this technology into the Chinese market.

As a breakthrough player in China, Genlight Neurotech is not only breaking through with technology but also preparing for market challenges, striving to promote the popularization of this high-end technology in the Chinese market.

Cao Peng, the founder and CEO of the company, once stated: "The magnetic resonance-guided laser ablation systems abroad cost millions of US dollars per set. Our entire system, from software to hardware, is independently developed, ensuring controllable costs."The future price in China will also be much cheaper.

Not only that, Genlight Neurotech also broke through the bottleneck of clinical application, and on October 19th, it was first applied at Zhujiang Hospital of Southern Medical University.Completed multi-lesion tumor ablation surgery across brain regions without intraoperative MRI.

Meanwhile, in addition to the dust settling on the listing in the Chinese market,The LaserRO™ system is still in the process of applying for FDA approval in the United States.Looking forward to entering the U.S. market.

We believe that with its excellent precision, minimally invasive nature, and flexible ablation options, the LaserRO™ MRI-guided laser ablation system will undoubtedly benefit more patients worldwide. At the same time, it will showcase China's breakthrough success in the critical field of visualized minimally invasive treatment for brain diseases.

From Catch-up to Disruption

9 Million Patients Initiate New Clinical TreatmentEpoch

The innovation peak of Genlight Neurotech is no accident. Behind it lies the company's years of relentless accumulation, as well as the valuable opportunities brought by the passionate collision between cutting-edge technology produced in China and the trends of the times.

Public information shows that Genlight Neurotech was established in 2020, gathering a top expert team in the fields of optics, precision machinery, medical imaging, and software algorithms.

Relying on strong research and development capabilities, Genlight Neurotech has successfully built three advanced technology platforms: brain-computer modulation, medical lasers, and brain-computer chips, providing innovative device solutions for various neurological disorders.

In addition to the recently approved LaserRO™ MRI-guided laser ablation system, for drug-resistant epilepsy,GenLight Neurotech also has another blockbuster product —— the closed-loop neurostimulator Epilcure™.

It not only successfully fills the gap in China-produced related fields, but also features a uniquely ingenious design, compact size, and lightweight.It also innovatively adopts a wireless charging solution., this breakthrough significantly extends the product's service life, offering patients a more convenient and long-lasting treatment experience.

Currently, the product has completed over a hundred clinical implants in several top hospitals, including Xuanwu Hospital in Beijing.Scheduled to complete follow-ups for all patients this year, and gain market approval by 2026.。

Not only that, but GenLight has also launched a series of product development projects for the treatment of Parkinson's disease and depression. At the same time, it has made strategic investments in the field of minimally invasive brain tumor surgery, committing to achieve import substitution and break the monopoly of foreign products in related fields.

According to publicly available data statistics,The number of epilepsy patients in China is approximately 9 million to 10 million, with around 400,000 new cases of epilepsy reported each year. The patient population is large.

Although current antiepileptic drugs (AEDs) are the first-line treatment for epilepsy, nearly one-third of patients do not respond effectively to medication.

In recent years, with the accelerated penetration of ablation technologies such as radiofrequency, microwave, and cryoablation, MRgLITT technology has gradually entered the field of brain disease treatment. Unlike traditional ablation methods, itMainly relying on two key technologies—"stereotactic precision puncture" and "intraoperative MRI real-time thermometry"—for real-time precision ablation,Not only can it ensure good treatment outcomes, but it also eliminates the need for craniotomy, effectively reducing the patient's surgical risks, complications, and psychological stress.

Currently, in China, the number of brain disease-related surgeries is increasing year by year. According to the data from the "China Health and Wellness Statistical Yearbook",In 2019, the number of craniotomy surgeries performed in China reached nearly 700,000 cases, representing a year-on-year increase of approximately 15%.This data fully demonstrates that the demand for brain disease treatment in China is enormous and shows a continuous growth trend. It also means that,In the future, MRgLITT technology and the LaserRO™ system will have great potential in the Chinese market.

It can be seen that in the field of MRgLITT technology, domestically produced products are not fighting alone. In the future, with the continuous expansion of clinical needs and the continuous efforts of China's indigenous research and development forces,The dream of Chinese substitution may truly be realized in the MRgLITT field.. Moreover, China-produced innovations are also expected to stand out in the wave of global medical technology innovation, becoming a core force driving the development of the industry.