Blue Laser Pioneer LanJi Medical Secures Two NMPA Class III Certificates Within Five Months for World’s First Blue Laser Surgical Systems

May 20, 2022Xi'an Blueray Medical Technologies, Ltd(hereinafter referred to as“"Blueray Medical") announced its independently developed medical laser device with the highest power globally——200W Blue Laser Surgical System, obtainClass III Medical Device Registration Certificate issued by the NMPA. This is not only a milestone for Blueray Medical itself, but also marksChina's Blue Laser EntersThe 200W EraandChina's technology in this field is thoroughly ahead of the rest of the world.。

Notably, this marks the second Class III medical device registration certificate secured by Blueray Medical in less than six months.

Why was this Xi’an-based company, founded in June 2016 and dormant for nearly six years, able to obtain regulatory approvals consecutively within less than half a year? What makes its prized blue laser technology so distinctive? How will the company develop in the future? With these questions in mind, VCBeat interviewed Blueray Medical.

Blueray Medical, established in June 2016 and located in the National High-Tech Industrial Development Zone in Xi’an, Shaanxi Province, has been dedicated to the research and development, manufacturing, and sales of high-end laser medical equipment since its inception.

Blueray Medical: Official Corporate Photos

Blueray Medical’s R&D primarily focuses on blue laser technology at a wavelength of 450 nm. This laser band was discovered by scientists in the early 1990s, and the underlying technology was awarded the Nobel Prize in Physics in 2014. Currently, Blueray Medical’s blue laser technology is mainly applied in the field of urology.

Currently, medical lasers available on the market include green lasers, holmium lasers, and thulium lasers.Blue Lasersuperior due to its shorter wavelengthHigh-Efficiency Tissue Vaporization and Cutting Capability, and at the same timeAppropriate Coagulation Layer Thickness, meeting the requirements of the periphery of the surgical fieldMinimal trauma, less intraoperative bleeding, and rapid postoperative recoverysafety requirements. In addition, blue laser diodes also featureCompact size, low cost, and high photoelectric conversion efficiencysuch features. Moreover, blue laserYesThe surgical procedure has relatively lenient environmental requirements., can be performed without requiring a water-rich environment,Expanded the application scenarios of laser surgery。

From clinical vision to tangible outcomes, the success is inseparable from Blueray Medical’s multidisciplinary team integrating medicine and engineering.The team of Professor He Dalin from the Department of Urology, First Affiliated Hospital of Xi'an Jiaotong University,Guided by the goal of solving clinical problems and meeting clinical needs, he has devoted years to in-depth research on the application of lasers in the diagnosis and treatment of urological diseases, demonstrating visionary expertise in both clinical practice and academia.The R&D technical team of Xi'an Blueray Medical,It has also been deeply engaged in the medical laser field for many years, possessing extensive experience and unique expertise in product research, development, and manufacturing.

Guided by the philosophy of integrating medicine and engineering, two highly specialized teams joined forces to embark on the development of blue laser medical devices. From identifying clinical pain points in the early stages to translating research achievements into practical applications in the later stages, Blueray Medical has established a complete closed-loop technical pathway. After five years of persistent scientific breakthroughs and clinical trials, Blueray Medical successfully obtained two regulatory approvals, positioning China at the forefront of the global medical laser industry.

Blueray Medical's Previous Round Investor: DaoTong InvestmentHe also expressed strong confidence in Blueray Medical: “With China’s aging population and improving quality of life, there is a high incidence of urological diseases such as benign prostatic hyperplasia and bladder tumors. Blue laser technology is advanced; beyond urology, its unique advantages can be applied across multiple areas of healthcare. Xi’an Blueray boasts an excellent team, including senior medical experts like Professor He Dalin, as well as a team of seasoned scientists in the laser industry led by Dr. Mu. This truly achieves integration of medicine and engineering to address clinical challenges.”

Blueray Medical Factory: Real Shots

Blueray Medical, which has assembled a wealth of top-tier talent from across the industry, continues to achieve breakthroughs in product research and development.

Five months ago, a piece of news shook the entire medical laser industry—the world’s first! Independently developed by China30W Blue Laser Surgical System Receives NMPA Class III Medical Device Registration Certificateand put into clinical use!

Blueray Medical 30W Blue Laser Surgical System

This device was jointly developed by Blueray Medical and the First Affiliated Hospital of Xi'an Jiaotong University, and can be used forMinimally invasive surgical procedures in urology, gastroenterology, gynecology, pulmonology, and otolaryngology.

The instrument consists of two main components: the main unit and a footswitch. The main unit integrates optics, mechanics, electronics, software, and computing capabilities. The master control system incorporates a cooling system, safety protection system, monitoring system, and laser power feedback compensation system, among others. During operation, the monitoring system performs real-time data acquisition of parameters such as device temperature, water flow, and output power. In the event of abnormal power output, the laser power feedback system automatically compensates for the power deviation.

Since its inception, the device has garnered widespread attention and support from various stakeholders. It has received funding and project support from key national initiatives, including the National Key R&D Program for Digital Diagnostic and Therapeutic Equipment, the General Program of the National Natural Science Foundation of China, Shaanxi Provincial Key Projects, and the Shaanxi Provincial Key Industrial Innovation Chain, as well as policy support from the Administrative Committee of Xi’an High-Tech Industries Development Zone.

Shortly after certification, the 30W blue laser surgical system was successfully used in clinical practice to perform transurethral enucleation of bladder tumors with blue laser. During the procedure, the blue laser surgical system enabled en bloc tumor enucleation, offering high resection efficiency, low noise, and excellent visibility. There was no obturator nerve reflex, virtually no intraoperative bleeding, and no tissue carbonization (which is conducive to wound healing). On the second postoperative day, the patient’s urinary catheter drainage was clear, his condition was stable, and he felt well, able to eat and drink normally. He soon recovered and was discharged.

Blueray Medical’s Independently Developed 200W Blue Laser Surgical System

The currently approved200W Blue Laser Surgical System, primarily used for the treatment ofBenign Prostatic Hyperplasia (BPH).

Benign Prostatic Hyperplasia (BPH) is the most common condition causing voiding dysfunction in middle-aged and elderly men. The incidence of BPH increases with age. According to survey data from the World Health Organization, more than half of men over the age of 50 are affected by prostate disorders. The prevalence of BPH exceeds 50% among men aged 60 and rises to as high as 83% by age 80.

In China, benign prostatic hyperplasia (BPH) is also a common condition in urology. BPH symptoms worsen over time, significantly impairing quality of life, and if left untreated, may lead to bladder, urinary tract, or kidney problems.

Traditional transurethral surgeries for benign prostatic hyperplasia (BPH), including transurethral resection and laser enucleation, can significantly improve symptoms and urinary flow rates. However, these procedures are associated with significant side effects, such as bleeding, urinary incontinence, and sexual dysfunction. Patients with cardiac disease or coagulation disorders face an increased risk of substantial blood loss. Other interventional treatment options also involve a trade-off between symptom relief and the risk of complications.

Blueray Medical Launches 200W Blue Laser Surgical SystemWith independent intellectual property rights,Not only does it address the aforementioned pain points, but it also serves asCurrentlyThe Laser with the Fastest Vaporization Speed on the Market, thereby avoiding the disadvantage of low vaporization and cutting efficiency associated with other laser energy platforms. This device offers the highest tissue vaporization efficiency with an appropriate coagulation layer thickness, enabling rapid vaporization of prostatic tissue obstructing the urethra. It also features minimal peripheral damage to the surgical field, reduced intraoperative bleeding, faster postoperative recovery, and low noise levels, significantly shortening surgeons’ operative time and enhancing patient satisfaction.

Recently, the Department of Urology at the First Affiliated Hospital of Xi’an Jiaotong University successfully performed two surgeries using a 200W blue laser surgical system. Both patients were admitted with urinary difficulty and diagnosed with benign prostatic hyperplasia (BPH) via B-ultrasound. After communication with the patients’ families, transurethral laser vaporization of the prostate was performed. During the procedures, a domestically produced blue laser surgical device was used for prostate vaporization, demonstrating high vaporization efficiency, low noise, and excellent visual field. There was virtually no intraoperative bleeding, and no tissue carbonization was observed. On the second postoperative day, the urine drained via the catheter was clear, the patients’ conditions were stable, and they reported feeling well, having resumed oral intake of food and fluids. The patients have now recovered and been discharged.

“We believe that the ‘craftsmanship spirit’ is not merely about pursuing ‘continuous improvement’ in products,” said Liu Haigang, General Manager of Blueray Medical, in an exclusive interview. “During the product planning phase, in addition to meeting applicable product standards and ensuring smooth regulatory registration, consideration should also be given to the accessibility of technology, with the aim of minimizing healthcare costs for patients. This has been the principle Blueray Medical has adhered to since its establishment.”

Mi Lei, Founding Partner of CAS StarCommenting on this, it was stated: “Blueray Medical is a key medical laser enterprise strategically positioned by CAS Star in the field of laser medicine, and stands as one of the representative companies in the rise of domestically produced medical devices. The recent certification of its high-power 200W blue laser surgical system marks a significant breakthrough in the independent research and development of major domestic medical devices in the semiconductor blue laser sector, further facilitating day-case surgeries and the decentralization of medical resources to grassroots levels. Blueray Medical’s blue laser surgical system features simple operation, precise cutting, excellent safety, and rapid recovery. CAS Star looks forward to the company’s sustained long-term development in the field of laser medicine.”

In addition to the aforementioned products, Blueray Medical also hasBlue Laser Dental Treatment System, Medical Laser Optical Fiber, UV Disinfectorand other products. Among them, medical laser optical fibers have alreadyApproved Class II Medical Device Registration Certificate and Production License, and successfully enteredNational Medical Insurance Code, suitable for commonly used laser devices on the current market, primarily for the treatment of urinary stones and benign prostatic hyperplasia (BPH), and also applicable to conditions such as bladder tumors and ureteral strictures.

Product Images of Blueray Medical Laser Fibers

“We have two judgments for the future. First, from a macro perspective,”In recent years, the state has attached great importance to the localization of medical equipment and the advancement of medical device technologies.The trend of domestic substitution is unstoppable. To address the critical challenge of technological bottlenecks, the national government issued the “Notice on Phased Promotion of the Establishment of National Medical Centers.” The First Affiliated Hospital of Xi’an Jiaotong University has been listed among the first batch of “guidance-category” entities for the establishment of National Medical Centers. We will strengthen our collaboration with the First Affiliated Hospital of Xi’an Jiaotong University and expand partnerships with more hospitals in the future, continuously optimizing and iterating our technologies and products to better align with clinical needs. Second, regarding the iteration trends of energy platforms, we judge thatExcitationThe laser scalpel is the development trend for the next decade.“Laser scalpels are suitable for any part of our body’s tissues and will have increasingly numerous and important applications in future medical scenarios.” Liu Haigang elaborated on Blueray Medical’s development blueprint to VCBeat.

In terms of financing, Blueray Medical secured tens of millions of yuan in funding from Daotong Investment and Natong Group in June 2021. Currently, Blueray Medical isSeeking a Next Round of RMB 50 Million in Financing, for the use of blue laser technology equipmentExpand IndicationsandMarket Promotion.

References: Xi’an Jiaotong University, “World’s First! China Independently Developed 30W Blue Laser Surgical Device!” and “Strong Collaboration Achieves New Milestones! World’s First 200W Blue Laser Surgical Device Successfully Applied in Clinical Practice”