GAOTON Medical Files IPO Prospectus, Aiming to Become a Full-Spectrum Manufacturer of Low-Temperature Plasma Surgical Systems Deployed in Nearly 10,000 Hospitals

The continuous evolution of surgical instruments has gradually steered surgical procedures toward minimally invasive and precise approaches.

Cutting, dissection, and hemostasis are the most common procedures in surgery. Clinically, instruments have evolved from conventional metal scalpels and hemostatic forceps to electrosurgical devices such as high-frequency electrocautery units and plasma scalpels. The delivery of energy via radiofrequency or plasma enables a single surgical instrument to perform multiple functions—including cutting, hemostasis, and ablation—thereby expanding its clinical applicability.

Traditional electrosurgical instruments directly apply high-frequency, high-voltage electricity to the human body, treating it as a charged conductor, which causes thermal damage to tissues. In contrast, plasma scalpels deliver electrical energy to sodium ions, generating plasma through their dissociation. Furthermore, the plasma scalpel tip and the tissue surface remain continuously protected by a saline solution, enabling low-temperature cutting and minimally invasive procedures.

In recent years, plasma scalpels have become indispensable instruments in surgical operating rooms, particularly in spinal surgery and sports medicine. It is no exaggeration to say that minimally invasive spinal procedures and sports medicine surgeries cannot be performed without them.

Low-temperature plasma technology is a technique in which electrical energy, delivered in a specific waveform through a multipolar electrode equipped with an integrated saline irrigation channel, excites sodium chloride molecules within human tissues to generate a plasma state. The high-speed charged particles within the plasma then directly break molecular bonds in the tissue, causing tissue proteins to vaporize and decompose into low-molecular-weight gases. This process achieves various therapeutic effects, including vaporization, cutting, perforation, ablation, shrinkage, dissection, hemostasis, and repair of blood vessels, mucosa, soft tissues, or nucleus pulposus tissues.

Traditional electrosurgical units utilize high-frequency currents for cutting and hemostasis, operating at temperatures ranging from approximately 120°C to 450°C. This often causes a burning sensation at the surgical site, leads to significant postoperative edema, and results in slower recovery. In contrast, plasma scalpels operate in a low-temperature environment (40–70°C) within an aqueous medium. This approach prevents thermal necrosis of the surrounding tissues and minimizes patient pain.

Moreover,Plasma scalpels offer rapid vaporization and ablation, with an effect confined to within 1 mm of the tip. Their concentrated energy shortens operative time, resulting in minimal patient trauma and faster recovery.Meanwhile,Low TemperaturePlasma scalpels integrate ablation, hemostasis, and cutting functions, enabling surgeons to minimize instrument changes during procedures, thereby reducing hospital procurement costs and operative time.

The price of low-temperature plasma knives has always been a major obstacle to technology promotion. According to the procurement catalogs of medical institutions across China, the price of domestically produced plasma knife tips is around RMB 3,000, while imported plasma knife tips generally cost around RMB 5,000. In spinal surgery, the unit price of plasma knife tips can even reach tens of thousands of yuan.

Moreover, the plasma knife tip, as a single-use consumable, incurs additional charges and is not yet fully reimbursable under medical insurance.

According to the "Notice on Adjusting the Charging Policies for Special Surgical Blades and Some Consumables in Our Province (Draft for Comments)" issued by the Anhui Provincial Healthcare Security Administration at the end of 2021,Cancel the existing surcharge policy for single-use plasma scalpels used in surgery, exclude them from medical service price items, and charge for them separately., sold at zero markup; non-disposable specialized surgical blades remain subject to the original surcharge policy. This adjustment includes disposable plasma blade tips as separately billable items, which can further encourage hospitals to adopt plasma blades.

The operational complexity of plasma scalpels also constitutes a major barrier to their widespread adoption. Unlike conventional surgical scalpels, the plasma scalpel tip must be connected to a suction pump to maintain saline circulation, thereby enabling electrical energy to generate plasma energy at the cutting electrode surface for tissue vaporization; this requires physicians to undergo a certain period of training. Furthermore, as the cutting depth of plasma scalpels is relatively shallow, making it difficult for surgeons to visualize the cutting margins, they must continuously monitor the edge position during dissection, which imposes higher demands on surgical proficiency.

Therefore, market promotion of plasma scalpels in China was quite challenging during the 20-year period from their introduction to the Chinese market in 1997 until 2017. Moreover, domestically produced plasma scalpels previously suffered from suboptimal quality and performance, with issues such as tip fracture and overheating, which further hindered their clinical adoption.

In recent years, the Chinese government has successively introduced a series of policies favoring domestically produced medical devices, imposing restrictions on imports and encouraging domestic substitution at the policy level. Plasma scalpels are increasingly penetrating primary care settings, entering specialized private hospitals, county-level hospitals, and even township health centers, thereby becoming more widely adopted in the field of electrosurgery.

Yang Xilian, founder of GAOTON Medical, stated: “China’s plasma knife market is advancing at a rate of approximately 50%, with the fastest growth observed in the sports medicine segment. Currently, the domestic market size for plasma knives remains below RMB 1 billion, while the total addressable market is estimated at around RMB 2 billion. Generally speaking,”Plasma scalpels can be utilized in any clinical department requiring procedures such as cutting, ablation, and hemostasis.。”

Plasma scalpels are primarily used in otolaryngology, sports medicine, spinal surgery, and urology, with their applications expanding to ophthalmology, breast surgery, neurosurgery, and general surgery.

In otolaryngology, plasma scalpels are primarily used to treat conditions such as tonsillar and adenoid hypertrophy, as well as laryngeal tumors, with their most frequent application being in tonsillectomy procedures. This prevalence is attributable to the high patient volume for tonsillar or adenoid hypertrophy and the fact that laryngeal surgeries require general anesthesia, allowing hospitals to implement reasonable fee structures. In contrast, issues such as inferior turbinate hypertrophy and epistaxis can typically be managed in outpatient settings; given the generally lower reimbursement rates in some regions, physicians may opt for alternative conservative treatment methods.

Currently, the factors hindering the widespread adoption of plasma scalpels in surgery are twofold. First is manufacturers’ R&D capabilities: differentiated plasma scalpel systems must be developed for different specialties. Given variations in lesions and the vascular anatomy surrounding pathological tissues across specialties, there are corresponding differences in plasma scalpel tip design, materials, manufacturing processes, and the energy output profiles of the generator units. Second is physicians’ usage habits; companies need to actively pursue medical-engineering collaborations and promote plasma scalpel products more extensively to grassroots healthcare facilities.

GAOTON Medical is committed to becoming a manufacturer of general-purpose low-temperature plasma systems. Its multifunctional low-temperature plasma surgical systems feature diverse functions and models, with a wide range of applications covering multiple departments, including otorhinolaryngology–head and neck surgery, spinal surgery, urology, gastroenterology, and pulmonology.The company spent nearly 15 years independently developing the hardware and software for its plasma knife system.

In the field of otolaryngology, GAOTON Medical has launched a patented plasma knife with tissue fragmentation capabilities. Previously, human tissue resected by plasma knives was aspirated through the handpiece, which often led to clogging. Once clogged, surgeons had to pause the procedure to clear the obstruction.GAOTON Medical's ENT plasma wand features a built-in crushing ring to prevent clogging during procedures, thereby reducing surgical time and enhancing the durability of the plasma device.

In the treatment of gastrointestinal and respiratory tract conditions, developing plasma scalpels presents significant challenges, as the slender electrode tips must simultaneously meet specific requirements for flexibility and mechanical strength. Leveraging over a decade of experience in gastroenterology, GAOTON Medical has successfully developed a bipolar plasma scalpel. Gastrointestinal diseases are prevalent, affecting a large patient population with an increasing trend toward younger demographics.

In China, the incidence and mortality rates of gastrointestinal diseases are continuously rising. Apart from monopolar electrosurgical units and argon plasma coagulators, there is a lack of safer and more effective surgical instruments both domestically and internationally; the plasma knife may be the only product capable of replacing existing devices.

In spinal surgery, GAOTON Medical has introduced a plasma electrode for use under transforaminal endoscopy. During transforaminal endoscopic procedures, surgeons need to inject large amounts of normal saline to irrigate the wound, blood, and excess tissue; maintaining a clear surgical field is essential for the smooth progress of the operation. However, existing transforaminal endoscopic electrodes lack suction functionality, causing normal saline to flow directly out through the working channel. This not only impairs the surgeon’s visual field but also increases the risk of postoperative infection.

Moreover, the human spine features a complex structure and curved morphology, resulting in limited operative space and high precision requirements during transforaminal endoscopy; consequently, the development of plasma electrodes for use under transforaminal endoscopy poses significant challenges.GAOTON Medical’s plasma knife for transforaminal endoscopy features integrated suction, combining vaporization, ablation, and hemostasis in one device. It can be precisely steered to the target site without compromising the integrity of the annulus fibrosus.

Endoscopic minimally invasive spinal surgery has penetrated into highly specialized private hospitals and county-level hospitals, and is even being performed at township health centers in southern China. These departments rely heavily on plasma scalpels during procedures, which is expected to drive significant volume growth.

Currently, global low-temperature plasma systems are evolving toward intelligence and multifunctional integration.

The multi-functional plasma electrode launched by GAOTON Medical integrates ablation, cutting, hemostasis, dissection, and suction into a single device. During surgery, physicians can reduce the use of other instruments, as one plasma electrode can perform most surgical procedures. This saves operative time, lowers the cost of additional instrument usage, and reduces the number of billable items for patients.

Moreover, the cost of multifunctional plasma electrodes has not increased significantly compared to standard electrodes, requiring only support from the main unit.GAOTON Medical’s low-temperature plasma system console has been upgraded to a new multifunctional touchscreen model, offering enhanced functionality and simplified operation. Available configurations include joint-specific, transforaminal endoscopic, and full-function models.

Beyond enhancing product intelligence and multifunctionality, GAOTON Medical is also committed to expanding the applications of its plasma surgical systems by developing specialized electrodes for various medical departments and advancing the software control capabilities of its main units, with the ultimate goal of covering the entire field of surgery. In addition to low-temperature plasma systems, GAOTON Medical is also developing interventional devices (including vascular and neuro-interventional instruments), such as disposable biopsy needles, vertebroplasty assistance systems, disposable puncture needles, and meniscus suture systems.

In 2003, GAOTON Medical was officially established in Xi’an. Starting from Yang Xilian’s solitary efforts, it grew into a distribution company and ultimately evolved into an R&D-focused medical device enterprise with over 500 employees. During the early stages of the company, Yang Xilian faced challenges such as technological barriers, talent shortages, and team instability.

Therefore, in its future development, the company places particular emphasis on talent cultivation and external collaboration. GAOTON Medical has strengthened its internal value chain, implemented long-term strategic planning and management layouts, and conducted talent training, thereby establishing five core modules, including sales networks and precision manufacturing.

Meanwhile, the company has intensified its external technical collaborations, partnering with expert teams from multiple Grade A tertiary hospitals in China to jointly develop plasma systems for multi-departmental applications. In addition to medical-engineering collaborations, GAOTON Medical engages in joint R&D with key national universities and participates in national research projects. To date, GAOTON Medical holds and has applied for more than 30 national patents.

Building on a foundation of clinical research, GAOTON Medical conducts product promotion and technical training across China to facilitate the broader adoption of plasma scalpels. The company organizes the “National Tour of Low-Temperature Plasma Workshops” to promote the dissemination and widespread use of low-temperature plasma technology.The company’s sales network covers all 31 provinces and municipalities across China, as well as select overseas markets, with its plasma knife products adopted by nearly 10,000 hospitals.In 2020, amid the pandemic, the company’s sales continued to grow steadily, reaching the hundred-million-yuan level.

In the future, GAOTON Medical will continue to expand its talent pool and build an R&D team of over 100 members. Meanwhile, through external collaborations, the company aims to broaden the applications of plasma scalpels and develop intelligent products that are more closely aligned with clinical needs. As Yang Xilian has consistently upheld, “A company must adhere to its bottom line and continuously provide valuable products for clinical practice,” thereby truly realizing the founding vision of “Supreme Excellence and Universal Accessibility.”