Disrupting Global Perceptions: Chinese Innovation Drives Worldwide Expansion, Reaching 27 Countries in 9 Months

The global market's inherent perception of Chinese medical devices is undergoing a fundamental reversal.

Over the past few decades, "going global" for China's medical device industry has been nearly synonymous with "contract manufacturing"—following established overseas technological pathways, iteratively optimizing products within existing frameworks, and concentrating core competitiveness on cost and efficiency. While this "me-too" approach has proven viable, it has never secured a seat at the central negotiating table. As a result, Chinese medical device manufacturers have accumulated strong production capabilities but have yet to gain a meaningful voice in technology.

Today, the pace of global expansion is undergoing a comprehensive revolution, and industry roles are being thoroughly reshaped. The logic behind the international development of China's medical device industry is being redefined under the leadership of "innovators." We are no longer followers; instead, we have become leaders whose original innovative technologies compel global industry experts to travel thousands of miles to learn from us. Chinese innovative medical devices are now taking the lead in the global market with a renewed presence.

Over the past nine months, Shanghai Nortion Medical, based on the principle of irreversible electroporation, has independently developed the "Composite Steep Pulse Therapy System." Leveraging its innovative advantages—being non-thermal, highly efficient, non-invasive, and easy to operate—along with robust clinical data from over 5,000 cases, the system has rapidly expanded its presence to 27 countries and regions worldwide—from establishing a regional benchmark clinical center in Turkey, to successive groups of overseas urology experts traveling to China for study and exchange, and further to achieving large-scale market access in multiple countries across Southeast Asia, Central and South America, Europe, and Oceania. This original Chinese, globally pioneering non-thermal ablation solution is rapidly penetrating the core of global prostate disease treatment.

As early as October 2024, Nortion Medical had already obtained EU CE Certification and U.S. FDA "Breakthrough Device Designation," completing the compliance reserves for overseas expansion. However, at that time, the company's strategic focus was mainly on China—by the end of 2025, the cumulative number of surgeries exceeded 5,000 cases, with the annual surgical volume increasing by more than 50% compared to 2024.

The true turning point came from a bullet that had long been fired.

In mid-2025, a Turkish urology specialist read the results of a multicenter clinical study published by Nortion Medical in JAMA Surgery in 2022, and subsequently reached out to its Shanghai headquarters through various channels based on related surgical reports. This deep cultivation, embodying the philosophy of "letting innovation take flight," marked the beginning of Nortion Medical's global expansion strategy.

From its first order to covering 27 countries and regions across four continents, Nortion Medical took only nine months.

In September 2025, the composite irreversible electroporation therapy device made its inaugural sales in Turkey; in October, the first batch was delivered in the Philippines, during which experts from the Middle East voluntarily came to China to observe clinical procedures; in November, distribution networks were established in six Middle Eastern countries, including Saudi Arabia and the United Arab Emirates; in December, shipments were made to Malaysia, achieving multi-regional coverage across Europe, Asia, and the Middle East within the year.

In 2026, Nortion Medical further accelerated its global expansion—in January, the first exports were made to Italy; in April, operations were simultaneously launched in ten countries, including Spain, Portugal, Belgium, Luxembourg, the Netherlands, Poland, Greece, Germany, the Czech Republic, and Romania, covering nearly half of Europe in a single month; in May, the first exports were completed to Singapore, Croatia, Hong Kong (China), and Taiwan, China; in July, the first exports were completed to Australia and New Zealand, while the signing of the contract and payment of royalties in Peru were also finalized in the same month. Meanwhile, contracts in the United Kingdom, Mexico, and Indonesia are being actively advanced, and negotiations are underway in 13 markets, including Brazil, Egypt, Argentina, Colombia, Kazakhstan, Thailand, and Vietnam...

Overseas Urology Experts Visit Nortion's Shanghai Headquarters for Study and Research

Market coverage across four continents is only the first step; the accelerated formation of the international training network marks the true beginning of technology taking root.

In early 2026, Turkish experts were the first to come to China to learn IRE technology. In February, the IRE International Training Center at Shanghai Renji Hospital was officially established and completed the third phase of training for Malaysian experts, promoting the export of IRE focal therapy for prostate cancer to Southeast Asia through surgical observation and clinical practice. Subsequently, experts from Italy, Spain, Portugal, and other countries visited China for exchanges. Of greater strategic significance, the previously trained Turkish team has launched an IRE training program in Eastern Europe, attracting physicians from Poland, Slovakia, Croatia, and other countries to Turkey for study—demonstrating how this Chinese-originated technology is progressively penetrating broader regions through these key node markets.

Overseas Urology Experts Observe IRE Procedures in China

During this process, the academic influence of Nortion Medical's IRE technology simultaneously surged.

In the first half of 2026, Nortion Medical made its mark at three premier academic platforms: the EAU, the AUA, and the 89th Spanish National Congress of Urology. At the EAU, Nortion Medical showcased to global peers the cutting-edge breakthroughs of China's original IRE technology; during the AUA, it engaged in in-depth dialogues with urology experts from the United States, Mexico, Colombia, and other countries on precision treatment for prostate cancer; at the Spanish National Congress, Nortion Medical collaborated with local partners to conduct live IRE technical demonstrations, earning professional recognition through real-world operational excellence.

Over the past decade, China's medical device industry has risen rapidly, with export volumes continuing to grow. However, the global market is not a uniform pie. A closer look at the export structure reveals that low-value consumables have long accounted for the majority of exports. Furthermore, the first step overseas for most companies has been to knock on doors in unfamiliar markets one by one, exchanging price competitiveness for market entry. This approach has resulted not only in a lack of share in the high-end medical device market but also in a long-term absence of influence over innovation discourse and recognition of Chinese brands.

In the era where "go global or get left behind" is the prevailing trend, Nortion Medical has carved out a distinctly different path for advancement. Since its establishment in 2016, the company has remained deeply committed to irreversible electroporation technology. After a decade of dedicated refinement, it has anchored its strategy in source innovation, pioneering an overseas expansion path driven by technological leadership and value creation.

Nine months, 27 countries: seemingly sudden, but in reality the concentrated release of Nortion Medical's decade-long commitment to innovation.

Prostate cancer ranks as the second most common cancer among men globally. According to the World Health Organization's "2026 Global Cancer Status Report," there were 1.54 million new cases of prostate cancer worldwide in 2024. A report in The Lancet further predicts that the global number of prostate cancer cases will double from 2020 to 2040, reaching 2.9 million. Regional disparities are also significant, with incidence rates in European, American, and South American countries generally more than four times higher than in China, indicating a substantially larger patient population overseas.

As the patient population continues to expand, can treatment modalities keep pace with clinical expectations?

For a long time, the treatment of prostate cancer has faced the dilemma of being unable to achieve both "tumor control" and "functional preservation." The demand for preserving sexual function and urinary continence is particularly prominent among patients in developed countries. Traditional radical surgery involves significant trauma, with high postoperative rates of urinary incontinence and erectile dysfunction, severely compromising patients' quality of life after surgery.

Irreversible electroporation, as an innovative minimally invasive focal therapy technique, offers a new option that achieves both "survival and quality of life" in this dilemma.

From the perspective of therapeutic mechanism, IRE acts on the cell membrane in the form of ultra-short pulses under a high-voltage electric field, creating irreparable nanoscale pores. This leads to an imbalance between the intracellular and extracellular environments, triggering necrosis or apoptosis, thereby achieving the desired therapeutic effect. Currently, overseas IRE technologies employ single-pulse delivery, which causes significant muscle contraction and twitching responses in patients during surgery. This may result in needle displacement during ablation, leading to incomplete ablation or certain complications, thus presenting notable limitations in treatment.

Nortion Medical's globally pioneering next-generation IRE—High-Frequency Irreversible Electroporation (H-FIRE)—by applying high-frequency, bipolar composite pulses, resolves the issue of electric field distortion under complex electrical parameters, effectively eliminating ablation blind spots caused by uneven electric field distribution. The ablation boundary error is ≤5mm, ensuring more thorough ablation while effectively reducing nerve stimulation and muscle contraction, achieving a quadruple breakthrough: complete ablation, functional preservation, minimally invasive treatment, and reduced complications.

Data from 1,452 patients demonstrate that Nortion Medical's high-frequency IRE achieves a 97% urinary continence preservation rate and a 91% sexual function preservation rate. The average procedure time is approximately 30 minutes, representing a 70% reduction compared to traditional surgical methods. Physicians with biopsy experience can master the technique after performing 3–5 cases.

More importantly, Nortion Medical is the first company globally to apply composite pulse technology to prostate cancer ablation and the only company worldwide approved for the indication of BPH.

In the field of urology, Nortion Medical holds two registration certificates for indications, covering prostate cancer and BPH, while overseas monopulse products are indicated solely for prostate cancer. With Nortion Medical's BPH indication now established in the European market, the company's technological advantages will be further amplified. Meanwhile, in December 2025, Nortion Medical's combined steep-pulse therapy device was officially approved for the indication of "ablation therapy for malignant solid liver tumors," marking a pivotal transition from urology to hepatobiliary surgery.

"Three-to-One"—This is not merely a lead in the number of registration certificates; it further signifies that the power to define global IRE technology and the voice in the industry are shifting.

Nortion Medical aims to advance high-frequency irreversible electroporation technology toward indications requiring stringent protection of vascular and neural functions, while establishing comprehensive solutions for mature indications. It is steadily expanding into multiple pipelines, including diabetes/weight loss, metastatic prostate cancer, pancreatic cancer, thyroid cancer, and COPD, to build a minimally invasive treatment ecosystem with IRE as the foundational support.

For Nortion Medical, which is advancing from deep domestic roots to a global footprint, the relationship between the Chinese and international markets is not a simple matter of addition.

Data from the IARC shows that prostate cancer incidence in developed regions such as Australia, New Zealand, and Europe, as well as in certain countries in Central and South America, is significantly higher than in Asia. More importantly, patients in these regions demonstrate greater acceptance of and willingness to pay for function-preserving, minimally invasive focal therapies, while the demand for high-quality personalized treatment remains largely unmet. This is the fundamental reason why the core value of Nortion Medical's IRE technology has been rapidly recognized in overseas markets.

According to Nortion Medical's estimates, the overseas market size for prostate cancer alone is 5–6 times that of the domestic market, not to mention indications with an even larger base, such as BPH.

The domestic market is also witnessing a critical window of opportunity. In August 2025, the National Healthcare Security Administration issued the "Guidelines for Establishing Price Items for Physical Therapy Medical Services (Trial)," incorporating ablation therapy fees (including IRE) into the reimbursement framework. The establishment of this charging pathway signifies that the clinical application of this technology now has a replicable and scalable institutional foundation, thereby clearing obstacles for subsequent market expansion across multiple indications.

Facing this two-way opportunity, Nortion Medical has established a clear globalization strategy: the domestic market as the foundation, with composite pulsed field ablation devices expected to be implemented in over 100 benchmark hospitals across China in 2026, with annual surgical volume exceeding 2,000 cases, representing a year-on-year increase of more than 150%, achieving the leap from technical validation to deep penetration; overseas, with Southeast Asia, Europe, the Middle East, and Central and South America as key hubs, clinical delivery has been completed across these four major regional hubs. Meanwhile, the company is concurrently advancing clinical trials and regulatory registration following the U.S. FDA's "Breakthrough Device Designation" for its proprietary high-frequency IRE technology, accelerating the delivery of this Chinese-originated innovation to patients worldwide.

Also advancing in parallel is the overseas clinical training system. As the global pioneer of high-frequency IRE technology, Nortion Medical not only possesses the qualifications to define technical standards but also bears the mission of promoting the widespread adoption and education of innovative therapies. Currently, the Shanghai Renji Hospital IRE International Training Center is in operation, and a second international training base in the Southwest region is also set to be established. The two centers will work in synergy to provide systematic IRE clinical training to healthcare professionals worldwide.

Turkish European Masterclass Demonstration Surgery

Furthermore, substantial progress has been made in Europe, a core overseas market. To date, the first hospital in Turkey to adopt this technology has successfully performed over 80 IRE procedures, with positive clinical feedback. The Philippines and Malaysia have also entered the phase of routine clinical application. These clinical validation sites will serve as technical demonstration centers for overseas regional markets, promoting the widespread and routine clinical adoption of China's original IRE technology globally.

From "passive" to "proactive," and from "trade exports" to "value-driven global expansion," Chinese medical device companies are undergoing a structural transformation. Nortion Medical stands at this pivotal historical juncture, proving one thing with its achievement of entering 27 countries in just 9 months: "Deep roots yield lush foliage; a wellspring runs long."