CuraWay's Chinese solution reshapes global access to tumor pulsed-field therapy

Against the backdrop of China's 15th Five-Year Plan and its "self-reliance and self-strengthening in science and technology" strategy, innovative enterprises across various sectors have become a powerful engine driving the nation's economic growth. Chinese products have long transcended mere imitation, evolving toward genuine innovation rooted in deep market insights. They now confidently respond to global demands with higher-quality, more targeted solutions, fueling a future full of potential for China. Such outstanding enterprises are continuously emerging in the healthcare sector, and CuraWay Medical stands as one such company, distinguished by its innovative capacity and international vision.

A grim reality persists in treating complex hepatic, biliary, and pancreatic malignancies: many are diagnosed when surgery is no longer feasible or offers limited efficacy. Existing minimally invasive therapies are constrained by safety and efficacy limitations, often failing to significantly prolong patient survival—an urgent clinical gap that demands solutions. Pulsed-field ablation (PFA) is recognized as a safe and effective technology for treating such complex tumors, capable of selectively destroying tumor cells while preserving vital adjacent structures and activating anti-tumor immunity. However, the prohibitively high cost of imported systems has restricted its widespread adoption globally, leaving many patients without access. As a result, many patients miss out on this advanced treatment, and broader clinical applications remain underdeveloped.

The highly intelligent and integrated PoriNova® composite pulsed-field ablation system, entirely independently developed in China, has overcome multiple critical "bottleneck" technologies. With nearly 20 Chinese invention patents filed—11 already granted—and a growing portfolio of international patents, the system lays a solid foundation for global expansion and a self-sustaining innovation ecosystem. To date, PoriNova® has obtained medical device registration certificates from China's NMPA (Class III), the U.S. FDA, Europe's CE-MDR, as well as approvals in multiple countries across the Middle East, South America, and Asia. It represents China's first and the world's second pulsed-field ablation system to secure FDA approval.

Beyond cost barriers, the clinical application of pulsed-field ablation (PFA) demands a high level of operational expertise. Challenges such as parallel needle placement during puncture procedures and multi-needle surgical planning have, to some extent, constrained the broader adoption of this technology. CuraWay operates a provincial-level enterprise research institute approved by the Zhejiang Provincial Department of Economy and Information Technology, where it focuses its R&D on intelligent precision minimally invasive technologies. The institute brings together interdisciplinary experts in biomedical engineering, electronic information, and clinical medicine. It was among the first globally to strategically develop intelligent minimally invasive interventional therapies, establishing a complete innovation chain from basic research to clinical translation.

Launched in China in 2024, the Guiding Star GNV-F1 puncture surgical robot assists physicians in addressing challenges related to needle puncture and placement, thereby improving the implementation of PoriNova® treatments. This innovation enables the wider adoption of this complex technology. Under the guidance of leading Chinese clinical experts, the Guiding Star robot boasts over twenty invention patents and more than forty utility model patents. It has achieved globally leading positions in key technological areas including optical positioning, robotic arm control, respiratory displacement sensing, and multi-needle placement systems, and is progressively entering international markets.

Additionally, CuraWay's tumor PFA system incorporates radiofrequency (RF) technology. This unique dual-energy electrothermal composite platform achieves effective hemostasis in highly vascular organs, significantly enhancing procedural safety.

The PoriNova® system has already reached markets in North America, Latin America, Europe, the Middle East, and Southeast Asia. CuraWay's global teams, located across the Asia-Pacific, Africa, the Middle East, and South America, are actively promoting its adoption through academic exchange, technical training, and clinical collaboration—earning international recognition for Chinese medical technology.

Driven by both policy support and the demands of the era, CuraWay, with breakthrough products like PoriNova®, is steadily emerging as a leading force in China's innovative medical device sector. It actively supports the country's push for self-developed, high-end medical equipment that ultimately benefits patients. Compared to imported systems priced at nearly ten million RMB, the China-developed PoriNova® system will be introduced at a more accessible price point. This not only alleviates procurement and operational pressures for hospitals but also ensures that a broader patient population can truly benefit from this cutting-edge technology—making precision minimally invasive therapy both affordable and accessible.