Ruibi Bio Achieves Dual Innovation Designations from China and the U.S. for Its Proprietary Nanosecond Pulsed Electric Field Ablation System
Recently, Hangzhou Ruidi Biotechnology Co., Ltd. has prepared a surprise for China's medical device industry: itsSelf-developed Steep Pulse Ablation System (Nanosecond Pulse Ablation System) Receives U.S. FDA “Breakthrough Device” Designation, Becoming the First Pulsed Electric Field Ablation Product in China to Earn This Recognition。
Given the leading position of U.S. medical devices globally, FDA-designated “Breakthrough Devices” represent, to a certain extent, the pinnacle of global innovation in the medical device industry. This recent designation,This signifies that the leadership and clinical value of the nanosecond pulsed ablation system have been recognized by international authoritative regulatory agencies, thereby accelerating its registration filing and product launch process in the U.S. market.。
Additionally, obtaining the “Breakthrough Medical Device” designation will enable the nanosecond pulsed ablation system, upon approval, toEligible for U.S. insurance coverage, accelerating commercial adoption. Gaining recognition in the U.S. market willAccelerating the Global Adoption of Nanosecond Pulsed Ablation Systems。
It is understood that the medical device granted “Breakthrough Medical Device” designation this timeNanosecond Pulsed Ablation System by Ruidi BiotechnologyBased onDevelopment of a Proprietary Next-Generation Nanosecond Pulsed Electric Field Ablation Technology Platform, Primarily for the Ablative Treatment of Solid Tumors Throughout the Body. Specifically, the nanosecond pulsed ablation system delivers high-voltage nanosecond pulsed electric fields of tens of thousands of volts to the patient’s tumor site, penetrating the cell membrane and entering the nucleus to induce irreversible electroporation in tumor cells, thereby triggering apoptosis.
“Breakthrough Devices” is a medical device review pathway established by the U.S. FDA, equivalent to the U.S. version of the green channel for innovative medical devices, aimed at accelerating the market adoption of related products. Upon receiving “Breakthrough Device” designation, the FDA provides prioritized review of device development and clinical trial protocols, support from review teams, and assistance with commercialization decisions for the designated products. However, very few products receive this designation each year due to the stringent criteria involved.
Designation as a “Breakthrough Medical Device” requires meeting two criteria simultaneously: first, the product must provide more effective treatment or diagnosis for life-threatening diseases or conditions involving irreversible failure; second, the device must incorporate breakthrough technology, have no marketed alternatives, demonstrate significant superiority over existing marketed alternatives, or offer usability that best serves the interests of patients.
(FDA “Breakthrough Device” Designation Criteria)
Ruidi Biotechnology’s newly certified Nanosecond Pulsed Ablation System is primarily indicated for solid tumors throughout the body, a category of diseases characterized by a large patient population, significant health burden, unmet clinical needs with existing therapies, and global attention.
Technically, compared with the ablation technologies currently on the market that use thermal or cryogenic energy, pulsed field technology offers advantages such as tissue selectivity, extremely short transmembrane time, and no accumulation of Joule heat. Therefore, it can break through the contraindications of traditional surgery and thermal/cryogenic ablation, enabling safe ablation in high-risk anatomical sites such as hepatocellular carcinoma in the hepatic hilum with dense vasculature and pancreatic cancer.
Furthermore, compared with the previous generation of kilovolt-level microsecond pulses, the nanosecond pulses developed by Hangzhou Ruidi Biotechnology Co., Ltd. have achieved multiple independent innovations. The voltage generated by its nanosecond pulse ablation system exceeds 10,000 volts, with a pulse width at the nanosecond level. These ultra-high-voltage, ultra-short pulses can traverse cell membranes and enter the nucleus, achieving superior ablation efficacy. To date, Hangzhou Ruidi Biotechnology has secured hundreds of core patents.
In fact, not only has the U.S. FDA recognized Hangzhou Ruidi Biotechnology Co., Ltd.’s nanosecond pulsed ablation system, but the National Medical Products Administration (NMPA) of China had already included Ruidi’s products in the Special Review Procedure for Innovative Medical Devices—commonly known as the “green channel”—as early as 2020. Having successively obtained both the Chinese Innovative Medical Device designation and the U.S. FDA Breakthrough Device designation, Ruidi Biotechnology’s nanosecond pulsed tumor ablation system has becomeThe World’s Only Tumor Pulsed Field Ablation System with Dual “Innovative” Designations in Both China and the United States。
The innovative designations granted by regulatory authorities in China and the United States will accelerate the approval of Hangzhou Ruidi Biotechnology Co., Ltd.’s nanosecond pulsed tumor ablation system by both the NMPA and the FDA. Additionally, Ruidi Biotechnology has successfully completed key milestones, including CE certification and manufacturing process transfer, thereby laying a solid foundation for global commercialization following its dual submissions in China and the U.S.
Notably, in addition to its nanosecond pulsed tumor ablation system for oncology applications, Hangzhou Ruidi Biotechnology Co., Ltd. has developed a Pulsed Field Ablation (PFA) system for atrial fibrillation based on its next-generation nanosecond electric pulse ablation technology platform. This product was also approved by the National Medical Products Administration (NMPA) at the end of 2023 to enter the Green Channel for innovative medical device review.
Leveraging its pioneering nanosecond pulse technology, Ruidi Biotechnology has secured two innovation designations from China’s National Medical Products Administration (NMPA) and one Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). This is poised to serve as a major catalyst for its commercialization efforts:The product’s connection to the two high-growth “blue ocean” markets of oncology and electrophysiology, endorsement by two premier international regulatory authorities—the NMPA and the FDA—and policy support in the world’s two largest medical device markets (the United States and China)—each of these key factors signals that Hangzhou Ruidi Biotechnology Co., Ltd. is poised for rapid performance growth and is on the verge of an explosive expansion phase.。
Since the surge in popularity of pulsed electric field (PEF) technology, at least 50 innovative enterprises in China have entered the PEF sector. Currently, however, Hangzhou Ruidi Biotechnology Co., Ltd. (Ruidi Bio) remains the only Chinese company in this field to achieve “dual innovation recognition” in both China and the United States. This accomplishment can be attributed to Ruidi Bio’s robust innovation capabilities.
It is reported that Ruidi Biotechnology, founded in 2014, is a global leader in nanosecond pulsed electric field (nsPEF) platform technology. The company is dedicated to the clinical translation of pulsed electric field technology and the development of electromagnetic medical solutions aimed at improving human life.
To date, Hangzhou Ruidi Biotechnology Co., Ltd. boasts a technical team of over 100 professionals, spanning multiple disciplines including pulsed power technology, biomedical engineering, bioelectromagnetics, and clinical medicine. Notably, Dr. Chen Xinhua, the founder of Hangzhou Ruidi Biotechnology and a clinical expert, participated in the research, clinical application, and translation of the world’s first pulsed electric field ablation technology during his studies in the United States, thereby accumulating extensive experience in scientific research and industrial translation of pulsed electric field technologies.
After years of accumulation by an interdisciplinary R&D team, Hangzhou Ruidi Biotechnology Co., Ltd. has established a globally leading next-generation pulsed electric field (PEF) technology platform. Based on this platform, the company has developed multiple product pipelines covering various clinical application scenarios, including oncology, cardiovascular disease, brain-computer interfaces, and respiratory medicine. By establishing a one-stop PEF technology translation system, Hangzhou Ruidi Biotechnology has led regional joint medical institutions in completing several national-level collaborative projects integrating medicine, industry, academia, and research, thereby demonstrating its robust R&D capabilities.
Meanwhile, Ruidi Biotechnology has achieved breakthroughs in multiple core technologies, including high-power pulse generators, high-performance conductive and insulating materials, implantable control chips, intelligent and digital transformation of devices, as well as control software and algorithms, further demonstrating its independent innovation capabilities.
Moreover, Ruidi Biotechnology places great emphasis on medical-engineering collaboration, applying its next-generation pulsed field ablation technology to address significant unmet clinical needs. Taking the nanosecond pulsed ablation system, which recently received “Breakthrough Medical Device” designation, as an example, this device achieves integrated innovation through interdisciplinary collaboration between medicine and engineering. It was developed through close cooperation between Ruidi Biotechnology’s overseas-returnee engineers and multidisciplinary teams of clinicians from leading medical centers, including the First Affiliated Hospital of Zhejiang University, Hangzhou Shulan Hospital, the First Affiliated Hospital of Zhengzhou University, the First Affiliated Hospital of Xinjiang Medical University, and Lishui Central Hospital.
In addition, other original innovative medical devices from Hangzhou Ruidi Biotechnology Co., Ltd. are currently undergoing prospective registration clinical studies at more than 50 top-tier (Grade III Class A) clinical centers across China, with multiple products expected to enter the regulatory submission phase in succession.
In 2024, a year marked by a complex and volatile market environment, Hangzhou Ruidi Biotechnology Co., Ltd. did not retreat or remain passive; instead, it decided to increase its R&D investment to consolidate its leading position in the field of pulsed electric fields. By implementing the strategy of “innovation-driven development and refined management,” the company continued to strengthen its technological advantages in pulsed electric field platforms, ensured the steady progress of clinical projects, and actively sought new breakthroughs in brain-computer interface application scenarios. Building on its existing integrated diagnostic and therapeutic innovation R&D platform, the company accelerated the integrated development of software, hardware, and AI algorithms. Furthermore, it enhanced the construction of its entire industry chain through automation and intelligent technologies, proactively entered the international stage, expanded overseas business, and achieved sustainable development.