Ruidi Bio Submits IPO Prospectus: Pioneering Nanosecond Pulsed Electric Field Technology to Overcome Tumor Ablation Barriers and Expand into Cardiovascular Therapeutics

Recently, the Ministry of Science and Technology conducted a comprehensive performance evaluation of the National Science and Technology Major Project tasks undertaken by Hangzhou Ruidi Biotechnology Co., Ltd., and approved it with a high score.

The expert panel commented:“The research team developed and manufactured an innovative, domestically produced nanosecond pulsed ablation system for liver cancer with independent intellectual property rights, obtaining a domestic medical device inspection certificate. Preclinical and clinical trial evaluations were conducted, and patients with liver cancer were treated without any safety incidents, showing favorable short-term outcomes. It is recommended to promptly complete standardized clinical trials that meet registration requirements.”

Meanwhile, the subsequent clinical studies for this National Science and Technology Major Project continue to proceed. RuidiNanosecond Knife Selected as a Recommended Project by the Ministry of Science and Technology and the National Health Commission for Exhibition at the National “13th Five-Year Plan” Scientific and Technological Innovation Achievements Exhibition

Data indicates that Ruidi Biotechnology is a globally leading high-tech enterprise specializing in advanced medical devices based on pulsed electric field technology. Leveraging a team of highly educated returnee experts at the forefront of technology, and leading an interdisciplinary professional team integrating medicine, engineering, and information technology, the company possesses comprehensive industrial experience encompassing research and development, type testing, clinical trials, regulatory submission and registration, as well as production and sales. Technologically, Ruidi Biotechnology has established a world-leading electromagnetic pulse technology platform, dedicated to the R&D of medical devices for minimally invasive, precision interventional procedures, particularly high-power pulse generators and minimally invasive puncture electrodes. Additionally, the company boasts strong R&D capabilities in intracorporeal contrast diagnostic localization, minimally invasive intervention, AI-guided navigation puncture software and hardware, biological agents, and combination drug-device products.

To date, Hangzhou Ruidi Biotechnology Co., Ltd. has developed a nanosecond pulsed tumor ablation system, launched multicenter clinical trials across China, performed over 100 procedures, and enrolled more than half of the required participants for its clinical trials. The company has also developed a pulsed field ablation system for cardiac atrial fibrillation and is preparing to initiate clinical trials in collaboration with Academician Ge Junbo’s team at Zhongshan Hospital, Fudan University. Furthermore, Ruidi Biotechnology has developed an endoscopic nanosecond pulse system and, through collaboration with Director Jiang Tian’an’s ultrasound team at the First Affiliated Hospital, Zhejiang University School of Medicine, has achieved significant breakthroughs in the research of precision diagnostic and therapeutic instruments for pancreatic cancer.

Currently, Ruidi Biotechnology primarily focuses on systemic solid tumors and cardiovascular diseases.

According to the latest data, China recorded 4.57 million new cancer cases in 2020, accounting for 23.7% of the global total. Among these, approximately 50% were cases of liver cancer, esophageal cancer, and gastric cancer. In terms of mortality, there were 3 million cancer-related deaths in China, representing 30% of the global total.

However, current oncology treatment regimens face significant challenges. The most common approach is surgery, which primarily targets the primary tumor and is highly invasive. Other options include radiotherapy, chemotherapy, and minimally invasive interventional ablation therapies. Radiotherapy and chemotherapy damage healthy cells and immune cells, resulting in substantial side effects. Meanwhile, commonly used ablation techniques, which rely on thermal or cryogenic energy, can injure healthy cells and adjacent tissues surrounding the lesion. This limitation creates "no-go zones" for traditional ablation therapy, such as the gallbladder, bile ducts, blood vessels, and nerves, and may also lead to incomplete ablation due to the "heat-sink effect." Furthermore, tumors are prone to recurrence and metastasis, particularly in cancers such as liver and pancreatic cancer, posing a severe challenge for disease control and prevention.

In response to this challenge, Ruidi Biotechnology has proposed a novel therapeutic strategy of “localized precise ablation + immune activation” and developed a nanosecond pulsed tumor ablation system with clinical potential for ablating liver cancer and other systemic solid tumors. The system has been approved by the National Medical Products Administration (NMPA) as an innovative medical device.

According to reports, the fundamental principle of the Nanosecond Knife is that pulsed electric fields act on tumor tissue, leveraging the unique bioelectric effects of these fields to kill tumor cells or induce apoptosis.Studies have shown that pulsed electric fields with different physical parameters (pulse width, electric field strength, and pulse frequency) can exert distinct cellular biological effects on the cell membrane, cytoplasm, and nucleus, respectively, thereby achieving tumor ablation.

Compared with traditional thermal ablation and cryoablation therapies, the nanosecond pulsed tumor ablation system developed by Ruidi Biotechnology offers unique advantages. Based on the principle of irreversible electroporation (IRE), it enables selective ablation of tumor tissue while preserving critical structures within the treatment zone, such as arteries, bile ducts, nerve bundles, and bronchi. Furthermore, it can treat tumors that are inaccessible to other devices, including those adjacent to blood vessels and nerves, achieving more complete ablation within the lesion. The therapy has minimal toxic side effects, relying solely on the pulsed electric field effect to destroy tumor cells. It features short treatment duration, ease of implementation, strong controllability, and real-time monitoring capabilities, without causing damage to surrounding tissues.

Based on the prospective, multicenter clinical trial of the nanosecond pulsed tumor ablation system, existing data have confirmed the nanosecond pulsed technologyCapable of achieving non-thermal energy ablation, it can break through the contraindications of traditional thermal ablation.Delivering breakthrough innovative therapies for the ablation of solid tumors in high-risk areas.

Compared to abroadMicrosecondIrreversible Electroporation Tumor Ablation Device Using Pulsed Electric Fields, Developed by Ruidi BiotechnologyNanosecondThe pulsed tumor ablation system offers advantages such as greater precision, higher energy, and sharper focus.MicrosecondPulsed electric fields kill tumor cells based on the principle of cell membrane electroporation, whileNanosecondPulsed electric fields rely on higher-density external electric field energy to penetrate the cell membrane and enter the nucleus, inducing a piezoelectric effect within the cell. This triggers sequential and diverse apoptotic effects in tumor cells by acting on the membranes of organelles such as the nucleus, nuclear envelope, and mitochondria.

Specifically, the nanosecond pulsed tumor ablation system can generate extremely high power, nanosecond-level pulse widths, and a high electric field strength of 10 kV/cm. The pulse width of the nanosecond pulsed electric field is shorter than the charging time of the extracellular membrane, allowing it to cross the membrane and enter the nucleus before the cell membrane is fully charged.Directly acts on cellular substructures, inducing tumor cell apoptosis, reduce Joule heating accumulation, transmembrane nuclear entry,Reduces the risk of electromyographic twitching and electrocardiographic abnormalities caused by cytoplasmic leakage due to cell membrane rupture.

Furthermore, nanosecond pulsed electric field (nsPEF) therapy for tumors can induce apoptosis, leading to the shrinkage or even complete disappearance of tumor tissue without the need for toxic chemotherapeutic agents, which holds significant importance for cancer treatment. Compared with thermal and cryoablation, pulsed electric field therapy is a novel, non-thermal energy-based ablation modality; and relative to microsecond pulsed ablation, nanosecond pulsed ablation represents the next generation of electric field ablation therapies.

Notably, nanosecond pulsed electric fields (nsPEFs) exhibit distinct characteristics compared to millisecond- and microsecond-range electric fields, including high field energy, high intensity, rapid rise time, and short duration of action, thereby eliciting unique bioelectrical responses in biological tissues. Applications such as electroporation-mediated gene delivery, acceleration of plant growth, controlled drug release, electrochemical intervention of biomolecules, non-thermal ablation therapy for thrombosis and cardiovascular diseases, stimulation of bone and skin tissue regeneration, and tumor ablation via pulsed electric fields have all demonstrated favorable clinical outcomes.At this stage, based on the principles and advantages of nanosecond pulsed ablation, Ruidi Biotechnology is primarily focused on the oncology and cardiovascular fields, developing minimally invasive interventional medical devices for non-thermal energy ablation in tumor and cardiovascular treatments.

According to reports, since its establishment in 2014, Hangzhou Ruidi Biotechnology Co., Ltd. has secured funding for 10 projects from the National Natural Science Foundation of China, leveraging its nanosecond pulse technology platform. Notably, over the past three years, the company has consecutively been awarded two National Major Science and Technology Projects, resulting in the development and delivery of innovative medical devices such as the nanosecond pulsed tumor ablation system.

Chen Xinhua, founder of Ruidi Biotechnology, stated: “As the host institution, Ruidi has established the Hangzhou Ruidi Biotechnology Nanosecond Pulse Medical Translation Municipal Enterprise High-Tech Research and Development Center, been recognized as a National High-Tech Enterprise, and set up the Zhejiang Provincial Key Laboratory for Medical Translation and Application of Pulsed Electric Fields, guiding the research, development, and design of medical devices based on underlying mechanistic principles.”

To date, Hangzhou Ruidi Biotechnology Co., Ltd. has filed 71 patent applications, leveraging its independently developed pulsed electric field technology platform and a professional team comprising highly educated returnees with cutting-edge expertise as well as specialists integrating medicine, engineering, and information technology. Its PCT patents target the European and U.S. markets, and its products have initiated the EU CE certification process.

As can be seen, Hangzhou Ruidi Biotechnology Co., Ltd. leverages its independently developed pulsed electric field platform and currently focuses primarily on oncology and cardiovascular diseases. This strategic focus stems from the company’s founding mission and philosophy: to address the challenges in tumor treatment and save more cancer patients.

Chen Xinhua told VCBeat, “I founded Ruidi to honor my father, a soldier who passed away prematurely, his life claimed by cancer. As a surgeon, I was unable to save him through surgery. During his treatment, I witnessed firsthand the plight of numerous cancer patients and their families, who faced a lack of access to minimally invasive treatment equipment and the prohibitive costs of imported drugs. From that moment on, I resolved to develop innovative, domestically produced medical devices, providing effective tools for fighting cancer for my father and other cancer patients and their families.”

Guided by Chen Xinhua’s original aspiration, Ruidi Biotechnology is committed to the research and development of innovative minimally invasive precision medical devices, focusing on enhancing quality of life through cutting-edge pulsed field technology, and building an internationally leading platform for minimally invasive precision diagnostic and therapeutic technologies.