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Nanosecond
Pulse Tumor Ablation System

The nanosecond pulse tumor ablation system is used for solid tumor ablation. Under the influence of a high-voltage nanosecond pulse electric field, it perforates the cell nucleus, inducing tumor cell apoptosis. Simultaneously, it affects intracellular membrane structures such as mitochondria, resulting in multiple effects that lead to apoptosis, achieving heatless selective ablation of tumors.


The entire system employs an intelligent and digital human-machine interface control system, effectively meeting the clinical needs of users for multiple pulse release modes.


Higher energy, more precise, and safer, this system overcomes the parameter limitations of existing pulse electric field technology, leading the next generation of domestically developed and innovative electric field ablation therapy, bringing a revolutionary ablation treatment option to patients in ablation-restricted areas.

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Procedure Selection

Pulsed Ablation
By designing an appropriate pulsed electric field, ablation energy is delivered through multiple short‑duration, high‑voltage electrical pulses, rendering the ablation process non‑thermal. This effectively induces cellular electroporation, allowing extracellular cations to enter cells, leading to fragmentation and cell death (pulsed electric field ablation is therefore also referred to as irreversible electroporation).
Surgery
A sufficient volume of functional liver tissue (with adequate blood supply, as well as satisfactory blood and bile drainage) is preserved to ensure postoperative hepatic functional compensation, reduce surgical complications, and lower surgical mortality.
Cryoablation
Heat is absorbed through the evaporation of liquid refrigerant inside the balloon, causing a rapid temperature drop around the ablation target. The low temperature damages or destroys abnormal cells in this region.
Radiofrequency Ablation
Under the guidance and monitoring of imaging equipment, a radiofrequency ablation needle is percutaneously inserted into tumor tissues such as those in the liver and lung. Upon energization, the radiofrequency electrode emits high-frequency radio waves that stimulate plasma oscillation in tissue cells. A spherical thermal zone with a diameter of 3–5 cm is generated at the tip of the ablation needle, and the resulting heat can raise the local temperature to above 90 °C.
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Treatment Technology

Fundamentals of Electroporation

The cell membrane can be regarded as a dielectric separating two conducting media, namely the cytoplasm and the extracellular medium. When exposed to an external electric field, the cell behaves as a closed capacitor. Thus, when the electric field–induced transmembrane voltage reaches a critical value, the electric field generates a transmembrane potential dependent on magnitude and location, which superimposes on the resting potential and leads to membrane "electroporation".

The cell membrane can be regarded as a dielectric separating two conducting media, namely the cytoplasm and the extracellular medium. When exposed to an external electric field, the cell behaves as a closed capacitor. Thus, when the electric field–induced transmembrane voltage reaches a critical value, the electric field generates a transmembrane potential dependent on magnitude and location.

1. Teissié J, Rols MP. An experimental evaluation of the critical potential difference inducing cell membrane electropermeabilization. Biophys J. 1993 Jul;65(1):409-13.

Focal tumor therapy

Tumor ablation techniques include radiofrequency, microwave, laser, high‑intensity focused ultrasound, and cryoablation, which are commonly used to treat tumors of the liver, prostate, breast, or lung. However, all these techniques are thermal and therefore subject to the heat sink effect, which may result in incomplete ablation and can cause thermal damage to non‑target tissues.

Under certain conditions, high‑voltage pulsed electric fields can induce the formation of pores on cell membranes. This phenomenon is known as “electroporation”. Under specific conditions, electroporation can be irreversible, leading to apoptosis. Irreversible electroporation has been shown effective in the treatment of various solid tumors such as liver cancer and prostate cancer¹,².

1.Young S, Rivard M, Kimyon R, et al. Accuracy of liver ablation zone prediction in a single 2450MHz 100 Watt generator model microwave ablation system: An in human study. Diagn Interv Imaging. 2020 Apr;101(4):225-233.


2. Tomita K, Iguchi T, Matsui Y, et al. Early enlarging cavitation after percutaneous radiofrequency ablation of lung tumors: Incidence, risk factors and outcome. Diagn Interv Imaging. 2022 Oct;103(10):464-471.

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Significant clinical advantages

Precision Therapy
Based on the varying threshold responses of different tissue cells to pulsed electric fields, IRE ablation avoids irreversible damage to critical structures surrounding the target lesion—including nerves, blood vessels, and bile ducts—through precise parameter control and adjustment.
Immune Response Activation
Apoptotic cells are phagocytosed by phagocytes before cell membrane rupture, avoiding inflammatory responses triggered by the massive release of intracellular contents. Meanwhile, it disrupts the tumor microenvironment, induces and activates anti‑tumor immune responses, and improves long‑term therapeutic outcomes.
Complete Ablation
Nanosecond pulsed electric fields can penetrate across the cell membrane into the nucleus, directly inducing perforation of mitochondria and the nucleus, and triggering programmed cell death, resulting in thorough ablation.
Non‑thermal Ablation
As an electric field‑based non‑thermal ablation modality, it is unaffected by the heat sink effect. This prevents reduced ablation efficacy caused by adjacent blood vessels and minimizes thermal injury during treatment.
Solid tumor
Liver cancer
Pancreatic cancer
Prostate cancer
Thyroid cancer
Atrial Fibrillation (AF)
COPD
Neuromodulation

Reference: Ren Zhigang, Chen Xinhua, Zheng Shusen, et al. Research Progress in Nanosecond Pulsed Tumor Ablation. *Chinese Journal of Biomedical Engineering*, 2014, 12(33-5).

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Advantage-Wide range of applications

Cell Diagram
One of the top ten scientific and technological progress in the world in 2002

Reversible Electroporation

Electrochemotherapy

  • Pulse width: ms~μs
  • Acts on the cell membrane

Irreversible
Electroporation

µsPEF, NanoKnife

  • Pulse width: µs
  • Electric field intensity: 1500 V/cm
  • Irreversible electroporation of cell membrane (pore size: 3 nm)
  • Uneven distribution of electric field
  • Cellular stress electric field: only a small amount penetrates into the cytoplasm
  • Cell necrosis

State-of-the-art technology Nanosecond Pulsed Electric Field (nsPEF)

nsPEF, Ruidi Biotechnology

  • Pulse width: ns
  • Electric field intensity: 30000 V/cm
  • Irreversible electroporation of cell and organelle membranes (pore size: 1 nm)
  • Uniform electric field distribution
  • Cellular stress electric field: intracellular and extracellular
  • Programmed cell death & immune activation
Wide range of applications
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Advantages of Nanosecond Pulsed Electric Field

Advantage 1
(Precision Cell Targeting)

Nanosecond pulses can trigger electroporation on intracellular organelles while reducing broad thermal spread to surrounding tissue.

This mechanism enables precise energy delivery in complex anatomical areas and helps preserve key vascular and neural structures.

It provides a controllable ablation strategy for indications that require higher procedural precision.

1. Batista Napotnik T, Polajzer T, Miklavcic D. Cell death due to electroporation - A review. Bioelectrochemistry. 2021 Oct;141:107871.

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Guidelines & Consensus
Clinical Practice Recommendations

Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 Edition) 1

Traditional thermal and cryoablation techniques should be used with caution in hepatocellular carcinoma adjacent to the hepatic hilum or near the first- and second-order bile ducts, and a safety distance of at least **>5 mm** from adjacent critical structures is recommended.

Ablation therapy should be used with caution for hepatocellular carcinoma adjacent to the hepatic hilum or near the first- and second-order bile ducts, to avoid complications such as bile duct injury.Percutaneous ethanol injection (PEI) is a relatively safe option, or ablation may be combined with PEI. If thermal ablation is used, a sufficient safety margin (at least >5 mm) must be maintained between the tumor and the first- and second-order bile ducts, and safe ablation parameters (low power, short duration, intermittent radiation) should be adopted. Temperature monitoring is recommended for ablation devices with this capability.
Expert consensus on the standard of radiofrequency ablation therapy for liver cancer

Complications after radiofrequency ablation of liver cancer may include post ablation syndrome, infection, gastrointestinal bleeding, intra-abdominal bleeding, tumor implantation, liver failure, adjacent organ damage, etc.

1. Post ablation syndrome: mainly manifested as fever, pain, etc., rare cases include hematuria, chills, etc., the specific cause is unknown. The main treatment includes strengthening postoperative monitoring, intravenous infusion, pain relief, symptomatic treatment, and regular liver and kidney function testing. 2. Infection: Mainly includes liver abscess, puncture site infection, etc. Prevention: Strict aseptic operation, antibiotics can be used to prevent infection after surgery. 3. Gastrointestinal bleeding: The main cause is bleeding from varicose veins in the lower esophagus or bleeding from stress ulcers. Prevention and treatment: For patients with severe portal hypertension, preoperative management of portal hypertension is recommended; Routine use of antacids after surgery to prevent stress ulcer bleeding. Post bleeding treatment: vital signs should be checked, fasting should be avoided, active volume expansion, intravenous infusion, hemostasis, blood transfusion, acid production, pressure boosting, etc. Endoscopic hemostasis should be performed if necessary. 4. Abdominal bleeding: Clinical manifestations depend on the amount of bleeding. Minor bleeding without obvious symptoms. When there is a large amount of bleeding, there is often bloating and abdominal pain, and in severe cases, cold sweat, decreased blood pressure, and shock symptoms. The main reason is that the tumor is relatively superficial and ruptures after puncture; Or the patient may have poor coagulation function and bleeding at the liver puncture site. Prevention: Strictly grasp the indications, and for patients with poor coagulation function in cirrhosis, correct them before treatment; For superficial lesions, it is best to use laparoscopy or open abdominal visualization. During percutaneous radiofrequency therapy, the number of punctures should be minimized, needle ablation should be performed, and ultrasound or CT scans should be performed again after ablation to rule out the presence of tumor rupture, bleeding, and other symptoms. Treatment: Check vital signs, actively expand volume, administer intravenous fluids, stop bleeding, transfuse blood, increase blood pressure, etc. If necessary, perform surgical exploration to stop bleeding. 5. Tumor implantation: mainly caused by repeated punctures. Prevention: Puncture should be accurately located to avoid repeated punctures; If the needle is inserted too deeply, the electrode needle should not be directly retracted, but should be repositioned after in-situ ablation. 6. Liver failure: The main reason is severe liver cirrhosis and poor liver function before treatment; Or serious complications may occur (such as infection, bleeding, etc.). Prevention and treatment: Strictly control the indications, and cases with Child Pugh C liver function, large ascites, severe jaundice, etc. are all contraindications; After surgery, pay attention to preventing the occurrence of other complications, preventing infections, and actively treating liver protection. 7. Adjacent organ damage: When the tumor is located near the gallbladder, gastrointestinal tract, bile duct, diaphragm, or in the first porta hepatis area, subcapsular area, etc., percutaneous ablation treatment through the puncture pathway may easily cause thermal damage to adjacent organs or vessels. For tumors in these areas, laparoscopic or open surgery under direct visualization should be used as much as possible for radiofrequency ablation treatment, and adjacent organs should be isolated and protected.
Clinical practice guidelines for ultrasound-guided irreversible electroporation ablation therapy for liver cancer (2023 edition)

Include important structures adjacent to the tumor, such as the porta hepatis, blood vessels, bile ducts, diaphragm, or gastrointestinal tract, as indications.

Indications and Contraindications - Indications: Malignant liver tumors diagnosed clinically or pathologically, with a single diameter ≤ 5cm; or multiple tumors (≤ 3 in number), with a maximum diameter ≤ 32 cm. Tumors are located adjacent to important structures such as the porta hepatis, blood vessels, bile ducts, diaphragm, or gastrointestinal tract; 3 liver function grades Child Pugh A/B; 4. For single tumors with a diameter greater than 5cm or multiple tumors with a diameter greater than 3cm that cannot be surgically removed, palliative ablation or combination with other treatment methods can be used; The expected survival period is over 3 months, and the Karnofsky functional status score is>50.
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Clinical Validation-Liver Cancer Program

The clinical trial was conducted at 6 clinical institutions, with a total of 187 subjects enrolled (187 in the experimental group, no control group [Note]).
The efficacy and safety results
are favorable.
Complete tumor ablation rate
83.96%
1 month after surgery
82.29%
3 month after surgery
82.32%
6 month after surgery
Primary endpoint:
The complete tumor ablation rate (CA rate) at 1 month after ablation was 83.96%, which was higher than the clinically expected CA rate of 80%, and the lower limit of the 95% confidence interval was also greater than the CA target value of 70%.
Secondary endpoints:
The tumor CA rate at 6 months after ablation was 82.32%, the local recurrence control rate (LCR rate) was 88.03%, and the objective response rate (ORR rate) was 83.10%.
Safety endpoint:
There were 17 adverse events (8.67%), including 2 device-related serious adverse events (1.02%), and the overall survival (OS) rate was 100%.
Note: According to verification with the NMPA, no ablation system has yet been approved for the indication of ablation in high-risk regions — namely, malignant liver tumors adjacent (less than 0.5cm) to critical structures (including the gallbladder, gastrointestinal tract, first hepatic hilum, second hepatic hilum, diaphragm, or any such site).Currently approved clinical indications for ablation devices are generally limited to patients with:- a single tumor with a maximum diameter ≤5 cm;- or no more than 3 tumors, each with a maximum diameter ≤3 cm, without invasion of blood vessels, bile ducts, or adjacent organs.The two are not comparable in terms of clinical indications; therefore, the establishment of a controlled trial is not applicable.

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