In April 2026, the “Steep Pulse Therapy Device” (trade name: Wknife) independently developed by Hangzhou winonco Medical officially passed the Special Review Procedure for Innovative Medical Devices of the National Medical Products Administration (NMPA) and was granted innovative medical device recognition for innovations such as non-thermal ablation reaching the whole lung (including the hilar region). This is the second time the company has won national-level innovation recognition, following the approval of the first product “Steep Pulse Therapy Device” in August 2025 for its advantageous innovation of “single needle + local anesthesia”, marking that the Chinese are expected to solve the world-class problem of ablating hilar lung cancer and to benefit more patients. It further demonstrates our company’s innovation-leading position in the field of precise non-thermal interventional tumor treatment.

Wknife technology originates from the NSFC key project undertaken by Professor Yao Chenguo’s team at Chongqing University starting in 2000. In 2002, the team was the first in the world to propose a new method for ablating tumors by high-voltage ultra-short pulsed electric field irreversible electroporation (IRE) (published in Acta Biophysica Sinica, 2002, 18(4):474-77; IEEE TPS, 2004, 32(4)), establishing China’s original innovation position in this field. Over the following two decades and more, the team continued to delve deeply, progressing from microsecond pulsed electroporation technology (traditional IRE) and high-frequency composite pulsed electric field electroporation technology (HF-IRE) across two generations of products to the latest-generation broad-spectrum synergistic pulse (S-IRE), achieving a fundamental transformation of Wknife in both principle and performance: significantly reducing muscle contraction and avoiding the use of general anesthesia and muscle relaxants; adopting a broad-spectrum, multi-parameter synergistic waveform that forms a uniform electric field in complex media; and enhancing the cell-killing effect and expanding the ablation zone.

Relying on the Wknife system, the Department of Respiratory and Critical Care Medicine of Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine, the interventional medicine team of Shanghai Zhongshan Hospital, and multiple other centers jointly successfully completed the first batch of human clinical trials in China and abroad of Wknife ablation of malignant pulmonary nodules (also covering validation of the percutaneous route), covering complex modes such as one-stop synchronous diagnosis and treatment, bilateral multiple lesions, and large-angle apices of the right upper lobe, and involving lesions at special sites adjacent to blood vessels, the trachea, and large-angle apices of the right upper lobe. The clinical results showed:

lSurgical success rate 100%;

lComplete lesion ablation rate 100%;

lNo serious complications such as bleeding or pneumothorax occurred during or after the procedure;

lThe mean postoperative hospital stay of patients was only 3 days, with rapid recovery;

lImmediate postoperative and 6-month postoperative imaging follow-up confirmed that the ablation zone had clear boundaries, with complete coverage of tumor tissue and marked shrinkage and absorption, indicating significant efficacy.

Percutaneous and Natural Orifice Clinical Trial

This clinical practice marks the first successful application in humans of an innovative regimen that integrates percutaneous lung cancer intervention with robot-assisted precise navigation technology and Wknife core non-thermal ablation technology, achieving precise, minimally invasive, and selective ablation of lung lesions with coverage of the whole lung. This is not only a breakthrough advance in the field of minimally invasive pulmonary intervention, but also confirms our company’s R&D strength and technological leadership in the field of precise interventional treatment of early-stage malignant lung tumors.

The renewed innovative medical device recognition is another key milestone in the industrialization of Wknife. Taking this recognition as a new starting point, winonco will join hands with top clinical institutions to accelerate product registration and market access, promote the implementation of a one-stop platform of “navigation + synchronous biopsy + Wknife precision ablation”, and build a minimally invasive tumor treatment ecosystem covering the entire process of “screening-diagnosis-navigation-ablation-follow-up”.

Hangzhou winonco Medical Technology Co., Ltd. is a National High-Tech Enterprise focusing on the field of minimally invasive tumor ablation and dedicated to advancing innovation in minimally invasive tumor solutions through technology R&D. Starting from its entirely self-developed high-voltage pulsed electric field irreversible electroporation technology as its core technology and covering a multi-physics, multi-modality technology platform, the company develops internationally leading minimally invasive tumor ablation solutions. Its core product Wknife enjoys fully independent intellectual property rights and has to date obtained a total of 151 invention patents in China and abroad (including PCT 18) and has repeatedly been granted national innovative medical device recognition. The company will continue to advance technological innovation and clinical translation, providing safer, more effective, and more accessible Chinese minimally invasive tumor solutions for patients worldwide.