Recently, the “Steep Pulse Therapy Device (trade name: Wknife),” independently developed by Hangzhou winonco Medical Technology Co., Ltd., officially passed the review of the Medical Device Technical Review Center of the National Medical Products Administration on August 5, 2025, was successfully included in the “Special Review Procedure for Innovative Medical Devices,” and was officially announced by the NMPA in its 2025 No. 7 announcement. This important progress marks the regulatory authority’s recognition of the company’s single-needle, local anesthesia technology for pulsed electric field tumor ablation devices.

In addition, the core principle-level patent of the Wknife was also recently granted in both China and the United States. To date, winonco Medical has filed a cumulative total of 144 invention patents in China and abroad, including 17 PCT international patents, building a comprehensive intellectual property protection system.

The core technology of winonco, the “Wknife” (SIRE), is a world-leading irreversible electroporation (IRE) tumor ablation system, with the following advantages:

Single-needle precision control, effortless local anesthesia:

The single-needle pulsed electric field tumor ablation procedure under local anesthesia achieves a clinical leap of traditional pulsed electric field tumor ablation technology from “general anesthesia” to “local anesthesia” and from “multiple parallel needles” to “single-needle ablation.” The procedure time is shortened to within 15 minutes; the patient remains awake and pain-free throughout; postoperative recovery is rapid with no residual carbonized nodules; and the ablation range of a single needle set can exceed 7 cm.

Non-thermal ablation:

By precisely disrupting the tumor cell membrane structure through a high-voltage ultrashort pulsed electric field, it offers the non-thermal selective advantage of ablating lesions while protecting healthy tissues such as important blood vessels and nerves. It can break through the clinical “forbidden zones” of existing treatment technologies and avoid the cold/heat injury and heat-sink effect of traditional thermal and cryoablation on surrounding nerves, blood vessels, and other tissues.

For many solid tumors in special locations that cannot be ablated, such as tumors at the hepatic hilum and pulmonary hilum, as well as pancreatic cancer and other tumors adjacent to major blood vessels, the Wknife can easily complete ablation treatment under local anesthesia, creating new hope for cancer patients.

Multi-pathway Integrated Expansion:

Studies show that the Wknife, combined with comprehensive therapies such as chemotherapy and immunotherapy, provides personalized minimally invasive solutions for complex advanced solid tumors.

The Wknife is the team’s third-generation IRE technology, built on more than 20 years of research and the first two generations of IRE products. It can significantly reduce the muscle contraction seen in the clinical application of current IRE products, avoiding the use of muscle relaxants and the need for intubation general anesthesia for respiration;

At the same time, by adopting a broad-spectrum, multi-parameter synergistic pulse waveform, it can achieve multi-site action on both the inner and outer cell membranes, enhance the cell-killing effect, lower the tissue ablation threshold, and expand the ablation range.

The Wknife overcomes the problems of existing IRE products such as high anesthesia requirements, strong muscle contraction, difficult needle placement, and small ablation range, making IRE tumor ablation treatment safer for patients and more convenient for physicians to perform.