The “malignant stenosis cryoablation system” independently developed by cryofocus has been officially approved for marketing by the National Medical Products Administration (NMPA). The system consists of a disposable airway cryoablation catheter (National Medical Device Registration No. 20253010479) and a cryotherapy device (National Medical Device Registration No. 20253010490). It is the world’s first balloon-type respiratory interventional product using liquid nitrogen freezing technology, marking a new breakthrough in the treatment of malignant airway stenosis in my country.

Targeting the needs of 250,000 patients and solving clinical treatment pain points
Malignant airway stenosis (MAS) is caused by primary or metastatic tumors in the lungs. Patients often experience breathing difficulties or even suffocation due to airway obstruction. According to the “2020 Global Cancer Statistics Report”, there are about 250,000 new MAS patients in my country each year. Traditional surgical procedures have limited applicability for advanced or complex cases, while interventional therapies such as thermal ablation are prone to complications such as airway perforation and tissue hyperplasia.
The new system of cryofocus Bio uses liquid nitrogen to rapidly freeze and ablate tumor tissue, which can not only kill diseased cells but also preserve the integrity of the airway structure. Its balloon design can cover multiple lesions at one time. Compared with traditional metal probes, the ablation efficiency is increased by about 30%, the risk of perforation is significantly reduced, and the incidence of postoperative restenosis is reduced.

Technological breakthrough: Liquid nitrogen + flexible balloon joint innovation
The system innovatively integrates liquid nitrogen high-efficiency freezing and flexible balloon catheter technology:

Depth controllable: The freezing penetration depth reaches the entire layer of the airway wall and the surrounding abnormal tissue to ensure the thoroughness of ablation;

Flexible adaptation: Provides a variety of balloon specifications to adapt to different stenosis sites and depths;

Efficient operation: The range of a single ablation is expanded, and the operation time is shortened by about 40%.
At present, the system has been included in the clinical treatment pathways of many domestic tertiary hospitals and has been recommended by experts at academic conferences.

Laying out the respiratory track and expanding multi-indication applications
Cryofocus Bio has been deeply engaged in the field of respiratory interventional cryotherapy since 2018. In addition to the malignant stenosis product approved this time, its products for indications such as benign airway stenosis, chronic obstructive pulmonary disease (COPD), and asthma have entered the registration clinical trial stage. Among them, COPD cryospray and peripulmonary nodule balloon cryosurgery projects were selected as major national science and technology projects. The latter combines bronchoscopic navigation and robotic technology to accurately treat small lung nodules.

In the future, the company plans to achieve multi-indication compatibility (such as asthma, lung nodules, etc.) on the same device platform, and accelerate the global layout of products through cooperation with companies such as Boston Scientific. The approval of the malignant stenosis product this time has laid the foundation for the subsequent commercialization of the pipeline.