Kangfeng Bio Receives NMPA Approval for World’s First Respiratory Intervention Balloon Cryoablation System

Cryofocus uses liquid nitrogen as the primary cryogen, striving to build a leading minimally invasive interventional cryoablation platform.

As is well known, cancer, cardiovascular and cerebrovascular diseases, chronic respiratory diseases, and metabolic disorders are internationally recognized as the four major chronic diseases threatening human health. While actively expanding its cryotherapy portfolio in oncology and cardiology, Cryofocus has comprehensively and systematically developed a pipeline of interventional pulmonology cryotherapy products to address the substantial clinical demand in China, which includes over 100 million patients with chronic obstructive pulmonary disease (COPD), approximately 50 million asthma patients, and a large population suffering from other respiratory conditions.

The first product in Cryofocus’s series of interventional pulmonology cryotherapy devices, the “Malignant Stenosis Cryoablation System,” has received marketing approval from the National Medical Products Administration (NMPA). Interventional pulmonology has long been a key focus and challenge in medical research. With the annual rise in cancer incidence in China, malignant airway stenosis (MAS) has become one of the important areas of research.

Malignant Stricture Cryoablation System (including "Disposable Airway Cryoablation Catheter" and "Cryotherapy Equipment")

(Catheter Registration Certificate No.: National Medical Device Registration 20253010479; Device Registration Certificate No.: National Medical Device Registration 20253010490)

It is reported that the cryoablation system for malignant strictures, which has recently received market approval, adoptsEco-friendly Liquid Nitrogen as a Cryogenic Source, able toEfficient Cryoablation of Airway Tumor Tissue，Applying cryoballoons of various specifications to ablate a wider airway area effectively reduces the incidence of airway restenosis. The availability of cryoballoons in multiple sizes accommodates tissue ablation needs across varying ranges and depths.

It is worth noting that,This system also holds potential application prospects for immune activation in airway tumors and for early-stage airway tumors.

MAS refers to airway stenosis caused by primary or metastatic lung tumors, leading to cough, hemoptysis, dyspnea, or fatal asphyxiation.

According to the *Global Cancer Statistics 2020* report, it is estimated that there are approximately 250,000 patients with malignant airway stenosis in China each year. In recent years, as the incidence of cancer has increased annually, the mortality rate among patients with airway stenosis has also risen year by year.

Surgical treatment for such conditions primarily includes sleeve resection and bronchial resection with airway reconstruction. However, many patients with malignant airway stenosis (MAS) are not candidates for surgery due to limitations imposed by the lesion site, poor general health status, or metastatic cancer. Consequently, endobronchial interventional recanalization has become the mainstay of treatment for MAS, aiming to improve patients' quality of life.

For interventional respiratory therapy targeting Malignant Airway Stenosis (MAS), in addition to mechanical recanalization, various energy-based ablation techniques can be employed to delay the onset of restenosis. However, thermal ablation is prone to complications such as airway perforation and airway tissue hyperplasia. In contrast, cryoablation not only effectively alleviates cancer-related symptoms but also offers advantages including minimal irritation to the airway mucosa and inhibition of scar and granuloma formation. Therefore, cryoablation represents a safer and more effective therapeutic approach.

Currently, bronchoscopic cryoablation for the treatment of malignant airway stenosis has been included in expert consensus guidelines both domestically and internationally.However, existing metal cryoablation probe products suffer from drawbacks such as low ablation efficiency, shallow ablation depth, and limited ablation range.Balloon cryoablation, as a novel interventional therapy, offers the advantages of high efficiency and favorable safety profile, making it a superior solution for the treatment of airway stenosis.

Cryofocus innovatively employs liquid nitrogen as the cryogenic source, achieving effective tumor cell ablation while preserving the structural integrity of the airway wall, thereby preventing complications such as perforation. Additionally, it offers cryoballoons in various specifications to meet the needs of cryoablation across different tissue ranges and depths, endowing the system with advantages including sufficient ablation depth, extensive coverage, and environmental friendliness.

The malignant stricture cryoablation system approved for the company this time has broken through the bottlenecks of traditional technology with its innovative design, and isThe world’s first balloon cryotherapy product for bronchoscopic interventional treatment of airway stenosis.

Specifically, this system employs liquid nitrogen cryoablation technology via a balloon catheter, enabling efficient and precise inactivation of deep-tissue cells within a short timeframe. This significantly enhances tumor ablation efficiency and reduces the risk of postoperative recurrence. Meanwhile, the large surface area of the cryoballoon allows for simultaneous coverage of multi-regional diseased tissue, effectively reducing the number of freezing points required during surgery and shortening operative time. The penetration depth of the cryoballoon reaches the airway wall and surrounding abnormal tissues, further ensuring the thoroughness and efficacy of the treatment.

The cryoablation system recently approved for market launch, as the first product in Cryofocus’s respiratory disease cryoablation portfolio, has garnered high clinical recognition. Currently, experts across China are frequently presenting research progress and outcomes related to this system at various academic conferences, demonstrating their endorsement. This also marks the initial success of the company’s earlier R&D efforts.

Since 2018, Cryofocus has been strategically positioning itself in the field of interventional pulmonology and has successively initiated R&D programs for multiple cryotherapy indications in respiratory interventions. In addition to its first approved product,Indications such as benign airway stenosis, COPD (chronic obstructive pulmonary disease), and asthmaBoth are currently in the phase of registered clinical trials. At present, the COPD cryospray project and the peripulmonary nodule balloon cryoablation project have both been successfully selected as projects supported by the National Science and Technology Major Project.Peribronchial Nodule Balloon Cryoablation Technology, which can be combined with navigation and respiratory interventional robots for bronchoscopic treatment of peribronchial nodules,This project also receives grant support from the National Respiratory Medicine Laboratory.

Cryofocus has been deeply engaged in the field of interventional cryotherapy for respiratory diseases, not onlyCollaborating with respiratory interventional experts from dozens of key hospitals across China on scientific research, its respiratory layout has also garnered significant attention from the international professional community. Currently,Strategic collaboration with Boston Scientific's Respiratory Interventional business line to shape the future.

With the approval of the malignant stricture cryoablation system and the deepening of its market promotion, multiple future products from Cryofocus—covering indications such as benign airway stenosis, asthma, COPD, and peripulmonary nodules—as well as technologies like cryoballoon and cryospray, can all be applied on the same device platform, namelyMulti-Purpose DeviceThe approval of this cryoablation system for malignant strictures lays a solid foundation for the rapid commercialization of other indications in the future.