In 2024 and 2025Q1, the Company's business has achieved various progress, including but not limited to:
- The Company passed the good manufacturing practice examination for its Atrial Fibrillation Cryoablation System (“AF Cryoablation System”) in January 2024;
- The Company received marketing approval for the Cryoadhesion System in January 2024, after securing the NMPA approval for the accompanying cryotherapy equipment in December 2023 and the disposable cryoprobe in January 2024;
- The Benign Stenosis Cryoablation System entered into the confirmatory clinical trial phase in January 2024;
- The Company has submitted the registration application for its Anti-Gastroesophageal Reflux System in May 2024;
- The Company entered into a distribution agreement with BSC International Medical Trading (Shanghai) Co., Ltd. in respect of respiratory intervention products in mainland China in July 2024;
- In October2024, the Company announced it entered into a scientific research collaboration agreement with the Guangzhou National Laboratory and the First Affiliated Hospital of Guangzhou Medical University. The Company will jointly participate in and complete the research and development of the liquid nitrogen ultra-low temperature cryoablation system and the research on cryoballoon ablation for lung cancer;
- The Company received the NMPA approval for its Malignant Stenosis Cryoablation System, System, which is one of the Group’s respiratory intervention products, in March 2025.
Continuous increase in value of comprehensive product portfolio
In 2024, Cryofocus Medtech’s revenue has maintained a strong growth trend within the interventional cryotherapy industry. The total revenue of Cryofocus Medtech increased by 30.7% YoY to RMB53.5 million for the year ended December 31, 2024.
Cryofocus Medtech is an innovative medical device company in China with a main focus on the field of minimally-invasive interventional cryotherapy. The Company uses liquid nitrogen as the main cryogenic source for cryotherapy systems by leveraging its unique liquid nitrogen cryoablation technology and advanced flexible catheter technology. Since its inception in 2013, Cryofocus Medtech has developed a comprehensive product portfolio mainly focusing on two therapeutic areas: 1) vascular interventional therapy for the treatment of atrial fibrillation, hypertension and other cardiovascular diseases; and 2) natural orifice transluminal endoscopic surgery, or NOTES, for the treatment of urinary, respiratory, and digestive diseases. The Company’s competitive advantage, technologies and product pipeline have helped establishing high entry barriers difficult for its competitors to surpass.
Cryofocus Medtech has developed a comprehensive product portfolio including 14 cryotherapy products and product candidates with a main focus on vascular intervention and NOTES, as well as 9 additional non-cryotherapy products and product candidates. The Company has commercialized ten products as of 31 March 2025.
Significant progress in business development driven by continued R&D innovation
During 2024, Cryofocus Medtech has made significant progress in the development of product candidates. The Company received marketing approval for the Cryoadhesion System in January 2024, after securing the NMPA approval for the accompanying cryotherapy equipment in December 2023 and the disposable cryoprobe in January 2024. On the same month, the Benign Stenosis Cryoablation System entered into the confirmatory clinical trial phase while the Company passed the good manufacturing practice (GMP) examination for its AF Cryoablation System, which has also been commercialized in China in September 2024. Moreover, the Company has submitted the registration application for its Anti-Gastroesophageal Reflux System in May 2024, and is expected to receive NMPA approval in 1H2025.
In 2024, the Company's total R&D expenditure was approximately RMB 73.46 million, basically remained the same as compared to the same period in 2023, and will continue to promote the commercialization of the Company's products under development.
According to the planning and expected progress of clinical trials of its product candidates, between 2025 and 2027, the Company will submit the product registration submission to the NMPA for 10 product candidates developed in different stages of clinical trials, including Cryo-RDN System, Asthma Cryoablation, COPD Cryospray system, Benign Stenosis Cryoablation System, Peri-Pulmonary Nodule Cryoablation System, Cough Cryospray System, Tuberculosis Cryospray System, Gastric Cryoablation System, Esophageal Cryospray System and Atrial Fibrillation Pulsed Field Ablation System. All of the abovementioned product candidates is expected to obtain commercialization approval from the NMPA in 2026 and 2027, respectively. Against this backdrop, it clearly showed that many of the Company's key product candidates under development will be expected to be commercialized in the next two to three years, continuously expanding Cryofocus Medtech’s revenue streams and providing strong support for its early realization of profitability.
Cryofocus Medtech has established a dedicated product development team led by industry experts with extensive experience in the medical device industry or in the field of engineering research and development. As of December 31, 2024, the Company’s product development team consisted of an in-house research and development team of 70 employees and a clinical operation team of 24 employees. Cryofocus Medtech has also developed relationships with industry leaders, including scientists, physicians and industry practitioners, giving the Company a thorough understanding of the clinical needs and demands of patients and physicians. The Company has built a comprehensive intellectual property portfolio in China and overseas to protect its technologies, including its core liquid nitrogen cryoablation technology, flexible catheter technology and other key technologies. As of December 31, 2024, Cryofocus Medtech owned 159 patents and 70 patent applications in China and overseas, representing an YoY increase of 39 patients and 28 patent applications.
In 2024, the Company manufactured, assembled and tested its products at the production facilities located in two regions, Ningbo, Zhejiang Province and Shanghai, with a total gross floor area of over 17,400 square meters. The Company produces commercial products, mainly including its Core Products as well as other commercialized products, including its Pulmonary Nodule Localization Needle, Laparoscopic Single Port Multi-Channel Access Platform, and also produces, assembles and tests sample products related to NOTES at its production facilities in Ningbo. The Company produces, assembles and tests sample products related to vascular intervention for product development at its facility in Shanghai.
Finally, it is worth noting that in July 2024, the Company entered into a distribution agreement with BSC International Medical Trading (Shanghai) Co., Ltd. (“BSC International “) in respect of respiratory intervention products in mainland China. BSC International is a subsidiary of Boston Scientific Corporation (NYSE stock symbol: BSX) in China. Boston Scientific is a global leader in medical technology, advancing life sciences by providing a broad range of high-performance solutions that address patient needs and reduce the cost of healthcare. Boston Scientific’s portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Pursuant to the Distribution Agreement, Cryofocus Medtech will market, promote and serve as the exclusive distributor of BSC International for products in the respiratory intervention field in mainland China, combining the resources and support of BSC International and Cryofocus Medtech to promote the commercialization of such designated products in mainland China.
Future and Outlook
The mission of Cryofocus Medtech is to become a global medical device platform in the field of minimally-invasive interventional cryotherapy, bringing benefits to patients and physicians worldwide with its cryotherapy technology.
In 2025, in order to achieve this goal, the Company plans to rapidly advance the clinical development and commercialization of its product candidates; further expand the product portfolio leveraging technology platforms and continue to focus on minimally-invasive interventional cryotherapy; continue to research and develop various underlying and supporting technologies; and selectively expand its worldwide footprint.
About Cryofocus Medtech (Shanghai) Co., Ltd. (6922.HK)
Cryofocus Medtech is an innovative medical device company in China with a main focus on the field of minimally-invasive interventional cryotherapy. Since its inception in 2013, the Company has developed a comprehensive product portfolio mainly focusing on two therapeutic areas: vascular interventional therapy and natural orifice transluminal endoscopic surgery, or NOTES. The product pipeline of Cryofocus Medtech includes a variety of cryotherapy systems and surgical consumables, four of which were recognized as "innovative medical devices" by the NMPA or its provincial counterparts, according to Frost & Sullivan.
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