Cryofocus Medtech Obtains NMPA Approval for the AF Cryoablation System

HONG KONG, Dec 12, 2023 - (ACN Newswire) - The innovative medical device company in China with a main focus on the field of minimally-invasive interventional cryotherapy, Cryofocus Medtech (Shanghai) Co., Ltd. (the "Company" or "Cryofocus Medtech", stock code: 6922.HK), on a voluntary basis to announce that the Company has obtained the marketing approval for its self-developed Atrial Fibrillation Cryoablation System ("AF Cryoablation System") from the National Medical Products Administration of the People's Republic of China (the "NMPA").

The AF Cryoablation System of Cryofocus Medtech, consisting of the cryoablation equipment, the balloon cryoablation catheter, the disposable intracardiac mapping catheter and the adjustable curved guide catheter, is the first cardiac product that applies cryoballoon with liquid nitrogen as the refrigerant for the treatment of drug-refractory recurrent symptomatic paroxysmal atrial fibrillation. Using liquid nitrogen as the refrigerant, the target tissue is rapidly cooled down by the ultra-low temperature generated by the liquid nitrogen, and the ablation range can be precisely controlled to achieve the therapeutic effect of necrosis of aberrant myocardial cells, which greatly improves the effectiveness and safety of the product. Unlike traditional point-by-point radiofrequency ablation, cryotherapy technology can realize one-time comprehensive ablation, which is safe, effective, convenient and reproducible. The cryoballoon ablation has become one of the standard methods to realize pulmonary vein isolation.

As the first cryoablation technology platform company in China that uses liquid nitrogen as the main cryogenic source, Cryofocus Medtech has overcome many key difficulties in the clinical application of liquid nitrogen cryogen and developed the original liquid nitrogen cryoablation technology in China, which can efficiently isolate pulmonary veins. Combined with ultra-vacuum heat insulation technology, the freezing medium can be transported to a treatment site under low pressure and the balloon temperature can be accurately controlled and monitored in real time, further improving the safety and effectiveness of the AF Cryoablation System. Meanwhile, in contrast to nitrous oxide (N₂O) as a freezing medium, nitrogen gas is safe, readily available and environmentally friendly, which is better for clinical promotion and application.

The approval of the AF Cryoablation System in China markets marks an important milestone in the business development of Cryofocus Medtech in vascular interventional cryotherapy. It will further enrich the Company's product portfolio, meet diversified market demands, and effectively enhance the Company's core competitiveness. Cryofocus Medtech is a global leader in minimally-invasive interventional cryotherapy, with extensive presence in two fast-growing areas, i.e. vascular Intervention and natural orifice transluminal endoscopic surgery (NOTES). The Company continues to launch multiple innovative cryoablation products to meet the urgent clinical treatment needs in China.

In the first half of 2023, Cryofocus Medtech continues to achieve positive progress in both product pipeline development and business operations. As of June 30, 2023, the Cryo-RDN System, developed by the Company to treat patients with refractory hypertension using an innovative 360-degree cryoballoon ablation technology on a circumferential surface, has also entered clinical trials of registration. The Company expects to obtain approval from the NMPA in the second half of 2025 and the Cryo-RDN System is expected to be the world's first cryoablation product that specifically focuses on the treatment of hypertension. Meanwhile, the Company's Asthma Cryoablation System and COPD Cryospray System entered into the confirmatory clinical trial phase in March 2023. It is expected to submit the product registration submission to the NMPA in the second half of 2025. In addition, as of June 30, 2023, Cryofocus Medtech submitted the registration application for the Cryoadhesion System, and it is expected to obtain approval from the NMPA for the product in the first quarter of 2024.

In the future, Cryofocus Medtech will continue to adhere to independent innovation, continuously promote the clinical development and commercialization of product candidates, further expand the product portfolio, and allow advanced cryoablation technology to benefit a large population of patients.

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. The Company's major product, the AF Cryoablation System, has demonstrated good efficacy and safety profiles in clinical trials.