Kangfeng Bio Successfully Develops Two Proprietary Cryoablation Technologies After Six Years of R&D, Breaking Foreign Monopoly

“As a ‘pioneer’ in the research and development of cryogenic technologies in the cardiovascular field, we are optimistic about the application and development of cryoablation technology,” said Di Yuepeng, founder of Cryofocus, with conviction.

Cryoablation is a medical technology that is both ancient and modern, with its origins traceable to the treatment of skin diseases three thousand years ago. With the establishment of modern cryobiomedicine,Cryoablation is defined as a surgical medical technique that applies freezing to eliminate target tissue.In recent years, cryoablation technology has been increasingly applied in clinical cardiovascular procedures due to its superior efficacy compared to traditional thermal ablation techniques and its advantage in reducing patient pain.

CryofocusFocusing on the Development and Application of Minimally Invasive Interventional Cryoablation Technology in Cardiovascular Medicine, committed to becoming a technological leader in cryo-interventional therapy for cardiovascular diseases in China. After six years of research and exploration, the company has overcome the technical bottlenecks of cryotechnology in the cardiovascular field,Filed over 50 patent applications, with some patents granted in European and American countries, and maintains independent intellectual property rights globally.

Cryofocus’s independently developed Cryofocus cryoablation system for treating patients with hypertension that is difficult to control with medication, and its cardiac cryoablation system for treating atrial fibrillation have reached or even surpassed international standards.ThisBoth products have separately passed the Special Review Procedure for Innovative Medical Devices of the National Medical Products Administration.

Atrial fibrillation is the most common paroxysmal arrhythmia. Its prevalence increases with age, reaching up to 10% in individuals aged 75 years and older. As an "epidemic" of population aging, atrial fibrillation elevates the risk of thromboembolism and stroke in patients, resulting in high disability rates.

According to statistics, there are approximately 30 million patients with atrial fibrillation worldwide, a figure projected to reach 70 million by 2060. Over the past decade, the prevalence of atrial fibrillation in China has increased 30-fold, while atrial fibrillation-related stroke has risen 13-fold.

Diao Yuepeng told VCBeat that treatment options for atrial fibrillation include conventional pharmacological therapy, catheter ablation, and surgical intervention. Pharmacological therapy has a low success rate, and long-term medication use is associated with numerous adverse drug reactions. Due to its invasiveness, high perioperative risk, and prolonged postoperative recovery time, surgical intervention is not considered a routine treatment modality.

Catheter ablation is performed via vascular puncture and catheter insertion, offering minimal invasiveness, rapid recovery, low procedural risk, and high success rates; thus, it has become a standard treatment for atrial fibrillation. Multiple domestic and international guidelines provide Class I, Level A recommendations for this procedure.Currently, radiofrequency ablation is the predominant method for catheter ablation of atrial fibrillation., radiofrequency ablation achieves tissue damage by disrupting the integrity of the endothelium and tissue structure through thermal coagulation, yet stillSome deficiencies exist:Low long-term success rate after a single ablation session, with certain risks of perioperative complications; intense pain during the procedure often necessitates analgesic medication; steep learning curve, hindering widespread adoption.

Cryoballoon Ablation: An Innovative Technology in Atrial Fibrillation AblationCryoballoon ablation has emerged as an innovative technology in the field of atrial fibrillation (AF) ablation in recent years. Due to its relatively straightforward procedure, short learning curve, high procedural success rate, and low incidence of serious complications, cryoablation has become one of the standard treatment modalities for atrial fibrillation.As of the end of 2018, more than 400,000 atrial fibrillation ablation procedures using Medtronic’s cryoballoon system had been performed worldwide. In China, since the first cryoablation procedure was conducted in December 2013, the cumulative number of cases has exceeded 20,000.

“Against this market backdrop, Cryofocus placed its R&D focus on cryotechnology from its inception. After six years of research and exploration, it mastered core cryotechnologies in the cardiovascular field and successfully developed two innovative medical devices, earning industry recognition,” Diao Yuepeng told VCBeat.

Cryofocus was established in 2013 and is located in the Times Medical Innovation Park within the Shanghai International Medical Zone. The company’s R&D team is one of its core competitive advantages, comprising more than half of the total workforce. The team includes American cryotherapy experts, returnee scholars, as well as PhDs and postdoctoral researchers from prestigious universities. Most members have previously held positions at renowned medical device companies such as Endocare, Medtronic, Lifetech Scientific, and MicroPort in Shanghai, bringing extensive R&D experience in areas including cryoablation technology, balloon catheter technology, and electrophysiological mapping technology.

“In addition to building a high-caliber R&D team, we alsoEstablished long-term industry-academia-research partnerships with renowned Grade A tertiary hospitals in China.“Diao Yuepeng introduced.

In recent years, Cryofocus has established long-term collaborative partnerships with renowned U.S. universities, as well as with Fudan University, the Shanghai Institute for Biological Sciences of the Chinese Academy of Sciences, Changhai Hospital, Huashan Hospital in Shanghai, Ruijin Hospital in Shanghai, and the PLA General Hospital. The company has also set up R&D centers or laboratories in California (USA), Hongkou District in Shanghai, and the Hangzhou Bay New Zone in Ningbo to further strengthen its research and development capabilities.

Diao Yuepeng introduced that the companyTwo independently developed innovative products are gradually becoming the industry “benchmark” for cryogenic technology in the cardiovascular field in China.They are as follows:Cardiac Cryoablation System for the Treatment of Paroxysmal Atrial Fibrillation; Cryofocus Cryoablation System for the Treatment of Patients with Drug-Resistant Hypertension. In addition, there are more than six ongoing research projects on cryotechnology in the cardiovascular field.

(Image provided by the company)

“High-end medical devices constitute an industry characterized by high technical thresholds, significant technological barriers, and multidisciplinary integration. Due to a relatively late start in this field, the domestic market is predominantly occupied by international giants, who maintain a monopoly on core technologies.”The only way to break through its predicament is independent innovation.“Diao Yuepeng introduced.

Cryoballoon Ablation for Atrial Fibrillation: The international standard utilizes a technology platform with nitrous oxide as the refrigerant. Cryofocus, based on clinical needs,Breaking away from traditional theoretical frameworks, we employ a technology platform that utilizes liquid nitrogen as the refrigerant.

Compared with the nitrous oxide technology platform, the liquid nitrogen technology platform has obvious advantages.First, the cooling source is clean and environmentally friendly; it offers a higher cooling rate, and its cooling capacity is adjustable, thereby reducing complications. Second, the gas source is readily accessible, facilitating the dissemination of the technology to lower-tier healthcare settings and alleviating the financial burden on patients. Studies have demonstrated that the cardiac cryoablation system developed by Cryofocus is non-inferior to comparable international products in terms of safety and efficacy.

Cryofocus, independently developed by Cryofocus Medtech, is the first system worldwide to apply deep cryoablation technology to renal artery sympathetic denervation. Compared with traditional radiofrequency ablation,Cryoablation enables 360-degree circumferential ablation, ensuring more thorough tissue destruction, while offering advantages such as simple operation, short procedure time, and minimal patient pain.Since Academician Ge Junbo of Zhongshan Hospital, Fudan University, performed the world’s first cryoablation-based renal denervation procedure at Zhongshan Hospital in 2015, several years of follow-up have demonstrated the safety and efficacy of this system.

It is precisely through relentless efforts to conquer core technologies and build up proprietary reserves of key technologies that the aforementioned two innovative products have been brought to market. Cryofocus has filed more than 50 patents related to cryoablation technology, including four PCT applications, and has currently been granted five U.S. invention patents. Diao Yuepeng stated,Currently, these two technologies are advancing through clinical trials and are expected to be successfully launched on the market around 2021.

“Refine and strengthen cryoablation technology,Break Monopolies and Replace Imports with More Sophisticated and Reliable Proprietary Technologies"...is our goal and the mission of Cryofocus," said Diao Yuepeng. He added that the company will continue to launch better products to serve patients more effectively. In addition, the company is strengthening its patent applications in Europe and the United States to prepare for future expansion into overseas markets.