Xinmai Medical Submits IPO Prospectus Highlighting Elation® Bronchial Radiofrequency Ablation System – China’s First Domestic System for Severe Asthma

According to statistics, in 2019, China had 45.7 million asthma patients, of which approximately 3.6-10% suffered from severe asthma with poor drug control. However, the bronchial radiofrequency ablation systems currently used in China are entirely imported. Not only do the high medical costs often deter patients, but the design of the ablation catheters and the ablation control procedures also differ in specificity and needs for Chinese patients.

SyMap's Elation® Bronchial Radiofrequency Ablation System adopts an original and patented fine-tuning progressive radiofrequency energy delivery/feedback control strategy, optimizing the fitting of key ablation parameters. It is more suitable for the pulmonary anatomical characteristics of the Chinese population and enhances the smoothness of surgical operations through more effective human-machine interaction. This further improves the safety and effectiveness of the procedure.Meanwhile, the Elation® Bronchial Radiofrequency Ablation System is also the only bronchial ablation product for treating asthma that has entered the National Medical Products Administration's Innovative Medical Device Special Review Procedure ("Green Channel").

On October 31 (Tuesday) at 19:30, the 34th session of VCBeat's "Strict Selection New Product Review" will feature Professor Wang Jie from Jiangsu Provincial People's Hospital, Zhang Jingjing from the Clinical Medical Department and Vice General Manager of SyMap, Zhu Xiaocan, R&D Director of SyMap, and Dai Jing, CFO of SyMap, presenting the Elation® Bronchial Radiofrequency Ablation System.

1、Utilized an original, innovative, and patented fine-tuning progressive radiofrequency energy delivery/feedback control strategy., optimizing the fitting of key ablation parameters such as energy, temperature, impedance, and current change feedback curves, further enhancing the safety and effectiveness of bronchial ablation.

2、Automatic DetectionBasket-shaped 4-electrodeWhether it adheres well, allowing the operator to determine whether effective ablation has been performed, ensuring better human-machine interaction.

3、The diameter of the catheter tip electrode is smaller., which is more suitable for the lung anatomical characteristics of Chinese people. The more reasonable selection and treatment of electrode materials ensure the operability and passability of the electrode, making it easier to reach the lesion on the inner wall of the trachea.

4、Special Treatment and Optimization Design of Basket-shaped Electrode Materials at the Catheter Tip, avoiding the deformation and non-expansion of catheter mesh electrodes that often occur with existing catheters on the market during use.

· High activation success rate, numerous successful activations;

· The unique wall-adhesion sensing and RF feedback mechanism ensures good human-machine interaction, reduces misoperations during surgery, and improves current issues in thermoplasty.

· The catheter tip electrode has a smaller diameter, the catheter material is moderately soft and hard, more in line with the anatomical structure of the Chinese airway, and can ablate to the distal small bronchi.

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Professor Wang Jie

Jiangsu Provincial People's Hospital

Graduated from New York Medical College, with postdoctoral/clinical training at Duke and Harvard University. Served as Assistant Professor and Associate Professor at Columbia University in the United States, Professor at Nanjing University, Dean of Nanjing University Medical School, Director of the Skirball Cardiovascular Research Center in the United States, Executive Vice President and Vice President of Jiangsu Provincial Clinical Medical Research Institute/Jiangsu Provincial People's Hospital, among others. Currently serves as a professor at Jiangsu Provincial Clinical Medical Research Institute/Jiangsu Provincial People's Hospital.

Has published over 200 professional papers, monographs, and abstracts, and owns more than 60 patents. He is an internationally renowned expert in the fields of heart failure and device-based treatment of hypertension. Serves as an editorial board member and reviewer for several authoritative professional journals in the United States, the United Kingdom, and Japan. He has also initiated and participated in more than ten innovative medical device and biopharmaceutical companies.

Zhang Jingjing

SyMap Vice General Manager Clinical Medicine Department

11 years of experience in the management of clinical trials for Class III active medical devices, former head of the "Space Medical" monitoring products for 7 years, responsible for the testing, validation, feedback, evaluation, and refinement of monitoring equipment. Completed clinical trials for two products, élance 5 elite and élance 7 elite (including invasive blood pressure, arrhythmia analysis, ST-segment measurement, and ETCO2 modules), which were approved in 2018.

7 years of ICU work experience, with rich clinical trial management experience, familiar with GCP, GLP operational standards, and the content and processes of clinical trial monitoring.

Dai Jing

CFO of SyMap

Mainly responsible for the company's finance, budget, internal control, and capital operations, etc. Worked at PricewaterhouseCoopers for over a decade as a senior manager in the audit department; served as the Chief Financial Officer and Board Secretary at BGI Med (2170.HK), leading the company’s listing on the Hong Kong Stock Exchange under Chapter 18A.

Zhu Xiaocan

SyMap R&D Director

With 10 years of R&D experience in the medical device industry, served as an R&D engineer and project manager at Elekta, a multinational company, and as the structural lead for new product development projects at Suzhou Jingo Medical. Holds a Bachelor of Engineering from a 985 institution and is a PMP-certified project manager. Has worked at SyMap for over four years, leading the development of the second-generation renal nerve mapping/selective ablation system.

"SyMap" is an internationally leading company dedicated to the research, development, and application of breakthrough innovative minimally invasive interventional technologies for treating major diseases in the cardiovascular and respiratory fields. It has a rich product pipeline at various stages of development: its globally pioneering renal nerve mapping/selective ablation system, SyMap-Cath®/SymPioneer®, designed for treating hypertension, is expected to gain NMPA approval for market entry through the Innovative Medical Device Special Approval Process in 2023; its bronchoscopic radiofrequency ablation system, Elation®, for treating severe asthma, is the only product in this field to have been approved by the NMPA for the Innovative Medical Device Special Approval Process, with expectations to be approved for marketing in 2024; its Precisely Controlled, Hypotonic Solution Assisted RF System ("Zedan" system), the world’s first treatment for early-stage lung cancer via bronchoscopy, has completed the First-in-Human (FIH) clinical study in Australia.

"SyMap" relies on a team of professional talents with internationally advanced levels and collaborates with world-renowned clinical scientists and researchers through disruptive minimally invasive interventional treatment technologies. "Leveraging China to impact the world," it aims to serve global patients with China's original disruptive products and has become an international leader in treating major cardiovascular and respiratory diseases using active minimally invasive interventional methods.

"VCBeat New Product Review," is a live broadcast column under "VCBeat" that supports the release of innovative medical products. The column's mission is: to support every milestone release of medical innovation products.

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