Xinmai Medical Completes Enrollment in Pivotal Clinical Trial for Elation® Bronchial Radiofrequency Ablation System – China’s Only NMPA Innovation-Designated Device for Severe Asthma

Sep 11, 2023 17:41 CST Updated 17:41

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Recently, SyMap (short for Suzhou SyMap Medical Technology Co., Ltd.) announced the launch of itsThe Registration Clinical Trial of Bronchial Radiofrequency Ablation System for the Treatment of Severe Persistent Asthma (BATA) Successfully Completes Enrollment of All PatientsThis significant milestone brings new hope to asthma patients.

The participating centers in this trial come from 15 hospitals across China and well-known experts in the field of respiratory medicine, with a total of 163 patients enrolled.A prospective, multicenter, randomized, controlled, single-blind (follow-up physician and patient) design was adopted to evaluate the safety and efficacy of the SyMap Elation® Bronchial Radiofrequency Ablation System in patients with severe asthma.This is the only bronchial ablation product for treating asthma that has entered the NMPA Innovative Medical Device Special Review Process ("Green Channel").

New Option for Severe Asthma Patients

More than 300 million people worldwide suffer from asthma, among which approximately 8 to 26.2 million are patients with severe asthma. Although they represent only a small portion of asthma patients, they incur substantial medical costs.The direct cost of a severe asthma attack is 892 euros, while the direct cost of a single severe asthma attack can be up to six times that of a moderate asthma attack, averaging 5260 euros.

Not only are treatment costs high, but the frequency of acute attacks is also much higher for severe asthma patients than for those with mild asthma. More than 60% of severe asthma patients experience over two acute attacks per year.Even under long-term high-dose medication treatment, effective control cannot be achieved.

To address this dilemma, SyMap has actively engaged in the exploration and development of innovative therapies, introducingThe bronchial radiofrequency ablation system with intellectual property protection – Elation® – is the only product in this field to have entered the NMPA Innovative Medical Device Special Review Process (“Green Channel”).The system consists of a bronchial radiofrequency ablation instrument and a disposable bronchial radiofrequency ablation catheter.

Bronchial Radiofrequency Ablation Device

The bronchial radiofrequency ablation instrument delivers controlled radiofrequency energy to the corresponding pathological location of the bronchus through a disposable bronchial radiofrequency ablation catheter.Bronchial Radiofrequency Ablation Device

Disposable Bronchial Radiofrequency Ablation Catheter

SyMap's disposable bronchial radiofrequency ablation catheter not only has temperature detection function but also impedance detection function, which can detect the contact between the electrode and the bronchial wall. After the basket-shaped four electrodes make good contact, the impedance value is displayed on the operation panel of the ablation instrument to monitor whether all four ablation electrodes forming the basket shape have good wall contact.Avoid misoperations where the current ablation system cannot detect electrode contact, leading to failure in discharging for ablation, and prevent damage caused by excessively high ablation temperatures due to poor electrode contact with temperature-sensing thermocouples.The front-end diameter of the ablation electrode has been reduced by 0.05mm to better suit the anatomical structure of the fourth-level bronchi in Chinese patients. The radiofrequency ablation energy output time of the ablation system is 10 seconds: within the first 6-7 seconds of ablation, the tissue temperature reaches 65°C and is maintained at this temperature for 3-4 seconds. If the ablation tissue temperature exceeds 68°C, an over-temperature alarm will be triggered, and the ablation system will automatically interrupt the radiofrequency energy output.

Multiple Products Approved

SyMap Medical Advances Towards IPO

SyMap was founded in 2012.Focusing on the R&D and application of breakthrough innovative minimally invasive interventional technologies for treating major diseases in the cardiovascular and respiratory fields, related to medical device products.。With a rich product pipeline at various stages:The Elation®™ Bronchoscopic Radiofrequency Ablation System for the treatment of severe asthma, which has entered the green channel this time, is the only product in this field approved by the NMPA to enter the special review process for innovative medical devices.Expected to be approved for marketing in 2024;

Its internationally pioneering/global leading renal nerve mapping/selective ablation system SyMapCath®™/SymPioneer®™ for the treatment of hypertension,Expected to be approved for marketing by the NMPA in 2023 through the special approval process for innovative medical devices.

The world's first Precisely Controlled, Hypertonic Solution Assisted RF System ("Zedan" system) for the treatment of early-stage lung cancer via bronchoscopy, developed by SyMap, has completed the First in Human (FIH) clinical trial in Australia.And recently announced the preliminary efficacy and safety results of the "Zedan" system in treating early-stage lung tumors at the 32nd European Respiratory Society (ERS) Annual Congress.

In addition, the companyAs of On July 14, 2023, SyMap underwent IPO coaching and filing, planning to list on the A-share STAR Market.The sponsor institution isChina International Capital Corporation Limited("referred to as 'CICC'").

It is understood that,Currently, the bronchial radiofrequency ablation systems used in China are entirely reliant on foreign imports.The instruments and catheters used are expensive, and the equipment size is not suitable for the Asian population. However, the front-end diameter of SyMap's bronchial ablation electrode is slightly reduced to better fit the anatomical structure of the third- and fourth-level bronchi of the Chinese population.Structure. If successfully launched, it will bring new hope to patients with moderate to severe asthma in China, which is of great clinical and social significance. Medical Device Frontline will continue to follow up.

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