Xinmai Medical's Innovative Renal Denervation System Receives NMPA Approval

Aug 06, 2024 17:51 CST Updated 17:52

SyMap

Innovative Device R&D Manufacturer in Cardiovascular and Respiratory Fields

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Source: Device Home,National Medical Products Administration

Recently, the National Medical Products Administration approved the registration applications of two innovative products from SyMap: the "Renal Artery Radiofrequency Ablation System" and the "Single-Use Renal Artery Radiofrequency Ablation Catheter."

The renal artery radiofrequency ablation system consists of a main unit, a footswitch, a hand controller, a neutral electrode cable, an equipotential balancing wire, and a power cord. The disposable renal artery radiofrequency ablation catheter is composed of an ablation catheter and a connecting cable. The renal artery radiofrequency ablation system delivers radiofrequency energy through a single channel, transmitting it via the catheter electrode to the intima of the renal artery. It utilizes thermal effects generated by the current to deactivate the surrounding sympathetic nerves of the renal artery, interrupting the transmission of sympathetic nerve excitation. Additionally, the catheter electrode can output electrical stimulation signals to map the renal artery, identifying sympathetic nerves through changes in blood pressure to achieve selective ablation. This product is suitable for use in the adjunctive treatment of resistant hypertension and drug-intolerant hypertension, targeting hypertensive patients who have a need to reduce medication dosage.

This product is the world's first renal artery RF ablation device capable of mapping renal nerves. It provides precise ablation locations for renal denervation procedures and offers effective feedback during and after the procedure to evaluate the immediate outcomes of renal denervation, meeting clinical needs in renal nerve ablation.

Co-founded by industry experts

Received investments from multiple venture capital firms

SyMap was founded in 2012.Year,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.Covering major diseases such as hypertension, heart failure, severe asthma, and arrhythmia.Multiple products have been approved by medical regulatory authorities in various countries.

Top Experts United

SyMapProf. Wang Jie, a top expert in the global cardiovascular field, and Jin Kewen, a senior figure in the medical industryCo-founded in Suzhou.

Professor Wang Jie's HistoryServed as Dean of Nanjing University Medical School, Executive Vice Dean of Jiangsu Provincial Clinical Medical Research Institute, Professor of Cardiology at Jiangsu Provincial People's Hospital and Columbia University Medical School, etc., leading multiple related projects, inPublished multiple papers in the field of cardiovascular and respiratory disease treatment, with over 20 years of experience in this field.

Another Co-FounderJin Kewen graduated from Rockefeller University (Molecular Cell Biology) / Columbia University (Finance),Formerly served as China Business Director of Wyeth Pharmaceuticals' Asia-Pacific Division, General Manager of Charles River Laboratories China, and Managing Director of Qiyun Innovation Workshop, successfully undertaking multiple rounds of entrepreneurship.

Received investments from SoftBank and Sequoia

Since its establishment,SyMap Completes Five Rounds of Financing, Accumulating Over 1 Billion Yuan。It has gained the favor of a large number of star capitals. The most recent instance was the E-round financing completed in 2021, securing nearly 100 million US dollars from VMS Group, Primavera Capital, Simiao Capital, Sequoia China, and others.

As of the current investorsIncluding globally renowned capital firms such as SoftBank China Capital, Oriza Ventures, Sequoia China, Jumin Venture Capital, Sumin Capital, PH Capital, Jisu Capital, Zhejiang Merchant Innovation Capital, Primavera Capital, VMS Group, and Simiao Capital, among others.Has already grown intoNew Players in Interventional Treatments in the Cardiovascular and Respiratory Fields.

Focusing on the Field of Radiofrequency Ablation

Multiple Products to Be Launched Soon

After more than 10 years of development, SyMap has builtRenal Denervation System for Mapping/Ablation to Treat HypertensionSyMapCath®/SymPioneer® Product Line, Used for TreatmentTransbronchial Radiofrequency Ablation System for Severe AsthmaElation® Product Line andEarly-stage Lung Cancer, Zedan System via BronchoscopeProduct line. What investors and industry insiders are most concerned about is stillRDN Pipeline。

Renal Artery Denervation

The sympathetic and parasympathetic nerves together form the autonomic nervous system of the human body. Under normal circumstances, these two functionally opposite systems are in a state of mutual balance and restraint. When the body is in a state of intense activity, the sympathetic nerve activity plays a dominant role.

In principle, sympathetic nerve excitement increases cardiac output, constricts blood vessels in the skin and internal organs, resulting in elevated blood pressure.Studies have shown that increased chronic renal sympathetic nerve activity is an important mechanism in the development of essential hypertension. Measurement of renal norepinephrine spillover in patients with essential hypertension has revealed levels 2-3 times higher than those in normotensive individuals. Therefore, inhibiting renal sympathetic nerve activity is an effective approach to treating hypertension.

Renal Artery Sympathetic Radiofrequency Ablation (RDN) as an Innovative Minimally Invasive Therapy for Treating Hypertension,By ablating the sympathetic nerves distributed outside the renal arteries through radiofrequency energy, the signal transmission between the brain and the sympathetic nerves is partially blocked, thereby reducing the overactive excitability of the sympathetic nerves in hypertensive patients.Can achieve long-term blood pressure reduction through a single minimally invasive surgery.

The World's Only Precise RDN Product

Currently, in the market, all RDN-related products that have been launched by various companies belong to the first-generation technology. The catheter enters the body and uses radiofrequency to ablate the renal sympathetic nerves.But the problem is that it is impossible to determine whether the target was hit, with poor accuracy.

The SyMapCath®/SymPioneer® products of SyMap,During the process of renal nerve removal, blood pressure and heart rate are synchronously monitored to map renal nerve function, with ablation performed at hotspots where blood pressure and heart rate increase.Thereby selectively removing renal sympathetic nerves while preserving renal parasympathetic nerves (or "sympathetic inhibitory nerves") and other neural components,This technology enhances the effectiveness and safety of RDN in treating hypertension and is currently the world's only product capable of precisely mapping and locating renal nerve distribution.

Products have been approved for clinical use

It is reported that SyMap's RDN, bronchoscopic radiofrequency ablation system, and bronchoscopic Zedan system have all been approved by relevant medical regulatory authorities to enter the clinical trial stage:

The Renal Denervation Mapping/Ablation System for Hypertension Treatment: SyMapCath®/SymPioneer®,Expected to be approved for marketing by the NMPA in 2023 through the special approval process for innovative medical devices.

Elation® Transbronchial Radiofrequency Ablation System for Treating Severe Asthma,It is the only product in this field to have been approved by the NMPA for entry into the special review process for innovative medical devices., is expected to be approved for marketing in 2024

The World's First Precisely Controlled, Hypertonic Solution Assisted RF System ("Zedan" System) for Treating Early-Stage Lung Cancer via BronchoscopeHas completed the First in Human (FIH) clinical study in Australia.

Due to its technological advantages, SyMap's various product lines have the potential to quickly capture the market and enter the profit stage shortly after receiving approval for listing. So, what kind of market is its main business, RDN?

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