Source:Medical Device Business Review

Author: Jiang Lecture

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Recently (June 12), the National Medical Products Administration (NMPA) announced the official approval ofHangzhou Noya Medtech Co., Ltd.'s innovative product registration application for the "Single-Use Radiofrequency Atrial Septal Puncture Needle."

According to the introduction on the official website of the National Medical Products Administration, "Noya's Disposable Radiofrequency Transseptal Puncture Needle" uses radiofrequency energy for puncture, requiring less mechanical force and offering more controllable puncture processes. By performing a transseptal puncture from the right atrium to the left atrium and establishing a passage between them, it assists subsequent interventional treatment devices in smoothly entering the left atrium, benefiting patients who are planned to undergo...Patients undergoing interventional cardiology treatment via transseptal puncture access, providing a brand-new treatment option.

With the rapid development of electrophysiological ablation procedures and structural heart surgeries, the number of surgeries performed via the femoral vein to the left atrium is increasing.Atrial Septal PunctureIt is one of the most commonly used techniques for left atrial interventional treatment and is widely applied inCatheter Ablation, Left Atrial Appendage Closure, Various Mitral Valve Surgeriesetc., can be said to be "the first door to open in left-heart interventional surgery."

However, traditional atrial septal puncture usesMechanical Puncture, ExistDifficult puncture, inaccurate puncture positioningThe difficulty, and may even cause serious complications (such as cardiac tamponade, heart rupture) due to misplaced puncture and force issues. Traditional mechanical puncture has extremely high requirements for surgeons, with a long learning curve, difficulty in accurately predicting the puncture point, and a relatively time-consuming puncture process, which largely restricts the development of some left-heart interventional surgeries.

Based on the significant pain points in clinical applications, a technological revolution for atrial septal puncture procedures that is "precise, safe, and less difficult" is imperative.

In this regard, the novel energy puncture method developed by Noya Medtech has demonstrated outstanding innovation capabilities. The "Single-Use Radiofrequency Atrial Septal Puncture Needle" consists of a catheter with a radiofrequency puncture electrode tip connected to a control handle. It is used via the femoral vein approach in conjunction with the radiofrequency generator and steerable sheath produced by the company.Short and highly focused RF energy for reliable, controllable, and convenient puncture.，Greatly improve the success rate and safety of atrial septal puncture surgery.

Compared with traditional mechanical atrial septal puncture products, Noya Medtech's radiofrequency atrial septal puncture needle adoptsRadiofrequency Energy Puncture, requiring less mechanical force. Under interventional surgical conditions, the puncture electrode is delivered to the patient's atrial septum, maintaining a basically vertical position with the atrial septum. Then, by delivering radiofrequency energy and a certain amount of thrust, it can quickly pass through the atrial septum to achieve the purpose of establishing left heart access.

The distal end is made of flexible material that can be bent, and when used in conjunction with other adjustable instruments, it allows for precise angle adjustments to reach the target tissue.Avoid causing harm to non-target tissues, the operator does not need to use a sharp mechanical needle to cross the atrial septum,Reduce the difficulty and complication rate of atrial septal puncture, and shorten the learning curve.

In product design, the fluid channel outlet is closer to the electrode head, allowing for more precise and safer punctures.The handle is equipped with an energy control switch., with a shorter response time than the foot pedal switch, improving the success rate and safety of transseptal puncture procedures.

In the field of left atrial interventional treatment, Noya Medtech, with its forward-looking vision and outstanding technical capabilities, has successfully applied radiofrequency energy puncture technology in clinical practice. Guided by the clinical need for precise atrial septal puncture, it has boldly ventured into the innovative field of new radiofrequency energy puncture. Particularly in addressing some clinical challenges such asComplex Atrial Septal Puncture: Neoplastic Lesion Atrial Septum (Thin, Elastic) and Fibrotic Atrial Septum (Thickened), which can improve the success rate of puncture and shorten the operation time of interatrial septal puncture, bringing a revolutionary breakthrough to the establishment of the left heart interventional treatment field.

Currently, Noya Medtech has launched a multicenter prospective clinical trial across China for its radiofrequency atrial septal puncture technology and has safely completed multiple complex atrial septal or trans-septal puncture procedures with specific requirements. These successful cases provide strong evidence of the capability of radiofrequency energy puncture technology to break through the traditional禁区 of establishing left heart access, adding another powerful tool to cardiovascular interventional therapy.

It is worth mentioning that, in July 2022, the First Clinical Research Center of Jiangsu Province successfully enrolled the first patient in collaboration with the First People's Hospital of Ningbo. This clinical study is chaired by Professor Kong Xiangqing, a renowned cardiac expert in China, as the Chairman of the Steering Committee.The first case of atrial septal puncture using Noya Medtech's radiofrequency atrial septal puncture system has been performed.This innovative surgery not only highlights the significant potential of radiofrequency atrial septal puncture technology in the field of interventional cardiology but also brings a new treatment option for patients with complex atrial septal conditions.

In the field of medical devices, Noya Medtech's radiofrequency atrial septal puncture technology has gained recognition for its outstanding performance and innovation.Recognition from Multiple Clinical Treatments in China, and has made significant breakthroughs in establishing clinical treatments for left-heart access, filling a gap in this field in China. Behind this achievement lies years of research and development groundwork by this company.

Noya was incubated and established by Denovo Medtech in 2017, an innovative medical enterprise dedicated to the research, development, manufacturing, and commercialization of heart failure treatment products.

Although Noya is relatively young, with its reliance onTop Resources of Noya Medtech, its management and R&D team has long been deeply engaged in the cardiovascular field for many years, gathering numerous high-level talents with doctoral and master's degrees in project R&D production, clinical quality registration, and market sales both in China and internationally.

It is precisely because of such a strong team that Noya has adhered to the strategy of independent product research and development since its establishment, successfully transforming its proprietary intellectual property into a competitive edge in the market. Its products, characterized by high levels of specialization, refinement, uniqueness, and innovation, demonstrate significant market advantages. Continuously launching cutting-edge interventional medical devices and technologies in the cardiovascular field, it has won numerous accolades."Outstanding Enterprise Award of China Innovation and Entrepreneurship Competition"。

Currently, Noya MedtechApplied for 83 patents, with 17 patents authorized cumulatively.Among them, a number of patents are aimed at the European and American international markets. At the same time, product certification is being actively initiated, building a solid patent moat for the market competition of innovative products such as radiofrequency atrial septal occluders.

From the currently approved situation, Noya's radiofrequency technology mainly focuses on the left heart interventional field. However, Noya, with its strong technical research and development capabilities, does not stop there. The recently approved "Disposable Radiofrequency Atrial Septal Puncture Needle" is just a microcosm of Noya's independent research and development. Prior to this, Noya had already obtained several "first certifications" in the cardiovascular field with its core technology.

Noya Medtech Launches the First Domestically Produced, Self-DevelopedAThrough™ RF Transseptal Puncture System, and clinical enrollment began in July 2022. At this time, there were no products of this type in clinical use in China, and this field was still a blank space. Noya Medtech's RF atrial septal puncture system officially ushers in a new era of clinical application for atrial septal puncture using RF energy.

Noya Medtech Co., Ltd.自主研发的Noya RF Atrial Shunt System, isThe World's First Atrial Shunt Product Using Radiofrequency Energy and Without Implants, which ensures no implants are left in the patient’s body, fundamentally avoiding issues such as device displacement and thrombosis. It also provides patients with the opportunity for future surgeries via the trans-septal route, filling the gap in heart failure treatment, especially for Heart Failure with Preserved Ejection Fraction (HFpEF), and ushers in a new era of atrial shunt catheter therapy that is implant-free and allows for adjustable diameter.

As a technology-oriented enterprise, Noya Medtech focuses more on the prospects of the field and the innovation of technology. In terms of future planning, Noya Medtech has set clear goals for both its technical roadmap and commercialization.

TechnicallyAt present, Noya's interventional cardiology field is still in its initial stage, with significant room for future development. Noya Medtech aims to optimize its technology and gradually establish it as the industry gold standard, which will be a long-term process. Throughout this journey, Noya Medtech will develop new technologies, aspiring to secure a leading position in the market through technological superiority.

In terms of commercializationIn addition to developing multiple high-precision technology products, Noya Medtech is also paving its own path toward industrialization by transforming medical engineering into a well-functioning mechanism. A mature medical-engineering transformation mechanism establishes a rational system that creates a win-win situation for both doctors and enterprises.

Taking Noya Medtech's NoYA™ Adjustable Atrial Shunt System as an example, it was designed and developed by Noya Medtech's engineering team in collaboration with multiple doctors from within and outside China.The combination of powerful strategies has made NoYA™ a milestone product in China's interventional cardiology treatment.Through continuous global collaborative innovation, China's medical innovation has been steadily advancing on the fast track of development, continuously enhancing the international discourse power and scientific research leadership of Chinese enterprises in the field of high-end medical devices.

The launch of the "Single-Use Radiofrequency Atrial Septal Puncture Needle" has once again provided a significant boost to Noya's commercialization process. It not only demonstrates the strong innovative capabilities of domestically produced enterprises but also further indicates that interventional treatment for structural heart disease is moving towards a new phase of high-end, refined procedures. The next blue ocean is emerging.

Atrial septal puncture, as a key technology, is closely connected with the cardiac electrophysiology, left atrial appendage closure, and mitral valve intervention markets.

According to Frost & Sullivan data, with the aggravation of population aging and the continuous increase in the number of patients, the volume of cardiac electrophysiology procedures in China is expected to achieve sustained growth. It is projected that by 2025, the number of cardiac electrophysiology procedures in China will reach 574,600 cases. Meanwhile, with the gradual promotion and application of emerging ablation technologies in clinical practice, the volumes of left atrial appendage closure procedures and various mitral valve interventional surgeries are also growing rapidly.

Overall, currentlyThe annual demand for atrial septal puncture has exceeded 200,000 procedures., there is a huge clinical treatment demand in China, with broad prospects.

However, as high-end medical equipment, the cardiac interventional device industry has certain technical and R&D barriers. At present, there are relatively few manufacturers developing RF transseptal puncture technology, and China's RF transseptal puncture device market is mainly dominated byMedtronic, Boston ScientificTwo Major Giants Dominate.

But with the increasing drawbacks of traditional mechanical puncture and the gradual growth of the atrial septal puncture market in China, a number of representative innovative medical device manufacturers have emerged in China, such as Noya.Self-developed Chinese Enterprises, and is continuously achieving technological breakthroughs and accelerating the product layout for domestic substitution.

In April this year, the RF-Lance® Radiofrequency Puncture Generator, independently developed by Shanghai Shape Memory Alloy Material Co., Ltd. (a wholly-owned subsidiary of Shanghai MicroPort EP MedTech Co., Ltd.), received registration approval from the National Medical Products Administration (NMPA) (Registration No.: 20243010854).

The significant advantage of this innovative instrument lies in its use of blunt electrodes to deliver brief and highly focused radiofrequency energy pulses, employing radiofrequency energy at the predetermined atrial septal puncture site to complete the atrial septal puncture procedure. This not only increases the success rate of the puncture, shortens operation time, but also enables more precise confirmation of the tip position while avoiding unnecessary tissue damage.

Huiyang Medical Technology is a company mainly engaged in research and experimental development. Huiyang focuses on the research, development, and industrialization of left atrial appendage occluders, catheters, and sheaths used in cardiac interventional surgeries.

According to the "Public Announcement of Special Review Results for Innovative Medical Devices" released by the Center for Medical Device Evaluation of the National Medical Products Administration on May 29, 2024, Huiyang Medical's radiofrequency atrial septal puncture device has entered the special review process, but relevant product information has not yet been disclosed.

At present, the momentum of Chinese-produced innovations is closely catching up. Compared with Medtronic and Boston Scientific, who have expanded their product lines by acquiring radiofrequency transseptal puncture technologies, the innovative forces of Chinese production have achieved this through...Self-developed technology breaks through, showing more advantages in occupying the market.

In addition to technological breakthroughs, domestically produced RF transseptal puncture products need to capture the market.Commercialization is also a major test.After all, only by transforming technological achievements into actual sales in the market can enterprises continuously invest in research and development, forming a virtuous cycle.

Taking Noya Medtech as an example, since launching the radiofrequency atrial septal puncture system in 2022, it has collaborated with multiple hospitals across China, conducting numerous medical clinical trials. Through the integration of medical and engineering approaches, it has brought benefits to both hospitals and enterprises, achieving mutual success.

Besides, the rapid advancement of domestically produced innovations in technology has also made its mark inUnder the东风of centralized procurement, a new phase of commercial development has been ushered in.

Given the increasingly severe trend of population aging in China, the number of patients with cardiovascular diseases as the main category is rising year by year, becoming an important driving force for the development of China's interventional electrophysiology sector. The cardiac interventional electrophysiology field that Noya Medtech has set its sights on is a breakthrough point under the centralized procurement policy.

According to the results announced in the previous electrophysiology procurement led by Fujian,The Maximum Reported Price for Adjustable Bend Atrial Septal Puncture Sheath is 9500 YuanThe policy of centralized procurement for cardiac interventional electrophysiology is milder than expected, reflecting the policy's support for R&D investment by companies in China.

Considering the superiority of radiofrequency atrial septal puncture, the terminal price of Noya Medtech's radiofrequency atrial septal puncture needle is expected to exceed 10,000 yuan after its market launch. In 2016, the number of atrial fibrillation radiofrequency ablation procedures in China was 30,600; by 2021, this figure had rapidly increased to 99,600, with an annual compound growth rate of 26.6%. By estimating the demand for atrial septal puncture in electrophysiological, left atrial appendage occlusion, and mitral valve treatment procedures,The market space for atrial septal puncture is nearly 10 billion yuan.

It is not difficult to see that high-quality and cost-effective products will become a new fertile ground in the interventional consumables market under the centralized procurement of high-value consumables. Amid the wave of centralized procurement, some pessimistically predict a significant drop in prices and a sharp decline in corporate profits. However, others astutely recognize the potential for a leap in market share and influence. Noya Medtech is one of the outstanding representatives of the latter.

In fact, centralized procurement is expected to drive the penetration rate of downstream interventional electrophysiology procedures, helping more domestically produced products achieve price reductions through increased volume.

On the other hand, centralized procurement may accelerate the reshuffling of the industry: some companies focusing on generic consumables with strong substitutability might be eliminated, while others that can continue to advance technology and revolutionize the industry will have the opportunity to seize a larger "share of the pie."

Against this backdrop, the continuous innovation of products becomes even more important, especially in an environment that strongly supports domestically produced goods.Whoever can achieve a breakthrough first will reap the most substantial rewards.In view of the current domestic market environment in China that prioritizes domestically produced products, as long as domestic companies develop products with high clinical applicability, their market share and commercialization process will undoubtedly grow rapidly with the support of favorable policies.

All views in this article do not constitute investment advice.Medical Device ManufacturerThe industry review remains neutral on all viewpoints in the article and is solely for sharing and exchange.