Inno Medical Announces Inno-Xmart, China's First NMPA-Approved Nitinol Braided Venous Stent System, in IPO Prospectus

Recently, Innomed's Inno-Xmart venous stent system was approved for marketing through the National Medical Products Administration’s special approval channel for innovative medical devices. It is used to treat non-thrombotic iliac vein compression syndrome and post-thrombotic syndrome, becoming...China's First Approved Braided Venous Stent。

The Inno-Xmart venous stent system consists of a self-expanding nitinol braided stent and a delivery system.The stent is seamlessly woven from 12 nickel-titanium alloy wires., which automatically expands and adheres to the blood vessel wall after being implanted in the human body, featuring excellent flexibility and radial support;The delivery system has a self-compensation function., overcomes the issue of uneven release caused by the shortening of braided stents, ensuring precise stent deployment in shape and position.Retrievable Stent, improve the safety of stent implantation. Meanwhile, the system hasThree Types of Stent DesignsTo meet different clinical needs.

Inno-Xmart Venous Stent System, independently developed by Innomed, possesses full independent intellectual property rights and has obtained multiple invention patents. The product underwent extensive multi-center clinical trial research across China, enrolling 193 subjects with iliac vein compression syndrome and post-thrombotic syndrome.The target lesion patency rate of patients one year after stent implantation reached 96.07%., with clinical performance superior to imported brands, and its safety and effectiveness have been fully validated.

The underlying logic behind the rapid approval and certification of supporting devices through the "green channel" of the drug administration is the enormous clinical demand and innovative product design.

Iliac Vein Compression Syndrome is a common peripheral venous disease in clinical practice, characterized by impaired venous return in the lower limbs and pelvic region. If not treated promptly, it can lead to venous valve insufficiency in the lower limbs, varicose veins, and even deep vein thrombosis, endangering the patient's life. Due to the anatomical features of the human body, the left common iliac vein is located behind the lumbar vertebrae and in front of the right iliac artery, making the iliac vein susceptible to "front and back compression" and repeated pressure stimulation. According to statistics from Frost & Sullivan, the number of iliac vein compression syndrome cases in China was 700,000 in 2019, and is expected to reach 2 million by 2030.

For iliac vein compression syndrome, the main treatment methods include conservative treatment, medication treatment, and surgical treatment. Patients with obvious symptoms such as lower limb swelling, severe iliac vein compression, or the formation of deep vein thrombosis require surgical treatment.

Due to its minimally invasive nature, safety, and high efficiency, as well as high long-term vessel patency and low re-obstruction rates, iliac vein stent intervention has become the primary treatment."Interpretation of Guidelines and Consensus on Lower Extremity Venous Obstructive Diseases" points out that patients with iliac vein compression exceeding 50% are recommended for stent implantation.But currently, the venous stent market in China is still dominated by imports, and the surgical penetration rate needs to be improved.

Clinical iliac vein compression syndrome stent intervention treatment mainly faces two major problems - the first is the lack of dedicated venous stents,Arterial stents are often used off-label for iliac vein treatment., but due to the anatomical differences between arteries and veins and the different pathological mechanisms causing vascular stenosis, the venous vessels have a larger diameter and a higher degree of iliac vein curvature. The arterial stent has insufficient radial force and conformability, leading to poor treatment outcomes; the second isThere are few varieties of imported venous stents specifically designed for use, and they are not suitable for the anatomical structure of the Chinese patient population., and because the iliocaval compression syndrome has a long course and low mortality rate, patients are not highly proactive in seeking treatment.

For millions of patients in China, it is crucial to develop dedicated domestically-produced venous stents. The technological barriers for venous stents are relatively high, as they must provide sufficient support and long-term anchoring without displacement while maintaining flexibility for precise deployment. Moreover, since venous diseases often occur at the grassroots level, an ideal venous stent should also be easy to operate and cost-effective.

The venous stent products currently on the market in China are all manufactured through laser cutting. These stents have high stress concentration at the cross-linked struts, which compromises their durability and poses a risk of displacement during use. While braided stents can avoid the risk of fracture, they have previously faced issues such as shortening during deployment. Additionally, the surface treatment process for braided stents is complex, resulting in a high threshold for research and development.

Innomed's founder Gong Xiaoyan mentioned: "Based on our surveys and interviews with clinical experts both in China and abroad, braided stents are superior to laser-cut stents for the treatment of iliac vascular lesions in the human body." It is through insights into clinical needs and an examination of technical pathways that Innomed has chosen to take on the challenge, developing braided venous stents.

Behind the first domestically-produced braided venous stent is a 10-year marathon run by Innomed's founder, Gong Xiaoyan, and his team.

As early as 2001, Gong Xiaoyan had already focused on the durability issues of peripheral vascular stents within the body. Instances of stent fractures inside the human body occurred from time to time, not only affecting treatment outcomes but also potentially causing complications such as thrombosis. He initiated and led an industry standard-setting group for the evaluation of peripheral stent durability and participated in publishing research findings on the fatigue of nickel-titanium alloys. During his tenure as Chief Engineer at Johnson & Johnson in the United States, he was involved in the entire process from R&D to commercialization of all Johnson & Johnson's medical implants primarily made of nickel-titanium alloys, accumulating extensive experience in R&D technology and product transformation.

In the early stages of research and work, solving the problem of peripheral stent fractures had always been Gong Xiaoyan's belief. Since the establishment of Innomed in 2013, his belief became the driving force for the team, and Gong Xiaoyan led the team forward.Build an Anti-Fatigue Peripheral Stent PlatformIn 2016, Innomed officially began its research on venous stents. By that time, the company's braided arterial stent, Inno-Spring, had completed its design finalization and won the German Red Dot Design Award, which greatly encouraged the team.

Gong Xiaoyan recalled that in the early stage of research and development, the team focused on solving three problems: 1. The balance between support force and compliance, or "both soft and hard" in layman's terms; 2. Stent displacement; 3. Inaccurate positioning.

Inno-Xmart Venous Stent AdoptedSeamless Braiding of Nickel-Titanium Alloy Wire, which can self-expand after release and has sufficient radial support to prevent migration. The stent also exhibits excellent flexibility, resistance to flat plate compression, and fatigue resistance. It has passed accelerated fatigue tests of 10 million cycles involving bending, flat plate compression, and torsion without fracture, as well as radial fatigue tests of 380 million cycles without fracture. Additionally, the stent tip features various designs to accommodate the anatomical structure of the human iliac region.

The delivery system has a self-compensation mechanism., solving the problem of braided stent shortening, ensuring accurate positioning, while the venous stent system adoptedRecyclable DesignBefore the stent is completely detached from the delivery system, it can be recaptured and redeployed, facilitating the doctor's repositioning to address emergencies during the delivery process and enhancing the safety of device operation.

At the same time, during the early development process, Innomed maintained close contact with well-known interventional experts both domestically and internationally, continuously absorbing feedback from clinical practice to quickly adjust product design. Based on this, after the company's products were approved, they also had a solid clinical foundation.

Innomed's Inno-Xmart Venous Stent System has launched registration clinical trials in 18 hospitals across China, led by Director Zhang Xiaoming from Peking University People's Hospital. The research protocol was rigorously designed to screen patients with iliac vein compression syndrome and post-thrombotic syndrome, ensuring the safety and efficacy of the iliac vein stent product in addressing iliofemoral venous obstruction. The results show,Inno-Xmart implant surgery success rate is 100%, with a target lesion patency rate of 96.07% one year post-surgery and a two-year follow-up patency rate of 95.42%.

Dr. Mahmood Razavi, a world-renowned interventional therapy expert from St. Joseph's Hospital in the United States, commented: "The new design of the Inno-Xmart nitinol braided stent offers an improved clinical handling interface. This product is highly suitable for maintaining lumen patency under external mechanical compression while retaining flexibility."

In recent years, the discipline construction of vascular surgery in China has accelerated, with increased patient awareness, enhanced talent training, and improved clinical guidelines, creating a favorable development environment for venous stent products. After obtaining certification, Inno-Xmart's venous stent will officially embark on the path to mass production and marketization, while the Innomed medical team has long been "ready and waiting."

Innomed has a professional production center that integrates a Class 10,000 cleanroom, R&D, and office facilities, with an area of over 10,000 square meters, and has passed the BSI ISO13485 quality management system certification. After completing clinical trials, the company has been preparing for mass production, rapidly expanding its production team and improving its production process capabilities. Currently...A new production base is under construction, which is expected to meet the rapidly growing market demand after completion.。

Gong Xiaoyan mentioned: "The key challenges in the production of braided stents lie in surface treatment and heat setting. After the stent is made, it needs to maintain its shape. If the setting is not done well, it may not reach the required dimensions. At the same time, product quality control is also crucial." Currently, Innomed has mastered the core production technology and established a strict production management process within the company.

At the market level, in addition to building its own sales team, Innomed is also expanding cooperation with high-quality agents across China to establish a comprehensive channel network.

Apart from the domestic market,Innomed has established contact with some overseas customers and is currently producing orders for venous stents to be shipped abroad.. Meanwhile,The company will accelerate the preparation for Inno-Xmart's CE certification.Innomed's arterial stent Inno-Spring has been rapidly promoted overseas after obtaining CE certification, and has entered over 20 countries this year, establishing a strong brand image and channel foundation, laying the groundwork for the future promotion of venous stents.

Innomed is committed to building a complete solution in the peripheral intervention field. The approval of the Inno-Xmart venous stent system this time has become an important part of the company's solution implementation, and it is also the smooth implementation of the company's first high-risk implantable medical device. In addition to venous stent products,Innomed's Inno-Spring arterial stent is preparing for NMPA registration, and its guidewire products have entered multiple top-tier hospitals in China. Meanwhile, the company is developing innovative products such as a thrombus aspiration system.。

In addition, Innomed is also collaborating with seasoned industry experts to focus on developing minimally invasive and interventional treatment products for heart valves.Currently, the company's mitral valve repair product and tricuspid valve repair product are both in the animal testing phase. It is expected that the former will enter human clinical trials by next year.。

In the future, Innomed will continue to develop more innovative products based on clinical needs and technical platforms. The company's second-generation venous stent is currently under development, while also advancing the efficient clinical trials, approvals, and promotion of existing products. Starting this year, the company will vigorously promote the marketization of the Inno-Xmart product line, while continuously optimizing product design based on clinical feedback.

Upon the approval of the Inno-Xmart venous stent system, Gong Xiaoyan wrote, "A decade of building an intravascular fatigue-resistant stent platform, realizing a belief held for over 20 years." Step by step, Innomed Medical will bring more groundbreaking products driven by belief and advanced technology platforms, ultimately benefiting a wide range of patients.

Innomed, established in 2013 and led by Dr. Gong Xiaoyan, an expert introduced through the National Key Entrepreneurial Talent Program and an academician of the Russian Academy of Natural Sciences, is a high-tech enterprise integrating the innovation, research and development, production, and sales of medical device products. It is dedicated to providing innovative quality solutions for intravascular implantation and interventional products. In 2017, Innomed was recognized as a National High-Tech Enterprise, and in 2019, it was named one of the top ten medical device solution providers in the Asia-Pacific region by Outlook Medtech.

Currently, Innomed has established a presence in three key segments: peripheral vascular, cardiac valves, and high-value consumables primarily focused on guidewires. In the peripheral vascular segment, Innomed offers products such as iliac vein stents, femoral-popliteal artery stents, covered stents, and thrombectomy systems. In the cardiac valve segment, it provides mitral valve repair and tricuspid valve repair solutions. In the guidewire segment, multiple products like angiographic guidewires and guiding guidewires have been launched, with more innovative guidewires under development. Additionally, several of the company’s products have received U.S. FDA 510(k) clearance and EU CE certification, and are exported to over 20 countries worldwide.