Home Chuangxin Medical Builds a Comprehensive Cardiovascular Product Portfolio from Surgical Bioprosthetic Valves to Arch Triple-Branch Stent Systems

Chuangxin Medical Builds a Comprehensive Cardiovascular Product Portfolio from Surgical Bioprosthetic Valves to Arch Triple-Branch Stent Systems

Oct 20, 2022 08:00 CST Updated 08:00

From clinical doctors to international famous brand general agents, and then to independently establishing medical device enterprises, this is the conventional path taken by many doctor entrepreneurs in the medical device industry.


The path taken by Zhao Yimin, the founder of HANGZHOU JIA HE ZHONG BANG BIOTECHNOLOGY CO.,LTD., is this one, with the difference being that,He has chosen the highly challenging field of cardiac and major vascular surgery. Instead of focusing on a single product narrative, he addresses persistent and pressing pain points in cardiac and major vascular clinical practice. He develops a series of products covering congenital heart disease, valvular heart disease, and major vascular diseases. Through a combination of high-end, mid-range, and low-end products, he steadily moves forward while courageously scaling new heights.

 

His original intention of starting a business was very simple — to provide truly effective and practical products for cardiovascular clinical practice, solving clinical problems, meeting doctors' urgent needs, alleviating patients' pain, and creating domestically produced products that lead in this field, achieving a competitive edge over imported similar products.

 

Zhao Yimin mentioned: "The R&D cycle for high-end products is long, and many are developed based on low-end products. A truly committed enterprise needs to achieve self-sustaining growth while breaking through high-end technologies, using low-end products to generate profits, perfect the product portfolio, and support the company's long-term development."

 

Currently, the bypass instruments and surgical biological patch products of HANGZHOU JIA HE ZHONG BANG BIOTECHNOLOGY CO.,LTD. have been approved and listed in multiple provinces and cities across China. The full biological valve has entered the NMPA's innovative medical device green channel, being the only domestically produced surgical biological valve to receive innovative approval; the globally pioneering aortic arch intraoperative and interventional trifurcated stent have both been submitted for type inspection.

 

Layout of congenital heart disease, valvular disease, and large vessel diseases to create a full range of product combinations


In 2008, HANGZHOU JIA HE ZHONG BANG BIOTECHNOLOGY CO.,LTD. was established. After experiencing failure due to raw material supply issues that prevented product realization, the company officially began developing its current series of innovative products in 2014.

 

In recent years, although medical technology has improved rapidly, medical resources are still very tight. The diagnosis and treatment of heart and large blood vessel diseases have long been a difficult problem. China is a major country with congenital heart disease, with 100,000 to 150,000 new patients each year and a total of about 2 million patients. Due to the uneven distribution of medical and patient resources in China, the mortality from congenital heart disease still shows characteristics of younger age groups.


At the same time, there are about 25 million patients with valvular disease in China. In contrast, although the number of patients with large vessel dissection aneurysms is not high, the mortality rate is extremely high, and the annual growth rate continues to be as high as 15%. If patients with aortic dissection are not treated in time, the mortality rate within 48 hours is as high as 50%.

 

Focusing on congenital heart disease, valvular heart disease, and aortic dissection, HANGZHOU JIA HE ZHONG BANG BIOTECHNOLOGY CO.,LTD. has selected products that are urgently needed in clinical practice.The company's development philosophy is to launch one generation, research and develop one generation, and establish one generation, forming a series of product sequences, so that the company's development momentum will become stronger and stronger. "The past seven years have been about laying the foundation."More than 7 years of accumulation has led to the rapid development of multiple original products by the company.

 

HANGZHOU JIA HE ZHONG BANG BIOTECHNOLOGY CO.,LTD.'s surgical biological patch has obtained the Class III certificate from the National Medical Products Administration, boasting excellent anti-calcification properties and a comprehensive patent layout. It has already been listed in multiple provinces and cities across China and is gradually entering several top-tier tertiary hospitals. In the field of congenital heart disease, defect repair mainly involves two approaches: interventional procedures and surgical operations. However, the application scope of occluders used in interventional procedures is limited. For surgical repair materials, there are three main options: polymer materials, autologous pericardium from patients, and biological patches. Overall, biological patches offer superior biocompatibility and treatment outcomes, indicating a large market potential. Currently, HANGZHOU JIA HE ZHONG BANG BIOTECHNOLOGY CO.,LTD. is still expanding the indications for this product.

 

World's First Fully Biological Valve Approved for NMPA Green Channel


In the field of valvular disease, HANGZHOU JIA HE ZHONG BANG BIOTECHNOLOGY CO.,LTD. launched the world's first elastic full bioprosthetic valve, featuring excellent cardiac compliance, anti-thrombosis, anti-bacterial adhesion, and resistance to degeneration.

 

To address the various drawbacks caused by the need for lifelong medication with mechanical valves, bioprosthetic valves have emerged. However, existing bioprosthetic valves also have many shortcomings, such as high stent strength, poor compliance, and uneven stress distribution across different leaflets, leading to premature damage of the leaflets subjected to higher stress and thus shortening the overall lifespan of the bioprosthetic valve. Moreover, most existing surgical bioprosthetic valves are manually sewn by experienced technicians, resulting in inconsistent production efficiency and quality.

 

In response to the technical and production issues of existing bioprosthetic valves, HANGZHOU JIA HE ZHONG BANG BIOTECHNOLOGY CO.,LTD.'s bioprosthetic valve has made four major innovations:1. All valves are made of biological materials to improve biocompatibility; 2. An elastic valve frame is designed so that the stress transmitted to different parts of the valve leaflets during heart contraction and relaxation is more uniform, slowing down the rate of valve degeneration; 3. The positioning and guiding path design of the valve allows technicians to sew standardized products after a short period of training, greatly increasing the yield rate of valve production, approaching that of foreign mature enterprises; 4. A unique anti-calcification treatment process is adopted, significantly enhancing the valve's anti-calcification performance.

 

The length of the valve's lifespan is mainly determined by structural design. In terms of structural design, such as stress distribution of the valve leaflets, height and thickness of the valve frame, and curvature design of the valve, HANGZHOU JIA HE ZHONG BANG BIOTECHNOLOGY CO.,LTD optimized and improved through numerous experiments to eventually achieve the final product.Currently, HANGZHOU JIA HE ZHONG BANG BIOTECHNOLOGY CO.,LTD.'s full bioprosthetic valve has been approved to enter the green channel of the National Medical Products Administration, with over half of the clinical enrollment completed, and is expected to finish clinical enrollment by the end of this year.

 

For patients with valvular heart disease, in addition to products such as full bioprosthetic valves and annuloplasty rings, HANGZHOU JIA HE ZHONG BANG BIOTECHNOLOGY CO.,LTD. is also developing an innovative valve repair device. This device is different from existing products on the market, such as annuloplasty rings and valve clamps. It is easier to operate, significantly reduces the technical requirements for surgeons, and serves as an excellent demonstration for the broader adoption of valve repair procedures in municipal and regional hospitals across China.

 

Pioneering Adaptive Aortic Arch Trifurcated Stent, Meeting Diverse Anatomical Needs


When it comes to fatal cardiovascular diseases, many people first think of myocardial infarction. In fact, there is another cardiovascular disease that is more dangerous with a higher mortality rate, even被称为 “the human body bomb.” It is aortic dissection.


Aortic dissection aneurysm is a large blood vessel disease in the cardiovascular field that is widely recognized for its sudden onset and dangerous condition. According to reports, the detection rate of large vessel dissection aneurysms in people over 50 years old in China is as high as 1%, with an annual incidence rate of 5-10 per 100,000 people, and an annual growth rate of 13-15%. The number of newly diagnosed patients each year ranges from 60,000 to 300,000 cases. In the United States, there are approximately 100,000 to 150,000 annual surgical procedures performed for such dissection aneurysms.

 

For aortic dissections or aortic aneurysms involving the aortic arch, there has been no optimal clinical solution. The existing "total aortic arch replacement + descending aortic elephant trunk stent implantation" procedure is complex, time-consuming, and causes significant trauma to patients. Moreover, given the scarcity of medical resources in China, few hospitals are capable of performing total arch replacement. Aortic diseases often onset rapidly with high mortality rates, and many patients die during the transfer process due to lack of timely treatment.

 

Based on the significant unmet clinical needs, HANGZHOU JIA HE ZHONG BANG BIOTECHNOLOGY CO.,LTD. has pioneered the launch of a globally original product — the Aortic Arch Three-Branch Interventional/Intraoperative Stent. Currently, both products have been submitted for type inspection.

 

HANGZHOU JIA HE ZHONG BANG BIOTECHNOLOGY CO.,LTD.'s Percutaneous Transluminal Aortic Arch Three-Branch Stent System completes endovascular repair of aortic arch dissection aneurysms (including other aortic syndromes) involving three branch vessels through interventional methods. Currently, for such perilous diseases, globally only surgical operations can be used. Although in recent years there have been integrated single-branch stent products that reconstruct one branch (left subclavian artery), they cannot reconstruct all branches above the aortic arch. Looking at research projects worldwide, no percutaneous aortic arch three-branch product achieving anatomical correction has been seen.

 

HANGZHOU JIA HE ZHONG BANG BIOTECHNOLOGY CO.,LTD.'s three-branched stent system, with its unique and ingenious design, meets the various anatomical differences of the aortic arch's three branches, completely resolving a major pain point that has troubled this disease. For the first time globally, it achieves percutaneous interventional implantation and anatomical correction of both the aortic arch and its branches, providing doctors and patients with a standardized endovascular intervention and a stent system for simultaneous reconstruction of the aortic arch and its three branches.

 

HANGZHOU JIA HE ZHONG BANG BIOTECHNOLOGY CO.,LTD.'s aortic arch stent, used for treating lesions involving the three branches of the aortic arch through surgical reconstruction of the aortic arch and its three supra-arch vessels, significantly reduces the surgical difficulty compared to the current gold standard Sun's procedure, cuts the existing operation time by more than 50%, and features minimal invasiveness and easy promotion to meet the rapidly growing market demand.

 

In addition to the above products, JIA HE ZHONG BANG BIOTECHNOLOGY is also developing products such as valved patches and annuloplasty rings.

 

In China's cardiac and major vascular field, imported products still dominate. For domestically produced devices, besides overcoming high technological barriers, whether they possess clinical applicability and ease of promotion are essential factors to consider. HANGZHOU JIA HE ZHONG BANG BIOTECHNOLOGY CO.,LTD. closely collaborates with cardiology and cardiac surgery experts to reduce product operational complexity and shorten the learning curve for doctors. In this way, highly complex procedures such as valve repair and replacement, and interventional arch branch stenting can be widely implemented in grassroots hospitals.

 

In Zhao Yimin's view, the company's core values—"Innovation realizes value, responsibility builds quality"—are not just a slogan but actual actions. These values need to be earnestly embodied in every aspect of product innovation, R&D, quality control, and standardized production, in order to continuously provide truly excellent products to clinicians and patients, and achieve the goal of long-term corporate development.


The driving force and confidence behind the long-term development of HANGZHOU JIA HE ZHONG BANG BIOTECHNOLOGY CO.,LTD. lie in its continuous and robust research and development and innovation capabilities, as well as an increasingly mature and solid quality control system, allowing products to come from clinical practice and return to clinical application.HANGZHOU JIA HE ZHONG BANG BIOTECHNOLOGY CO.,LTD. owns more than 60 patents, with extensive patent layouts in Europe, America, Japan, India, and other regions outside of China.

 

Unlike treating difficult and complicated diseases, running a company has no "clinical guidelines." While taking this challenging yet correct path, HANGZHOU JIA HE ZHONG BANG BIOTECHNOLOGY CO.,LTD. always adheres to its original intention of making good products and healing people.The company's existing products will be approved successively within the next three years, entering the harvest period. Going forward, the company will continue to develop products focused on heart and major vascular diseases, benefiting a wide range of patients.