Domestic Breakthrough in a $10B Market: BaTe Medical Launches China's First Constrained Peripheral Drug-Coated Balloon Amid 95% Import Dominance
Barty Medical
Vascular Interventional and Implantable Device R&D Manufacturer
Source: Medical Device Business Review
Author: Jin Fan
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China's First Domestically Produced
Recently, according to the information from the National Medical Products Administration,Barty MedicalSelf-developed peripheralConstrained Drug-Coated Balloon Dilatation Catheter Matrix Super PTX®, officially approved for marketing.
It is reported that this product is based on Barty Medical's Matrix Super® Peripheral Constrained Balloon Platform, which was approved in December last year.China's First Peripheral Constrained Drug-Coated Balloon，Fully integrates the advantages of peripheral restraint balloons and drug-coated balloons., for the first time, achieved a one-stop luminal preparation and treatment process for peripheral arterial endovascular therapy.Applicable for interventional treatment of renal arteries, iliac arteries, femoral-popliteal arteries, and infrapopliteal arteries.
For endovascular treatment of lower limb arteries, ensuring sufficient and ideal endovascular preparation is a crucial step. However, the biggest challenge in clinical practice lies in severe dissections that can occur during lumen preparation due to vascular occlusion or calcified lesions.NoNot only will it increase the difficulty of obtaining a lumen, but it will also affect the penetration of drugs into calcified lesions.。
Moreover, based on current multiple large-scale clinical trials, even in the case of longer lesions or calcified lesions after vascular dilation treatment, the incidence of dissection remains high. Additionally, after drug-coated balloon dilation, there will still be...Prognostic Risk of Residual Stenosis and Elastic Recoil, sometimesRemedial stent implantation is still required.
Based on the pain points of clinical treatment and the limitations of existing technologies, a revolution in balloon technology is imperative.
Achieve a clinical effect of 1+1-1>2,Lead the New Revolution in Peripheral Balloons
Matrix Super PTX® Peripheral Constrained Drug-Coated Balloon Dilatation Catheter, with its innovative design concept,ByA single product achieves the clinical effects of two products and effectively reduces the implantation of remedial stents, achieving a clinical effect of 1+1-1>2.，A New Era of Peripheral Interventional Balloon Treatment Has Begun.
The catheter adopts a unique nitinol wire structure design, achieving non-traumatic and uniform expansion during balloon inflation., reducing the occurrence of flow-limiting dissectionsAt the same time, the drug coating can also rely on the constrained balloon platform to better adhere to the blood vessel wall, achieving rapid release and effective transfer of the drug, and maintaining a therapeutic concentration in the blood vessel wall for a long period.Maintain Long-term Patency of the Lumen。
Matrix Super PTX®
Matrix Super PTX® must have undergone rigorous clinical trials to successfully reach the market. Prior to its launch, a large-scale clinical study on Matrix Super PTX® was completed, led by Professor Wei Guo, Director of the Vascular Surgery Department at the Chinese People's Liberation Army General Hospital, with participation from 24 clinical centers.
The research results show that, compared with the traditional treatment method of fully pre-expanding with multiple bare balloons before performing drug-coated balloon dilation, whetherImmediate器械Success Rate, Surgical Success Rate, or Long-term Follow-up Vascular Patency Rateetc., Matrix Super PTX® Peripheral Constrained Drug-Coated Balloon achieved satisfactory non-inferiority results in all key clinical indicators.Not only simplified the surgical procedure, shortened the vascular preparation time, and improved treatment efficiency, but also greatly reduced the economic burden on patients.。
The launch of Matrix Super PTX® marks a solid step forward in the field of peripheral interventional treatment in China, heralding a new chapter in the localization of high-performance vascular interventional devices, providing clinical patients with more and better treatment options.
The Era of Intervention Without Implants
In recent years, interventional treatment has developed rapidly with its characteristics of minimal trauma, multiple indications, definite efficacy, and fast postoperative recovery, becoming the third largest therapeutic discipline after internal medicine and surgery, showing unlimited market potential.
However, in recent years, the impact of centralized procurement has led to a profound transformation in traditional interventional consumables. Following the drop of coronary stents into the "hundred-yuan era," this wave of change has quickly swept through the neurology and peripheral fields. Finding new growth drivers has become an essential survival option for all device manufacturers."Intervention without implantation" has become a trend in market development.。
Based on Continuous Innovation
Create a competitive landscape of "unique offerings and superior quality"
Against this backdrop, Barty Medical, founded just nine years ago, adheres to the development philosophy of independent innovation and continuously increases its investment in research and development.Input force has made breakthrough progress in multiple fields such as coronary intervention and peripheral intervention.Successfully launched multiple "world's first, China's first" products, with innovative technology breakthroughs achieving "what others don't have, we have; what others have, we excel."Highlights its leading position and extraordinary strength in the field of interventional treatment.
Approved for marketing in May 2021, it isThe only national innovative medical device product with a drug coating and no excipients among currently marketed similar products in China., which not only enhances the biocompatibility of the drug coating and reduces vascular inflammatory response, but also avoids allergic reactions caused by the introduction of excipients.。
This was independently developed by Barty Medical and collaboratively improved by the team of Academician Ge Junbo from Zhongshan Hospital.The world's first "intervention without implantation" drug-device combination product for in-situ lesions of large coronary vessels., which has currently completed the world's first human clinical trial (FIM trial), and will launch the registration clinical trial in 2024.
Approved for marketing in December 2023, it isChina's First Domestically Produced Constrained Balloon Product, and it is also the only constrained balloon currently available in lengths of 150mm and 200mm, fully meeting the localized clinical needs of Chinese patients who tend to seek medical attention late and have longer vascular lesions.
Looking Forward to the Global Market
International Perspective Accelerates Commercialization Process
Barty Medical not only continues to lead in technological innovation but also, with its broad international perspective, has built an unshakable competitive advantage in the commercialization journey of its products.
November 2023,Barty Medical signed an in-depth strategic cooperation agreement with Baxter Medical, the leader in the global hemodialysis industry, in the field of hemodialysis access.。
Through this collaboration, Barty Medical will leverage Baxter's extensive experience and resources in the hemodialysis field to promote a series of innovative products, such as high-pressure balloons and disposable catheter sheath sets, for the maintenance of hemodialysis access in patients undergoing hemodialysis. While safeguarding the lifeline of hemodialysis for nearly a million hemodialysis access patients in China, this collaboration also accelerates the commercialization of Barty Medical’s products.
While partnering with international giants, Barty Medical spares no effort in attracting elite talents with extensive industry experience and international foresight, demonstrating its firm determination to build an international brand.
Particularly worth mentioning is that, in 2022,The company invitedMr. Hu Chao, former head of Edwards Medical's sales operations in Greater China, serves as the General Manager.Mr. Hu Chao not only has nearly 10 years of clinical experience in cardiothoracic surgery, but also has over 20 years of in-depth experience in the cardiovascular intervention field, accumulating rich expertise in technology promotion and marketing management. His joining undoubtedly injects new momentum into Barty Medical's operation management and international strategic layout.
Currently, Barty Medical's products have been exported to more than 20 countries and regions, achieving tens of millions in overseas sales. The company is also actively exploring potential markets such as the United States, Japan, and Southeast Asia, further strengthening its market share and competitiveness on the international stage.
A 10-billion-yuan Market with 95% Imports
After the centralized procurement of coronary stents, the growth of the coronary intervention market has entered a period of moderation, and peripheral intervention has become a new hotbed for exploration in the vascular intervention field.
As the main battlefield for peripheral interventions, the peripheral artery market has gained significant attention. According to Xingye Securities, the size of the peripheral artery market reached 5 billion yuan in 2019.And it is expected that by 2030, this figure will increase to 12.2 billion yuan., with a compound annual growth rate (CAGR) as high as 15.7%.
On the one hand, in terms of the number of patients,Patients with Peripheral Artery Disease (PAD) have a large base., the market growth potential should not be underestimated. Moreover, with the enhancement of vascular surgery construction capabilities in China, the number of hospitals conducting peripheral interventional treatments continues to rise,The number of patients receiving peripheral treatment is also gradually increasing.。
Frost & Sullivan once predicted that by 2030, the number of PAD patients in China is expected to reach 62 million, and the number of surgeries will reach 602,000.
On the other hand, unlike the current situation in the coronary intervention field where domestically produced alternatives have basically achieved dominance,The market share of imported products in China's peripheral artery intervention field exceeds 95%., which indicates that under the wave of domestic substitution, Chinese manufacturers will have greater development opportunities and space.
Based on this, in recent years, in the field of peripheral arterial intervention, domestically produced products have shown strong momentum in both market share and technological innovation.
Since the end of 2021, the trend of centralized procurement has extended to the peripheral interventional field. Domestic brands, leveraging advantages in product quality and supply chain channels, are accelerating market penetration. For instance, in the two centralized procurement events for peripheral interventions in Henan Province led by the First Affiliated Hospital of Zhengzhou University and Henan Provincial People's Hospital in March 2024,The proportion of products won by local companies is higher than that of multinational products in all surgical procedures.
Besides, unlike the low-price winning bids for coronary stents, the current centralized procurement rules are set more scientifically and reasonably, with milder price reductions. The winning companies can maintain a certain profit margin, further promoting the development of peripheral interventions in China.
Riding the wave of centralized procurement, China has also achieved a remarkable transformation in the field of peripheral interventional technology, shifting from initial imitation and following to leading with independent technology, gradually broadening the market landscape originally dominated by imported products.
Taking the field of peripheral artery drug balloons as an exampleIn China, multiple drug-coated balloon products have been approved for marketing and have demonstrated good efficacy and safety in clinical settings, providing more treatment options for doctors and patients.
For exampleCryomedSelf-developedThe World's First Drug-Coated Balloon for Below-the-Knee Arterial DiseaseCompared with traditional PTA balloons, it has advantages such as inhibiting intimal hyperplasia when treating infrapopliteal artery lesions.
Moreover, another significant development trend in the peripheral artery market——New Combination of Drugs and Devices, China has also made breakthrough progress. Cutting-edge technology products such as absorbable stents, drug-eluting stents, and covered stents are all actively deployed by domestic companies.
For exampleYuanxin Technology, a subsidiary of LifeTech ScientificThe heavy-duty launch of the IBS Titan™ Absorbable Drug-Eluting Peripheral Stent System, specifically designed for infrapopliteal artery disease, isThe World's First Fully Degradable Vascular Stent Made from Iron-Based Main Material, which not only successfully completed its first clinical enrollment in Europe and has submitted an EU CE registration application, but also received U.S. FDA "compassionate use" approval.
Overall, although China started relatively late in the field of peripheral interventions and faces the challenge of a relative scarcity of domestically produced products, the starting gun for domestic substitution has been fired. The rise of domestic power is unstoppable. Innovative medical device companies represented by Barty Medical, CinnoMed, and Lifetech Scientific are stepping forward bravely to become the backbone leading the rapid rise of China's peripheral intervention technology. In the future, we are likely to see more of China’s innovative strength in the global peripheral intervention market.
The content of this article is for reference only and does not constitute investment advice. Readers are expected to effectively distinguish.If any platform reprints this article, it must take responsibility for the content of the article. Medical Device Business Review is not responsible for the impact of secondary dissemination caused by the reprint.
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