Biotronik Medical Builds an 'Implant-Free Intervention' Product Portfolio Focused on Coronary and Peripheral Interventions, with Products Adopted by Over 1,000 Hospitals

The Concept of Intervention without Implantation is Emerging, with Innovative Products like Drug-Coated Balloons and Bioresorbable Stents Being Introduced.

In long-term practice, clinicians have recognized that the long-term implantation of stents in blood vessels may lead to complications such as in-stent restenosis, thrombosis, and infection. Additionally, patients need to take antiplatelet drugs for a long time, and their compliance also needs improvement. The short-term expansion of blood vessels by ordinary balloons may also result in vascular elastic recoil and the need for stent re-implantation.The emergence of drug-coated balloons has, to a certain extent, addressed the drawbacks of conventional stents and balloons. While dilating the diseased part of the blood vessel, they release medication, achieving a "traceless" treatment.

With the further popularization of the concept of "intervention without implant" in clinical practice, the usage of drug-coated balloons has rapidly increased, and the related market size is also expanding quickly. According to statistics and analysis by Frost & Sullivan, since its initial approval for the treatment of coronary artery disease in China, the usage of drug-coated balloons domestically surged from 7,500 units in 2016 to 290,000 units in 2021. The market size of coronary drug-coated balloons also grew rapidly from 135 million yuan in 2016 to 2.009 billion yuan in 2021, and it is expected that by 2025, the market size will further increase to 4.386 billion yuan.

Currently, the clinical indications for drug-coated balloons are relatively narrow, mainly used for the treatment of in-stent restenosis after bare-metal stents and drug-eluting stents, and can also be applied to primary coronary lesions such as small vessel disease and bifurcation vessel disease. Recently,Research by Qiao Shubin and Liu Rong from Fuwai Hospital shows that drug-coated balloon treatment can also be used for treating de novo lesions in large coronary arteries.With the accumulation of clinical evidence and the launch of innovative products, the indications for drug-coated balloons may further expand, leading to market growth.

The global drug-coated balloon market is still dominated by imports, with multinational giants such as Medtronic and Boston Scientific occupying the leading positions. However, following the pace of domestic innovation, Chinese companies are gradually breaking through.

Barty Medical is one of the pioneers in this field. The company was founded in 2015 and focuses on the research, production, and sales of high-end medical device products for vascular intervention. In the seven years since its establishment, Barty Medical has obtained 9 NMPA Class III certificates and 8 CE certifications, with 3 of its products entering the National Innovative Medical Device Green Channel.

China is a major country with cardiovascular diseases, with 330 million patients, showing a large demand for vascular interventional treatments.

The coronary intervention market in China is relatively mature, with an annual number of PCI procedures exceeding one million. Conventional stents and balloon products have basically achieved domestic production, but products in niche markets such as drug-coated balloons, shockwave balloons, and bioresorbable stents are still immature, leaving significant room for domestic substitution. Meanwhile, the peripheral intervention market in China is still in its early stages, with devices like stents and balloons currently dominated by imported products. However, with the development of grassroots vascular surgery infrastructure, the volume of peripheral interventional procedures is growing at a rate of over 20%, indicating strong potential for growth in the related device market.

Targeting the unmet needs in coronary intervention and peripheral intervention, Barty Medical has been focusing on the research and development of balloon products since its establishment, successively launching innovative products such as paclitaxel drug-coated balloons and stent-mounted drug balloons.

Drug-coated balloons have high technical barriers, and some products suffer from issues such as premature drug detachment and insufficient drug release. During the delivery of drug-coated balloons, blood flow can wash over the balloon, potentially reducing the concentration of the attached drug. Moreover, since the balloon's adherence to the vessel wall may block blood flow, the expansion time is relatively short, which also shortens the drug release duration. Drug-coated balloons need to release drugs efficiently within a short period, but if drug transfer is insufficient, vascular elastic recoil may occur.

An excellent drug-coated balloon must meet three characteristics: First, during the delivery process, the drug can adhere well to the surface of the balloon; second, the rapid transfer of the drug is completed in a short time; third, the drug is continuously released within the blood vessel.

Barty Medical's coronary drug-coated balloon features a paclitaxel nanoneedle crystal-controlled release drug coating, applied through ultrasonic atomization spraying.Compared with traditional technologies such as dip coating and two-fluid spraying, ultrasonic spraying technology can prepare more uniform thin film coatings, featuring precise drug loading and high utilization of the drug solution.The drug coating prepared by ultrasonic spraying technology has controllable release, and the paclitaxel crystals on the balloon surface are less than 300 nanometers. Even if they fall on the vessel wall, they will not cause distal vascular embolism.

Moreover,Barty Medical's drug-coated balloon does not require excipients, avoiding allergic reactions and vascular inflammation. The effective concentration in vascular tissue can be maintained for at least 28 days after balloon treatment, continuously suppressing intimal hyperplasia. Meanwhile, Barty Medical’s balloon has a smaller outer diameter, excellent pushability and trackability, allowing it to effectively treat various vascular conditions.

In April 2021, Barty Medical's Fengtai® Coronary Drug-Coated Balloon received approval from the National Medical Products Administration (NMPA). The product had previously entered the special approval channel for innovative medical devices. Currently,Barty Medical's Paclitaxel Coronary Drug-Coated Balloon Product Has Been Promoted Across 29 Provinces and Cities in China, Entering Over 300 Hospitals。

Based on the technology of drug-coated balloons, Barty Medical continues to launch innovative products to meet clinical needs.

In clinical applications, when drug-coated balloons are expanded, uncontrolled balloons can generate three types of stress: shear stress, radial stress, and longitudinal stress, which can easily cause vascular injury, leading to severe intimal tearing and elastic recoil. This can result in flow-limiting dissections, necessitating the implantation of another stent, which not only prolongs treatment time but also increases treatment costs.

In response to the above issues,Barty Medical Launches Drug-Coated Balloon with Stent: The nitinol wires on its surface enable controlled and uniform expansion, thereby mitigating the three types of stress caused by uncontrolled expansion. This effectively dilates the lesion while avoiding dissections caused by vascular injury. Additionally, it can cut through coronary plaques, enhancing the efficacy of drug release. Combining vascular pre-dilation and drug therapy into one reduces the need for additional consumables.。

To reduce blood flow obstruction during the drug-coated balloon expansion process, Barty Medical's stent-equipped PTCA drug-coated balloon also incorporates blood perfusion holes to ensure coronary artery blood supply, thereby extending balloon inflation time and enhancing the transfer rate of paclitaxel. The stent-equipped PTCA drug-coated balloon can be used for treating de novo lesions in large coronary arteries, further addressing clinical needs.

Previously, Barty Medical's peripheral and coronary stent-mounted drug-coated balloons entered the green channel in March and June 2022, respectively.Barty Medical's Stent-Mounted PTCA Drug-Coated Balloon Expected to Become the World’s First Marketed Drug-Coated Balloon.

Beyond its innovative balloon products, Barty Medical also focuses on the layout of conventional products, striving to create a complete product portfolio. In the coronary field, Barty Medical has launched pre-dilation and post-dilation balloons, guiding catheters, angiography catheters, and other access-assisting consumables. In the peripheral vascular field, Barty Medical offers standard and high-pressure balloons, guiding catheters, angiography catheters, and other access-assisting consumables.

Beyond original research capabilities, mass production capacity is a hurdle for companies to turn products into commodities.

Barty Medical focuses on the construction of manufacturing systems and quality control systems, achieving mass production while ensuring product quality. Approximately one-fifth of Barty Medical's employees have previously worked in internationally leading medical device companies, adhering to the principle that "the precondition for a product’s successful market launch is safety and reliability."The company owns a 10,000-class (locally 100-class) clean workshop that complies with the latest international and national GMP standards, and is equipped with professional and comprehensive facilities and equipment.

Previously, several provinces and cities in China have carried out centralized procurement of drug-coated balloons, with the price reduction for coronary balloons ranging between 70% to 96%, and an average price reduction of over 80%.

In the view of Mr. Yan Yuqiang, founder of Barty Medical, the centralized procurement of coronary drug-coated balloons is not a negative signal indicating shrinking profit margins in the market. The national centralized procurement of drug-coated balloons treats the product as a standard treatment method, hoping to achieve wider adoption by controlling prices. Nowadays, an increasing number of grassroots hospitals are establishing catheterization labs, and the clinical environment is gradually maturing. With the centralized procurement of coronary drug-coated balloons, although prices have dropped, usage has significantly increased. The key lies in having innovative products; companies must introduce higher-quality products despite the price reduction.

Moreover,Recently, the National Healthcare Security Administration stated that due to the immature clinical use of innovative medical devices and the temporary difficulty in estimating their usage volume, it is still challenging to implement a bulk procurement approach.Innovative medical devices are temporarily excluded from centralized procurement, leaving some market space for multiple innovative products within Barty Medical. Meanwhile, under the broader context of medical insurance cost control, DRG payment policies are being implemented across regions; however, devices entering the innovative fast-track channel are not subject to cost-control restrictions. Barty Medical has three products in the National Medical Products Administration's green channel, providing significant advantages in clinical implementation.

The right product direction, gradually relaxed policy environment, and a strong and stable internal team are all contributing factors to Barty Medical's development.

The founding team members of Barty Medical have all worked for many years in multinational medical device companies, possessing a deep understanding of the industry. Currently, the company has over 200 employees, including more than 40 R&D staff from both within and outside China, as well as a marketing team of over 50 people. The core members have extensive international marketing experience and a global perspective. The company's products have been sold in more than ten countries, including South Korea, Japan, and Turkey.

At the same time,Barty Medical places high importance on medical-engineering cooperation and has partnerships with PLA General Hospital, Xuanwu Hospital, Changhai Hospital, Shanghai Ninth People's Hospital, and Zhejiang First Hospital.The company actively promotes cooperation with authoritative medical institutions and scientists in the United States, laying out global multi-center clinical trials, academic promotion, and market promotion.

In the future, Barty Medical will continue to focus on product development, market promotion, and financial growth simultaneously. The company will improve its existing products while accelerating the development of more innovative interventional products. It will also strengthen the market promotion of current products to increase their market share and expedite a new round of financing.

References:

"Chinese Expert Consensus on the Clinical Application of Drug-Coated Balloons"

"Drug-Coated Balloons Can Also Be Used for Large Coronary Vessels! Study by Qiao Shubin et al. from Fuwai Hospital" — HealthCare Arena