Brosmed Medical Achieves 'Triple CE Certification in One Day', Pioneering Next-Gen Balloon Catheter Technologies

On February 19, BrosMed Medical announced that three products, representing internationally advanced technologies and unique innovations in vascular interventional balloon catheters, had consecutively received CE certification from EU notified bodies on the same day after years of research and development. These products are set to enter the markets of the European Union and related regions.

These three innovative products are: the Alveo™ Coronary High-Pressure CTO Micro-Balloon (0.75mm), the Wedge™ NC Coronary Guidewire Scoring High-Pressure Balloon Dilatation Catheter, and the Tri-Wedge™ (Teweizhi) Triple-Wire Vascular Access Balloon Dilatation Catheter. Against the backdrop of China’s initial victory in the nationwide fight against the COVID-19 pandemic, this modest triumph in the field of technological innovation for high-end medical devices in China brings a refreshing and inspiring sense of progress.

Li Bin, CEO of BrosMed Medical, stated: “The three products that have recently obtained EU CE registration approval from the company possess high technological sophistication and innovativeness. Among them, Alveo™ and Tri-Wedge™ are both globally unique patented products, representing the latest and most cutting-edge technological innovations in this field, designed to address pain points in relevant clinical applications. Meanwhile, Wedge™ NC also features exclusive patented innovations, aimed at resolving challenging issues in clinical practice.”

BrosMed Medical, a rising star among China’s high-tech medical device enterprises, has consistently launched exclusive, innovative, high-end medical devices with internationally advanced technologies. This achievement also reflects the solid efforts and rapid progress of China’s medical device industry in the high-end sector.

“BrosMed Medical’s triple success in a single day in securing CE registration for high-end medical devices is unprecedented. Nevertheless, we believe and anticipate that in the future development of China’s medical device industry, there will be more companies like BrosMed Medical, leveraging their ‘hardcore’ technologies to expand globally. Together with BrosMed Medical, they will jointly uphold the brand banner of ‘Intelligent Manufacturing in China’ in the international high-end medical device market.”

Among these three products, the Tri-Wedge™ (Tewei Zhi) Triple-Wire Vascular Access Balloon Dilatation Catheter stands out as a representative achievement of BrosMed Medical’s sustained R&D efforts and global product strategy, earning acclaim from renowned clinical experts in Taiwan as a “premier product.”

After four years of investment in clinical research and innovation in Japan, a global leader in vascular access therapy, BrosMed Medical has launched a specialized scoring dilation balloon catheter for vascular access. This device features excellent low-pressure dilation capabilities for severe stenosis and hyperplastic lesions, along with superior performance in crossing narrow lesions and navigating vessels with complex anatomies.

Li Bin stated, “The three triangular metal wires uniformly distributed on the outer wall of the balloon can generate stress concentration with a micro-cutting effect during the dilation of calcified stenotic lesions. This enables regular rupture of the stenotic plaque and hyperplasia under lower dilation pressures, effectively reducing the high-pressure burst-like disordered tearing associated with previous techniques. Consequently, it mitigates severe pain experienced by patients during treatment, as well as postoperative complications such as vascular dissection and short-term severe restenosis resulting from disordered tearing during vascular repair.”

“The Alveo™ coronary high-pressure CTO micro-balloon, with a post-dilation diameter of only 0.75 mm, currently boasts the smallest crossing and expanded outer diameters globally. It is a coronary balloon catheter specifically designed for treating severe and complex stenotic lesions,” introduced Li Bin. “The Alveo™ features an ultra-slim crossing profile and an excellent pushability structure, ensuring it can assist physicians in easily and agilely navigating through complex or severely stenotic lesions.”

Leveraging BrosMed Medical’s years of accumulated, globally leading patented technologies in the design and manufacturing of CTO balloons, and combining these with extensive clinical needs, we have innovated the materials and design of this product. Specifically engineered for ultra-high pressure resistance and puncture resistance, AlveoTM enables physicians to dilate severely calcified lesions using high-pressure inflation, significantly reducing procedural time for complex cases and lowering both the complexity and medical costs associated with the multi-device approaches previously required for lesion management.

According to Li Bin, the Wedge™ NC Coronary High-Pressure Scoring Wire Balloon Dilatation Catheter is another testament to the company’s years of dedicated expertise in the field of scoring wire balloon catheter technology, boasting internationally leading technical standards. It serves as a powerful surgical tool for treating diffuse stenotic lesions, severely calcified lesions, and in-stent restenosis.

Wedge™ NC is currently undergoing broader clinical application studies at multiple European clinical centers, led by numerous renowned clinical experts from Belgium, Italy, and other countries. It is hoped that in the near future, in-depth research and outcome reports on this product and its associated technology will bring greater hope and benefits to physicians and patients alike.

Amid the call for import substitution, domestic vascular interventional devices and consumables have undergone earth-shaking changes, evolving from initial imitation and following of foreign products to innovative offerings that lead internationally. Many enterprises have made significant contributions to this transformation. If a contribution ranking were established for these companies, BrosMed Medical would undoubtedly be on the list.

How Did BrosMed Medical Emerge as a Leader in China’s Balloon Catheter Industry? How Did It Achieve Three Major Breakthroughs in a Single Day, Launching Three Products with Internationally Leading Technologies on the Global Market, and What Is the Extent of Its Technological Prowess? Today, VCBeat conducted an exclusive interview with BrosMed Medical to trace its development journey and explore the logic behind its future growth.

In 2012, similar to other high-end medical devices, the localization rate of vascular interventional consumables was extremely low. As an entrepreneur preparing for venture creation during that period, Li Bin believed that the core issue lay in the weak foundation of China’s high-end medical industry, with domestic products lagging significantly behind international giants in terms of technology and innovation at the time.

As one of the earliest practitioners in China’s coronary intervention technology and manufacturing industry, Li Bin dedicated himself to researching and analyzing the current status and opportunities of China’s high-end medical device industry while pursuing his MBA at Fudan University. By examining the low domestic production rate in the high-end medical device sector, he foresaw the rapid arrival of the major trend of import substitution.

“At the time, I judged that import substitution was an unstoppable general trend and a matter of urgency. As one of the earliest practitioners and professional technical talents in this industry in China, I hoped to seize this historical opportunity to contribute Chinese strength to the development of China’s high-end medical industry, while also realizing the personal and team’s life value. Therefore, I gave up many things and founded BrosMed Medical to focus on researching technology and products.”

Li Bin joked, “The ideal is full-bodied, but reality is cruel. After all, it was my first time starting a business independently; I had grand ambitions but lacked experience. I suffered many setbacks, took many detours, and missed quite a few opportunities.”

The research, development, and industrialization of high-end medical device products are generally characterized by being technology-intensive and capital-intensive, with long development cycles and high time costs. During its first three years, BrosMed Medical was consistently engaged in product R&D and rapid cash burn. Due to the founding team’s underestimation of the challenges inherent in startups and the required R&D investment, financial pressure quickly mounted. Issues common to startups—such as cash flow breakdowns, low team morale, staff turnover, and insufficient resources—inevitably emerged one after another.

Much like the tale of many “ugly ducklings,” BrosMed Medical navigated its precarious startup phase through the founding team’s self-funded efforts and steadfast perseverance, timely support from angel investors, discerning backing from Cowin Capital and JF Capital, and strategic guidance from Yuesheng Venture Capital and Northern Light Venture Capital. This journey ultimately enabled the company to embark on a remarkable trajectory in the field of balloon catheter-based interventions.

Looking back at the history of BrosMed Medical, in just eight years, it has pioneered numerous innovations and achieved remarkable feats in China’s high-end medical device sector. The market for high-value consumables in vascular intervention, including cardiovascular interventional therapy, represents the largest segment of the global high-end medical device industry. It has long been a stage dominated by international medical device giants, with a few industry oligarchs controlling nearly 70% of the global market share and firmly maintaining their leading advantages in product technology and brand influence.

BrosMed Medical’s coronary and peripheral balloon catheters are the only high-end medical device products among Chinese domestic brands to have achieved large-scale market launch and sales in the three major medically advanced regions—the United States, Japan, and the European Union—to date.

Although BrosMed Medical’s products have been on the market for only five years, they are now exported to more than 40 countries and regions. In some countries, the company has achieved double-digit market share, breaking through the technological barriers and market monopolies held by international giants. In global clinical applications and technical competitions, BrosMed Medical holds its own against any international competitor.

In less than three years since its relaunch in the Chinese market, it has rapidly emerged as a leader in the domestic coronary balloon catheter market, achieving annual growth rates several times over and earning strong preference among clinicians and the market. It is steadily realizing BrosMed Medical’s corporate resolve and market philosophy of “Quality Balloons, Made in China.”

BrosMed Medical is often referred to by many in the industry as an “outlier” within China’s high-end medical sector, with a development philosophy and business model that remain unclear to outsiders and most investors. Many attribute this to BrosMed Medical’s low-profile approach, quietly generating substantial profits. In reality, BrosMed Medical is forging an unconventional path, pursuing a unique development strategy that diverges from the standard practices adopted by the vast majority of domestic medical device companies.

“Since its inception, BrosMed Medical has approached the research and development of technology and industry from a global market perspective. By pursuing a dual-pronged strategy in both international and domestic markets, the company has achieved rapid growth while mitigating the persistent challenges of high time and cycle costs inherent in the high-end medical device industry.”

Li Bin stated, “Over the past five years, BrosMed Medical has adhered to this as its fundamental corporate development philosophy. The company’s efforts in technological innovation, product registration, and market expansion have all been guided by the principle of ‘walking on two legs.’ Of course, this ‘unique expertise’ is not easily replicable by every company; it demands a high degree of internationalization from the core management team, as well as strong capabilities for continuous learning and evolution.”

As can be seen from the development history of BrosMed Medical, its success, as stated by founder Li Bin, stems from the core team’s excellent global vision and ability to navigate international markets, coupled with their rapid learning and model innovation capabilities in the domestic market.

As a leading enterprise in China’s vascular interventional balloon catheter market, BrosMed Medical has established the Guangdong Provincial Engineering Technology Center for Vascular Interventional Therapy and Medical Devices, as well as the Dongguan Key Laboratory for Research and Development of Vascular Interventional Medical Devices. After several years of steady development, its globally marketed product portfolio now spans three major therapeutic areas and more than ten categories, with double-digit projects currently under research and development. The company has formed a technology and product development platform led by internationally advanced vascular interventional medical device technologies, along with a sustainable R&D ecosystem.

With BrosMed Medical’s corporate mission being “to become the leader in China’s high-value consumables sector for vascular intervention,” and given its steady progress, dedicated cultivation, and increasingly solid core competitiveness, can the day when this young team in China’s vascular intervention industry reaps the fruits of success be far off?