Cordis Acquires MedAlliance for $1.135 Billion, Betting Big on Sirolimus Drug-Coated Balloon SELUTION SLR™

Following the approval of China’s first rapamycin-based drug-coated balloon, another major development has occurred in the drug-coated balloon market.

Cordis, a giant in cardiovascular interventional devices, announces the acquisition of MedAlliance for a total consideration of up to $1.135 billion, comprising an initial investment of $35 million, an upfront closing payment of $200 million, regulatory milestone payments of up to $125 million, and performance milestone payments of up to $775 million.

Through the acquisition of MedAlliance, the Company expects to provide the SELUTION SLR™ sirolimus-eluting balloon to two million patients worldwide by 2027. Shar Matin, CEO of Cordis, stated, “We are furthering Cordis’s legacy of innovation and market disruption through MedAlliance and its first-in-class MicroReservoir sirolimus-eluting balloon, SELUTION SLR™.”

In fact, MedAlliance had already established its reputation prior to this. Salubris has made multiple capital injections into the company, acquiring intellectual property rights, technologies, and exclusive licensing rights for mainland China related to MedAlliance’s sirolimus-eluting drug-coated balloon, SELUTION SLR™. Xinchen Capital also became the single largest shareholder of MedAlliance.It can be said that the sirolimus drug-coated balloon underpins MedAlliance’s high valuation.

As a fellow pioneer in the global market for rapamycin-based drug-coated balloons, Bluesail Medical has also recently obtained regulatory approval. Its Boteng® drug-coated balloon product has been approved in China, while the international version is planned to launch first in Europe, where it will compete directly with MedAlliance’s SELUTION SLR™ drug-coated balloon.

Facing the SELUTION SLR™ drug-coated balloon, which has received multiple FDA Breakthrough Device designations and obtained EU CE certification, Bluesail Medical’s competitive confidence may stem from its exclusive patented drug BA9 and its long-accumulated expertise in combined drug-device technologies. The BA9 used in Boteng® is the world’s only third-generation rapamycin derivative, featuring tenfold greater lipophilicity than conventional rapamycin or its derivatives. In contrast, the SELUTION SLR™ drug-coated balloon utilizes standard rapamycin, achieving breakthroughs primarily through its drug-coating technology. If the latter is akin to equipping a warrior with armor, the former represents deploying elite troops.

Beyond their competitive relationship, MedAlliance and Biosensors International, a subsidiary of Bluesail Medical, share deeper historical ties.According to the MedAlliance website, John Shulze, Founder and CTO of MedAlliance, was previously a co-founder of Biosensors International. Jeffrey B. Jump, Chairman and CEO of the company, also served as CEO of Biosensors International. A closer look at the 11-member management team listed on the MedAlliance website reveals that seven of them are former executives from Biosensors International.

This is no coincidence. Biosensors International was among the first companies globally to pioneer drug-device combination products based on rapamycin analogs. Between 2003 and 2016, Biosensors International licensed Terumo to apply Biolimus and its coating technology to the Nobori coronary stent, and it also sold BA9’s predecessor drug to Guidant. Biosensors International’s prominent position in the industry is widely recognized; it has driven product development at major industry players through external collaborations and shaped industry evolution by supplying talent.

However, the two companies have taken divergent paths. MedAlliance has adhered to an independent development strategy, focusing on a single product within the sirolimus-coated balloon category, which now commands a premium price. In contrast, Biosensors International was acquired by Bluesail Medical in 2018 for a total consideration of approximately RMB 6 billion, becoming a strategic cornerstone in Bluesail’s expansion into high-end medical devices. Currently, Biosensors International’s revenue structure is dominated by coronary stents, supplemented by heart valves, while its sirolimus-coated balloon business is beginning to yield significant results. The recent substantial acquisition of MedAlliance for USD 1.135 billion sends a positive signal to Bluesail Medical and the broader market, suggesting that sirolimus-coated balloons are poised to become the next blockbuster product.

The Rise of the “Intervention Without Implantation” Concept: Drug-Coated Balloons Become a Clinical and Market Focus. The emergence of drug-coated balloons has addressed issues such as thrombosis and long-term prognosis associated with permanently implanted stents, while also overcoming the limitations of conventional balloon angioplasty, including short therapeutic duration and suboptimal efficacy. By releasing anti-proliferative drugs at the site of vascular lesion dilation, drug-coated balloons achieve “scar-free” treatment and hold promise for replacing stents in certain indications.

Previously, the clinical indications for drug-coated balloons (DCBs) were relatively narrow, primarily used for treating in-stent restenosis (ISR) after bare-metal stent and drug-eluting stent implantation. They were also applicable to primary coronary lesions such as small vessel disease and bifurcation lesions. According to the "Chinese Expert Consensus on the Clinical Application of Drug-Coated Balloons," ISR is the preferred indication for DCBs, and standalone DCB therapy may be the preferred treatment option for small vessel disease.

Recent studies conducted by Qiao Shubin, Liu Rong, and colleagues at Fuwai Hospital have demonstrated that drug-coated balloons (DCBs) can also be used to treat de novo lesions in large coronary arteries. As clinical evidence accumulates and innovative products are launched, the indications for drug-coated balloons are likely to expand further, driving continuous growth in their market share.

According to Frost & Sullivan’s statistical analysis,Since its initial approval in China for the treatment of coronary artery disease, the usage volume of drug-coated balloons (DCBs) in the country surged from 7,500 units in 2016 to 290,000 units in 2021. The market size of coronary DCBs also grew rapidly from RMB 135 million in 2016 to RMB 2.009 billion in 2021, and is projected to further climb to RMB 4.386 billion by 2025.

Currently, multiple drug-coated balloon (DCB) products have been launched both domestically and internationally, with the vast majority utilizing paclitaxel coatings. In clinical practice, DCBs are required to release the drug into vascular tissue within a short timeframe while sustaining inhibition of cellular proliferation. Paclitaxel exhibits favorable lipophilicity, resulting in high tissue absorption efficiency and prolonged therapeutic efficacy; however, it carries certain risks of biological toxicity and may cause complications such as distal embolization.

In contrast, rapamycin offers superior safety and efficacy, making it a preferred choice for drug-eluting stents. However, due to its hydrophilicity, it is prone to detachment during balloon delivery and cannot be rapidly absorbed by the vasculature within a short timeframe; consequently, it has not yet been widely adopted in the field of drug-coated balloons.

Developing sirolimus drug-coated balloons with improved lipophilicity and prolonged therapeutic efficacy has become a key focus for the company.Particularly after the Jiangsu-led 12-province alliance’s centralized procurement of coronary drug-eluting devices, where the winning bids (all paclitaxel-coated balloons) saw an average price reduction of 70%, sirolimus-coated balloons have become the focal point of market attention.

In China, listed companies such as Bluesail Medical, Salubris, and MicroPort have entered the sirolimus-coated balloon market. As more clinical evidence emerges, the efficacy and superiority of sirolimus-coated balloons in treating coronary and peripheral vascular diseases have been further validated. Bluesail Medical has become the first domestic company to reap the benefits.

In September 2022, the UmoSirolimus-Coated Coronary Balloon Dilatation Catheter (Baiteng®), developed by Jiwei Medical, a subsidiary of Bluesail Medical, was approved by the National Medical Products Administration (NMPA) via the Innovative Medical Device Green Channel for the treatment of de novo lesions in small coronary vessels. It became the first sirolimus-class drug-coated balloon approved in China, marking a breakthrough for domestically produced products.This also marks a new milestone in China’s sirolimus drug-coated balloon market.

The Baiteng® drug-coated balloon features Bluesail Medical’s proprietary patented rapamycin derivative, Biolimus A9® (BA9), which exhibits tenfold greater lipophilicity than other sirolimus-class drugs. Its unique crystallization process enhances drug stability, while polyethylene oxide (PEO) is employed as the drug excipient due to its excellent hydrophilicity and biocompatibility. The hydrophilic coating swells upon water absorption, thereby promoting drug apposition to the vessel wall and improving tissue uptake efficiency, while simultaneously reducing the risk of allergic reactions.

The results of the BIO-RISE CHINA multicenter clinical trial, led by Academician Han Yaling from the General Hospital of the Northern Theater Command, demonstrated that the Boteng® BA9 drug-coated balloon exhibited significantly superior clinical efficacy compared to conventional PTCA balloons in the treatment of de novo lesions in small coronary arteries (vessel diameter ≥2.0 mm and ≤2.75 mm), thereby confirming the safety and effectiveness of the Boteng® drug-coated balloon for treating small vessel disease. These findings were announced at a keynote session of the TCT conference.Baiteng® Becomes the First Domestically Produced Drug-Coated Balloon with Clinical Study Results Featured in a Key Dedicated Session at the TCT Conference。

Bluesail Medical is currently applying to the National Healthcare Security Administration for a medical consumable code for its Boteng® drug-coated balloon product, with the product expected to be officially launched in the market in 2023.

Bluesail Medical is also conducting a multicenter, randomized, controlled clinical trial in China on its BA9 drug-coated balloon for the treatment of in-stent restenosis (ISR), with the control group using SeQuent Please NEO, a next-generation drug-coated balloon from the German giant B. Braun; meanwhile, it is also carrying out a multicenter, randomized, controlled clinical trial in Europe for the ISR indication, with the control group using the SeQuent Please paclitaxel drug-coated balloon. Currently, both clinical trials have completed enrollment.

In addition to upgrading existing products and expanding their indications and sales reach, Bluesail Medical is also conducting validation work on next-generation drug-coated balloons.According to reports, the drug absorption efficacy of the new-generation drug-coated balloon product is 60 times higher than that of existing products, and the product has currently entered the animal testing phase.Multi-pronged domestic and international strategies to advance product R&D improvements and market promotion are expected to further consolidate Bluesail Medical's leading position.

Furthermore, the centralized procurement of high-value medical consumables has become normalized, with multiple provinces and municipalities in China having already conducted centralized procurement for drug-coated balloons. In response to this trend, Bluesail Medical has chosen to focus on developing innovative products, facilitating their entry through green channels, and designing products tailored to specific indications. The company holds exclusive global patents for rapamycin-based drugs, enabling rapid product iteration based on clinical needs. With synchronized R&D efforts both domestically and internationally, Bluesail Medical maintains a competitive advantage in the global market. Additionally, the company boasts global manufacturing capabilities, with production bases in Weihai (Shandong Province), Germany, and Singapore. It also produces raw materials in-house, allowing it to independently control production quality and efficiency, thereby achieving volume growth through competitive pricing.

Currently, national policies are being relaxed. The National Medical Products Administration has stated that innovative medical devices will not be included in centralized procurement for the time being. At present, the focus of centralized procurement remains on medical consumables with high clinical usage, mature clinical application, high procurement value, and sufficient market competition.

Bluesail Medical remains committed to the path of independent R&D for high-end medical devices. Over the four-year period from 2018 to 2021, Bluesail Medical’s R&D investment reached RMB 1.34 billion. From BioFreedom® approved by the U.S. FDA and BioFreedom® Ultra approved by Japan’s PMDA earlier this year, to the XinKuo drug-eluting stent, XinXun balloon dilation catheter, and XinXun NC non-compliant balloon dilation catheter approved in China, and further to the domestic market approval of ChangYuan® intracranial balloon dilation catheter—the company’s first neurovascular product—BoTeng® has become the fifth product under Bluesail Medical’s high-value medical consumables segment to gain approval in China this year, and the seventh to be approved in major global markets. After years of investment and accumulation, Bluesail Medical’s products are poised to flourish worldwide.

This $1.135 billion mega-acquisition not only validates the value of sirolimus-eluting drug-coated balloons in the market, but also serves as a reassurance to the medical device sector, which has shown signs of anxiety in recent years. It demonstrates that a single star product and leading core technologies can still support high valuations, and companies characterized by innovation, focus, and sustainability remain promising.

Reference Article: “Chinese Expert Consensus on the Clinical Application of Drug-Coated Balloons”

“MedAlliance to be Acquired by Cordis”——MedAlliance Official Website