Coreser Acquires XinZhi Medical to Enter Drug-Coated Balloon Market and Strengthen Coronary Intervention Portfolio

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Kossel Medtech (Suzhou) Co., Ltd. (hereinafter referred to as “Kossel”) has acquired Shanghai XinZhi Medical Technology Co., Ltd. (hereinafter referred to as “XinZhi Medical”), marking a key strategic move in its transition from a leading peripheral intervention company to a pan-vascular intervention platform enterprise, precisely seizing the industry transformation window of “intervention without implantation” in coronary interventions.Through this acquisition, Kossel has rapidly strengthened its core technologies in drug-coated balloons (DCBs), incorporating sirolimus- and paclitaxel-eluting balloon products into its portfolio, thereby securing strategically competitive technologies with global appeal. Meanwhile, the company has further perfected its coronary product matrix—comprising scoring balloons, drug-coated balloons, and drug-eluting stents—to deliver comprehensive clinical solutions.

From a development perspective, there is still room for the volume of PCI procedures in China to double, while the global penetration rate of drug-coated balloons remains low. Coupled with Kossel’s full-chain R&D and manufacturing capabilities and its mature commercialization network both domestically and internationally, the clinical penetration of its coronary products will continue to accelerate. This acquisition is not merely a reinforcement of product technology, but a key step for Kossel to align with industry trends and achieve a strategic brand upgrade. It opens up new growth spaces in coronary intervention and global development, highlighting strong long-term competitiveness and promising prospects.

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The medical device industry is undergoing a profound reshuffling driven by centralized procurement. According to IQVIA data, the Chinese medical device market reached RMB 487 billion in ex-factory value in 2025, representing a year-on-year growth of 1% and entering a period of deep adjustment. However, tempered by centralized procurement, the vascular intervention sector has emerged as a highly resilient growth engine within the industry, achieving a year-on-year growth rate of 8% in 2025, far exceeding the industry average.

Behind the differentiation lies the structural reshaping brought about by national centralized procurement. The sixth batch of national centralized volume-based procurement for high-value medical consumables, which has been implemented, focuses on drug-coated balloons and urological intervention consumables. For the first time, it introduces rules such as "anchor pricing," clearly opposing "involution" and leaving room for innovative products with clinical value. Centralized procurement is no longer a simple "price slash," but rather the core engine driving the industry's shift from price competition to value competition, accelerating domestic substitution and market consolidation.

In this industry environment, product innovation and mergers and acquisitions have gradually become important pathways for medical device companies to seek survival and development. Throughout the year, there has been a noticeable increase in the implementation of strategic initiatives by industry players focused on innovative R&D and capital-driven M&A activities.According to VCBeat, Kossel, a company in the peripheral intervention field, has recently completed the acquisition of Xinzhi Medical, a manufacturer of coronary drug-coated balloons.Following the strategic acquisition of Baiquantong Medical to strengthen its peripheral vascular intervention diagnosis and treatment segment, this acquisition marks another significant move by the company in the coronary intervention field. As industry consolidation accelerates, Kossel’s series of capital operations not only demonstrate its strategic capital allocation capabilities but also reflect the current development trends in the vascular intervention sector.

Kossel Acquires Xinzhi Medical, Strengthening Its Core Drug-Coated Balloon Technology Platform and Incorporating Sirolimus- and Paclitaxel-Coated Balloons into Its Coronary Intervention Product Portfolio

Kossel’s current M&A is based on two core judgments:First, the market potential for functional balloons is clearly expanding; second, innovative rapamycin-coated balloon technology has reached the tipping point for large-scale clinical application.。

In terms of market potential, the volume of drug-coated balloons has grown rapidly following centralized procurement. The concept of "intervention without implantation" is reshaping global standards for coronary diagnosis and treatment, with drug-coated balloons serving as the core vehicle for this transformation. Data indicates that the market size for general-purpose coronary balloons has declined after the implementation of centralized procurement.However, the market size for functional balloons, including scoring balloons, cutting balloons, nodule balloons, and drug-coated balloons, has achieved continuous growth.

Data Source: Frost & Sullivan

Kossel keenly captured this clinical trend, according to the founder and CEO of KosselHu QingIt stated: “Kossel has been deeply engaged in the vascular intervention field for over a decade, and the coronary market represents a significant sector worthy of strategic investment. In 2024, the volume of percutaneous coronary intervention (PCI) procedures in China reached 2.21 million. However, there remains a substantial gap in PCI penetration rates between China and developed countries. With an aging population and rising penetration rates, we project the ceiling for domestic PCI procedure volume to be between 4 million and 5 million, indicating that the market still has room to double. Furthermore, under the trend of ‘intervention without implantation,’ the application of drug-coated balloons (DCBs) in PCI procedures is continuously increasing, making this a critical window for industry transformation. Driven by centralized volume-based procurement in China, the proportion of DCBs in PCI procedures has exceeded 18%, whereas DCB penetration in overseas markets remains very low, suggesting that the global expansion of DCBs is just beginning.”

Data Source: Sullivan Analysis

Judged by technological maturity, sirolimus-coated balloons are approaching the threshold for large-scale application. Sirolimus-coated balloons are poised to become the next-generation mainstream solution.

Drug-coated balloons utilize either paclitaxel or rapamycin as the coating agent, with paclitaxel currently being the predominant choice. In fact, compared to paclitaxel, rapamycin offers advantages in terms of anti-restenosis efficacy, safety profile, and therapeutic scope, resulting in higher acceptance among physicians. However, a long-standing technical bottleneck previously hindered the adoption of rapamycin-coated balloons: the low lipophilicity of rapamycin made it difficult to achieve effective drug transfer to the vessel wall within a short timeframe, thereby allowing paclitaxel to dominate the market. In recent years, this technical barrier has been overcome, as innovative excipient technologies have resolved the challenge of poor adhesion of rapamycin to the balloon surface.

Xinzhi Medical is one of the few high-quality enterprises in China that has mastered the core excipient technology for sirolimus drug-coated balloons.Its independently developed sirolimus-coated drug-eluting balloon was approved for market launch by the National Medical Products Administration (NMPA) in 2025, placing its technological maturity and product development among the global first tier. The core value of Kossel’s current acquisition lies not only in completing its coronary drug-eluting balloon product portfolio but also in strategically positioning itself ahead of the curve in the iterative advancement of coronary intervention technologies, thereby securing a strategic product with globally differentiated competitive advantages.

Globally, sirolimus-coated drug-coated balloons (DCBs) are emerging as the new benchmark. At the 2025 Transcatheter Cardiovascular Therapeutics (TCT) conference, a key real-world study demonstrated that sirolimus-coated DCBs achieved non-inferior outcomes compared to stents in a real-world population comprising over 60% complex lesions and de novo large-vessel lesions. This indicates an industry trend toward sirolimus-based DCBs replacing certain traditional stents, highlighting significant market potential.

Executive President of KosselPan XingzhenIt pointed out: “The introduction of rapamycin-coated balloons represents a major breakthrough in the field of cardiovascular interventional therapy, providing clinicians with more treatment options. The advantages of rapamycin in anti-restenosis efficacy and safety profile have made it an innovative focus of attention for cardiologists worldwide, indicating substantial future global market potential.”

Hu QingHe stated, “The field of coronary drug-coated balloons features high technical barriers and stringent regulatory thresholds, with very few companies possessing true end-to-end competitiveness. Kossel has completed its global layout, and its U.S.-based R&D and manufacturing base serves as a strategic pillar for our participation in global competition. Based on this assessment, increasing investment in coronary solutions is Kossel’s strategic choice to evolve from a regional leader into a world-class vascular intervention platform.”

Following the acquisition of XinZhi Medical, Kossel successfully established a core coronary product portfolio comprising “spinous process balloons + dual-technology drug-coated balloons + drug-eluting stents.” This portfolio comprehensively covers all clinical scenarios in coronary intervention, including pre-procedural vessel preparation, intra-procedural implant-free therapy, and necessary stent implantation, thereby creating a systematic and integrated solution for coronary interventional diagnosis and treatment.

During the vessel preparation phase, the company’s core product, Seledora® Coronary Spur Balloon, precisely meets the pretreatment needs of complex coronary lesions, such as moderate-to-severe calcified lesions, effectively addressing clinical challenges in vascular pretreatment. The product has established a strategic promotional partnership with Medtronic and has been included in multiple regional centralized procurement catalogs. Following thorough clinical implementation and commercial validation, it has achieved solid market recognition.

In the balloon therapy segment, Kossel has acquired a dual drug-coated balloon (DCB) platform. Its paclitaxel-coated balloon features a unique MultiLayer PTX coating technology, ensuring uniform and robust adhesion with a drug loss rate of less than 15%. This product has been successfully selected in China’s national volume-based procurement program and is expected to benefit a large number of patients across the country. The sirolimus-coated balloon incorporates core proprietary technologies, placing it among the global leaders in development progress. Following the acquisition, Kossel will accelerate its clinical application, with plans to achieve commercialization in multiple international markets in the future.

In the stent field, Kossel offers ultra-thin-walled drug-eluting stents:MiStent® Absorbable Polymer-Coated Sirolimus-Eluting Coronary Stent SystemMiStent® Coronary Drug-Eluting Stent features proprietary supercritical fluid coating technology, which distributes sirolimus in a “crystalline” form within biodegradable PLGA polymer. This drug-eluting stent achieves rapid endothelialization through low initial drug release, while sustained elution occurs as the polymer degrades over time, balancing fast healing with prolonged therapeutic efficacy. The combination of thin-strut design and controlled degradation meets the requirements of precision PCI for long-term patency. MiStent® Coronary Drug-Eluting Stent has received regulatory approval, offering a novel clinical option for PCI procedures.

In addition to the aforementioned flagship products, Kossel also offers accessory products such as guidewires, hemostatic devices, and pressure pumps, catering to diverse clinical needs. This diversified product portfolio creates synergies in academic promotion and commercialization, accelerating Kossel’s penetration in the field of coronary intervention.

Through this, Kossel has formally established a platform-based layout featuring the synergistic development of four major product lines: peripheral intervention, coronary intervention, electrophysiology, and core medical raw materials, with these four business segments driving growth.

Kossel’s ability to continuously advance its precision-oriented product portfolio is fundamentally underpinned by its strategic focus and deep clinical insights cultivated through long-term dedication to the vascular intervention field. The acquisition of Xinzhij Medical represents a precise extension of Kossel’s product line, driven by unmet clinical needs and aligned with technological advancements in the industry. Over the next three to five years, the company will continue to intensify its investment in innovative R&D and clinical implementation within the coronary arena. Leveraging a comprehensive product matrix, Kossel aims to achieve high-density clinical coverage, further enrich its pan-vascular intervention pipeline, and accelerate the commercialization of more innovative medical devices with high clinical value, thereby solidifying its position as a leading platform enterprise in the industry.

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[1] The National Center for Medical Quality Control of Cardiovascular Diseases reported that the volume of PCI procedures reached 2.21 million cases in 2024.

[2] From 2019 to 2023, the proportion of drug-coated balloon usage was 6.4%, 10.9%, 15%, 17.6%, and 18.5%, respectively. — CCIF & CCPCC 2024.