Domestic Innovative Absorbable Magnesium Alloy Stent Company Achieves Full Industrial Chain Integration, Poised for Market Leap

Bioabsorbable Stents Are Sparking the Fourth Revolution in Coronary Intervention.

According to Frost & Sullivan's analysis report, the market size of fully bioresorbable stent products in China is projected to grow from RMB 200 million in 2019 to RMB 6.6 billion in 2030,Compound Annual Growth Rate (CAGR) of 38.5%This is undoubtedly a market with enormous potential.

The primary function of a coronary stent is to maintain arterial patency by providing sufficient structural support to the diseased vessel during the healing phase. Once vascular healing is complete, the stent has fulfilled its “mission.” Traditional coronary stents remain permanently within the patient’s vasculature. Over time, this persistent presence can restrict normal vascular motion, induce chronic and sustained inflammation, and subsequently lead to in-stent restenosis (defined as a ≥50% reduction in luminal area on post-procedural coronary angiography, which may occur in both the early and late postoperative periods). Additionally, it may predispose patients to thrombosis, thereby increasing the complexity of disease management.

Is there a stent that can restore diseased blood vessels to their natural state, or even to “pristine condition,” after achieving the effects of dilating narrowed vessels and releasing anti-restenosis drugs? Inspired by this concept, leading global medical device companies have devoted themselves to the research and development of “bioresorbable stents.” The key lies in identifying a material that can “gracefully withdraw” at the appropriate time after fulfilling its therapeutic role, being completely absorbed by the human body.

Compared to traditional stents,Patients with bioresorbable scaffolds do not require lifelong anticoagulant therapy, reducing the risk of bleeding., patients stand to gain greater long-term clinical benefits. On the other hand, as traditional drug-eluting stents have been included in volume-based procurement programs, capital has also begun to focus on composite innovative stents.

Bioabsorbable Stents Are Becoming the New Trend in Coronary Intervention

Based on material classification, bioresorbable scaffolds are primarily divided into two major categories: bioresorbable polymer scaffolds and bioresorbable metal scaffolds. The former is predominantly composed of poly-L-lactic acid (PLLA), while the latter includes three types: magnesium alloys, iron alloys, and zinc alloys.

Bioabsorbable polymer scaffolds were the first to be commercialized, with numerous companies in China and abroad adopting this approach. Internationally, Abbott’s Absorb GT1 from the United States is representative of this class, while two similar products have also been approved in China. Relevant clinical study results indicate that poly-L-lactic acid (PLLA) scaffolds require particular attention regarding target lesion failure rate, target vessel myocardial infarction, scaffold thrombosis, and application in small vessels. Further research and analysis also suggest that improving the clinical performance of bioabsorbable polymer scaffolds necessitates continuous enhancements in their mechanical properties, structural integrity, inflammation control, and degradation rate.

Stents made from absorbable metallic materials, particularly magnesium alloy stents, have gained increasing recognition within the industry for their advantages after years of scientific research and clinical practice.

From the perspectives of mechanical properties and biocompatibility, polylactic acid (PLA) exhibits significantly inferior mechanical and physical properties compared to metallic materials. To maintain sufficient radial support, PLA stents must be designed with greater thickness, wider struts, and higher vessel coverage, which subsequently hinders endothelialization, activates platelets, and promotes thrombosis. In contrast, magnesium alloys provide adequate support without increasing stent thickness, thereby minimizing early elastic recoil after implantation. Furthermore, the primary degradation product of bioresorbable magnesium alloy stents is magnesium ions, an essential element for the human body that poses no harm. Upon complete degradation of the stent, the artery can restore its original morphology and function, exhibiting vasomotor responses comparable to those of healthy vessels.

From the perspective of degradation cycle, polylactic acid stents have a degradation period of at least three years, which means they may continuously trigger inflammatory responses in patients for an extended period. AndAbsorbable magnesium alloy stents fully degrade within approximately one year in the human body, after which patients no longer require dual antiplatelet therapy (DAPT). This offers substantial benefits, particularly for patients at high risk of bleeding and those with clopidogrel resistance.。

China’s “Chinese Expert Consensus on the Clinical Application of Bioresorbable Coronary Stents” recommends that patients with stable coronary artery disease undergoing bioresorbable stent implantation should receive dual antiplatelet therapy (DAPT) for at least 12 months post-procedure to reduce the risk of stent thrombosis. The nursing care requirements for bioresorbable magnesium alloy stents closely align with the recommendations of the Expert Consensus, thereby facilitating their practical clinical application.

In summary, magnesium alloy stents are emerging as a high-growth potential segment within the field of bioresorbable stents. However, controlling the degradation timeline of magnesium alloys is by no means an easy task.Magnesium exhibits high chemical reactivity; if control measures are inadequate, magnesium alloys will fully degrade within an extremely short period after implantation in the human body, failing to achieve the intended outcomes of interventional procedures.Therefore, achieving stable and effective control over the degradation rate of magnesium alloys has become the core technical challenge, significantly raising the R&D threshold and excluding most companies from this high-potential sector.

Recently, Biotronik announced the 5-year follow-up results of the BIOSOLVE-II study. The results showed that the incidence rates of target lesion failure (TLF) (8%) and target lesion revascularization (TLR) (5.6%) with the Magmaris scaffold were lower than those observed in the drug-eluting stent (DES) arm of Abbott’s first-generation Absorb study at 5 years post-procedure (TLF: 11.6%; TLR: 5.8%). Furthermore, no definite cases of scaffold thrombosis were identified throughout the entire 5-year follow-up period. Magmaris is a bioresorbable magnesium alloy scaffold.

Turning our attention to the domestic market, a veteran player in the vascular intervention industry based in Beijing, China, is currently on par with its German counterparts and jointly maintaining a leading position.

A corporate executive from Beijing Amsino Medical Instruments Co., Ltd. stated, “As early as 2013, when we were marketing drug-eluting stents (DES), we recognized that bioresorbable stents would likely gradually replace traditional stents in the future. At that time, most domestic players flocked to the market for bioresorbable polylactic acid stents. However, after careful analysis and evaluation, we ultimately chose to pursue the track of bioresorbable magnesium alloy stents, initiating our early-stage research.”

Founded in 1999, Amsino has established a broad presence in the coronary, neuro, and peripheral intervention markets, making it a veritable “veteran” in the field of vascular interventions.

Eight years ago, Amsino embarked on early explorations in the field of bioresorbable magnesium alloy stents. Four years ago, it initiated industry-academia collaboration with relevant national key laboratories, implementing comprehensive improvements starting from raw materials—including magnesium alloy composition, smelting, processing, stent structure, drug coating, and manufacturing processes—ultimately controlling the degradation rate within the range required for clinical applications.

When discussing the transition to a new track, company management recalled: “To control the degradation rate of magnesium alloy stents in the human body, achieving technological breakthroughs at only one or two points is certainly insufficient; it is essential to approach the issue from the perspective of the entire industry chain. ThereforeFrom the outset of its entry into the magnesium alloy sector, the company has adhered to a core philosophy: maintaining autonomous control over the entire industry chain, spanning from material R&D and processing to product development and manufacturing."If we continue to follow the conventional path and position ourselves in the mid-to-downstream segments, it will likely be unsustainable in the long run."

In 2019, Amsino welcomed a new management team and attracted a cohort of innovative talents in the medical device sector. With professional backgrounds in international investment banking and capital operations, the new leadership strengthened Amsino’s engagement with top-tier investment institutions such as CITIC Securities and CICC, while further deepening university-industry collaborations.The Company collaborates with Academician Pan Fusheng’s team at Chongqing University in the field of absorbable magnesium alloys, with Academician Zhang Xingdong’s team at Sichuan University in the field of biomaterials, and engages in comprehensive clinical cooperation with Capital Medical University.

In just three years, Amsino’s bioresorbable magnesium alloy coronary stent and infrainguinal artery bioresorbable magnesium alloy stent have demonstrated favorable mechanical properties and biocompatibility. After implantation in the human body, they provide effective support for three months, then begin to degrade, and are fully absorbed within approximately one year.To date, Amsino has submitted its below-the-knee magnesium alloy stent for type testing, and its coronary magnesium alloy stent is also scheduled to be submitted for type testing within the year.

In previous animal experiments, researchers extracted blood vessels from animals that had been implanted with magnesium alloy stents for six months. The magnesium alloy stents had largely degraded, and the blood vessels at the implantation sites had regained their elasticity, achieving the goal of being “as good as new.”

Today, Amsino, by “taking the road less traveled,” has established a closed-loop, full-industry-chain for bioresorbable magnesium alloy stents and possesses the capacity to support mass production, thereby emerging as a key player in this sector.

Amsino’s executive stated, “The pandemic impacted the shipment speed of upstream overseas suppliers, thereby objectively serving as a litmus test for domestic pharmaceutical and medical device companies. Prior to Amsino, only one German company worldwide was capable of processing absorbable magnesium alloy rods into tubes. Now, no one can hold us hostage by choking off our supply.”

The market for bioresorbable stent companies encompasses not only the 11 million patients with coronary heart disease in China, but also the 45 million patients with lower extremity arterial disease.This is undoubtedly a market worth tens of billions.

In China, the worsening of high-risk factors for coronary heart disease (CHD), such as population aging, hypertension, diabetes, hyperlipidemia, and obesity, has driven a year-on-year increase in the CHD patient population, with an increasingly evident trend toward younger patients, thereby raising the demand for interventional therapy. Although coronary intervention is the earliest-developed and most localized interventional field in China, the domestic percutaneous coronary intervention (PCI) rate is only one-third of that in Europe and Japan and one-quarter of that in the United States, indicating that the market is far from saturated. Meanwhile, China’s peripheral vascular intervention market is also far from saturation, presenting substantial growth potential.

Bioabsorbable stents integrate the advantages of traditional drug-eluting stents and drug-coated balloons, providing sufficient radial support during the treatment of diseased vessels and subsequently degrading and disappearing after an appropriate duration, thereby achieving “scarless therapy.” However, even though bioabsorbable magnesium alloy stents demonstrate certain advantages over drug-coated stents, no products have yet received regulatory approval in the Chinese market. Compared with the substantial market size, there are very few domestically developed original bioabsorbable stents available.

The Fading Hype Around Absorbable Polymer Stents Offers an Opportunity for Chinese Players in Other Tracks. Some domestic companies are strategically positioning themselves for transformation, a welcome development. Whether homegrown innovative products can seize this historic opportunity to achieve overtaking on the bend remains to be seen.