Breakthrough in Embolic Microspheres: Haowei Medical Redefines Drug-Eluting Beads for Interventional Oncology

The landscape of interventional oncology is undergoing new changes.

First, transarterial chemoembolization (TACE) has become the preferred treatment for intermediate-to-advanced stage primary liver cancer, as recommended by the "Guidelines for Diagnosis and Treatment of Primary Liver Cancer"; second, embolic microspheres have been included in the scope of centralized procurement; third,China’s First Absorbable Embolic Microspheres for Uterine Fibroid Embolization Successfully Enter Clinical Trials(Developed by Suzhou Haowei Medical Technology Co., Ltd., hereinafter referred to as “Haowei Medical”).

It is evident that TACE is gradually transitioning from its traditional role as an adjunctive therapy to a central pillar in the comprehensive treatment of solid tumors.

Driven by the national centralized procurement policy and domestic innovative forces such as Haowei Medical, the market for domestically produced microsphere technology is continuing to expand. This growth is facilitating the decentralization of diagnosis and treatment for diseases such as liver cancer, lung cancer, and uterine fibroids to primary healthcare institutions, while establishing localized application pathways through clinical practice, thereby laying the foundation for large-scale technological adoption.

A New Era of Interventional Oncology Has Arrived.

TACE can be divided into conventional TACE (cTACE) and drug-eluting bead TACE (D-TACE).

Unlike cTACE, D-TACE primarily employs drug-eluting beads as the embolic agent, offering dual efficacy by both occluding blood supply and providing sustained local drug release. This approach increases local drug concentration within the tumor, thereby achieving the dual goals of optimizing therapeutic efficacy and controlling systemic toxic side effects. Extensive studies have confirmed that, compared with cTACE, D-TACE significantly reduces systemic exposure to chemotherapeutic agents and the incidence of related adverse events.

Across domestic and international markets, although related products have been launched, significant challenges remain, including incomplete embolization, suboptimal drug release efficiency, pronounced patient pain, and clinical benefits falling short of expectations. As with other medical device products, technological innovation in drug-eluting microspheres still requires continuous iteration to achieve performance breakthroughs.

Guo Ping, General Manager of Haowei Medical, and his team possess over a decade of experience in underlying technology development, industrialization, and commercialization. They have successfully achieved sales records of RMB 1 billion for a single product, with more than 20 products obtaining domestic and international certifications.As a leading pioneer in the field of microspheres in China,Guo Ping believes that the current directions for improving embolic microsphere technology mainly focus on two dimensions: optimizing the embolization efficacy of materials and enhancing drug delivery capabilities., and identified a way to overcome the performance bottlenecks of existing drug-loaded microspheres. In summary, this can be categorized into three points:

In terms of embolization efficacy, embolic materials have been upgraded from traditional particulate formulations to microsphere systems,The next step in technological evolution will focus on uniform-sized microspheres.Both domestic and international studies have confirmed that microspheres with uniform particle size can penetrate the distal vasculature to achieve more thorough embolization. Meanwhile, highly elastic microspheres can achieve conformal embolization by adapting to changes in vascular morphology, further enhancing occlusion efficacy.

In the Improvement of Drug Loading and Release Performance, existing drug-loaded microspheres are limited by their surface charge characteristics and are mainly suitable for carrying positively charged drugs.Embedding positively charged functional groups into the microsphere matrix via chemical modification techniques enables the loading of negatively charged drugs and facilitates the encapsulation of biological agents, including peptides, proteins, antibodies, and even viruses.

In terms of optimizing the release mechanism,To address the issues associated with existing non-degradable materials, such as significant inter-individual variability in drug release and unstable blood drug concentrations resulting from reliance on ion exchange,Biodegradable drug-loaded microspheres achieve concentrated drug release within a specific time frame by regulating the material degradation cycle,Holds promise for overcoming the efficacy bottlenecks of conventional techniques, advancing interventional therapy into the era of precise controlled release.

Based on this logic, Haowei Medical has established microspheres technology as its core competitive barrier.Leveraging dual technology platforms of microspheres and hydrogels, we focus on the R&D of sustained-release local therapeutic devices, formulations, and drug delivery materials.Established a robust product pipeline,Comprehensive Solutions for Drug Delivery and Localized Therapy.

Guided by the aforementioned strategic thinking, Haowei Medical overcame challenges in materials and formulations, developing UniPearls with independent intellectual property rights.^®Embolic Microspheres, UniPearls^®not onlyOvercomes the drawbacks of poor elasticity and inadequate vascular conformability associated with previous-generation polyvinyl alcohol (PVA) microspheres., alsoOvercame numerous challenges to produce microspheres with uniform particle size, thereby compared to the previous generation of non-uniform particle size microspheresCan access more distal peripheral vessels to achieve a more thorough embolization effect。

It is worth mentioning that, as of now, Haowei Medical's uniformly sized Unipearls^®Drug-eluting embolic microspheres were approved in November 2023 and August 2024, respectively.FDA and NMPA Marketing Authorization; its new generation of biodegradable drug-eluting microspheres has initiated Phase I clinical trials and completed enrollment of the first cohort of subjects; under the new surgical procedure, HiFlamingo, which is compatible with embolization microspheres,^®The balloon occlusion catheter received NMPA market approval in April 2024, HiSwan^®Steerable Microcatheter Received NMPA Marketing Approval in January 2025

Uniform particle sizeUnipearls^®Drug-Eluting Embolic MicrospheresIt is one of the core products of Haowei Medical.

At the outset of developing this product, the Haowei Medical team recognized that,The particle size of embolic microspheres has a significant impact on the efficacy of tumor embolization. Microspheres with smaller particle sizes and a narrow size distribution, can penetrate deeper into the terminal tumor vasculature, effectively inhibit the establishment of collateral circulation, reduce the risk of residual perfusion, and thereby promote complete tumor necrosis. Microspheres with a broader particle size distribution are relatively dispersed; larger particles may block smaller ones from reaching the distal vessels.In contrast, embolic microspheres with uniform particle size tend to aggregate more within blood vessels. They are better suited to meet the requirements of segmental embolization based on varying vessel diameters in current TACE therapies, thereby achieving superior clinical outcomes.It is based on this logic that Haowei Medical has created UniPearls.^®Drug-eluting embolic microspheres, which received formal FDA approval in 2023.

Subsequently, the team iteratively upgraded the product to createSecond-Generation Uniform-Sized Drug-Loaded Embolic Microspheres: UniPearls^®(NMPA Registration No. 20243131548).

This product utilizes sodium polyacrylate-polyvinyl alcohol material., primarily used for the treatment of liver tumors and metastatic liver cancer from colorectal cancer, etc., featuringUniform particle size, rapid drug loading in 5 minutes, high elasticity, comprehensive specifications, and reduced patient painand other characteristics. AsThe Only Drug-Loaded Microspheres with Uniform Particle Size Among Similar Materials Worldwide, it ensures deep penetration of microspheres into the terminal tumor vasculature to form dense emboli, enabling drug release in closer proximity to tumor tissue. This enhances the thoroughness of embolization while significantly reducing clinical procedure time and physicians’ radiation exposure. During the procedure, physicians can complete drug loading through a simple mixing step, thanks to a rapid drug-loading design that further optimizes the operational efficiency of interventional therapy. Compared with previous-generation PVA microspheres, these microspheres do not shrink after drug loading and do not rebound after drug elution, thereby reducing pain caused by vascular irritation during treatment. Coupled with a comprehensive particle size range from 70 μm to 1000 μm, they better meet clinical requirements for varying vessel diameters and desired embolization effects.

Haowei Medical has developed HiFlamingo to meet the delivery needs of drugs and embolic materials.^®Occlusion Balloon Catheter, HiSwan^®Adjustable-curve microcatheters, Swan-neck microcatheters, and other ancillary products,Jointly Develop an Integrated Solution for Interventional Targeted Therapy with Synergistic Pharmaceutical and Device Components. By inflating the balloon within the tumor-feeding artery to alter local hemodynamics, the occlusion balloon catheter significantly enhances the retention efficiency of embolic agents and drugs in the tumor region during TACE procedures, while effectively preventing ectopic migration of embolic materials, thereby optimizing therapeutic efficacy through mechanistic improvement.

HiFlamingo, as a Core Supporting Product^®Occlusion Balloon Catheter: Its technical design fully embodies a clinical needs-oriented approach. The product adopts a coaxial dual-lumen structure, enabling independent operation of drug injection and balloon occlusion. With a distal outer diameter of only 2.1F, the catheter can navigate into small vascular branches to perform precise treatments. The 6mm compliant balloon accommodates occlusion requirements for the vast majority of vessel diameters, while the 0.5mm inner lumen is compatible with the delivery of various specifications of embolic materials.

HiSwan^®Steerable MicrocatheterThe steerable microcatheter is the latest generation of superselective microcatheters. Its distal tip direction can be adjusted via a dial handle, with Haowei Medical’s products supporting up to 180° of deflection. Featuring full-body radiopacity, it enables rapid navigation through complex vasculature and stenoses for precise superselection. With a maximum inner lumen diameter of 0.021″ (0.53 mm), it offers high-flow and large-volume infusion capabilities to meet diverse clinical needs.

With HiFlamingo^®Occlusion Balloon Catheter System, HiSwan^®The Launch of Steerable Microcatheters, Coupled with UniPearls^®Drug-Eluting Embolic Microspheres Approved for Market Launch in China and the US: Haowei Medical’s Tumor Interventional Product Portfolio Provides Clinicians with More Powerful Tools, Inevitably Elevating Embolization Therapy Techniques and Outcomes to New Heights.

Haowei Medical has achieved remarkable success in just four years since its establishment. However, the team has not rested on its laurels; instead, it continues to regard innovation as the core driver of development, dedicated to researching and developing innovative products with clinical value.

The team recognized a significant product and market gap in China for drug-eluting absorbable microspheres, as existing radioactive microsphere materials offer poor cost-effectiveness and their clinical efficacy has reached a bottleneck. Therefore, while continuing to advance existing products such as UniPearls^®As drug-eluting embolic microsphere technology undergoes iterative advancements, the team has also proactively established a strategic presenceChina's First LifeSpheres^™Absorbable Embolic Microspheres, seize the technological high ground of the industry.

The core advantages of absorbable embolic microspheres lie inAchieving rapid drug release holds significant value in the treatment of malignant tumors and supports repeated therapeutic interventions. For benign conditions, it not only effectively treats the underlying disease but also preserves quality of life and normal physiological functions; for instance, it can effectively treat uterine fibroids while preserving fertility, and manage benign prostatic hyperplasia without impairing sexual function. According to animal experimental data from Haowei Medical, compared with non-degradable microspheres, absorbable embolic microspheres nearly double the drug release rate, achieving a release rate of close to 100% in physiological saline.

According to Haowei Medical's test data, LifeSpheres, independently developed by Haowei Medical^™Absorbable embolic microspheres combineSuperior biosafety, adjustable degradation cycle, controlled drug release, and elasticity and suspension properties tailored to meet the needs of clinical interventions.such characteristics, outperforming similar foreign products across multiple indicators.

LifeSpheres^™Absorbable embolic microspheres can be hydrolyzed into carbon dioxide and water under physiological conditions for excretion from the body, with residual substances cleared via the kidneys and intestines. They are characterized by excellent hydrophilicity, good biocompatibility, uniform particle size, superior suspendability and elastic deformability, and stable delivery performance.

Currently, the clinical trial conducted by Haowei Medical for this product is the first clinical study in China on the use of absorbable embolic microspheres for the treatment of uterine fibroids. With favorable safety and efficacy feedback, the study has entered a phase of rapid, large-scale enrollment.Patient enrollment and follow-up are scheduled for completion in 2025, LifeSpheres^™Expected to be approved for market launch in 2026.

Furthermore, Haowei Medical is also actively exploring cutting-edge technologies such as radioactive microspheres to deliver more precise and effective treatment regimens for patients through innovative therapies.

Since last year, the field of peripheral interventions has launched a large-scale centralized volume-based procurement process.

Following the implementation of the national centralized procurement, the alliance-based centralized procurement for peripheral interventions, led by Gansu Province, was also successfully carried out. The procured categories included microcatheters, microwires, gelatin sponges, embolic adhesives, and embolic microspheres for peripheral vascular interventions. Subsequently, Henan Province rapidly initiated volume-based follow-up procurement for neurovascular and peripheral interventions. In this centralized procurement, Haowei Medical actively responded to the national call, offering Chinese-made products with uniform particle size at the lowest price.Successfully Selected for the Centralized Procurement Enterprise List. Given such superior product quality and pricing, despite having no historical sales volume at the time of its initial launch,Over 100 hospitals have adopted UniPearls^®Drug-eluting embolic microspheres, with adoption by numerous top-tier tertiary hospitals in China. In the Henan provincial centralized procurement program, occlusion balloon catheters also successfully won bids.

From Haowei Medical’s strategic choice to proactively embrace centralized procurement, one can readily discern its underlying logic of deep cultivation in the medical field:The ultimate realization of corporate value lies in enabling innovative technologies to break through the barriers of high-end markets and translate into clinical value that benefits the general public.

Leveraging the centralized procurement policy, Haowei Medical will accelerate the penetration of its core products, such as drug-eluting microspheres and embolization balloon catheters, into county-level hospitals and remote areas. This initiative aims to extend precise interventional therapies for conditions like liver cancer and uterine fibroids to a broader patient population, ensuring that ordinary citizens have access to internationally recognized first-line treatment regimens. Moving forward, Haowei Medical will reshape the market landscape through a strategic combination of innovative positioning and comprehensive coverage. By establishing differentiated competitive barriers based on technologies such as uniform particle size and biodegradable materials, and by expanding into diverse clinical scenarios including vascular surgery, the company will extend its product applications from single-disease tumor treatment to meet a wider range of interventional needs.

In terms of its marketing system, Haowei Medical pioneered the “Four-Wheel Drive” marketing model, matching different resources with distributors based on their respective strengths and capabilities, empowering partners through multi-dimensional support for mutual growth. Meanwhile,In 2025, the company has cumulatively signed distribution agreements in dozens of countries, while simultaneously accelerating the expansion of its business footprint both domestically and internationally.

When innovation is no longer confined to technological breakthroughs in the laboratory, but resonates deeply with policy directions, market dynamics, and patient needs, enterprises will gain not only commercial growth but also long-term vitality centered on the practice of technology accessibility.