Emibochuang Files IPO Prospectus for Its Yttrium-90 Microsphere Radioembolization Surgical Planning System

Boston Scientific and Grand Pharma have brought Yttrium-90 drug-eluting microspheres embolization into the clinical and investment spotlight.

As Yttrium-90 (Y-90) drug-loaded microspheres are scheduled for market launch, the promotion and supporting applications of interventional embolization procedures should also be prioritized. The high technical difficulty of Y-90 microsphere interventional embolization may pose a significant barrier to its clinical adoption.

To this end, Amibo Innovation has launched a Yttrium-90 microsphere radioembolization surgical planning system, dedicated to reducing the complexity of interventional embolization procedures and advancing precision therapy for patients with liver cancer.The system provides physicians with interventional embolization surgical plans preoperatively, and offers real-time navigation, real-time quantitative analysis of potential procedural risks, and pre-procedural alerts intraoperatively.

As a pioneer in the field of Yttrium-90 (Y-90) transarterial radioembolization systems, EmiBocreat is backed by a multidisciplinary team of four experts in simulation, medicine, and computer science. Among them, Dr. Dai Kun, the company’s CEO and a simulation expert, previously served as Technical Lead at QuEST, an engineering simulation consulting firm, where he led and participated in dozens of engineering simulation consulting projects for major corporations such as Pratt & Whitney, General Electric, and Boeing.

Dr. Wang Zixuan, Chief Expert in Medical and Product Architecture, has published more than 70 papers domestically and internationally; Dr. Zhu Hai, Chief Medical Expert, led fundamental research on prostate cancer that was awarded the Second Prize for Scientific and Technological Progress by Qingdao Municipality; and Dr. Qi Quan, Chief AI Algorithm Expert, has long conducted research in computer graphics and geometric reconstruction of human tissues.

With the necessary technology and expertise in place, the four PhDs began to consider how to apply the experience of senior physicians to clinical practice, thereby achieving interdisciplinary integration across clinical medicine, computer simulation, and artificial intelligence.

Guided by clinical needs, Aimibo Chuang has turned its attention to the field of interventional embolization.

China is the country with the highest cancer burden, recording the largest number of new cancer cases and cancer-related deaths annually.According to the latest 2020 global cancer burden data released by the International Agency for Research on Cancer (IARC) of the World Health Organization, there were 4.57 million new cancer cases and 3 million cancer deaths in China in 2020.

In the protracted struggle between humanity and cancer, surgery, radiotherapy, and chemotherapy remain the three most effective treatment modalities. For patients with early-stage cancer, surgical resection is the preferred therapeutic approach, as timely removal of the lesion can achieve a radical cure. However, the efficacy of surgical intervention is significantly diminished in patients with intermediate- to advanced-stage cancer.

Liver cancer has an insidious onset, with no symptoms apparent in the early stages, and is characterized by rapid progression and high malignancy. Approximately 70% of liver cancer patients are already at an intermediate or advanced stage at the time of diagnosis, losing the opportunity for surgical treatment, and thus mostly opt for non-surgical treatments. With the development of vascular interventional radiology,Tumor Interventional Embolization Becomes the First Choice for Non-Surgical Treatment of Liver Cancer Patients。

Interventional embolization therapy refers to the occlusion of abnormal tumor vasculature using embolic agents, thereby inducing ischemic necrosis. During interventional embolization procedures,The specific embolization sites and quantity are primarily determined based on the operator’s prior experience., leading to variability in surgical quality. Due to reliance on experience, some physicians are unable to accurately estimate the embolization site and drug dosage, potentially resulting in inadvertent embolization of normal tissues during the procedure and causing unnecessary organ damage.

Moreover, during interventional embolization procedures, physicians primarilyDetermining Blood Vessels and Embolization Sites via Two-Dimensional Imaging, making it difficult for some surgeons to distinguish overlapping vessels, which significantly increases surgical risk.

Due to the high radioactivity of the Yttrium-90 (Y-90) radionuclide, Y-90 radioembolization imposes more stringent operational requirements on the operator. Inadequate control over the injection site, dosage, or infusion rate may result in damage to normal organs caused by Y-90 microspheres.

Addressing the clinical needs and challenges of interventional embolization, the four founders of Aimibo Chuang quickly reached a consensus and embarked on the research and development of hardware and software related to yttrium-90 (Y-90) microsphere radioembolization, with a commitment to enhancing the accuracy, reliability, and homogeneity of interventional embolization procedures while reducing surgical risks.

“If we start by tackling the more challenging yttrium-90 microsphere embolization, we will also have the confidence to explore other interventional embolization systems.”

Leveraging core digital twin technology and deeply integrating fluid dynamics, 3D vascular reconstruction, and CFD-based drug radiation dose calculation, the Yttrium-90 microsphere radioembolization surgical planning system developed by Aimibo Chuangchuang enables preoperative surgical planning and provides precisely calculated infusion quantities of drug-loaded microspheres. During embolization procedures, the system facilitates real-time navigation, real-time quantitative analysis of potential operational risks, and pre-procedural alerts.

During the physician's infusion of radioactive microspheres, the system interface canReal-time Display of Microsphere Distribution in Blood Vessels. When the microspheres exhibit a distribution inconsistent with the surgical plan, or when they are at risk of entering vascular branches supplying normal tissues and organs, the system provides operational warnings and navigation guidance to the physician.

In the context of uneven distribution of medical resources, intelligent early warning and navigation systems for interventional embolization procedures can not only fundamentally reduce surgical risks and complications but also promote the widespread adoption of these procedures.

Currently,Amibochuang’s surgical planning system has completed the architecture for its modeling, computational fluid dynamics, and analytical software systems.. Next, the R&D team will leverage extensive human physiological data and animal studies to calibrate and iteratively refine the system, thereby enhancing its accuracy.

Currently, two yttrium-90 (Y-90) microsphere products are commercially available worldwide: Boston Scientific’s TheraSphere Y-90 glass microspheres and Sirtex Medical’s SIR-Spheres Y-90 resin microspheres (Sirtex was acquired by Grand Pharma in consortium with CDH Investments). The localization of both products in China is accelerating.

Boston Scientific transferred its yttrium-90 (Y-90) radioactive glass microsphere technology to NewJet Medical to facilitate the regulatory approval and domestic production of Y-90 microspheres in China. In November 2020, the National Medical Products Administration (NMPA) of China formally accepted the marketing authorization application for Grand Pharma’s Y-90 resin microspheres.

In October 2021, Grand Pharma’s Yttrium-90 resin microspheres completed their first clinical implantation in a liver cancer patient in China. Prior to this, the product had been used to treat over 100,000 patients across more than 50 countries and regions worldwide.

In addition, domestic enterprises Yunke Pharmaceutical and Keraichi are also actively developing Yttrium-90 microsphere products.

The entry of large enterprises and capital will accelerate the approval process for Yttrium-90 (Y-90) microspheres in China. Once the product is launched, a surge in surgical demand will flow to hospitals at all levels, creating a need for such a surgical system among less-experienced physicians at primary care institutions.

Amibo Innovation will seize key time nodes bySoftware Sales Model, Software Service Cooperation Model with Pharmaceutical Distributors, and Cooperation Model with Manufacturers of Digital Subtraction Angiography (DSA) X-ray Systems for Interventional SurgeryThree sales models are employed to promote the surgical system.

In the multi-billion-dollar interventional market, Amibo’s “ambitions” extend far beyond software.

Following the development of its intelligent navigation and early warning system for interventional embolization procedures, the company plans to develop an interventional embolization surgical robot to achieve intelligent and automated procedures, thereby shielding physicians from radiation exposure. The company also intends to launch AI-enabled interventional operating rooms, providing comprehensive solutions for interventional therapy.