Lisheng Medical Files IPO Prospectus: Pioneering Breast Minimally Invasive Solutions with Global Cryo-Technology

As the field of interventional oncology heats up, the market for minimally invasive interventional procedures for breast cancer appears to have been “forgotten.”

Unlike common cancers such as lung cancer and colorectal cancer, breast cancer is not associated with a high mortality rate. The cure rate for early-stage breast cancer can reach 80%–90%, and even in advanced stages, there are numerous treatment options available. Consequently, clinical practitioners and the industry have historically paid limited attention to minimally invasive therapies for breast cancer.

According to data released by the International Agency for Research on Cancer (IARC) of the World Health Organization, there were 2.26 million new cases of breast cancer and 2.2 million new cases of lung cancer worldwide in 2020.Breast Cancer Replaces Lung Cancer as the World's Most Common Cancer.In the same year, approximately 420,000 new cases of breast cancer were diagnosed among Chinese women, with a trend toward younger age at onset.

The rising number of patients and a tumor interventional market scale worth tens of billions are all stimulating the innovation capabilities of Chinese medical enterprises.Lisheng Medical focuses on the track of minimally invasive interventional procedures for breast conditions, with its business spanning tumor diagnosis, tracking and localization, minimally invasive interventional therapy, and patient management. The company has launched the Cassi directional vacuum-assisted biopsy system and the Bikang breast tissue marker products, while also independently developing the Cassi handheld cryoablation device.

Since 1999, Li Chenguang, founder of Lisheng Medical, has been active in the medical device industry, having held positions at several multinational corporations. During his years working for foreign enterprises, he observed that many high-quality products were monopolized by imports, indicating that there is still a long road ahead for the localization of medical devices. With a deep-seated aspiration to build a domestic brand, he firmly believes in developing products that are high in quality, easy to operate, and affordable for patients.

In the field of interventional oncology, Li Chenguang has dedicated four years to clinical practice, primarily managing tumors of the liver, lungs, and other sites. Through his collaboration with the Department of Interventional Radiology, he identified a significant demand among breast cancer patients for minimally invasive treatment options. At that time, early screening for breast cancer was not widely adopted, and many patients required surgical mastectomy or lumpectomy upon diagnosis.

“Minimally invasive interventional procedures for breast conditions will certainly see significant development in the next 3–5 years.” Guided by this conviction, Li Chenguang established Lisheng Medical in Shanghai.

“Accumulation + Opportunity” has shaped Lisheng Medical’s development path of “Acquisition + In-house R&D.”On one hand, Lisheng Medical independently plans and develops its own products; on the other hand, the company introduces advanced overseas technologies through acquisitions to rapidly enter the market.

In 2014, Cyon Medical Technology acquired 100% ownership of Sanarus Corporation (USA) and its breast cryo-biopsy system along with related patented technologies. Subsequently, in 2015, the company fully acquired Beacon Corporation (USA) and its breast markers along with related patented technologies.In 2019, Lisheng Medical acquired Saion Medical Technology as a wholly-owned subsidiary.

Prior to founding Lisheng Medical, Li Chenguang had long served as the distributor for products from Saion Medical. In its early stages, Lisheng Medical focused on interventional products related to those of Saion Medical, while Li Chenguang continuously contemplated the company’s future strategic direction. Opportunities always favor entrepreneurs who are prepared and visionary. As the original owners of Saion Medical approached retirement, Lisheng Medical decided to acquire the company.

“First, Saion Medical holds multiple core products, global patents, and registration certificates in the field of minimally invasive interventional therapy for breast cancer. Upon acquiring this company, we can rapidly transition into the medical device manufacturing sector. Second, my original intention in founding the startup was to build a distinguished Chinese brand. By starting with the introduction of advanced technologies and products, we can save considerable time and effort, thereby compensating for the company’s early-stage product deficiencies. Building on existing technologies and patents, we can collaborate with clinical experts to identify further innovative opportunities and extend our current solutions.”

Overseas technologies and products are not ready for immediate use upon acquisition, and the localization process is rarely smooth. Overseas companies’ technologies are primarily developed based on Caucasian populations in Europe and America, whose physiological characteristics differ slightly from those of Chinese individuals, necessitating product adaptations. Moreover, the production of imported products relies on foreign raw materials and advanced manufacturing processes, where domestic enterprises may face slight shortcomings in hardware capabilities.

On its path to localization, Lisheng Medical has progressed steadily and methodically. The company has retained the entire system of Saion Medical, implementing quality management systems and factory infrastructure in accordance with international standards. Lisheng Medical’s Shanghai R&D and Sales Center occupies 1,000 square meters of office space, while its production centers in Jiangsu and Hunan feature 4,000 square meters and 1,300 square meters of cleanroom and office space, respectively. Additionally, the company maintains branch offices in Austin, United States, and Madrid, Spain.

Breast cancer has a high cure rate in its early stages. Over 80% of breast cancer cases clinically present as breast lumps. Early screening and diagnosis can help improve the overall cure rate and reduce mortality.Breast tissue biopsy is the gold standard for breast cancer diagnosis., including open surgical biopsy, fine-needle aspiration biopsy, and core needle biopsy.

Core needle biopsy, a commonly used clinical procedure, offers high accuracy. In this technique, physicians insert a spring-loaded needle through a skin incision into the lesion to obtain tissue samples; the hollow, spring-loaded device can be repeatedly fired into the target area. However, this biopsy method is time-consuming and demands considerable expertise and experience from the operator. Typically, 6–8 passes are required to acquire sufficient breast tissue. Moreover, due to its hollow design, the tip of the core needle is relatively soft, whereas breast masses are generally firm. Consequently, the needle is prone to deviation, or insufficient insertion depth may result in inadequate sample volume per pass.

Lisheng Medical Launches Cassi Directional Cryo-Coring Biopsy System with No Forward Thrust Action.The product features a guide needle at the front end to facilitate positioning of the rear-end rotating cutting needle, thereby minimizing sampling deviation and other tissue injuries.. Meanwhile,Through globally exclusive cryogenic technology, breast tissue can be adhered to the needle wall, ensuring that surrounding tissue does not easily detach during the vacuum-assisted biopsy sampling process after the physician activates the device, thereby increasing the effective tissue yield per sample.. Therefore, sampling with the Cassi system generally requires only 1–2 needle insertions, significantly reducing surgical trauma and improving procedural efficiency.

Since the end of 2019, Shanghai Lisheng Medical Technology Co., Ltd. has begun promoting the Cassi system in the Chinese market. To date, Cassi products have been adopted by nearly 40 hospitals across China. Meanwhile, the next-generation Cassi III, rebranded as a domestically produced product under Kexin, obtained its NMPA registration certificate in November 2021. The needle device independently developed by Shanghai Lisheng Medical is not only used for breast biopsies but also covers biopsy diagnoses for other soft tissue tumors, and it is scheduled to be launched on the market next year. With this milestone, Li Chenguang’s dream of developing domestically produced medical devices has truly taken its first step.

Furthermore, breast tissue markers can be placed into the lesioned breast tissue to visualize the biopsy site under radiographic imaging, facilitating precise preoperative localization, follow-up tracking, and neoadjuvant chemotherapy.The Bikuan Breast Tissue Marker, launched by Lisheng Medical, features a simple design and precise positioning, with minimal risk of displacement after implantation.。Moreover, the marker is clearly visualized under ultrasound, CT, and MRI.

Building on its existing cryoablation technologies and products, Lisheng Medical is also developing minimally invasive interventional therapy products for breast cancer.

Clinically, the treatment of breast cancer is primarily based on surgical procedures to remove the primary tumor and reduce the risk of recurrence. However, mastectomy may cause certain physiological and psychological impacts on patients. Moreover, as breast cancer patients are becoming increasingly younger, there is a higher demand for postoperative breast aesthetics. Therefore, minimally invasive breast-conserving therapy has emerged in clinical practice in recent years.

Cryoablation technology is being gradually introduced into the minimally invasive treatment of breast cancer. Previously, several leading medical institutions in the United States, including Cornell University, Mayo Clinic, and MD Anderson Cancer Center, formally published reports in the Annals of Surgical Oncology, the official journal of the American Society of Breast Surgeons (ASBrS) and the Society of Surgical Oncology (SSO), indicating that cryoablation is a viable alternative to traditional surgery for many patients with early-stage breast cancer.

Cryoablation, as an interventional therapy for breast cancer, offers the advantages of minimal invasiveness, favorable therapeutic efficacy, and a potential reduction in recurrence rates. However, cryoablation has certain limitations; compared with thermal ablation, it is less efficient, and the argon and helium gases previously used in many cryoablation procedures have been difficult to source, resulting in high equipment manufacturing costs. Building on the technology and design of the Cassi cryobiopsy system, Shanghai Lisheng Medical Technology Co., Ltd. aims to develop a user-friendly and cost-effective cryoablation product for breast cancer treatment.

“In the field of minimally invasive interventional therapy for breast cancer, Lisheng Medical will adopt a two-step strategy: first addressing benign breast tumors, and then tackling malignant breast cancer.”

On the path of innovative R&D, Lisheng Medical is not “alone”; behind the company are university research teams from Shanghai Jiao Tong University and Soochow University, alongside partners such as Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, and The First Affiliated Hospital, Zhejiang University School of Medicine.

“Guided by the market demand for minimally invasive interventional procedures in breast cancer and supported by a high-efficiency execution team, Lisheng Medical will next focus on bringing the Cassi cryo-biopsy system and tumor marker products to market, developing cryoablation products, and expanding its industry influence. In the future, we hope to participate in the disease management of breast cancer patients by integrating our products with big data and artificial intelligence.”

Reference Article: “Saving the Breast! Cryoablation for Early-Stage Breast Cancer Without Surgery”