Xishan Tech Launches China's First Domestic Breast Biopsy and Excision Needle, Set to Break Import Monopoly

On April 17, Chongqing Xishan Technology Co., Ltd. (hereinafter referred to as “Xishan Technology”), based in the Liangjiang Digital Economy Industrial Park, launched China’s first domestically produced sterile disposable biopsy needle for breast tissue. This follows its successful global rollout of eight independently developed stapler product lines on April 11. The new device will facilitate timely diagnosis and treatment of breast diseases in women, breaking the long-standing import monopoly in this category and achieving import substitution for similar products.

According to the latest statistical data from relevant authorities, the average age at diagnosis of breast cancer in China is 45 to 55 years, which is 10 years younger than that of Western women. There are approximately 278,900 new cases of female breast cancer annually in China, accounting for 16.51% of all malignant tumors in women and ranking first among female malignancies. It has become one of the malignant tumors seriously threatening the health of Chinese women, with some industry insiders referring to it as the “number one killer” of female malignant tumors.

Li Hongyuan, Chief Physician and Professor in the Department of Endocrinology and Breast Surgery at the First Affiliated Hospital of Chongqing Medical University, stated in an interview with reporters that breast diseases are common and frequently occurring conditions. They currently represent a major threat to women’s physical and mental health. In recent years, factors such as anxiety, insomnia, staying up late, excessive alcohol consumption, smoking, and poor dietary habits—often triggered by high work and life stress—have led to dysregulation of endocrine system function in many women, resulting in a continuously rising incidence of breast diseases.

“Breast diseases are primarily categorized into five major types: mastitis, mammary gland hyperplasia, breast fibroadenoma, breast cysts, and breast cancer. The etiological factors are complex; if treatment is delayed or inappropriate, pathological changes may occur, potentially even life-threatening complications.”

Reporters learned during interviews that as early as 2017, the Health Examination Center of Southwest Hospital affiliated with the Third Military Medical University released the “Chongqing Female Health Examination Report for 2016.” An analysis of the health examination records of 74,490 women showed that breast diseases and cervical cysts had the highest incidence rates, with breast diseases ranking first among young women.

In the same year, a citywide screening for breast diseases among women of childbearing age was conducted in Chongqing Municipality, covering 533,268 women across its 36 districts and counties. The average prevalence rate was 36.06%, with the incidence showing an upward trend as age increased.

“Before 2000, most patients underwent biopsy to determine the extent of disease, with surgical excision selected for lesion removal. At that time, fine-needle aspiration biopsy was commonly used but yielded a certain rate of inaccurate diagnoses. Open surgical biopsy achieved better diagnostic outcomes but involved larger wounds and greater tissue trauma. After 2000, vacuum-assisted minimally invasive breast biopsy and rotational cutting biopsy systems were introduced into China, significantly improving diagnostic accuracy and procedural success rates (reaching 98%–100%).”

“Since 2000, China has lacked domestically produced brands of vacuum-assisted breast biopsy and excision systems. Hospitals in China have relied entirely on imported products, which entail high equipment and consumable costs, thereby imposing a substantial financial burden on patients. After three years of dedicated research and development, our company is launching today a sterile, single-use breast biopsy needle that better aligns with the clinical practices of physicians in the Chinese market. This product also helps reduce proportional national healthcare insurance expenditures and lowers treatment costs for patients.”

Guo Yijun, Chairman of Xishan Technology, stated in an interview with reporters that approximately 300,000 patients in China require breast biopsy or surgical treatment using breast biopsy and vacuum-assisted excision systems each year. Based on an average cost of RMB 5,000 per procedure for consumables and equipment usage, the annual market sales volume for these products is estimated at RMB 1.5 billion. If domestic products were to fully replace imports, it would not only significantly reduce medical and health insurance expenditures but also make substantial contributions to the recruitment of scientific research talent, job creation, and tax revenue.

“With regard to surgical resection, the traditional surgical approach for breast conditions is open surgery. This method causes significant trauma, resulting in severe pain, substantial bleeding, slow postoperative recovery, and aesthetic impairment due to scarring on the skin surface and residual nodules in the internal breast tissue. The single-use sterile breast biopsy needle integrates rotational cutting with biopsy sampling into a single device. It not only minimizes incision size and enhances surgical efficiency but also spares patients the distress of undergoing two separate procedures.”

“Xishan Technology has launched a single-use sterile breast biopsy needle today, which adopts the vacuum-assisted biopsy (VAB) method to address the issue of insufficient tissue sampling associated with other biopsy techniques. This approach facilitates more accurate differentiation between benign and malignant breast lesions and yields more pathological data, thereby enabling more precise and effective treatment plans for patients.”

“To date, the use of breast biopsy and vacuum-assisted excision systems has become well-established and widespread in hospitals across China. These procedures are convenient to perform and yield sufficient tissue samples for diagnosis. However, the breast biopsy and vacuum-assisted excision systems and consumables commonly used in clinical practice are entirely imported, resulting in high prices and elevated costs for acquisition, accessories, operation, and maintenance, which in turn leads to high treatment costs for patients.”

“In addition to the single-use sterile breast biopsy needle launched today, our vacuum-assisted biopsy (VAB)-based breast biopsy and excision system will also be brought to market in the near future, thereby achieving comprehensive import substitution across both equipment and consumables.”

Through further interviews, the reporter learned that the current main methods for breast mass biopsy include: open surgical biopsy (OSB), fine-needle aspiration cytology (FNAC), core needle biopsy (CNB), and vacuum-assisted biopsy (VAB).

Among these, open surgical biopsy (OSB) has drawbacks such as significant trauma, prolonged operative time, and high costs; postoperative scar formation and breast deformation are poorly accepted by many female patients. Fine-needle aspiration (FNA) and core needle biopsy (CNB) suffer from limitations including small tissue sample volumes and incomplete preservation of tissue architecture in the specimens. The obtained samples are prone to histological underestimation, which may delay timely treatment, result in an inadequate understanding of the biological characteristics of breast cancer, prevent accurate determination of the tumor’s extent of invasion, and even potentially induce tumor metastasis.

According to Guo Yijun, as of now, apart from Xishan Technology, no other domestic manufacturers produce breast biopsy and vacuum-assisted excision systems, making us the first in China.