Oray Medical's FolliCT Laser Navigation System Receives NMPA Approval, Advancing Precision in Lung Nodule Biopsy and Lung Cancer Intervention
Lung cancer is the leading cause of cancer-related mortality worldwide, with approximately 350 people dying from the disease each day in the United States. In China, lung cancer also ranks first in mortality among all malignant tumors, with a five-year survival rate for advanced-stage cases of less than 10%. As the smoking population grows and air pollution worsens in China, the number of individuals affected by lung cancer continues to rise, with patients increasingly trending toward younger age groups. The national government has been consistently promoting early screening, diagnosis, and treatment of lung cancer. Since the vast majority of early-stage lung cancers present as pulmonary nodules on CT scans, accurately determining whether these nodules are benign or malignant is of critical importance.
Pathological examination after percutaneous needle biopsy of pulmonary nodules is the gold standard for lung cancer diagnosis., enabling definitive determination of tumor type and facilitating timely treatment for patients. However, percutaneous needle biopsy of pulmonary nodules under CT or DSA guidance is technically challenging, requiring substantial operator experience and skill. The puncture angle and depth must be judged subjectively by the operator, resulting in lower accuracy. Improper technique may lead to complications such as pneumothorax, pulmonary hemorrhage, or even pulmonary embolism, which can be life-threatening in severe cases. Additionally, 6–8 scan iterations are typically required to identify the target location; if patient positioning changes before or after scanning, repeat scans may be necessary, posing risks of excessive X-ray radiation exposure to both patients and medical staff.
Auride Medical Technology (Shanghai) Co., Ltd. (hereinafter referred to as “Auride”) has launched the FolliCT Laser Navigation and Positioning System, which assists physicians in localizing pulmonary nodules and performing puncture procedures, with the aim of making percutaneous puncture of pulmonary nodules simpler and faster.The product had previously obtained CE certification, was launched overseas, and gained widespread application. In April this year, FolliCT received approval from the NMPA, officially commencing its clinical use in China.
With the widespread adoption of low-dose computed tomography (LDCT) screening, an increasing number of pulmonary nodules are being detected. Since 5%–10% of pulmonary nodules may progress to early-stage lung cancer, accurately distinguishing between benign and malignant nodules is critical for the prevention and early management of lung cancer.
Currently, clinical decisions are primarily based on the growth of pulmonary nodules over a six-month period. When the probability of malignancy is low (typically associated with smaller nodule volume), regular follow-up is generally recommended. Conversely, if the pulmonary nodules exhibit rapid growth within six months and the likelihood of malignancy is high, surgical resection followed by pathological examination may be performed directly. However, this approach involves significant uncertainty, and patients often face challenges in adhering to regular follow-up schedules.
According to Ye Li, Deputy General Manager of Aurui Medical, “The emergence of minimally invasive puncture technology has helped patients determine the nature of pulmonary nodules at an earlier stage. Among the population aged 15 and above in mainland China, approximately 411 million people have pulmonary nodules. Of these, 30% (those with nodules measuring 8 mm or larger, or multiple nodules) require puncture biopsy, meaning that around 130 million individuals need this procedure. Although tens of millions of patients require puncture biopsy annually, currently fewer than one million patients undergo biopsy puncture (including surgical localization and ablation therapy).”
Percutaneous puncture of pulmonary nodules is technically challenging, testing physicians’ familiarity with human anatomical structures and their ability to mentally reconstruct three-dimensional lung anatomy, while also relying on their clinical experience. Moreover,During percutaneous lung nodule biopsy, physicians must perform multiple CT scans to locate the puncture site and determine the puncture angle and depth.，Generally, it takes experienced medical personnel more than 30 minutes to perform a percutaneous puncture procedure.。
Currently, there is a shortage of physicians in China proficient in percutaneous needle biopsy for pulmonary nodules. Due to the uneven distribution of medical resources, highly skilled specialists are predominantly concentrated in tertiary hospitals located in first-tier cities. However, the majority of patients reside in second- and third-tier cities or rural areas, where awareness of treatment and diagnostic capabilities are insufficient, leading to late detection of lung lesions. Many patients thus reach the stage requiring biopsy to determine whether the nodules are benign or malignant. Nevertheless, the overload at tertiary hospitals and the inability of primary care facilities to perform these procedures often delay patient diagnosis and treatment.
Aurite’s FolliCT laser positioning system specifically addresses the pain point of percutaneous puncture for pulmonary nodules. This integrated hardware-software product automatically calculates the puncture site and angle based on CT images, and generates a puncture path. By following this path, physicians can accurately reach lesions measuring 8 mm or larger.
According to Ye Li: “With the FolliCT system, physicians can complete needle puncture localization with only two to three scans, thereby reducing the number of CT scans, minimizing radiation exposure for both patients and medical staff, and improving surgical efficiency. Typically, clinicians with a certain level of clinical experience can master the operation after brief training, and the percutaneous puncture procedure can be completed within 15 minutes.”
The FolliCT laser positioning system reduces the difficulty of percutaneous lung puncture, facilitating the decentralization of percutaneous lung biopsy and tumor ablation procedures to second- and third-tier cities and rural areas.
Regarding percutaneous puncture for pulmonary nodules, current innovations in China are primarily focused on magnetic navigation systems or puncture surgical robots; however, their high cost remains a barrier to clinical adoption. In recent years, some companies have also leveraged AI imaging technologies to assist physicians in diagnosing pulmonary nodules. On this matter, Ye Li stated, “AI imaging is mainly used for preliminary screening or partial diagnosis, which can help reduce overtreatment to a certain extent. Nevertheless, pathological biopsy remains the sole gold standard for lung cancer diagnosis, providing a definitive ‘yes’ or ‘no’ answer.”
Currently,FolliCT has entered more than 60 hospitals in Europe, Australia, Hong Kong (China), and Taiwan (China), achieving an installed base of nearly 100 units.Meanwhile,Auride has entered into strategic partnerships with multiple internationally renowned medical imaging companies, leveraging their advanced imaging equipment and robust channel resources to promote solutions to clinical departments.。
The technology behind the FolliCT system originated from a project team at the University of Oslo in Norway. Similar to many university research teams, their primary strengths lie in R&D and product design. Although they successfully achieved product commercialization and market entry in Europe, they remain relatively weak in sales and marketing.
Based on a thorough evaluation of the product’s technology and leveraging the team’s strengths in commercialization, Bai Tao, CEO of Aoruide, together with co-founder Ye Li and their founding team, acquired the company. This move transformed FolliCT into a fully independent brand and relocated its Norwegian manufacturing operations to the Netherlands and China, where it established its own production facilities and R&D centers. The integration of technological innovation with market expertise has driven the brand’s rapid growth. In 2020, Aoruide obtained CE certification and ISO 13485 certification in Europe; in 2023, it secured registration approval from China’s National Medical Products Administration (NMPA).
The Auride team is not only introducing innovative technologies from overseas but also continuously optimizing and iterating them on the basis of localization.
Following the introduction of the FolliCT product, the company has progressively optimized its core components, such as enhancing chip miniaturization and functional integration. This transformation has turned a bulky device requiring complex computations into one that is quick to operate and highly portable, while also improving equipment stability to ensure computational accuracy remains unaffected by temperature, humidity, and other environmental factors. Meanwhile, AuruiDe is integrating its supply chain within China.Currently, the localization rate of key components for FolliCT has exceeded 80%, and its R&D iteration and production are no longer constrained by overseas suppliers.。
Ye Li stated, “All of our products are designed for global markets. The country of origin for their core components is not critical; product details such as shape and color can be adapted to suit different sales regions. We will strengthen collaborations with both domestic and international enterprises, focusing on product iteration, strategic planning, logistics, and global procurement.”
"Behind international development lies solid team support and rich resource integration."
Bai Tao, CEO of Aoruide, has over 30 years of experience in the medical device industry. Having co-founded two companies, he is a serial entrepreneur with extensive expertise in team building and corporate management. Vice General Manager Ye Li specializes in precision medical devices and has worked for several renowned domestic and international medical device companies, bringing nearly 30 years of experience in medical equipment marketing and market promotion.
Li Jianbin, the company’s Director of Production and QA, has previously worked for renowned medical device companies both in China and abroad. He also co-founded two enterprises and one publicly listed company, bringing extensive experience in the research and development, production, and quality control of medical devices. Wu Jinsong, the Technical Director, holds a background in biomedical engineering. Having served at multiple well-known medical device firms domestically and internationally, he has participated in the development of various medical equipment products and possesses profound technical expertise and R&D experience.
Meanwhile, Aoruide collaborates with numerous renowned universities and hospitals both domestically and internationally, incorporating feedback from frontline research and clinical practice. The company adheres to a “bring in, go out” model, with a subsidiary established in the Netherlands serving as the hub for building connections with multiple European hospitals to facilitate academic exchanges and clinical education, thereby leveraging significant local advantages in its overseas expansion.Currently, Aoruide is gradually developing markets in the Middle East, South Asia, and the Americas.。
In the future, Aurui De will strengthen the clinical promotion of FolliCT products, covering as many hospitals in second- and third-tier cities as possible to facilitate the broader adoption of percutaneous puncture technology for pulmonary nodules. Meanwhile,The company also plans to expand its product line into the field of oncology therapeutics., with the aim of establishing strategic partnerships with companies specializing in microwave ablation, radiofrequency ablation, and cryoablation, to build a comprehensive solution for the diagnosis and treatment of pulmonary diseases.
Ye Li stated, “Currently, ablation technology is widely used in the treatment of thyroid, breast, liver, and prostate tumors, but few companies apply it to lung tumor therapy. This is primarily due to the high difficulty and risks associated with percutaneous pulmonary interventions. Guided by our puncture navigation system, the procedural complexity can be reduced, enabling more primary-care physicians to master percutaneous lung puncture techniques. Consequently, companies in the ablation field will be more inclined to develop their products for the treatment of pulmonary diseases.”
Previously, Aurede had completed its Pre-A round of financing. It is reported thatThe company is planning to launch its Series A financing round.。