SHANGHAI, April 30, 2025 /PRNewswire/ -- JediCare Medical Technology Co., Ltd. a Shanghai, China based company ("the Company"), jointly with West China Hospital of Sichuan University, recently announced the successful completion of first-in-human ("FIH") feasibility study of its innovative, propriety pulmonary nodule excision device—the "Pulmonary Nodule Grabbing System", the world's first-of-its-kind pulmonary nodule percutaneous sphere resection device.
The prospective, single-center, single arm, FIH feasibility study was aimed to evaluate the safety, efficacy and usability of the JediCare's Pulmonary Nodule Grabbing System in percutaneously removing pulmonary nodule by Percutaneous Sphere Resection ("PSR"). To date, 8 patients were treated by this ultra-minimal invasive procedure and device, successfully meeting the end points set for this FIH study. the PI of the study and leader of the approach has been Prof. Lunxu Liu, MD, Executive Vice President of West China Hospital of Sichuan University and Director of the Thoracic Oncology Institute of the hospital.
The study confirms that the PSR procedure using the Grabbing System can accurately remove a suspected pulmonary nodule together with adequate margin of healthy tissue surrounding it, in a safe, operator friendly percutaneous way, thus allowing for full pathology as well as significantly preserve pulmonary function. The highly innovative, single use Grabbing System can remove pulmonary nodule ≤10mm in diameter with only a 3mm entry point in the skin. Under imaging guidance, the Grabbing System is accurately advanced to the target nodule. Then, the spherical excision device of the Grabbing System is progressively deployed via the device sheath to encapsulate the nodule and surrounding parenchyma. Its distal electrosurgical lasso-like part excises the tissue by applying electric energy to coagulate the margins after excision, mitigating bleeding risks. The excised tissue sample is capsulated and remains hermetically sealed within the device for extraction, leaving a 15mm spherical resection cavity within the lung parenchyma. During three months postoperatively, this cavity is gradually filled by adjacent lung tissue through physiological healing process. By avoiding the structural disruption, the PSR procedure can minimize lung parenchymal loss, preserving nearly 95% of pulmonary function post-procedure compared to VATS.
The development of the PSR procedure and the Pulmonary Nodule Grabbing System, once regulatory approved, will be a game changer in handling early-stages of the disease, allowing fast recovery, and easing the anxiety of patients. It expected to be the next generation product and procedure that propelled the evolution of pulmonary surgery from minimally invasive thoracoscopic techniques to ultra-minimal invasive percutaneous approaches, heralding a new era for thoracic surgery.
Ms. N, a 54-year-old woman, was the first patient treated with the PSR procedure and the Grabbing System. In 2021, "A nodule with approximately 4mm in diameter was detected on my right lung during routine health exam" said Ms. N, "Follow-up imaging in 2023 showed that the nodule was growing. Initially it was recommended by some physicians to continuous monitoring this nodule while others suggested surgical resection. I felt very anxious and confused" continued Ms. N, "Faced with conflicting medical advices (observation vs. open surgery) and in psychological distress over potential malignancy or excessive tissue removal losing lung function, I sought consultation with Prof. Lunxu Liu."
On October 25, 2023, Prof. Liu's team performed PSR procedure on her. Histopathology result confirmed the nodule as adenocarcinoma in situ (IASLC 2021). Recovery from the procedure was very fast, with only bandage covering the 3mm puncture on the skin and no serious bleeding or pain. The 12 months follow up showed no recurrence, preserved lung function (FEV1: 2.68 before procedure vs. 2.64 three-months post procedure), and substantial ease of Ms. N's anxiety.
"Conventional minimally invasive surgeries for pulmonary nodules today, including thoracoscopic wedge resection, segmentectomy, and lobectomy, need to remove significant portions of healthy lung tissue thus not only effect patients' pulmonary function, but also limit the option for earlier intervention of small nodules. The PSR procedure is the world's first to enable en bloc removal of pulmonary nodule ≤10mm through a 3-mm skin incision, a procedure which redefines minimally invasive pulmonary surgery."
Prof. Lunxu Liu, MD, stated, "This innovative PSR procedure addresses current therapeutic goals and unmet needs for low-grade indolent tumors or early-stage lung cancers (e.g., ground-glass opacity-dominant lesions) and precancerous lesions, while minimizing surgical trauma. West China Hospital of Sichuan University is the first in the world to complete human feasibility study for the PSR procedure, preliminarily confirmed the safety and efficacy of the Grabbing System. We will work with JediCare to expedite the adoption of the Grabbing System to additional medical centers in China, and to enable the early excision of high-risk pulmonary nodules while preserve patient's pulmonary function by the PSR procedure."
Mr. Sun Fei, Founder and CEO of Jedicare: "JediCare, jointly with West China Hospital of Sichun University have achieved millimeter-level precision excision capability for pulmonary nodules, the first time globally. JediCare remains committed to address clinical challenges and unmet needs in lung cancer through innovation, providing smart and cost effective solutions to patient. To date, several of Jedicare's developed innovation thoracic surgical devices have been approved in China. By establishing a global, diversified patent portfolios covering image processing algorithms, minimally invasive device design, trade secrets and proprietary production processes, JediCare has built barriers for competition. Jedicare is actively exploring pathways to bring "China innovations" to the global stage."
About JediCare:
JediCare Medical Technology Co., Ltd., founded in 2018, focuses on developing and commercialization of integrated solutions for diagnosis and treatment of early stage pulmonary nodules/lung cancer. The Company has developed ultra-minimal invasive digital surgical platform integrating "AI+AR" (augmented reality navigation and minimally invasive surgical instruments). To date, it has pioneered innovations including a monocular vision-based head-mounted augmented reality navigation system, single-use 3D pulmonary nodule localization device, and single-use Pulmonary Nodule Grabbing System. In 2024, JediCare was recognized as an "Top Performer in the AI Medical Device Innovation Challenge" jointly announced by the Ministry of Industry and Information Technology's Department of Science and Technology and the National Medical Products Administration's Department of Medical Device Registration of China.
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SOURCE JediCare Medical Technology Co., Ltd.
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