Tangji Medical's Gastrointestinal Bypass Stent System Granted FDA Breakthrough Device Designation

MDCE CRO Successfully Supports Hangzhou Tangji Medical Technology Co., Ltd.Gastric Bypass Stent System Received FDA Breakthrough Device Designation in October 2024.This achievement not onlyMarking the era represented by Tangji MedicalChinese Innovative Medical Device Companies Take a Milestone Step in the U.S. Market, Poised to Benefit Global Metabolic DiseaseA Revolutionary Breakthrough in Patient TreatmentMDCE CRO will leverage its extensive network of overseas academic experts, along with its outstanding overseas clinical trial and global registration services, to continue driving the international expansion of innovative Chinese medical devices. In doing so, it aims to make greater contributions to the sustainable development and enhanced global competitiveness of Chinese pharmaceutical companies, as well as to the health and well-being of patients worldwide.

Official Letter from the U.S. Food and Drug Administration (FDA)

Hangzhou Tangji Medical Technology Co., Ltd. is a national high-tech enterprise dedicated to building an innovative platform for gastrointestinal interventional therapies, related medical devices, and disease management solutions. It has successivelySuccessfully developed multiple new medical technologies targeting patients with metabolic disorders, including type 2 diabetes, obesity, and non-alcoholic steatohepatitis.

The “Gastric Bypass Stent System” received approval for a Class III Innovative Medical Device certificate from the National Medical Products Administration on January 17, 2024, becoming the world’s first Class III innovative medical device registration certificate for endoscopic intestinal intervention in the treatment of obesity.

This technology employs a minimally invasive endoscopic approach to implant and secure a composite membrane tube, supported by a nitinol stent, in the duodenum and proximal small intestine. During bypass, the membrane tube isolates food from contact with the intestinal mucosa in the upper small intestine, directing it straight into the distal segments. This alteration modifies the process of food digestion and absorption, reduces caloric intake, and thereby achieves weight loss and improvement of metabolic diseases.

In this project, the client’s initial strategy for demonstrating eligibility for Breakthrough Device Designation (BDD) was to “directly infer the advantages of the BDD indication from data on domestically innovative medical devices.” However, through in-depth research into U.S. regulations and clinical literature, MDCE CRO compared the subject device with other standard-of-care (SOC) treatments and found that the arguments under this approach were insufficient to effectively support the application. In response, MDCE CRO promptly adjusted the regulatory strategy, proposed a new line of reasoning and indication recommendations, and assisted the client in rewriting and resubmitting the BDD application materials based on more compelling evidence.

● Strategy Formulation:MDCE CRO identified insufficiencies in the original rationale through comprehensive regulatory and clinical literature reviews, proposed novel argumentation strategies and indications recommendations, and assisted the client in resubmitting the application materials.

● Global Registration Services: MDCE CRO provided Tangji Medical with comprehensive overseas registration services. In particular, during the FDA approval process, the MDCE team assisted in preparing key technical documentation and successfully addressed multiple FDA regulatory requirements, thereby accelerating the approval process and enabling rapid advancement of the device through the FDA review procedure.

● Compliance and Regulation:In terms of compliance, MDCE CRO ensures that all submitted documents meet the high standards of the U.S. FDA, helping Tangji address regulatory challenges during the review process.

This FDA Breakthrough Device designation not only recognizes the innovation and clinical potential of the Gastric Bypass Stent System, but also grants it priority premarket review status, laying a solid foundation for its entry into the United States—the world’s most stringent and mature medical market. Meanwhile, more patients with metabolic diseases worldwide are expected to benefit from this breakthrough technology, further enhancing Tangji Medical’s global competitiveness. MDCE CRO will continue to support the globalization of Chinese enterprises, facilitating the entry of more innovative products into international markets.

“Tangji Medical has always been driven by innovation and patient-centricity, continuously advancing the transformation of metabolic disease treatment. We are delighted to partner with MDCE CRO in successfully securing FDA Breakthrough Device Designation for our Gastric Bypass Stent System.”This significant milestone not only marks a solid step forward in our journey to enter the U.S. and global markets, but also lays an important foundation for future international multicenter studies.“We look forward to leveraging this innovative technology to bring more effective treatment options to patients with non-alcoholic steatohepatitis (NASH) worldwide, thereby benefiting millions of individuals with metabolic diseases.”

—Zuo Yuxing, Founder of Tangji Medical

“We are honored to have supported Tangji Medical’s gastric bypass stent system in obtaining the FDA Breakthrough Device designation. This success not only”This demonstrates MDCE CRO’s professional expertise in the registration of complex medical devices and further showcases the potential of China’s innovative medical devices in the global market. As an innovative therapeutic solution, the “Gastric Bypass Stent” is bringing new hope to patients with metabolic diseases.“MDCE CRO will continue to dedicate itself to providing global regulatory registration and clinical trial support to more Chinese medical enterprises, facilitating the smooth entry of their innovative products into high-standard international markets and promoting the development of China’s pharmaceutical industry on the global stage.”

—Deng Xiaoyu, Founder of MDCE CRO

MDCE CRO is a pharmaceutical and medical device R&D outsourcing service company with global clinical trials as its core business. Leveraging Harvard University’s global medical research resources and academic influence, MDCE CRO has established a comprehensive overseas service value chain, providing customized global expansion solutions for Chinese biopharmaceutical and medical device enterprises. Its services encompass overseas clinical development strategy and design, management and operations of overseas clinical trials, overseas product registration, and international commercialization planning. Since its inception, MDCE CRO has successfully facilitated the overseas launch of more than 60 biopharmaceutical and medical device projects, generating cumulative overseas profits exceeding RMB 20 billion for its clients. Currently, MDCE CRO boasts an in-house overseas clinical trial team of over 100 professionals, collaborates with more than 2,000 experts, and has partnered with over 100 renowned overseas hospitals, covering regions including the European Union, North America, Australia and New Zealand, Southeast Asia, Japan and South Korea, the Middle East, and Africa.