Project Overview:
In March 2025, DK Medical Technology (Suzhou) Co., Ltd. led by MDCE CRODKutting®International Multicenter Randomized Controlled Trial (RCT) Project on the Use of Scoring Balloons in the Treatment of Stenosis in Artificial Blood Vessels(ClinicalTrials.gov NCT06503692) The kick-off meeting was successfully held at the National University Hospital of Singapore. This is another key milestone for the project following the ethical review approval in January this year.Marks DK Medtech's official entry into the implementation of overseas clinical trials and the commercial scaling phase, with global expansion entering the financial return period.This project is not only another successful case of scientific and technological cooperation between China and Singapore, but also a vivid practice of long-term diversified cooperation exploration between the two countries in the field of medical technology.
Group Photo at the Launch Event
*The main researcher in the middle is Prof Jackie Ho Pei, Fellow of the Royal College of Surgeons of England, Fellow of the Royal College of Surgeons of Edinburgh, and Fellow of the Hong Kong Academy of Medicine. The MDCE CRO Singapore team and the DK Medtech Singapore team also provided on-site support.
Project Overview: Singapore Clinical Trials Facilitate Global Market Layout
Developed independently by DK MedtechDKutting® Scored Balloon Dilation Catheter, adopts an exclusive patented design (CN201810478242.X), and is equipped withGood passability, uniform expansion, high burst pressureAnd many other advantages. Since its approval by the NMPA in November 2022, the product has been highly praised in the fields of peripheral vascular disease and hemodialysis access. Recently,DKutting® Scored Balloon Dilation Catheter SuccessfullyObtained EU CE MDR Certification, which represents that this innovative product has officially obtained the qualification for market entry and is steadily advancing into the European Union market.
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This project aims to leverage Singapore's world-class medical resources and rigorous clinical trial system to provide strong support for DK Medtech’s entry into the Southeast Asian market, further accelerating its global strategic layout and showcasing the independent research and development capabilities and outstanding quality of China-produced medical devices to the world.
This project joins forces with the team led by Professor Jackie Ho Pei from the National University of Singapore.Professor Jackie Ho Pei is an internationally renowned authority in the field of vascular surgery, holding multiple prestigious honors such as Fellow of the Royal College of Surgeons of Edinburgh (Edin), Fellow of the Royal College of Surgeons of England (FCS), and Fellow of the Hong Kong Academy of Medicine (FHKAM). She is also a fellow of the Western Vascular Society and the Asian Surgical Association. She currently serves as the Director of Endovascular Therapy in the Department of Cardiac, Thoracic, and Vascular Surgery (CTVS) at the National University Heart Centre, Singapore (NUHCS). As a leading figure in the field of endovascular therapy, she has driven innovation in clinical techniques and made significant contributions to the global development of vascular surgery.This project collaboration is expected to achieve new breakthroughs in the field of artificial blood vessel stenosis treatment, bringing more advanced treatment options to patients worldwide.Since the project began, MDCE CRO has been the long-trusted overseas partner of DK Medtech.Relying on a localized professional team and "registration + clinical + commercialization" one-stop serviceAbility, efficiently completing key steps such as data review, project initiation, and ethical approval, laying a solid foundation for subsequent trial progress and commercial scale-up.
Highlights of the Launch Conference: Efficient Collaboration and Professional Empowerment
Efficient Collaboration:MDCE CRO's Singapore team collaborates with clients and research centers through online and offline interactions, efficiently completing all agenda items of the kick-off meeting.
Professional Empowerment:Comprehensive training on key issues such as product introduction, trial protocols, data collection, and safety reports to ensure all parties fully understand the trial protocols and requirements.
Milestone Significance:The successful launch in Singapore marks the product's official entry into the overseas clinical implementation phase, further advancing its globalization process.
Why Choose MDCE CRO?
As a leader in China's medical device overseas CRO field, MDCE CRO has established localized service networks in the United States, Europe, Southeast Asia, and other regions, cumulatively promoting 80+ Chinese medical devices and biopharmaceutical products to the global market. With deep expertise in the details of Southeast Asia’s clinical trial regulations and practical operational challenges, we provide enterprises with:
- Overseas Clinical Trial Design and Execution Operations
- Local Research Centers, Investigators Quick Matching and Qualification Review
- Overseas Commercialization Planning
Prospect: Going Global, Shining with China's Innovation StrengthWith the successful conclusion of the launch meeting, this international multi-center randomized controlled clinical trial project has officially entered the subject enrollment phase. MDCE CRO will continue to ensure the smooth and efficient progress of the trial with its professional capabilities, assisting DK Medtech in achieving its global layout and commercial scaling as soon as possible, while further strengthening the exploration of scientific and technological cooperation between China and Singapore.Principal Investigator: Professor Jackie Ho PeiFellow of the Royal College of Surgeons of Edinburgh (Edin), Fellow of the Royal College of Surgeons of England (FCS), and Fellow of the Hong Kong Academy of Medicine (FHKAM), as well as a Fellow of the Western Vascular Society and the Asian Surgical Association, and a visiting scholar at Stanford University. Currently serves as the Director of Endovascular Therapy in the Cardiac, Thoracic, and Vascular Surgery Department (CTVS) at the National University Heart Centre, Singapore (NUHCS).Since its establishment in 2015, DK Medtech has always adhered to innovation as its driving force and has become a leading Chinese enterprise in the full range of interventional balloon innovations. It has developed more than ten types of balloons, including standard balloons, high-pressure balloons, scoring balloons, and drug-coated scoring balloons.Product lines cover almost all vascular interventional fields, including cardiovascular intervention, peripheral intervention, and neurointervention.The demand. Through its self-developed directional scoring technology, it has been applied in coronary scoring balloons, peripheral scoring balloons, and drug-coated scoring balloons. According to the published pre-market RCT studies of the products, their clinical performance shows significantly better clinical benefits compared to the imported control groups. It has achieved excellent results and a strong market position in niche markets and has signed multiple strategic cooperation agreements with well-known foreign companies such as Medtronic and Asahi Intecc.MDCE CRO is a medical device research and development outsourcing service company with global clinical trials as its core business.Relying on Harvard University's global medical research resources and academic influence, we build an overseas service full industry chain to provide customized overseas solutions for China's medical device enterprises. Services include overseas clinical development strategy and design, overseas clinical trial management and operation, overseas product registration, and overseas commercialization layout. Since its establishment,MDCE CRO has successfully assisted over80Medical device and biopharmaceutical projects have been successfully implemented overseas, with their professional services cumulatively bringing over20 BillionOverseas Profits of the RenminbiCurrently, MDCE CRO has an overseas clinical trial team of over 100 people, collaborates with more than 2,000 experts, and has signed agreements with over 100 well-known overseas partner hospitals, covering regions such as the EU, North America, Australia/New Zealand, Southeast Asia, Japan/Korea, the Middle East, and Africa.For intended cooperation, please scan the QR code below~
