Dingke Medical Files IPO Prospectus: Providing Comprehensive Balloon Solutions for Coronary Artery Disease and Hemodialysis Access

“Compared to the high level of domestication of drug-eluting stents, Chinese strength in balloon products will inevitably be the next keyword in the trend of domestic substitution,” said Weng Yulin, founder of DK Medtech.

As is well known, the concept of “intervention without implantation” has long been a pursued goal in percutaneous coronary intervention (PCI). Among the available solutions, bioresorbable scaffolds and drug-coated balloons have garnered significant attention in recent years. With Abbott’s Absorb BVS bioresorbable scaffold withdrawn from the global market in September 2017, the importance of drug-coated balloons has become increasingly prominent.

While drug-eluting stents have achieved a high degree of localization in China, the balloon catheter market—characterized by significantly higher usage volumes in interventional procedures—remains dominated by imported brands. How can Chinese manufacturers advance the localization of balloon products? And how can they demonstrate differentiation amidst intense competition? Recently, VCBeat conducted an exclusive interview with Weng Yulin, founder of DK Medtech, to address these questions.

Prior to founding his startup, Weng Yulin was a key R&D member at Biosensors International, the world’s fourth-largest manufacturer of drug-eluting stents. Leveraging his extensive experience in the development of implantable and interventional products, Weng identified the potential market opportunity for drug-coated balloons.

Cardiovascular disease, the leading cause of death globally, commands a market size worth tens of billions of US dollars, making it the second-largest segment in the medical device industry, surpassed only by in vitro diagnostics (IVD). In recent years, the volume of percutaneous coronary intervention (PCI) procedures in China has exhibited rapid growth. From 2009 to 2018, the number of cases increased from 228,000 to 915,000, representing a compound annual growth rate (CAGR) of 16.7%, with the domestic stent market reaching a scale of tens of billions of RMB. Among these, drug-eluting stents (DES) are high-value consumables that have pioneered import substitution in PCI procedures, with domestic brands currently holding a market share of over 60%. However, drug-eluting stents, as permanent implants, present certain limitations, such as the need for long-term antiplatelet therapy, difficulties in undergoing magnetic resonance imaging (MRI), in-stent restenosis, and late thrombosis.

“Against this backdrop, the emergence of drug-coated balloons not only helps address a series of issues associated with stents but also significantly meets the needs of patients who do not require stent implantation,” introduced Weng Yulin. In addition to their favorable clinical outcomes, the opportunity for drug-coated balloons is also reflected in the “relative blue ocean” of the domestic market. “The establishment of DK Medtech was precisely aimed at seizing this market opportunity,” stated Weng Yulin. In June 2016, he returned to China to start his business, founding DK Medtech in Suzhou BioBay, with a focus on the research, development, and manufacturing of various vascular interventional balloon products. Explaining the name “DK Medtech,” he noted that “Ding” (鼎) symbolizes top-tier excellence and a commitment to quality. “I hope that every detail of the products developed by DK Medtech will achieve outstanding and distinctive excellence,” said Weng Yulin.

Since settling in Suzhou in 2016 to completing its Series B financing in 2018, DK Medtech has maintained a trajectory of “fast yet steady” growth. According to Weng Yulin, DK Medtech has currently established a product portfolio of balloon kits targeting two major areas: “coronary heart disease” and “hemodialysis access.” In terms of product diversity and regulatory approval progress, the company holds a leading position among domestic brands.

“Coronary Artery Disease” Balloon Product Line: Covering a Series of Key Steps in PCI Procedures—Predilation, Adequate Preconditioning, Drug-Coated Balloons, and Post-dilation—Positioned as a Comprehensive Balloon Solution for PCI. “Hemodialysis Access” Balloon Product Line: Addressing the Heavy Economic Burden Faced by Hemodialysis Patients in China, This Line Offers a Portfolio of Low-, Mid-, and High-End Products at Different Price Points, Providing Diverse Options for Patients with Varying Financial Capacities.

Discussing the product line layout, Weng Yulin stated: "Our guiding principle for product line development is to prioritize essential needs—specifically, life-saving therapeutic devices are our top priority. Consequently, we have naturally focused on two critical patient populations: those with coronary heart disease and those requiring hemodialysis. DK Medtech undoubtedly ranks first among domestic manufacturers in terms of progress in its hemodialysis access product line."

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Why Does DK Medtech Focus on the Emerging Field of "Hemodialysis Access"?

According to Weng Yulin, approximately 80% of hemodialysis access maintenance procedures in the United States are performed via interventional surgery. With a population of 600,000 hemodialysis patients, around 1.2 million peripheral balloons are used annually in the U.S. In China, interventional procedures for hemodialysis access have experienced rapid and widespread growth since 2015. It is estimated that balloon usage in this field reached approximately 70,000 units in 2019, all of which were imported brands. In September 2017, BARD (now acquired by BD), a giant in the nephrology sector, received FDA approval for its peripheral drug-coated balloon, Lutonix, for the indication of "arteriovenous fistula stenosis," marking the dawn of the drug-coated balloon era in hemodialysis access intervention. In July 2019, Medtronic’s In.Pact AV also gained FDA approval, further underscoring the immense potential of drug-coated balloons in this field.

(Weng Yulin, Founder of DK Medtech)

Pain points in the interventional treatment of hemodialysis access include a high rate of restenosis. Highly fibrotic stenotic lesions, when subjected to high-pressure balloon dilation, suffer from severe irregular tearing of the intima, leading to excessive neointimal hyperplasia and poor prognosis. In percutaneous coronary intervention (PCI), scoring balloons and drug-coated balloons are readily available to address this issue through physical and pharmacological mechanisms, respectively. Considering the financial hardship faced by hemodialysis patients, DK Medtech launched the world’s exclusive “scoring drug-coated balloon” for hemodialysis access in 2017. This scoring drug-coated balloon integrates high-pressure dilation, scoring, and drug delivery into a single device, thereby reducing the number of devices required for each patient.

“This exclusive product has received unanimous recognition and anticipation from experts both domestically and internationally, making it highly likely to become a blockbuster in the international market.” Discussing the uniqueness and innovativeness of the “Scoring Drug-Coated Balloon,” Weng Yulin commented.

Leveraging its strong execution and innovation capabilities, DK Medtech has garnered favor from investment institutions such as Yuanhe Origin, Qiming Venture Partners, and Heyu No. 1. By 2018, the company had accumulated nearly RMB 100 million in investment. Discussing the company’s future development, Weng Yulin stated, “Apple is the company I admire most. From the MacBook and iPod to the iPhone and iPad, each has been a blockbuster product; essentially, they represent the same category of products perfected to the extreme. DK Medtech is the only Chinese company covering the full spectrum of balloon categories—plain, scoring, and drug-coated. We aspire to become the ‘Apple’ among balloon catheter companies.”

Weng Yulin is a trainee of the China Cardiovascular Doctors Innovation Club (CCI) and represented CCI at the innovative product roadshow during ICI 2019 in Israel. Regarding product innovation, Weng Yulin summarized, “Academician Ge Junbo once stated that true innovation must originate from physicians, as only they truly understand clinical needs. Every product developed by DK Medtech continuously incorporates physician feedback starting from the conceptual stage. Both now and in the future, DK Medtech will collaborate with clinicians to create high-quality domestically produced innovative products, benefiting more patients.”