Interpretation of the Blue Book on Special Scoring Balloons in Vascular Intervention and Strategic Outlook on DK Medical's Directional Scoring Technology – Arterial Select New Product Review Episode 52

Special Balloons as an Important Vascular Intervention Medical Device

On March 5, 2024, Frost & Sullivan (referred to as "Sullivan"), a global growth consulting firm, releasedBlue Paper on the Current Status and Development Trends of the Special Balloon Industry for Vascular Interventions. In the release of the Blue Book content, Frost & Sullivan summarized the technological development of special balloons mainly intoGuidewire technology, cutting technology, spinous process technology, mastoid technology andNotch Technology, these five major stages.

And as the latest stage of scoring technology, in addition to the current predominance of wire-based scoring upgraded from guidewire technology,DK MedtechDK Medical Technology Co., Ltd. (hereinafter referred to as "DK Medtech")Self-developed directional scoring technology：Made with metal winding technology, the cutting piece combines metal sharpness and flexibility, demonstrating excellent performance in dilating vascular stenosis., currently, whether in clinical actual use or market classification,All will classify directional scoring technology as a separate category.。

According to the official product information released by DK Medtech,CurrentlyThe production application of this technology is used in coronary scoring balloons, peripheral scoring balloons, and peripheral scoring drug-coated balloons., and according to the published RCT studies before the product's market release, the results showed a certain level of superiority compared to the control group.

Currently, DK Medtech is in the first tier in the field of hemodialysis access., not only excels in the commercial performance of traditional high-pressure balloons but also offers a comprehensive solution for various balloons in hemodialysis access. In July 2023,The world's first integrated "「High Pressure」、「Notch」、「Drug」"Three-in-One Peripheral Scoring Drug-Coated Balloon.With high burst pressure and high expansion success rate, the scoring reduces excessive vascular injury, and the drug coating inhibits postoperative intimal hyperplasia, solving multiple pain points with one product. The large-scale, multi-center clinical study (NCT04226599) of this product has proven that: without the need for pre-dilation, Dissolve AV achieved results comparable to the control group using imported high-pressure balloons.Comprehensive advantages including a higher success rate of dilation, larger lumen gain, less residual stenosis, and a higher rate of primary patency.。

Figure: Dissolve AV Peripheral Scoring Drug-Coated Balloon

DK Medtech, a local enterprise specializing in balloon development, began researching and developing the Dissolve AV scoring drug-coated balloon in 2017, which「High Pressure」、「Notch」、「Drug」Three functions combined, specifically designed for dialysis access stenosis, taking into account the actual conditions of Chinese renal dialysis patients, to create an innovative product with greater health economic value.

April 2 (Tuesday) 19:30, VCBeat New Product Review Session 52, invitedBoard Secretary of DK Medtech, Jin Wen; Partner of VCBeat & Dean of VCBeat, Jiang Tianjiao, bringing"Interpretation of the Blue Paper on Special Balloons for Vascular Intervention" Roundtable DialogueStrategic Outlook on DK Medtech's Directional Scoring。

1. According to the characteristics of stenosis in dialysis access, there are many high-resistance lesions with significant fibrosis, which require high-pressure balloons for adequate dilation during PTA procedures.

2. Traditional high-pressure balloons cause random and violent tearing during vascular expansion, leading to severe vessel damage that easily results in excessive intimal hyperplasia during the postoperative repair process.

3. Pressure-focused balloons (cutting/scoring) have fixed protrusions on the balloon surface that increase localized radial pressure on the vessel wall, achieving uniform and controllable expansion effects while reducing excessive damage to the blood vessel.

4. Paclitaxel has an anti-proliferative effect, which can inhibit the proliferation of vascular smooth muscle cells and the growth of the vascular intima. The application of paclitaxel-coated balloons in coronary and lower limb artery interventions has exceeded 10 years. Several drug-coated balloons (DCBs) have been approved for dialysis access indications in China and abroad, and their efficacy in prolonging patency time is gradually being recognized.

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Jin Wen

Board Secretary of DK Medtech

Formerly worked at multinational corporations such as Boston Scientific and Johnson & Johnson Medical, with over a decade of experience in the medical industry, deeply engaged in the productization and commercialization of medical devices in the pan-vascular interventional field.

Jiang Tianjiao

Partner of VCBeat & Dean of VCBeat Research Institute

Expert of the Medical Big Data Expert Group of the National Health Commission, Author of "China Medical Big Data Industry Development Report"

Hainan Provincial Health Commission Digital Therapeutics Task Force Expert Member Author of China's First White Paper on Digital Therapeutics

Invited Expert Speaker at the Annual Meeting of the Chinese Society of Clinical Oncology (CSCO)

Peking Union Medical College Graduate School Instructor

Peking University Health Science Center/Peking University Guanghua School of Management Medical Industry Lecturer

Fudan University School of Management | Healthcare Industry Lecturer

CEIBS Healthcare MBA Instructor

Invited Expert Speaker of Medtronic Asia Technology Forum, China Region

Formerly served as an analyst at Founder Securities Research Institute, ranked first in the "New Fortune" Best Analyst Awards, first in the "Crystal Ball" Best Analyst Awards, and first in the "Golden Bull Award" Best Analyst Awards. During his tenure as a director of Founder Securities' Industrial Finance Department, he led market capitalization management work for multiple listed companies.

Jiang Tianjiao has authored the following books: "Reconstructing the Greater Health Industry," co-authored "Internet Transformation - Decoding Chinese Management Models" and "Internet + Healthcare," with forthcoming publications including "Digital Therapeutics," "Lessons from Medical Technology Giants," and "Pharmaceutical Innovation from a Macro-Historical Perspective."

The representative research reports written by Jiang Tianjiao include "Research on the Cardiovascular Interventional Devices Industry," "TAVR Industry Research," "Breakthrough in Mitral Valve," "2022 Structural Heart Disease Industry Development Report," "Tricuspid Valve Intervention Industry Research Report," China's first "Digital Therapeutics Industry White Paper," "China Ophthalmology Medical Innovation Report," "Small Molecule Innovative Drug PROTAC Technology Development Report," "Bispecific Antibody Year-End Development Report," "ADC Drug Frontier Development Report," "Immune Cell Therapy Industry Research," "Gene Therapy Industry Research," "Circular RNA Frontier Innovation Report," and more than a hundred other healthcare and innovative pharmaceutical industry research reports.

DK Medtech was founded in 2015 as a high-tech company specializing in the research, development, and production of vascular interventional products. Committed to addressing the complex challenges of current disease treatments, its main business lines are focused on coronary intervention, peripheral intervention, and neurointervention, providing corresponding solutions. The company has systematically developed more than ten types of various products, owns independent PCT intellectual property rights, and offers Chinese patients a range of products with superior performance.

DK Medtech will continue to refine its corresponding technologies in research and development as well as production, standing side by side with patients worldwide and walking alongside life.

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