Yongki Heo, CEO of Glymerix
-Hyaluronic acid is a biopolymer naturally present in the human body, serving as a material capable of protecting tissue surfaces and providing a lubricating and cushioning environment
-The flagship item is ‘Bladder-Coat’, an intravesical instillation medical device formulated with hyaluronic acid and chondroitin sulfate
Hyaluronic acid is a biopolymer naturally present in the human body, utilized to protect tissue surfaces and create a lubricating and cushioning environment. Glymerix views this material not merely as a simple ingredient but as the foundational starting point for a medical device platform.
“Our first product is an intravesical instillation medical device utilizing hyaluronic acid and chondroitin sulfate”, stated CEO Heo. “Following this, we have a roadmap to expand our hyaluronic acid-based medical device portfolio to include adhesion barriers, wound dressings, and drug-delivery hydrogels. Currently, we are prioritizing the prototype manufacturing of Bladder-Coat, the pilot process development, and preparations for GMP and regulatory approvals. As we are in the early stages, rather than hastily expanding our product lineup, we are focusing on securing the manufacturing and regulatory foundations necessary to actually produce and verify our products.”
Glymerix’s flagship item is ‘Bladder-Coat’, an intravesical instillation medical device based on hyaluronic acid and chondroitin sulfate. “The protective function of the bladder mucosa can weaken due to recurrent inflammation, irritation, or surgical procedures”, Heo explained. “Hyaluronic acid and chondroitin sulfate are materials that can be utilized to form a physical protective environment similar to the protective layer of the bladder wall.”
Bladder-Coat aims to be provided in a pre-filled syringe (PFS) format, allowing medical professionals to immediately administer a precise dosage. Compared to existing products that require separate compounding or preparation steps, this format offers significant advantages in user convenience, dosing consistency and aseptic management. This product represents the first phase of Glymerix’s platform strategy. Through this initial product, Glymerix plans to first validate the process foundations necessary for commercialization—such as hyaluronic acid-based formulation design, sterile filtration, filling, packaging, and quality control—and subsequently evaluate the potential for expansion into adhesion barriers, wound dressings, and drug-delivery hydrogels.
However, the current product is in the development and regulatory preparation stage, and its specific intended use and performance claims will be finalized in accordance with the regulatory scope approved by the Ministry of Food and Drug Safety (MFDS).
The company’s greatest competitive advantage is viewing hyaluronic acid not just as a single product ingredient, but as a platform material expandable into multiple medical devices. Starting with an intravesical instillation product, the company is preparing a framework to extend into adhesion barriers, wound dressings, and drug-delivery hydrogels based on the same core material.
The second advantage is its ready-to-use product format designed for clinical settings. While the composition of a medical device is important, how conveniently and consistently medical professionals can use it is equally crucial. Glymerix is designing its first product in a pre-filled syringe format to enhance usability, precise dosing, and sterile handling.
The third advantage is its manufacturing process-centric approach. The quality of biopolymers like hyaluronic acid can vary depending on viscosity, sterilization, filling, and packaging conditions. Glymerix is designing the raw material compounding, sterile filtration, filling, and packaging processes as a pilot process, establishing a foundation to verify product-specific recipes and process parameters.
The fourth advantage is the simultaneous consideration of clinical perspectives and manufacturing/regulatory strategies. From the initial product stage, the company is reviewing usability from a clinician's viewpoint and verifying GMP and regulatory strategies in collaboration with specialized institutions, thereby increasing the feasibility of actual commercialization.
Date of Establishment: January 2026
Core Businesses: Development of hyaluronic acid-based medical devices Development of intravesical instillation medical devices using hyaluronic acid and chondroitin sulfate. Development of subsequent products, including hyaluronic acid-based adhesion barriers, wound dressings, and drug-delivery hydrogels.
Key Achievements: Selected for and currently executing the 2026 Initial Start-up Package (General Type). Selected for the 2026 Medical Device Regulatory Approval Consulting Support Program by the Korea Health Industry Development Institute (KHIDI). Conducting GMP and medical device regulatory strategy reviews in collaboration with specialized institutions. Onboarded core team members, including a Clinical CTO, and finalized preparations for corporate establishment.
reporter jinho lee
jinho2323@hankyung.com
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