GYEONGGI-DO

Technological Innovation for the Human Race

A Leading Company in Technological Innovation for the Pursuit of

Universal Human Value

 

                                 <Portable artificial kidney>                                  <Hemodialysis therapy device for critically ill patients>                                         

                                                                          

 

Q. Please provide an introduction to Synopex.

 

A. Before introducing the product, let me briefly explain about renal dialysis. Patients with chronic kidney failure (kidney function less than 15%) typically undergo treatments such as hemodialysis or peritoneal dialysis, or receive a kidney transplant. Most patients prefer hemodialysis, which can be safely and conveniently administered in their living environment.

Hemodialysis is an integrated industry that requires essential investments in equipment and facilities. Currently, in South Korea, there is a lack of production facilities and experts, leading to a dependence on strategic imports of the necessary equipment for treatment.

Synopex has successfully localized essential hemodialysis equipment and related products for patients with chronic kidney failure. The company has obtained GMP certification and manufacturing permits. Currently, it is in the process of obtaining approval from the Korean Ministry of Food and Drug Safety for the sale and export of its products.

 

Q. Please share information about the domestic and international industry situation.

 

A. According to the recent international statistics from the authoritative US Renal Data System (USRDS) in 2020, the increase in patients with chronic kidney disease in South Korea ranks fourth globally, with 355 patients per million population. The growth rate is the second highest in the world at 18.8%. In terms of the increase in diabetic patients, South Korea ranks second globally with a growth rate of 49.8% and 177 patients per million population, placing fourth globally. The number of patients undergoing dialysis is also the second highest globally, with 2,798 patients per million population. These figures indicate a rising trend in the number of patients with related conditions, suggesting a steady increase in demand and supply for hemodialysis. Chronic kidney disease, despite having treatment costs per capita 4.5 times that of cancer patients, relies on imported medical devices. Particularly, hemodialysis machines are imported in limited models from a few suppliers, affecting the diversity and appropriateness of treatments and resulting in a situation where high-quality dialysis cannot be guaranteed.

In the global market, it is predicted to grow at an annual rate of 3.8% until 2028, reaching a market size of approximately a trillion dollars. The growth momentum, particularly in the Asia-Pacific region, is expected to replace the traditional major markets of North America and Europe, indicating a steady growth trajectory.

 

 

<Hemodialysis machine filter>

 

 

Q. Please discuss the advantages and features of Synopex products.

 

A. Hemodialysis operates on the principle of filtering out waste products using a filter, making filter technology a key competitive advantage for the company. Synopex is globally recognized in the field of filters, being responsible for 60% of the filters used in Samsung Semiconductor. Recently, the company has successfully collaborated with the Korean government initiative and achieved localization in the production of devices essential for hemodialysis.

From production to packaging, Synopex ensures the highest level of cleanliness through the implementation of a world-class cleanliness management system. This preventive measure helps to avoid contamination during the product manufacturing process. The company employs state-of-the-art automated production facilities and manufacturing robots to achieve precision and uniformity in producing high-quality products. In addition, Synopex’s major strengths lie in its high durability and excellent waste removal technology.

 

 <Jestin Lee Ph.D. Executive Director>

Q. What are the plans for entering the international market in the future?

 

A. In the domestic market, it is estimated that there are approximately 170,000 individuals directly associated with hemodialysis. While the established market presence is an advantage, the potential for limited growth could be a disadvantage. Therefore, international expansion is crucial. Currently, the company is in the process of obtaining ISO 13485 certification to proceed with CE MDR. Additionally, plans are underway to pursue US FDA certification in the first half of 2024.

Furthermore, there are plans to enter the Muslim market, which constitutes one-third of the global population, by conducting local market research and establishing networks with healthcare institutions. Additionally, there are plans for local medical professional demonstrations and support for conferences to pioneer the Indian market.

We plan to establish a system that allows real-time searching for products and consumables online. Additionally, efforts will be made to promote Synopex’s excellent technological capabilities by participating in world-renowned conferences related to hemodialysis, where technology introductions and presentations can be conducted.

Furthermore, efforts will be made to advance in global competition by securing the core technology through supporting the localization of critical components, actively investing in R&D for software development, and conducting thorough clinical trials. The aim is to position hemodialysis equipment as a key product for national strategic exports.

 

 

Website: https://www.synopex.com/eng/main/