[Edaily Reporter YU JIN-HEE ] DOP has emerged as the biggest beneficiary following the passage of a partial amendment to the Waste Management Act, which paves the way for the medical use of human fat. DOP, a company specializing in biomaterial-based human tissues, plans to capture the market by leveraging its pre-established patents and supercritical technology. If this strategy comes to fruition, the company is expected to easily achieve its revenue target of 500억 won next year, following this year’s 300억 won in sales.

Passage in the National Assembly Plenary Session Marks a Turning Point in Regulatory Relaxation

On the 18th, a partial amendment to the Waste Management Act permitting the medical use of human-derived fat was passed by an overwhelming majority in the National Assembly plenary session. It received 239 votes in favor out of 251 lawmakers present. This establishes the legal basis for utilizing human-derived fat—which was previously classified as tissue-based medical waste under current law and incinerated in its entirety—in the research and development of pharmaceuticals and medical devices.

The law will take effect one year after its promulgation. The government plans to consult with relevant ministries, including the Ministry of Food and Drug Safety and the Ministry of Health and Welfare. It will establish a management system covering the entire process—from collection to storage, processing, and utilization. The industry views this legislative amendment as a turning point that will reshape the regenerative medicine sector. The key lies in which company can most quickly translate this change into commercial success.

According to the human tissue industry, DOP is drawing attention as a key beneficiary of this legislative amendment. This is the result of the company’s focus on research into biomaterials derived from human adipose tissue since its founding in 2015. It currently holds numerous patents related to the decellularization of human and animal adipose tissue both domestically and internationally. According to its internal technology business plan, the company began securing core technology rights in 2017.

The method for isolating collagen from liposuction waste using a supercritical process was filed for a domestic patent in 2017 and successfully registered. U.S. patent registration was also completed in May 2023. This technology involves extracting collagen from liposuction byproducts using a supercritical carbon dioxide process. The U.S. patent registration demonstrates the company’s global technological competitiveness.

The technology for extracellular matrix (ECM) derived from animal fat and its preservation solution was registered in Korea in 2021. Following the registration of a Chinese patent in 2023, the U.S. patent registration was completed in April 2025. This means the company has secured multinational patents for the manufacturing and preservation technologies of fat-derived ECM.

The ECM extraction method using supercritical fluids and the ECM biomaterial for tissue regeneration have been registered in Korea. Following a PCT international application, patent examinations are currently underway in the U.S. and China. In 2023, the company filed a domestic application for decellularized adipose tissue-derived ECM produced via the supercritical fluid extraction process and its applications, which is currently under examination. A key feature is the company’s differentiation from competitors by establishing a full-cycle IP portfolio—encompassing extraction, processing, preservation, and application—rather than relying on a single patent.

Commercialization Network and Preclinical Data Beyond the Laboratory

Dop has concurrently conducted research aimed at actual commercialization. It has carried out joint research with Seoul St. Mary’s Hospital of The Catholic University of Korea and Hanyang University. This research focuses on developing biological dressing materials using bioactive proteins derived from human adipose tissue.

This project, funded by the Ministry of SMEs and Startups and the Ministry of Trade, Industry and Energy, was carried out over six years from 2018 to 2024. Based on these results, the company is also pursuing joint regulatory approval with Medicon. Through the Korea Institute of Non-Clinical Sciences (KINS), it has completed in vivo efficacy evaluations of decellularized adipose tissue. This data will serve as a key asset in future approval procedures with the Ministry of Food and Drug Safety (MFDS).

To use human adipose tissue for medical purposes, cellular components must be removed. A sophisticated decellularization process that preserves the extracellular matrix (ECM), growth factors, and collagen structure is essential. Conventional methods using surfactants or enzymes had drawbacks, including biosafety issues caused by residual substances and damage to tissue structure.

DOP’s core technology, E-CELL®, is a decellularization process based on supercritical carbon dioxide. It leverages the high penetrability and residue-free properties unique to supercritical fluids. The decellularization process is completed within approximately three hours, simultaneously performing sterilization and virus inactivation. Due to the structural characteristics of adipose tissue, it is difficult to ensure quality reproducibility using conventional methods.

DOP’s process has secured a technological advantage. DOP directly operates a tissue bank licensed by the Ministry of Food and Drug Safety. It is equipped with production facilities certified under Good Manufacturing Practice (GMP) and Good Testing Practice (GTP) standards, as well as infrastructure spanning 1,652.89 square meters (approximately 500 pyeong). This means that as soon as the law takes effect, the company will be able to provide a one-stop service from raw material collection to finished product manufacturing.

The adipose ECM market, which has garnered attention following this legislative amendment, has already reached a market size in the 1000억원 range in the United States alone. Shinhan Investment & Securities forecasts that the ECM skin booster market will grow from approximately 99억원 last year to 1729억원 next year. When adipose ECM is factored in, the market size will expand further.

Dope is setting its sights squarely on the global market. To this end, the company has signed Letters of Intent (LOIs) with U.S.-based MTF Biologics and Australia’s Australian Biotechnology. By securing overseas procurement channels for human tissue raw materials—including adipose tissue—the company has laid the groundwork for diversifying its raw material supply. As a “Global IP Star Company” selected by the Korean Intellectual Property Office and the Korea Invention Promotion Association, Dope is also working to strengthen its overseas patent portfolio.

DOP has also established a foothold for entering the European market. It signed an LOI with BISLIFE, which operates a European tissue bank network, to build a strategic partnership. This appears to be a strategic move to secure a stable supply base for human tissue and drive global business expansion.

BISLIFE is a European tissue bank certification body headquartered in the Netherlands. It serves as a hub that oversees the entire process—from the collection and processing of human tissue to its storage and distribution throughout Europe. It operates in strict compliance with European Union (EU) regulations and international guidelines. This partnership signifies the company’s acquisition of the necessary certifications and network access to enter the European regenerative medicine market.

This confident move stems from the company’s strong financial performance. Driven by business diversification and expanded exports, the company is on an upward trajectory. Revenue, which stood at 1.5 billion won in 2022, surpassed 20 billion won for the first time last year. This year, bolstered by the effects of its European expansion, the company is poised to achieve revenue of over 30 billion won. For next year, it has set a revenue target of over 50 billion won.

Building on this growth momentum, DOP plans to pursue a KOSDAQ listing within the year. Together with its lead underwriter, Mirae Asset Securities, the company is preparing for a technology-based special listing. It has completed a preliminary technology evaluation, and its enterprise value in the over-the-counter market is estimated at 130 billion won. The company plans to invest the funds raised through the listing into upgrading its GMP facility and establishing itself as a global leader in regenerative medicine.

Shin Yong-woo, CEO of DOPH, emphasized, “Materials derived from human adipose tissue are high-value resources rich in stem cells, collagen, and growth factors,” adding, “We have already accumulated relevant technologies, patents, and preclinical data over several years, and we will use this legislative amendment as an opportunity to rapidly translate our research achievements into commercial products.”