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DOF begins to target the human tissue transplant material market with the world's first supercritical technology

기사 원문 : 도프,세계 최초 초임계 기술로 인체조직 이식재 시장 공략 본격화 (getnews.co.kr)

 

DOF begins to target the human tissue transplant material market with the world's first supercritical technology

A new product with safety and viability secured through supercritical ‘decellularization’, resulting in rapid growth in related market sales due to the specialized advantages

 

Jaeseung Lee, medical reporter / PhD in biomedical engineering Entered 2023.07.25 10:53 Modified 2023.07.25 11:35

 

 

DOF (CEO Shin Yong-woo), a tissue-based regenerative medicine company, is the world's first to use supercritical technology to decellularize human tissues such as skin and nerves without surfactants, thereby reducing processing time while securing the competitiveness of stability and engraftment of human tissue transplant materials. and is a bio venture that succeeded in commercialization by securing cost advantage.

 

◆DOF, the world’s first surfactant-free human tissue transplant material decellularization success and commercialization

 

Supercritical technology applies pressure above a certain level to carbon dioxide (CO2), which is harmless to the human body and the environment, and adjusts the temperature appropriately, transforming the human body into an intermediate state of 'supercritical fluid' that cannot be distinguished between gas and liquid without an evaporation process. It is the core of tissue-specific decellular processing technology.

 

This carbon dioxide (CO2) supercritical fluid has the property of dissolving fat. In order to transform human tissue donated to a tissue bank into a human tissue graft material suitable for transplantation, it dissolves phospholipids in the cytoplasm and nuclear membrane, which are the main causes of transplant rejection, and cellular material. It is an essential process for decellularization to remove .

 

In addition, human tissue transplant material obtained through the decellularization process can maintain the extracellular matrix (ECM) content of the donated human tissue, contributing to the recovery of the living body by supporting and proliferating cells and preserving growth factors. It has the decisive advantage of increasing the engraftment of human tissue transplant materials.

 

 

Above all, it is safe and harmless to the human body because it decellularizes tissues using carbon dioxide (CO2), an eco-friendly process, using a process that has already been commercialized. When tissue is previously decellularized with surfactant, fatal side effects may occur at the transplant site if the surfactant is not removed from the tissue. In addition, by using the supercritical process, the tissue processing time for decellularization, which previously took 3 to 5 days, can be shortened to less than 2 days (skin) and 1 day (nerves), which simplifies the processing process, resulting in less tissue destruction and cost competitiveness compared to competitors. It is advantageous for securing and storing tissues.

 

◆The global market size for human tissue-based implants is KRW 13 trillion. DOF is popular for its specialized advantages as a new product.

 

These human tissue transplant materials are used to recover physical disabilities in patients with defects or damage to human tissue due to breast cancer, etc., or for patients with various diseases such as burns and fractures. The market where human tissue is most widely used is the acellular dermal matrix market.

 

In particular, the industry estimates that the market for breast reconstruction acellular allogeneic dermis for breast cancer patients will be worth KRW 100 billion in Korea alone and around KRW 6 trillion globally this year. The surgical and plastic surgery market is worth 40 billion won domestically and 4 trillion won globally. These markets are expected to grow by more than 15% every year. The global market size for allogeneic nerve graft materials using donor body tissue amounts to 13 trillion won.

 

Accordingly, DOF's main allograft products include SC DERM, an acellular allogeneic skin, SC CONNECT, an acellular allogeneic nerve, and SC FILL, a filler type made by injecting skin with a syringe.

 

SC DERM is mainly used for breast reconstruction after breast cancer surgery. SC DERM is also used for rotator cuff surgery and skin reconstruction for patients with bedsores and burns. SC CONNECT is used for patients who have lost nerves due to accidents, breast cancer, etc. SC CONNECT is the first nerve implant to be supplied to the domestic market other than Axogen in the United States. SC CONNECT was registered with the Ministry of Food and Drug Safety in February 2022 and began supplying to the market in March of this year. In particular, compared to Axogen, the supply price of DOF products can be reduced by about 42% through supercritical technology, which is advantageous in supply price competition. Unlike the disadvantage of having to cut and transplant nerves in specific areas during existing autologous nerve transplants, it is possible to enlarge allogeneic nerves. There is a high possibility of insurance coverage in the future. SC FILL is sometimes used as a filler substitute in plastic surgery, but it has excellent performance as a treatment for knee joints.

 

◆Achieved 1,000 procedures in just one year of market launch. Approved by the US FDA, established a local factory in China to target the global market.

 

Shin Yong-woo, CEO of DOF, said, “We began supplying products to the market in earnest in the second half of last year. Currently, we are supplying transplant materials to about 10 major university hospitals in Korea. There have been over 1,000 cases of the procedure so far. If this trend continues, the number of cases is expected to exceed 2,000 by the end of this year. “Achieving 2,000 procedures in just one year after introducing a completely new biomaterial to the market can be considered a great success unprecedented in the world,” he said. “The number of large hospitals supplying transplant materials will also increase to about 20 this year.” It is expected that DOF's products have not had a single side effect or transplant ineligibility result as a result of transplantation since 2022. “The satisfaction level of doctors and patients is very high,” he said.

 

CEO Shin said, “With regard to targeting overseas markets, we will soon launch heterogeneous wound dressings and cartilage products for heterogeneous plastic surgery in addition to existing products and establish overseas branches and factories based in the United States, China, and the Middle East. In particular, China plans to join hands with a local company and establish a production plant in China as a joint venture. “The United States plans to obtain approval from the U.S. Food and Drug Administration (FDA) for three human tissue-based implant products, including SC DERM, an acellular allogeneic skin currently sold in Korea, within two years and begin to encroach on the market in earnest,” he said. “We are in discussions with multiple global bio companies to license out human tissue transplant material manufacturing technology using the critical process,” he said, revealing strategies and blueprints for global competitors Alloderm, eveB, and Exogen.