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DOF, the world's first company to succeed decellularization with carbon dioxide... Harmless and safe

More than 1,000 procedures including breast reconstruction… Side effects/disqualification cases ‘0’

Focusing on breast reconstruction and nerve transplantation... Indicated for rotator cuffs, bedsores, burns, etc.

 

 

As the number of breast cancer patients in Korea increases, the number of breast reconstruction surgeries is also increasing significantly every year. According to the Health Insurance Review and Assessment Service, the number of breast reconstruction patients was 5,728 (treatment costs KRW 13.7 billion) in 2017, 6,925 in 2018 (treatment costs KRW 16.7 billion), 7,133 (KRW 16.7 billion) in 2019, 7,156 (KRW 16.6 billion) in 2020, and 2021. It is increasing every year, with 7,497 people (KRW 17.6 billion) per year and 8,024 people (KRW 16.6 billion) by 2022.

 

Breast reconstruction surgery requires implants and skin grafts. However, as concerns were raised in 2019 that patients who had Allergan's breast implants developed anaplastic large cell lymphoma, a rare cancer, and a global recall was issued, tissues transplanted into the human body are subject to side effects issues. Not free.

 

However, there is a company that has recently developed and commercialized the world's first supercritical decellularization technology using carbon dioxide (CO₂) rather than surfactant, thereby setting a record of zero side effects. DOF (CEO Shin Yong-woo), a bio venture specialized in human tissue-based implants located in Dongtan, Gyeonggi-do, is the main character.

 

CEO Shin Yong-woo, who leads DOF, is not a doctor, pharmacist, or someone who majored in biotechnology. As an engineer who majored in chemical engineering, he went through the Hanwha Petrochemical Central Research Institute and learned about nanotechnology during overseas training. CEO Shin, who founded a nanotechnology research and development company in 2015, succeeded in decellularizing human tissue using supercritical technology for the first time in the world in the field of biomaterials and tissue engineering by combining biotechnology while developing NT-based coating solutions and films.

 

When carbon dioxide exceeds a certain pressure and temperature, it becomes a ‘supercritical fluid’ that is neither liquid nor gas. Carbon dioxide in a supercritical fluid state transforms human tissue into a graft material suitable for transplantation through a decellularization process that dissolves phospholipids in the cytoplasm and nuclear membrane, which are the main causes of transplant rejection. While most transplant materials decellularize tissues using surfactants, DOF is harmless and safe to the human body because it decellularizes tissues using carbon dioxide, an eco-friendly method, without using surfactants. Since the transplant material was officially launched in November of last year, more than 1,000 transplants have been performed at 10 university hospitals across the country, but there has not been a single case of side effects or incompatibility.

 

I met with CEO Shin Yong-woo and heard about DOF's supercritical decellularization technology and future plans in the human tissue transplant material market.

 

- The term ‘supercritical’ is unfamiliar. Please briefly introduce DOF’s core technologies.

 

DOF's main business is supplying human tissue-based implants. In order to transplant human tissue, a decellularization process is essential, and DOF succeeded in commercializing it for the first time in the world by applying supercritical technology using carbon dioxide to human tissue.

 

When carbon dioxide exceeds a certain pressure and temperature, it becomes a ‘supercritical fluid’ that is neither liquid nor gas. At this time, carbon dioxide is used as a solvent to dissolve the phospholipids of the cytoplasm and nuclear membrane of tissues, that is, for decellularization. Implant companies around the world have been using chemicals such as surfactants for decellularization. This method involves soaking human tissue in surfactant for 24 hours and then washing it for 48 hours.

 

Carbon dioxide in a supercritical fluid state has the advantage of being able to decellularize materials without leaving any residual substances. It is harmless and safe to the human body. Since there is no washing process, there is no deviation due to the worker's condition. Therefore, it is not only suitable for decellularization of transplanted tissue where immune rejection can occur, but also has a high engraftment rate because it maintains similar components and physical properties as the original tissue. The decellularization time, which previously took 3 to 5 days, can be shortened to 2 days, making it highly competitive in terms of cost.

 

-What are DOF’s products that use supercritical technology?

 

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

 

‘SC DERM’ is mainly used for breast reconstruction after breast cancer surgery, 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 or breast cancer, and improves motor and sensory functions by regenerating peripheral nerves. SC CONNECT is the first nerve graft material supplied in Korea other than Axogen in the United States. It was registered with the Ministry of Food and Drug Safety in February 2022 and launched in earnest on the market in March of this year.

 

‘SC FILL’ can be used as a filler substitute in plastic surgery, but it also has excellent performance as a treatment for knee joints.

 

- It seems to be used for various purposes other than breast reconstruction.

 

Still, the market where human tissue is used the most is in the field of acellular dermal matrix used in breast reconstruction. It is also used in fields such as orthopedics, such as rotator cuff surgery, and urology, mainly as filler, which is a plastic human implant material. However, as the number of breast cancer patients continues to increase, the breast reconstruction ADM market is expected to grow by more than 15% every year in the future.

 

In the case of allogeneic nerves, the global market size is approximately 13 trillion won. Usually, when transplanting a nerve problem, an autologous nerve is often transplanted, but as a result, many patients complain of discomfort after the surgery because the nerve in a specific area has to be sacrificed. However, when using DOF's allogeneic nerve, there is no need to sacrifice the nerve in a specific area, and it is possible to supply it at the lowest price with supercritical technology, reducing the cost burden on patients.

 

The amazing effects of supercritical technology, change doctor’s minds

 

- Where are DOF products currently supplied, and what are the evaluations of medical staff who have used them?

 

The product was released in August last year, but it began to be distributed on the market in November. To date, more than 1,000 procedures have been performed, and not a single case has resulted in side effects or ineligibility for transplantation.

 

We are supplying transplant materials to about 10 major university hospitals, including Seoul National University Bundang Hospital, Ajou University Hospital, and Pusan National University Hospital, and we expect to exceed 2,000 cases by the end of this year as we have begun full-fledged agency sales.

 

Doctors who have used DOF products say that they are really good. When using existing products, reoperation may be required once in 100 to 130 cases, and in 1 to 2 out of 10 cases, red breast syndrome or seroma occurs and antibiotics are prescribed, although reoperation is not required. There are cases where it must be done, but there are no such side effects, so there are quite a few doctors who show interest in ‘supercritical technology’. Perhaps because the number of such people is increasing, sales have increased rapidly in less than a year. It appears that achieving the 10 billion goal this year will be easy.

 

- Even so, doctors seem to have no choice but to be conservative due to the nature of human transplant tissue. No matter how good the treatment material is, doctors do not easily change the prescription unless there is solid scientific evidence. Therefore, it seems more necessary than anything else to establish evidence that DOF's human tissue transplant material is safe and beneficial to patients.

 

Doctors seemed to be a bit reluctant to use new products. This may be because they believe that new products have risks. We are accumulating data to eliminate these problems. However, due to the nature of transplantation, data can only be accumulated about a year after transplantation, so clinical papers will likely be published next year at the earliest.

 

- I wonder if there is any quality control plan for DOF products.

 

To manage human tissue, you must have facilities, equipment, and a quality control system. DOF received tissue banking permission from the Ministry of Food and Drug Safety in 2021. Accordingly, thorough quality control is carried out in accordance with the Standard Operating Procedure Manual (SOPM) based on GTP (Ministry of Food and Drug Safety's Human Tissue Management Guidelines).

 

Systematic document management is essential because there is always a possibility of affecting the safety of the organization during the process of collection, storage, processing, storage, and distribution. DOP has enabled traceability through a document recording system in the event of side effects, and ensures organizational safety through continuous education and internal audits.

 

- Breast reconstruction surgery is currently covered by health insurance. How much is the cost burden for patients during breast reconstruction surgery?

 

Most tissues used for human tissue transplantation are expensive. This is because our country does not have many body donations, so most of them rely on imports. For example, on average, about 16cm x 16cm is used for breast reconstruction, and the listed material cost is 43,000 won per 1cm x 1cm. If it is 16cm x 16cm, it costs approximately 10 million won. During breast reconstruction surgery, implant materials are subject to selective coverage, so 50% is covered by health insurance and 50% is paid by the patient himself.

 

If the donation culture becomes more active in our country, the burden on patients will be reduced because they will no longer have to pay expensive money to import tissues. In the hope that the domestic human tissue donation movement will become more active, DOF is running a sticker with the phrase ‘Tissue Donation Saves Lives’ on its corporate car. Additionally, as part of the campaign, eco bags are being produced and distributed at events such as academic conferences.

 

An eco-bag produced with the hope that the domestic human tissue donation movement will become more active.

 

- You said you were running a human tissue bank.

 

A tissue bank is an institution that collects, stores, and sells human tissue with permission from the Ministry of Food and Drug Safety. Screening is difficult because managing human tissue requires facilities, equipment, and a quality control system. DOF's tissue bank decellularizes imported processed tissues and supplies them to hospitals. It can process and distribute 11 types of tissues, including bone, cartilage, skin, ligaments, and blood vessels.

 

- Do you have any strategies for targeting domestic and overseas markets?

 

First, we want to increase market share by increasing domestic awareness. Since the product has been supplied since the second half of last year, it is not yet well-known in Korea. Therefore, we plan to actively carry out D2D (Doctor to Doctor) marketing through KOL (key opinion leader) doctors who use DOF's products.

 

We plan to focus our efforts on pioneering and entering overseas markets. We also built an overseas marketing network by participating in the ‘Asian Pacific Federation of Societies for Surgery of the Hand 2023’ held in Singapore last May. Currently, we are forming strategic partnerships with domestic and foreign companies to export to various countries such as China, Vietnam, Indonesia, and South America and to enter the global market. In order to continue to grow into a global company, we plan to build a strategic product pipeline and expand our business to stand out in the global market.

 

- I understand that they recently succeeded in attracting Series B investment and secured 15.5 billion won. I think this is a significant achievement in the freezing investment market, but I wonder if there are any plans for listing.

 

We are preparing for listing in the fall of 2025. In the next two years, supercritical decellularization technology will become a game changer in the human tissue transplant material market. Please watch DOF’s challenge.