Applications of the treatment will expand to different indications in need to regenerative therapeutic strategies, including scar removal, burns, and pressure/diabetic foot ulcers– CISION PR Newswire
ROKIT Healthcare Announces a Novel Application of Dermal Regeneration Platform Using Proprietary Three-Dimensional Bioprinting Strategy
ROKIT Healthcare, Inc., a regenerative medicine company focused on the development of novel regenerative therapeutic strategies using three-dimensional (3D) biofabrication technologies for treatment of various medical conditions including dermatological, orthopedic, and autoimmune disorders, announced a novel application of dermal regeneration platform using autologous cells and its proprietary 3D bioprinter INVIVO®. This new regenerative therapeutic platform will be further studied in clinical settings for patients in need of treatment for damages suffered from dermal scarring.
Rokit Healthcare 3D Bio Printer INVIVO
Skin scarring is one of the most common medical conditions that can arise after almost every dermal injury, some of which can cause considerable physical, aesthetic, psychological and social problems that result in millions of elective operations and operations after trauma.
ROKIT’s treatment strategy uses INVIVO®, ROKIT’s proprietary 3D bioprinter, and patient’s autologous tissues and cells to “print” a dermal patch graft to treat scarred lesions. Combination of the 3D printing technology that allows for uniform and equal-density distribution of the cells and the use of patient’s autologous tissue/cells can lead to rapid migration of keratinocytes and neovascularization at the wound site, resulting in effective regeneration of the skin at treated lesion.
“It is a novel way of overcoming some of the most pronounced limitations associated with traditional stem cell therapy. The current practice of directly injecting expanded or cultured stem cells using syringes severely limits cell viability and accurate, uniformly distributed delivery of effective stem cells unto the disease area,” stated Seok-Hwan You, Chief Executive Officer of ROKIT Healthcare. “Utilizing 3D bioprinting techniques allows for effective delivery of autologous cells unto the wound site, minimizing cell loss and greatly enhancing cell viability and proliferation.”
ROKIT will further evaluate the effectiveness of the treatment in investigator-initiated clinical studies, which will initially open in Korea, with expansion to multiple countries worldwide. The company plans to expand the application of this novel treatment strategy to other dermatological conditions such as burns, pressure ulcers, and diabetic foot ulcers.
About ROKIT Healthcare, Inc.
ROKIT Healthcare, Inc. is a South Korea based regenerative medicine company headquartered in Seoul, South Korea, with satellite offices in Sulzbach, Germany and Boston, MA. The company is focused on the development and commercialization of personalized regenerative therapeutics using its proprietary 3D bioprinter INVIVO® and unique biofabrication strategies, for areas of high unmet medical need, including dermatological, orthopedic and autoimmune disorders. Additional information about ROKIT is available at www.rokithealthcare.com.
ROKIT Healthcare Forward-Looking Statement:
This press release contains certain forward-looking statements regarding, among other things, statements relating to goals, plans and projections regarding the Company’s financial position, results of operations, market position, product development and business strategy. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and ROKIT undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.
“ROKIT Healthcare starts the world’s first 3D bio-printing self-cartilage regenerative clinical trial with Harvard Medical School, Massachusetts General Hospita”– ROKIT Healthcare
Opens up possibilities to regenerate cartilage with self-cell instead of metal artificial joint
Developing 3D cartilage regeneration method beyond the limit of current 2D injection therapy
ROKIT Healthcare(CEO Seo-Whan You) starts a large-scale animal experiment, that develops human long-term regeneration platform, produced an autologous cell cartilage structure with a 3D bio-printer and successfully proved the effect of autologous cartilage regeneration through animal experiments in South Korea, with MGH(Massachusetts General Hospital). The cartilage regeneration procedure using the 3D bio printer developed by Rokit Healthcare Co., Ltd. reproduces the shape of the damaged cartilage tissue from the MRI / CT data in a patient-customized manner. They have applied for domestic and foreign patents last year on using bio ink to regenerate damaged cartilage area with minimal incision.
Conventional injection cartilage therapy has many structural limitations in treating very complex 3-D human cartilage, but since it is an innovative method of regenerating autografts by outputting three-dimensional images of the damaged area correctly, It is a state-of-the-art new medical technology.
Dr. Charles Bragdon, deputy director of the MGH Harris Orthopedics Lab, said that the 3-dimensional cartilage regeneration technique developed at Rokit Healthcare will be a technique that can be used for the treatment of degenerative arthritis caused by aging. He will present the technology at The American Society of Orthopedic Surgeons (AAOS),and willing to collaborate with global cartographic orthopedic surgeons for clinical application studies.
“In the first half year, we will conduct research on human subjects as early as this year.” Yoo Seok-hwan, CEO of Rokit Healthcare, said. They have already confirmed that the cartilage tissue produced by our cartilage regenerating technique is differentiated into hyaline cartilage rather than fibrous cartilage through domestic animal experiments.
ROKIT Healthcare, a company that develops human long-term regeneration platforms, raised KRW 11 billion investments. The company plans to develop a long-term organ regenerative platform and to go public the listing on the KOSDAQ.
According to the venture capital industry, Rokit Healthcare has recently increase capital by issuing new stocks to institutional investors. The investment attraction was conducted for a total of three institutions including Korea Development Bank and Daily Partners including KB Investment, which was an existing investment company. The total investment is 11 billion KRW, which is estimated to have tripled the enterprise value compared to the investment attraction which took place about a year and six months ago. In addition to the investment completed this year, Rokit Healthcare is also undergoing additional institutional investment of approximately KRW 20 billion.
Rokit Healthcare plans to launch a full-scale global commercialization of its long-term renewal platform as a result of this investment inducement. The investment will be used for the development costs of the long-term reconstruction platform such as skin regeneration and cartilage regeneration platform using the 3D bio printer “INVIVO” developed by Rokit Healthcare and company operating funds. In addition, it said that it is concluding negotiations for additional investment of about 20 billion won in the first quarter of 2019.
Rokit Healthcare selected Mirae Asset Daewoo Securities as its managing director in July last year and is spurring the company’s public offering.
Rokit Healthcare is a bio-venture company founded in 2012 by CEO Seok-Hwan Yoo, who was CEO of Celltrion Healthcare. “In 2016, we succeeded in developing and launching INVIVO, the world’s first desktop 3D bio-printer, and is conducting research and development to provide personalized long-term renewable medical services using 3D bio-printers” he said. According to company officials, Rokit Healthcare will launch a skin rejuvenation medical platform service in South Korea and abroad after completing clinical trials for skin regeneration in the first half of this year.
“Rokit health care makes inroads in the human organ reproduction by establishing Tissue Bank”– ROKIT Healthcare
ROKIT Healthcare, a company that develops human long-term regeneration platform, has been granted permission to establish a tissue bank and is currently undergoing an import approval process from the FDA (Food and Drug Administration)
Rokit Healthcare Tissue Bank will donate and distribute cartilage (costal cartilage) that can be transplanted from a postmortem human tissue donor, and use it for long-term regeneration by transplanting and processing into patients who need transplantation or regeneration. .
Yoo Seok-hwan, CEO of Rokit Healthcare, said, “We will work with human organ bank in the US to resolve the shortage of organ donation in South Korea and receive the approval from the pharmacy to provide patients with organ regeneration and rehabilitation. And we hope that the safe supply of human tissue implants will be boosted.”
“This year will be our milestone as we will contribute to stable supply and demand by securing all the safe, self-derived cells and allogenic biomaterials derived from human body by donating tissues through tissue banks.”
“World’s First 3D Human Stem Cell Skin Regeneration Clinical Practice”– ROKIT Healthcare
- Forming high cell adhesion rate, cell density and autologous extracellular matrix through bioprinting can solve the problems of current stem cell injection therapy of low cell adhesion and cancer induction.
- Future applications will expand with scar removal, diabetic foot, and pressure ulcer.
- Signed on MOU on technical cooperation for export of skin regeneration platform to Europe and Turkey
ROKIT Healthcare, a company that develops human long-term regeneration platform, is to be in clinical practice from February. For the first time in the world, Rokit Healthcare starts trials to immunize stem cells and extracellular matrix separated from autologous fat using 3D bio-printer (INVIVO). They are working with Yonsei Severance Hospital and Idea Hospital. “3D autologous stem cell skin regeneration method,” which prints and transplants a donor-free dermis without rejection.
About this new treatment, Rokit Healthcare Ltd (CEO, Seok Hwan You) said it is a new way of solving the most difficult limitations of stem cell therapy. The main problem with current syringe stem cell therapy approaches is that only 10% of the injected cells survive and the remaining 90% or more of the cells are washed away from the affected area and delivered to unintended sites, and it can be carcinogenic. Another problem is that when stem cells are delivered by injection, they are not uniformly distributed onto the affected area, so it is difficult to predict the therapeutic effect. Furthermore, when the cells are densely packed, nutrients and oxygen cannot be delivered, consequently, the cells that are supposed to be cure the diseased area die.
In Rokit Healthcare, it is possible to treat lesions of the same size with the amount of stem cells 10 times lower than the injection therapy due to the fact that the cells are not lost as the printed stem cells and extracellular matrix are outputted as a solid form of the hydrogel. Also, since the cells are output and maintained at an equal density, the proliferation and viability of cells can be greatly enhanced.
In addition, the autologous extracellular matrix (extracellular matrix) was used to rapidly grow cells to accelerate engraftment and tissue formation, and a bioactive scaffold was constructed as an autologous extracellular matrix. . In this way, the bioactive scaffold made of autologous extracellular matrix contains growth factors and cytokines, so that the cell is a network and plays a very important role in the induction of blood vessels and the formation of new blood vessels for growth, differentiation, and engraftment.
Another benefit of this treatment is that it is a non-stitching treatment, so it is effective in minimizing scarring and also for plastic scar reconstruction. This excellent global clinical section of Korea is proceeding with clinical trials in the US and Europe. Also the MOU on technology exporting, skin regeneration platforms, with Slovakia and large hospitals in Turkey has been confirmed in December. If this treatment is successful, it can be extended to burns, diabetic foot as well as scar reconstruction. There is much attention towards Rokit Healthcare to open up new horizons for advanced medical care.
▲유석환 로킷헬스케어 대표가 서울 금천구 본사에서 바이오 3차원(3D) 프린터 ‘인비보’의 작동원리와 기능 등을 설명하고 있다.
올해 안에 세계 최초로 3차원(3D) 바이오프린팅 재생의료를 상용화할 계획입니다. 최종 목표는 인공장기를 생산하는 거죠. – ROKIT Healthcare Chairman/CEO You Seokhwan
심장근육 대체 ‘하트패치’도 개발
연내 전임상…2021년 상업화
올해 말 코스닥 상장 추진
유석환 로킷헬스케어 대표는 “지난해 손상된 피부를 재생하는 기술을 개발하고 현재 피부 상처, 당뇨병성 족부궤양, 욕창 등에 대한 임상을 세브란스병원, 이데아성형외과 등에서 하고 있다”며 이렇게 말했다. 피부 재생 시술은 오는 5월부터 상업화할 수 있을 것으로 보인다. 당뇨병성 족부궤양, 욕창 등도 연말께 의료기관에서 3D 프린터로 치료받을 수 있을 전망이다. 환자 맞춤형 치료에 큰 잠재력이 있다는 평가를 받는 3D 바이오프린터 재생의료가 마침내 현실화하는 것이다.
“3D 바이오프린팅 재생의료 플랫폼 제공”
2012년 설립된 로킷헬스케어는 2016년 자체 개발한 3D 바이오프린터 ‘인비보’를 출시했다. 인비보는 기존 제품과 가격대는 비슷하면서도 미국 식품의약국(FDA)이 허가한 모든 바이오잉크로 세포가 손상되지 않게 제품을 출력한다. 지금까지 미국, 독일 등 10여 개국에 300대 이상 팔았다. 유 대표는 2007년부터 셀트리온헬스케어 대표를 지내다가 창업했다. 그는 “소비자의 취향을 최대한 반영하는 다품종 소량생산으로 산업 환경이 변하고 있다는 생각에 3D 프린터에 주목하게 됐다”고 했다.
유 대표는 로킷헬스케어가 단순한 제조업체가 아니라 플랫폼 기업이라고 강조했다. 지난해 9월 회사 이름을 ‘로킷’에서 ‘로킷헬스케어’로 바꾼 것도 그런 취지에서다. 그는 “처음엔 3D 바이오프린터를 제조하는 것으로 시작했지만 지금은 3D 바이오프린팅 기술로 환자에게 맞춤형 재생의료를 제공하는 플랫폼 기업을 목표로 하고 있다”고 했다. 의료기관에 3D 바이오프린팅 재생의료에 필요한 각종 장비와 소모품, 기기, 서비스 등을 제공하는 게 이 회사의 비즈니스 모델이다. 그는 “우리가 하고 있는 것은 3D 바이오프린터로 할 수 있는 치료의 10%도 안 된다”며 “우리 플랫폼을 이용해 다양한 재생의료를 선보일 것”이라고 밝혔다.
이 회사는 3D 바이오프린터 제작은 물론 인체조직을 만드는 데 쓰이는 바이오잉크, 인공장기 토대가 되는 오르가노이드 등을 개발하고 있다. 오르가노이드는 혈관 없이 생존할 수 있는 최소 기관이다. 유 대표는 “직원의 80%가 바이오를 전공했고 박사급 인력만 7명에 달한다”며 “지속적으로 바이오 기술자를 영입해 올해 인력을 50% 이상 늘릴 것”이라고 했다.
연골, 망막, 심장근육까지 재생
로킷헬스케어는 피부 재생, 연골, 망막, 심장근육 등 여러 신체조직을 재생하는 데 3D 바이오프린팅 기술이 유효한지 검증하고 있다. 동물 20여 마리를 대상으로 한 전임상에서 연골 재생 효과를 확인했다. 이달부터 미국 하버드대 의대 부속 매사추세츠병원과 함께 연골재생치료 동물실험을 한다. 상반기까지 미국, 유럽 등지에서 실험을 마친 뒤 연말께 환자에게 적용할 예정이다. 재생의료 기술을 접목한 화장품도 하반기께 출시한다. 3D 프린터로 제작한 모발 이식도 연내 상용화할 계획이다.
심근경색으로 괴사한 심장근육 일부를 대체할 수 있는 ‘하트패치’는 독일의 유수 연구기관인 프라운호퍼 국립연구소와 공동 연구하고 있다. 사람의 심근세포를 활용해 혈관 없이 생존하면서 수축과 이완을 반복하는 동전 크기의 패치를 제작한 뒤 괴사한 심근 조직을 떼어낸 자리에 붙이면 심장근육으로 바뀐다. 올해 전임상을 시작해 2021년께 상업화할 계획이다. 실명 위험이 큰 황반변성을 치료할 수 있는 망막 시트도 개발 중이다.
로킷헬스케어는 세계 시장을 겨냥하고 있다. 대우자동차 유럽본부 최고운영책임자, 미국 보안업체 타이코 아시아태평양 총괄수석부사장, 셀트리온헬스케어 대표 등을 지내며 쌓은 글로벌 비즈니스 감각과 풍부한 네트워크가 큰 자산이다. 유 대표는 “연골 재생 시장은 124조원, 피부 재생 시장은 60조원에 달한다”며 “미국, 유럽 등 선진국을 포함해 재생의료 규제 장벽이 높지 않은 일본, 터키, 인도 등에 적극적으로 진출할 것”이라고 말했다. 로킷헬스케어는 올해 말 코스닥시장에 상장할 계획이다.