HONG KONG – Rokit Healthcare Inc. is working toward its goal of listing on the Korean stock exchange by July or August 2021. The Seoul, South Korea-based company will issue 12 million shares and targets setting the price range as early as July 2021. KB Securities Co. Ltd. and Mirae Asset will serve as organizers for the IPO.
4D teknolojisi dünyada ilk kez yanık tedavisi için kullanılıyor. Ankara Şehir Hastanesinde kullanılan yöntemle hastaların kendi yağ dokusundan oluşan hücreler, 4 boyutlu yazıcı ile şekillendirilerek vücudun yanık olan bölgesine uygulanıyor.
4D (4 boyutlu) yazıcı teknolojisi dünyada ilk kez yanık tedavisi için kullanılmaya başlandı. Yaklaşık 3 ay önce Ankara Şehir Hastanesinde uygulanmaya başlayan yöntem ile vatandaşlar sağlığına kavuşuyor. Güney Koreli Rokit firmasının geliştirdiği Dr. Onvivo isimli 4 boyutlu yazıcı ile vücudunda yanıklar oluşan hastanın kendi yağ dokusu hücreleri alınarak tedavi ediliyor. Yanığın oluştuğu kısımların taranarak o bölgenin ölçüleri bilgisayara yükleniyor, daha sonra o bölgeyle birebir uyumlu kalıp oluşuyor ve hastadan alınan yağ hücreleri bir karışım ile birlikte belirli aşamalardan geçirilerek 4 boyutlu yazıcıya yerleştiriliyor. Yazıcı hazırlanan kalıba yanık olan yerle birebir aynı ölçülere sahip olan tedavi malzemesini boşaltıyor ve daha sonra hastaya uygulanıyor. Bu sayede daha önce yanık tedavilerinde kullanılan; hastanın vücudunun sağlam bir yerinden alınan deri ile yanık bölgenin tedavi edilmesi yöntemine gerek kalmıyor. Dünyanın çeşitli yerlerinde de kronik yaralar için uygulanmaya çalışılan, ama yeterli bilgi ve deneyim olmadığı için sonuca ulaşılamayan sistem; Ankara Şehir Hastanesi Yanık Tedavi Merkezi Sorumlu Hekimi Prof. Dr. Ahmet Çınar Yastı’nın koordinasyonu sayesinde 3 aydır başarıyla uygulanıyor.
“Bu dünyada ilk kez uygulanıyor, burada bizim ülkemizde ve bizim hastanemizde uygulanıyor”
Bu teknolojinin dünyada ilk kez Türkiye’de kendi yanık ünitelerinde kullanıldığına dikkat çeken Yanık Tedavi Merkezi Sorumlu Hekimi Prof. Dr. Ahmet Çınar Yastı, “Elimizdeki teknoloji ile biz fonksiyon kaybını ve bilhassa da kozmetik olarak renk farklılıklarını minimal seviyelere getirecek bir çalışma üzerinde devam etmekteyiz. Erken verilerden aldığımız sonuçlar bize bunun şuana kadar bildiğimiz ve kullandığımız tekniklere göre çok daha üstün ve çok daha iyi olduğunu göstermekte. Yine gurur verici olarak söylemek istiyorum; bu dünyada ilk kez uygulanıyor, burada bizim ülkemizde ve bizim hastanemizde uygulanıyor. Sonuçlarımız da yüz ağartıcı, biz de bunun gururunu paylaşıyoruz” şeklinde konuştu.
“Türk tıbbı bugün muasır medeniyetler seviyesini yakalamış hatta bazı konularda geçmiş durumda”
Türkiye’de tıbbın çok geliştiğini ve dünya çapında doktorlar yetiştiğini, vurgulayan Prof. Dr. Ahmet Çınar Yastı, “Daha önce, isim vermek istemiyorum ama 4-5 ülkede, hatta kuzey ülkelerinde denenip başarılı olamamış bazı vakalarda. Bizim burada başarılı sonuçlar aldığımızı gördük. Biz tabi işin mutfağında değil şuan klinik tarafındayız. Mutfak tarafı Kore’den geldi. Ama neyi, ne zaman ve nasıl kullanacağını bilmek, kullandığınız obje ne ise onun kadar kıymetli. Bu durumda zamanlama, yaranın hazırlığı, hastanın hazırlığı, takip etme süreciniz, yani pansuman sıklığına ve pansuman şekline kadar bunlar hep kıymetli parametreler. Doğru uygulamanın burada olduğunu onlardan öğrendik. Yani şunu demek istiyorum Türk hekimleri, Türk tıbbı bugün muasır medeniyetler seviyesini yakalamış hatta bazı konularda geçmiş durumda. Biz de bilim adamları olarak buna gereken desteği verelim ve halkımız da bunun refahını ve mutluluğunu yüreklerinde hissetsinler diye düşünüyorum” ifadelerini kullandı.
“Formula 1’de dünya şampiyonu olan arabanın pilotu, arabanın üretildiği ülkeden değil”
Önemli olan konunun teknolojinin nereden geldiği değil, nasıl kullanıldığı ve bu teknolojinin ülkemiz ve dünya insanlığına kazandırdıkları olduğunun altını çizen Prof. Dr. Yastı, “Kore’de çıkan bir teknolojiyle bugün eğer Türkiye’de ortak bir iş yapılıp uluslararası alanda iyi sonuçlar kazanan bir merkez oluyorsak; demek ki sadece Kore ile değil, dünyanın her yeri ile olan iletişimimizi ve birlikteliğimizi iyi kullanmak lazım. Bugün Formula 1 yarışlarına bakacak olursak, dünya şampiyonu olan arabanın pilotu, arabanın üretildiği ülkeden değil. Başka bir ülkenin pilotu arabayı sürüyor. Demek ki operasyon, koordinasyon daha iyiyi yakalamak için muhakkak ki gerekli. Bugün Türkiye için de biz öne vatandaşımızın daha sonra da bütün insanların iyiliğini düşünüyorsak tabi ki birlikte çalışmalar ve bilimin birlikte desteklenmesi çok önemli” diye konuştu.
“Hastanın herhangi bir vücut bölgesinde ekstra bir yara açılmadan, var olan yarasını iyileştirme sağlanmış oluyor”
Hastanın yağ dokularını toplayarak 4 boyutlu yazıcıya aktarılması işlemini gerçekleştiren, Ankara Şehir Hastanesi Yanık Tedavi Merkezi doktorlarından Genel Cerrahi Uzmanı Dr. Merve Akın, “Öncelikle uzun süreli kapanmayan yaraların kapanma yönteminde daha önce kullanılan, tarihsel olarak yıllardır kullanılan yöntemlere karşı avantajı; hastanın herhangi bir vücut bölgesinden ekstra bir yara açılmadan, var olan yarasını iyileştirme sağlanmış oluyor. Bildiğiniz gibi özellikle diyabetik hastalarda yara iyileşmesi çok zor olduğu için, hastanın yarasını bir başka yara açarak iyileştirmektense, herhangi bir yara açmadan alınan yağ hücresi, 4 boyutlu yazıcıda şekillendirilerek hastanın yarasına uygulanıyor. Böylece hastaların konforu daha fazla olmuş oluyor” açıklamasında bulundu.
Utku Şimşek – Erdinç Türkcan – Yunus Emre Kartal
Bioprinting has the potential to revolutionize the healthcare industry by creating living human cells or tissues for use in regenerative medicine. Hundreds of thousands of people around the world are on transplant waiting lists. However, there aren’t nearly enough donor organs available to fill this demand.
Imagine a technology that can create organs from scratch. That is the idea behind bioprinting. Bioprinting technology has not yet evolved to the point of printing organs. However, it has advanced enough to print simpler tissues such as skin, meniscus, cartilage, and even blood vessels. Yet bioprinting has massive potential to extend human life through the eventual printing and replacing of human organs.
What is Bioprinting?
Bioprinting works very similarly to 3D printing. 3D printing uses a technique that deposits layers of material on top of each other. This creates a 3-dimensional object one layer at a time. While 3D printers use plastic or other materials, bioprinters use a printable material called “bio-ink.” A bio-ink is a mixture of living cells and other biomaterials. The key to creating a “bio-ink” is having access to a healthy supply from a living human (donor).
For optimal usage of bio-ink, raw materials should come from the patient. It is easier for the immune system to work with autologous tissues (meaning that the donor and recipient are the same people). The reason for this is because they are less likely to be rejected by the body.
Bioprinters – How do they Work?
Bioprinting offers a new opportunity for the development and preparation of personalized medicines. The advantages of bioprinters are that they minimize time and risk. As well as save costs for re-creating healthy tissue to implant into a patient. Seok Hwan, You believes that hospitals and clinics will soon need to have a bioprinter inside the operating theatre. This will be a new form of point-of-care personalized healthcare solution that maximizes the benefits of autologous regenerative technologies.
ROKIT Healthcare’s signature 4D bioprinter is Dr. INVIVO, which ROKIT has already been supplying for material engineering and advanced prototyping in biomedical fields with materials like PEEK and ULTEM (polyetherimide). Now they are dedicated to providing bio-inks that are optimized for human tissue printing. Their ideal bio-ink formulations satisfy material and biological requirements that mimic cellular components found in tissue-specific microenvironments.
Seok-Hwan You -founder and CEO of ROKIT Healthcare
- HumaTein – A bio-ink solution based on the cell-sheet technology that replicates the tunable stiffness of the tissue to be differentiated, ensuring optimal regenerative efficacy.
- INVIVO GEL – a gelatin-based bioink that is comprised of modified natural ECM components. The benefits of INVIVO GEL are that it has tailorable properties, good compatibility, and uniformity, which makes it easier to print while keeping structural stability.
Mr. You explains, “We envision integrating the 3D bioprinter and its applications into traditional healthcare services, realizing the idea of bioprinting as a medical service.”
How Companies can benefit from Bioprinting
Many industries can benefit from bioprinting technology. The fields to which bioprinting applies range from tissue engineering and regenerative medicine to micro-tissue development for pharmaceutical testing as an alternative to animal experiments. Today, most new drugs have to go through an animal testing process. This ensures they are safe to use on humans. These animals are bred explicitly for testing and then euthanized once the testing process is finished. Bioprinting offers the potential to create functional, living, human tissue, or particular organs that are more accurate since they are based on human bio-inks. Therefore this process offers much more predictive results.
Some of the top clients of ROKIT Healthcare include:
- Research labs at Universities
- Government institutions
- Hospital Laboratories
- Pharmaceutical companies
With 3D bioprinting-based therapy solutions such as skin and cartilage regeneration platforms, the applications of bioprinting can expand beyond life sciences research to use in medical practice.
“Bioprinting must converge with other preventive medicine and diagnostic technologies, digitalization, and healthcare management strategies to be truly effective at the level of patient outcomes. ROKIT Healthcare seeks to address regenerative medicine and healthcare from a much wider vantage point, with bioprinting as an important – but not the only – area of our endeavors,” says ROKIT CEO You.
The Future of Bioprinting
Seok-Hwan You says the next step in bioprinting is integrating 3D bioprinters and their applications into traditional healthcare services. This will play a significant role in making the idea of bioprinting as a medical device a reality. Hospitals worldwide are already adding dedicated facilities for bioprinting; however, the eventual goal is to have a bioprinter right next to every operating table.
Besides this, there need to be more clinical trials on 3D bioprinted living tissues transplanted into patients. These are the first steps to advancing the technology to produce personalized organs to replace body parts as they wear out. ROKIT has already finished its clinical trials for bioprinting based skin regeneration for diabetic foot ulcer patients in India. Now the company has distribution deals with hospitals in several countries so they can offer skin generation bioprinting therapy to foot ulcer patients.
“ROKIT Healthcare’s greatest focus lies not on synthetic plastics, but natural ingredients like human ECM, as supporting materials for 3D printed living cells,” said Mr. You.
The biggest challenge that players in the 3D industry face is closing the gap between the available technology and clients’ actual needs in bioprinting research. Therefore, it is crucial to understand that bioprinting, is not only about manufacturing structures with structural stability. Rather it is about promoting cell growth and viability. Furthermore, ROKIT Healthcare is dedicated to building a base for developing next-generation bioprinting technologies and biomaterial applications.
Diabetic Foot Ulcers
Before getting into the treatments for diabetic foot ulcers we first need to explain what they are. Diabetic foot ulcers are sores that occur on the soles of people with diabetes because of a breakdown in the skin tissue. The most common areas for these types of ulcers are on the underside of the toes or on the heels. Around 15 percent of diabetic people suffer from this problem. Once these ulcers occur, there is a high risk for amputation (14 to 24%). While the majority of them can heal (60 to 80%), it is very important to get treatment for diabetic foot ulcers right away.
Standard Treatments for Diabetic Foot Ulcers
In choosing the right treatment for a diabetic foot ulcer, it is important to first determine the cause. Is it related to nerve tissue? Is it related to blood vessels? Vascular ulcers are more serious. A specialist surgeon will need to do a full examination. They will ultimately decide whether the patient needs surgery and recommend the right treatment plan. Overall, it is important that the patient stays off their feet as much as possible. Being on your feet too often can make the ulcer become worse and grow in size. Below are some of the standard treatments for diabetic foot ulcers.
Types of treatments for diabetic foot ulcers:
- Corrective footwear (diabetic shoes, casts, dressings, shoe inserts, or foot braces)
- Removal of dead tissue (done by a doctor)
- Skin grafting Antibiotics (a tissue sample of the ulcer will be sent to a lab to determine which antibiotic to prescribe)
- Daily foot baths (the ulcer needs to be cleaned daily with antiseptic or a superoxide solution) with medical-grade honey in an ointment form
Bioprinted Skin Patches for Diabetic Foot Ulcers
After years of investigating ways to manage treatment for diabetic foot ulcers, Korean bioprinter manufacturer, ROKIT Healthcare has finally announced the success of a new treatment for diabetic foot ulcers through a customized tissue regeneration platform based on its 4D bioprinting technology. The treatment platform uses ROKIT’s 4D bioprinter Dr. INVIVO, which is the world’s first sterile, all-in-one 4D bioprinter/organ regenerator.
This new treatment has been globally commercialized after successfully testing on diabetic patients in India. Dr. INVIVO is already available in 48 countries. In addition to domestic patents, the company has obtained certifications from the European Medicines Agency (EMA) and is currently undergoing the required procedures from the Food and Drug Administration (FDA) that would allow commercialization in the United States. ROKIT’s autologous (meaning the recipient of the tissue is also the donor) skin regeneration procedure using Dr. INVIVO has already received regulatory approval for non-advanced therapy medicinal products (non-ATMP) by the EMA for the treatment of diabetic ulcers, pressure ulcers, scar revision, and burn wounds, meaning Dr. INVIVO can be used in the operating room.
ROKIT will continue its clinical trials in South Korea, North America, Europe, and East Asia. It is a fast, safe, and cost-effective regenerative therapy solution. It has been proven to result in a significant reduction in wound size after only a one-time treatment. In addition, it promotes skin regeneration.
Treatments for Diabetic Foot Ulcers – The Process of using Bioprinted Skin Patches
- The process begins with fat tissue taken from the patient (for example through liposuction).
- This fat tissue sample is then used to prepare an extracellular matrix (ECM) mixture to form a “bioink”. A “bioink” is a mixture of materials and cells.
- The “bioink” is loaded into ROKIT’s Dr. INVIVO 4D bioprinter to produce a dermal patch.
- Lastly, the damaged tissue is removed and replaced with the patch.
Most patients will show a complete closure of the wound in 2 to 5 weeks. Compare this to conventional treatments for diabetic foot ulcers, which can take months to heal and require multiple rounds of treatment or an extended period of observation. In addition, the treatment platform includes all of the procedures required to treat diabetic foot ulcers, including 3D scanning of the affected area, diagnosis, bioprinting with personalized “bioink”, and a procedure kit. However, the key to this new form of treatment was ROKIT’s Dr. INVIVO 4D bioprinter, which provides a fast regeneration solution for customized treatment of diabetic foot ulcers. Therefore, not only does it offer a precise and rapid process to print the patch, but Dr. INVIVO also creates a personalized therapy solution by building patient-specific designs.
Treating diabetic foot ulcers is only the beginning
ROKIT Healthcare’s unique treatment platform is already moving into cartilage regeneration for other forms of tissue damage and disease.
“Imagine a 3D bioprinting service in a hospital that can renew your damaged or worn-out body parts. The human body is composed of cells, proteins, and extracellular materials that we can also use as bioink to regenerate organs. Therefore we can regrow the injured body back to its original shape and function. 4D bioprinting technology is the best method to create human organs, such as skin, cartilage, and bone tissue. We are living in the era of the fourth industrial revolution that will ideally change human lifestyles, including our healthcare services. Now, ROKIT Healthcare is a pioneer in advanced cutting edge 4D bioprinting technology,” said Dr. Jeehee Kim, president of ROKIT Healthcare’s DFU and Skin Regeneration Strategy Business Unit.
NMN supplement is known to raise NAD+ levels and help improve ‘aging-related’ diseases (ie. cardiovascular, brain, diabetes, and immunity related diseases). ROKIT America’s NMN sales in Korea have increased by approximately 1,100% compared to that of April, 2020. It has now expanded its business to OEM sales for pharmaceutical companies in China, healthcare & pharmaceutical companies in UAE, and tertiary hospitals in Korea. NMN ingredients are currently pending approval as ‘Certified Functional Ingredients’ through the Korean FDA (MFDS)
Rokit has signed a term sheet with a Dubai based venture capital company to develop and operate a wellness center in Kőszeg, Hungary. The project aims to develop 3.3 hectare lot with ancient trees and a palace that will be renovated to a luxurious wellness anti-aging center for Rokit’s unique regenerative medicine technology and anti-aging products/services.As part of ROKIT’s IPO process in Korea, an Interim Audit was conducted by KPMG designated by The Financial Supervisory Service. Discussions on the Valuation and Liquidity Classification of Redeemable Convertible Preference Shares, and the Collectability of Account Receivables were done in ovember 2020. Rokit’s capital has increased $2.16 million (DRADS CAPITAL Inc.) plus $4.12 million (Vision Creator, a venture investor group focusing on high-tech, bio-healthcare industry in Korea and China).
DFCon (Diabetic Foot Conference) 2020: ROKIT’s abstract on “4D Bioprinting Technology and Skin Regeneration Platform in DFU Treatment” was selected for DFCon’s EPoster Session in presented by Dr. Jeehee Kim, President of R&D Center and DFU Strategic Business Unit at ROKIT.
EWMA(European Wound Management Association): ROKIT participated in a semi-live presentation on “4D Bioprinting Technology and Skin Regeneration Platform in Diabetic Foot Ulcer Treatment”. Dr. Rajesh Kesavan presented an e-poster with successful result of the clinical study conducted with ROKIT Healthcare in India in 2019.
ROKIT completed DFU clinical trials in Korea and India. Results from these studies showed 100% wound healing for all tested patients with chronic diabetic foot ulcers. Data from these studies have been analyzed and submitted for publication at SCI journals targeting a release by the end of this year.
Clinical study at DFU Lewis Gale Medical Center, Virginia, USA: study start date of December 2020. Dr. David G. Armstrong is the PI on this study evaluating the efficiency of autologous minimally manipulated homologous adipose tissue (AMHAT) in improving DFU. Dr. Armstrong is a worldrenowned podiatric surgeon, professor of surgery and Director at Keck School of Medicine of University of Southern California (USC), and a co-founder and director of the international diabetic foot conference, DFCon.
Clinical study at Ankara City Hospital, Turkey: study start date of November 2020. Dr. Ahmet Cinar Yasti is the PI on this study investigating DFURegen treatment. Dr. Yasti is a General Secretary of the Turkish Surgeon Society and Director of the Burn/Wound Center at Ankara City Hospital.
1st human case of Cartilage Regeneration treatment using Dr. INVIVO 4D bioprinting technology took place on November 24 in Egypt: Cartilage Regeneration Platform is a therapeutic solution for osteoarthritis. By adopting our most cutting-edge technology, Dr. INVIVO 4D bioprinting, we aim to fully regenerate damaged cartilage tissue from arthritis ulcers. From the collaborative pre-clinical trial project with Mass General Hospital, we have already collected promising efficacy results. ROKIT will verify and validate the procedure in clinical scale at Assiut University Hospital in Egypt.
On November 23rd, ROKIT began a large pre-clinical animal model trial for HumaTein SKIN SPRAY. HumaTein SKIN-SPRAY is specially developed for treating soldiers with traumatic burn injuries in the field. HumaTein SKIN-SPRAY uses HumaTein technology that not only prevents infection as a first aid but also induces simultaneous skin regeneration that could dramatically reduce scar formation and hospitalization length to enhance patients’ quality of life.
DRADS Capital announced its investment in ROKIT Healthcare Inc., a South Korean biotechnology company developing innovative 4D bioprinting techniques and applications, in its Series C funding round of undisclosed amount. DRADS Capital is a Boston-based venture capital fund which specializes in making strategic investments in life sciences, biotechnology and artificial intelligence. ROKIT Healthcare Inc. introduces a cutting-edge organ regeneration platform based on 4D printing and clinical diagnosis technology for age-related diseases, such as rheumatoid arthritis and Alzheimer’s disease, to the global anti-aging market. (Graphic: Business Wire)
“ROKIT introduces a cutting-edge organ regeneration platform based on 4D printing and clinical diagnosis technology for age-related diseases, such as rheumatoid arthritis and Alzheimer’s disease, to the global anti-aging market.”
SEOUL, South Korea–(BUSINESS WIRE)–DRADS Capital announced today its investment in ROKIT Healthcare Inc., a South Korean biotechnology company developing innovative 4D bioprinting techniques and applications, in its Series C funding round of undisclosed amount. Founded in 2018, DRADS Capital is a Boston-based venture capital fund which specializes in making strategic investments in life sciences, biotechnology and artificial intelligence (AI). One of its notable founders is Dr. Rudolph E. Tanzi, who is the Joseph P. and Rose F. Kennedy Professor of Neurology at Harvard University, Vice-Chair of Neurology and Director of the Genetics and Aging Research Unit at Massachusetts General Hospital (MGH). He was also named to TIME magazine’s list of TIME 100 Most Influential People in the World in 2015.
Nagarajan Pillay, founding Managing Director of DRADS Capital and former Senior Vice President of Pepsi Bottling Franchise, commented on the investment, “We stand behind ROKIT’s fundamental belief that ‘aging is disease’ and their aim to change the world with customized organ regeneration platforms. As the lead investor in ROKIT’s Series C funding round, we believe that ROKIT’s novel organ regeneration technology will dramatically improve clinical therapeutics in the field of wound healing. Their recently published paper in the Diabetes Journal shows how their 4D bioprinter ‘Dr. INVIVO’ — the world’s first sterile, all-in-one 4D organ regenerator — is used to regenerate skin as a treatment for diabetic foot ulcers, negating the need for amputation and skin grafting. It is without a doubt that ROKIT Healthcare Inc. will make great strides under the leadership of Chairman Seokhwan You in the era of organ regeneration.” Dr. Tanzi also expressed his excitement about ROKIT, stating “We are thrilled and honored to be aligned with ROKIT Healthcare and the tremendous promise of their regenerative bioprinting technologies.”
Chairman You, the founder and CEO of ROKIT Healthcare Inc., stated: “ROKIT introduces a cutting-edge organ regeneration platform based on 4D printing and clinical diagnosis technology for age-related diseases, such as rheumatoid arthritis and Alzheimer’s disease, to the global anti-aging market.” Chairman You, who is also the former CEO of Celltrion Healthcare, a South Korean biopharmaceutical company valued at $14 billion today, added: “With our extensive experiences in the biomedical industry, ROKIT Healthcare will make every effort to continue growing as an innovative global company by expanding its business domain ranging from personalized organ regeneration to anti-aging markets. This will be headed by our revolutionary Diabetic Foot Ulcer Platform, DFURegen, which will combat this incurable disease with a global market share of about USD 40 billion.” The company plans to go public in 2021.