Newsletter | Vol.1

Organ Regeneration AI & Bioprinting

Introduction

Why Personalized Medicine?

Most medical treatments are designed for the “average patient” as a one-size-fits-all-approach, which may be successful for some patients but not for others. Precision medicine, sometimes known as “personalized medicine” is an innovative approach to tailoring disease prevention and treatment that takes into account differences in people’s genes, environments, and lifestyles. The goal of precision medicine is to target the right treatments to the right patients at the right time.

Advances in precision medicine have already led to powerful new discoveries and FDA-approved treatments that are tailored to specific characteristics of individuals, such as a person’s genetic makeup, or the genetic profile of an individual’s tumor. Patients with a variety of cancers routinely undergo molecular testing as part of patient care, enabling physicians to select treatments that improve chances of survival and reduce exposure to adverse effects.

Source: https://www.fda.gov/medical-devices/in-vitro-diagnostics/precision-medicine

Organ Regeneration

Korea aims to establish biohealth as a national core industry

► Korean version of ‘Boston Cluster’

According to the Korea Policy Briefing, President Yoon Seok-yeol has expressed the strong will of government to gather and support the biohealth industry as a national key strategic industry over the <Biohealth New Market Creation Strategy Meeting> at the State Guest House on February 28, 2023. The global market size of biohealth field has reached 2,600 trillion won with great growth potential that is expected to protect public health and create quality jobs at the same time. President Yoon emphasized that drastic innovation and investment should be followed first, and that medical, health, and care services should be converted to a digital basis to make intensive investments to preoccupy the global market. In particular, he promised to actively consider creating a Korean version of the ‘Boston Cluster’ so that venture companies and young people can challenge and lead the biohealth field.

► The top 7 bio issues of K-BIO 2023

Medical technology is advancing at a tremendous speed, such as diagnostic technology that discovers biomarkers, which are the causative genes, diagnostic aid technology that precisely analyzes MRI, and AI new drug development that predicts failure and shortens the clinical period when developing new drugs. Reflecting this trend of the times, The Korea Bio Association and Reed Exhibitions Korea held the comprehensive bio convention ‘BIOPLUS-INTERPHEX KOREA 2023’ from July 12th to 14th at COEX, Seoul, inviting global experts from all fields of the bio industry. The professional session was held under the theme of ‘The top 7 bio issues of K-Bio 2023’, and the current medical technology development trend and policy proposals were highlighted.

Source: ROKIT Healthcare, Fabricating with 3D Bioprinter on a curved surface

► The Convergence of the 4th industrial revolution and medical technology… “Prevention” rather than “cure”

he medical paradigm has shifted to ‘precision medicine’, which refers to the customization of medical treatment according to the individual genetic characteristics of each patient. There are many types of customized medicine, but the regenerative medicine market is trending up recently.

Regenerative medicine is a field of medicine that restores function by regenerating damaged or defective organs or tissues. According to Grandview Research, a global research institute, regenerative medicine is a next-generation technology that will solve the shortage of transplant organs, and the market size is expected to reach $5.3 billion (about KRW 6.83 trillion) by 2030. One of the representative examples of regenerative medicine include ‘commercialization of skin patches and cartilage regeneration platforms’ by ROKIT Healthcare in Korea.

ROKIT Healthcare is a company that has commercialized patient-specific patch technology that can be used to treat diabetic foot ulcers (diabetic foot) by combining bioprinting with artificial intelligence (AI). It has already signed supply contracts with more than 20 countries around the world.

► The top 7 bio issues of K-BIO 2023

Medical technology is advancing at a tremendous speed, such as diagnostic technology that discovers biomarkers, which are the causative genes, diagnostic aid technology that precisely analyzes MRI, and AI new drug development that predicts failure and shortens the clinical period when developing new drugs. Reflecting this trend of the times, The Korea Bio Association and Reed Exhibitions Korea held the comprehensive bio convention ‘BIOPLUS-INTERPHEX KOREA 2023’ from July 12th to 14th at COEX, Seoul, inviting global experts from all fields of the bio industry. The professional session was held under the theme of ‘The top 7 bio issues of K-Bio 2023’, and the current medical technology development trend and policy proposals were highlighted.

CEO You Seok-hwan interpreted that organ regeneration technology would become a “game changer” in the bio industry. He said, “According to the report of Time magazine, the life expectancy of a recently born baby reaches 142 years. Due to the increase in life expectancy and the aging population, regenerative medicine has become a necessity rather than an option.” Since the human body has cellular heterogeneity, it is very difficult to treat chronic diseases with a single drug. On the other hand, it is true that the bioprinting organ regeneration platform is expected as a treatment alternative for intractable diseases such as chronic wounds, osteoarthritis, and renal failure, for which there is no appropriate treatment method. CEO You took Diabetic Foot as an example and said, “Typically, 50% of people who have had their feet amputated due to diabetes die within 5 years, but with organ regeneration, it eliminates the need for amputation.” Pharmaceutical-centered treatment has been the mainstream, but in the future, K-Bio and organ regeneration bioprinting technology will accelerate the transition to a personalized, patient-centered paradigm around the world. CEO You concluded his presentation saying that the “Organ Regeneration bioprinting technology with Artificial Intelligence is expected to contribute more to creating a future-oriented medical paradigm”

"Organ Regeneration Technology would become a “game changer” in the bio industry. According to the report of Time magazine, the life expectancy of a recently born baby reaches 142 years. Due to the increase in life expectancy and the aging population, regenerative medicine has become a necessity rather than an option."

ROKIT HEALTHCARE CEO You Seok-hwan explaining the need for regenerative medicine at Bioplus-Interpex Korea 2023, under the topic of ‘The top 7 bio issues of K-Bio 2023’.

Organ Regeneration

European CE MDR certification for organ regenerative medical devices

ROKIT HEALTHCARE Inc.[“ROKIT” as follows], Organ Regeneration Bio-healthcare company, announced that the medical device ‘Dr. INIVIVO AI Regen Kit’, used for regenerating organs with artificial intelligence (AI) and bioprinting, has already obtained medical device approval from the U.S. FDA and the Korean Food and Drug Administration. On the 1st of August, Dr. INVIVO AI Regen Kit has also obtained CE MDR (Medical Devices Regulation (EU) 2017/745), the essential safety regulation for the sale of medical devices in Europe with stricter safety, efficacy, and quality review standards applied than the existing MDD CE certification.

CE MDR-certified medical devices can be sold in a total of 31 countries, including the European Union (EU), which includes 27 countries, as well as the European Economic Community (EEA) and Switzerland. Europe is the world’s largest market for regenerative medicine, with an annual growth rate of about 10%.

ROKIT’s organ Regeneration Platform, a digital autologous wound repair solution that creates a 3D tissue regeneration patch at the point of care is the first of its kind to converge the advantages of artificial intelligence(AI), 3D bioprinting and Dr. INVIVO AI Regen Kit (autologous adipose tissue solutions) to offer the safest and the most effective wound healing.

Dr. INVIVO AI Regen Kit, the regenerative treatment solution can be used to treat chronic wounds such as diabetic foot ulcers (hereinafter referred to as “diabetic foot”) in the field of skin regeneration. ROKIT conducts clinical research on diabetic foot treatment in many countries and published its safety and effectiveness in five SCI-level international academic journals, proving its scientific achievements and commercializing them worldwide. Unlike conventional wound treatment methods that rely on highly invasive and scar-producing skin autograft surgery and dressings that are made of xenograft/allografts, Dr. INVIVO AI Regen Kit is both minimally invasive (with a small volume of adipose tissue extracted after a small incision) and causes no immune rejection and poses minimal risk of hospitalization because it is an autologous, same-day procedure that finishes within an hour. It is a product that has revolutionized the field of regenerative medicine with low medical costs.

► A bridgehead for global market expansion of the global market

Seok-hwan You, CEO of ROKIT Healthcare said, “This CE MDR approval will serve as a bridgehead for entering the global market as well as the European market, and will be able to provide cutting-edge medical services to more patients. ROKIT will research and innovate to become a world leader in the field of organ regeneration, such as striving to advance artificial intelligence-based medical devices and bioprinting technology, and expanding the application of organ regneration.”

Organ Regeneration

The Korea Health Care Research Institue (NECA) announced organ regeneration platform as an innovative medical technology with stability and potential

ROKIT Healthcare’s ‘3D bioprinting-based wound treatment using autologous adipose tissue’ was recognized as a new medical technology. It is a personalized therapy that accelerates wound healing using a 3D wound specific regenerative patch made of the patient’s own adipose tissue fabricated with a 3D bioprinter.

In the ‘7th New Medical Technology Evaluation Committee’ review, the Korea Health Care Research Institute (NECA) announced that a technology to protect the affected area and promote treatment through cell proliferation by making and applying autologous adipose tissue patches with a 3D bioprinter for patients with chronic diabetic foot ulcers that do not respond to standard treatment is subject to innovative medical technology evaluation, and notified as an innovative medical technology with stability and potential.

► The United States take their first step towards Organ Regeneration

ROKIT’s organ regeneration platform is first-of-its-kind to converge the advantages of artificial intelligence (AI), 3D bioprinting and autologous adipose tissue solutions to offer the safest and the most effective wound healing at the point of care. Unlike conventional methods, ROKIT’s organ regeneration platform is:

An AI-assisted scanning software that uses deep learning to detect the wound, segment it and digitally assess its dimensions. Not only that, it binds the full pipeline from capturing wound images to create 3D printable files so the healthcare professionals do not need to handle the long process of 3D modeling or slicing before using the 3D bioprinter.

A patch perfectly customized to the patient’s wound at the point of care, because the patch is 3D printed to fit the wound like a puzzle piece, it maximizes the wound edges coming together to accelerate wound healing and ultimate closure.

Minimally invasive (with a small volume of adipose tissue extracted after a small incision) and causes no immune rejection and poses minimal risk of hospitalization because it is an autologous, same-day procedure that finishes within an hour.

The convergence of these innovative technologies, detecting wound digitally with AI technology, generating patient-centered wound patches and the minimal risk of hospitalization with same-day procedure sets ROKIT’s organ regeneration treatment as an innovative medical technology with stability and potential.

Skin Regeneration

The United States take their first step towards Organ Regeneration

On July 31, 2023, ROKIT Healthcare [ROKIT], a leading 3D bioprinting firm specializing in innovative medical solutions, has successfully made its first export to the U.S.

The U.S. represents the largest medical device and wound care market and is considered a country with the No. 5 highest number of diabetes patients of 37 million people and 3.5 million diabetic foot ulcer patients. The U.S. spends $176 billion annually on direct costs for diabetes care, of which one third is lower extremity and diabetic foot care-related.

The U.S. is home to some of the largest global initiatives for regenerative medicine and biomanufacturing, including BioFABUSA, a national public-private partnership including companies, academic institutions and not-for profit organizations such as the Department of Defense and the Advanced Regenerative Manufacturing Institute (ARMI).

As the U.S. has been investing hugely into innovations in biomanufacturing technologies like 3D printing in combination with the science of regenerative medicine, in this megatrend context introducing ROKIT’s solution to the U.S. holds great promise to its future.

As of April 2023, ROKIT has made a five-year distribution partnership contract with a U.S. biotech Tides Medical. Tides Medical has been dedicated to providing amniotic tissue grafts and wound care services in the last 10+ years, while ROKIT specializes in the development of state-of-the-art 3D bioprinters for regenerating chronic wounds. By combining their expertise and resources, these two companies strive to revolutionize the field of medical care and improve patient outcomes.

With the first export made in July, ROKIT and Tides Medical are jointly preparing for the official launch of the platform in the U.S. starting with clinical demonstrations in five priority states with key opinion leading institutions in diabetic foot ulcer treatment, including New York, Ohio, Virginia, Michigan, and Louisiana. The two companies are also in the process of making the treatment accessible to a larger patient base through contacts with the American Medical Association and the Center for Medicare and Medicaid services for insurance market access.

Skin Regeneration

The Kingdom of Saudi Arabia: to save more lives who suffer from Diabetic Foot Ulcer

ROKIT Healthcare [ROKIT] has introduced the skin regeneration platform to the Kingdom of Saudi Arabia with a commercialization launch marked by seminars, clinical demonstrations, and visits to the top government and private medical institutions.

Saudi Arabia represents a region with one of the highest prevalence of diabetes (18%) with 4.3 million patients, and this prevalence is expected to rise to more than 20% in 2030. Approximately 640,000 people in the country (15% of all diabetic patients) are estimated to be suffering from diabetic foot ulcer.

For this reason the Saudi Ministry of Health and Welfare (MoH) has allocated close to 20% of its total annual budget for diabetes and set a goal to reduce its prevalence rate by 10% by 2030. Also the Saudi government has been making efforts to achieve “Vision 2030”, a unique transformative economic, social and healthcare reform blueprint, which has been focusing on adoption of novel biotechnology and artificial intelligence solutions.

Since completing the Saudi Food and Drug Administration’s approval for the skin regeneration platform in October 2022, ROKIT and its Saudi partner Cigalah Healthcare Company [Cigalah] have been presenting the technology to key opinion leaders and institutions. Particularly noteworthy institutions include the Ministry of Health Diabetes Center and Unit Management and the National Unified Procurement Company (NUPCO), which centralizes procurement and distribution of medical devices in the government sector.

Over the months from February to June 2023, ROKIT and Cigalah conducted clinical demonstrations at a total of 6 hospitals in 3 cities (Jeddah, Damman and Taif), completing 15 patient cases (e.g., 11 DFU, 1 breast skin necrosis, 1 leg ulcer, 1 hand trauma, and 1 burn scar patient). The skin regeneration platform was introduced to MoH-affiliated public hospitals including the King Abdulaziz University Hospital, military hospitals such as the Al Hada Armed Forces Hospital, and top private institutions such as Saudi German Hospital and Dr. Erfan and Bagedo General Hospital.

As an outcome of these activities, two hospitals – Dr. Erfan and Bagedo General Hospital and WeCare Clinic (Dammam) signed consignment agreements to purchase the platform and become the first centers of excellence in the country. Now, ROKIT and Cigalah have submitted an application to the Saudi Council of Insurance with the primary objective of establishing the treatment’s own insurance code and making this innovative treatment accessible to a larger patient base.

Cartilage Regeneration

Peru secured distribution of innovative cartilage regeneration treatment platform

In February, Peru has secured the distribution of the innovative cartilage regeneration platform using artificial intelligence and bioprinting with ROKIT Healthcare, a global leader in organ regeneration. The size of the contract is 52 million dollars for 5 years and about 65 billion won, and it is said that with this contract, an artificial intelligence customized cartilage regeneration platform will be launched in all hospitals in Peru by April.

Cartilage disease usually requires about a year of rehabilitation and there is no other treatment other than artificial joint surgery with many side effects. Compare to that, ROKIT Healthcare’s cartilage regeneration platform offers a faster and safer alternative, as it was analyzed to recover within 8 weeks including treatment, hospitalization and rehabilitation period. Therefore the innovative customized cartilage regeneration platform, which regenerates autologous cartilage with artificial intelligence and bioprinting, has a high reputation throughout South America. In addition, ROKIT Healthcare is showing its achievements in pioneering the South American market through a number of contracts with the skin regeneration platform in Brazil, Argentina, Paraguay, and Uruguay after the approvement of the Brazilian Food and Drug Administration (ANVISA) last year.

1) Rehabilitation Following Microfracture for Chondral Injury in the Knee, Cartistem Implantation of Femoral Condyle Rehabilitation Protocol, Total Knee Arthroplasty Rehabilitation Protocol, Standard of Care: Autologous Chondrocyte Implantation 2) The projected burden of primary total knee and hip replacement for osteoarthritis in Australia to the year 2030 3) 2018_Cost effectiveness of Stem cell therapy compared with Microfracture in Korea

Kidney Regeneration

The increase interest of Kidney Regeneration

Photo of Seoul National University College of Medicine

Photo of Asan Hospital5

The research team at ROKIT Healthcare is paying attention to chronic renal failure after diabetic feet and osteoarthritis. Recently, in recognition of the possibility of commercializing the kidney regeneration platform, it was selected as a pan-ministerial regeneration medical technology development project (2023-2025) consortium with a research team at Seoul National University College of Medicine and Asan Hospital.

Chronic renal failure is a condition in which renal function has been reduced due to continuous damage to the kidney, and if the glomerular filtration rate falls below a certain level, hemodialysis or kidney transplantation is needed to replace the renal function. However, once dialysis begins, the patient has to undergo dialysis three to four times a week, and wait for more than five years for kidney transplant.

The research team analyzed that the development of a patch that will delay the timing of dialysis can improve the quality of life of patients. In a preclinical test of mice that actually caused kidney failure, the effect of preventing fibrosis was observed when a patch was attached to a broken kidney.

Dr. Ryu Jina, head of kidney regeneration research, said, “The patch for kidney failure has added a bioink called ‘momentum’ to the bioprinting and AI fusion technology treatment platform. When this patch was inserted, it was confirmed that the expression of genes related to kidney fibrosis decreased and blood vessel flow in the kidney improved.” The paper on the treatment was published in an SCIE-level journal and was also introduced at the World Kidney Society held in Thailand in March and received a lot of attention from participants.

Artificial Intelligence

The world’s fastest and most accurate 3D scanning technology with Organ Regeneration

ROKIT Healthcare’s FastSurf is a promising development that could transform the 3D reconstruction industry. The technology’s accuracy and speed have the potential to disrupt the industry and provide significant benefits. The method could also have implications for related industries, such as virtual and augmented reality, where accurate 3D models are crucial for creating immersive experiences.

ROKIT Healthcare has developed a breakthrough technology in 3D scanning. The company has introduced a neural surface reconstruction method called FastSurf that is the fastest and most accurate method available.

FastSurf is an accelerated neural radiance field (NeRF) framework that utilizes depth information to reconstruct 3D scenes with high-frequency details. The method uses a dense feature grid and a shallow multi-layer perceptron to optimize the surface of the entire scene quickly and accurately. Additionally, FastSurf incorporates a classical real-time 3D surface reconstruction method, the truncated signed distance field (TSDF) Fusion, as prior knowledge to pretrain the feature grid, which accelerates the training.

The technology has significant implications for a range of industries, including healthcare and manufacturing. FastSurf could be used to create accurate 3D models of organs for medical treatments as well as simulations and training, and it could also be used in the production of 3D printed products, where accuracy and detail are essential.

Marketing & Community Development

Bio-printing Regenerative Medicine Research Association Symposium demonstrates clinical capabilities with Organ Regeneration

On March 24th, ROKIT and the Bio-printing Regenerative Medicine Research Association (BPRM) held its inaugural symposium at the Seoul National University Hospital Innovative Medical Technology Research Institute. The event was a great success, with a total of 118 people in attendance, including 88 in person and 30 online.

At the symposium, 3D bio-printing venture company ROKIT Healthcare explained its excellent clinical capabilities in treating diabetic foot ulcers. The company’s approach involves extracting fat from the patient to create bio-ink and then using a 3D bio-printer and AI vision technology to attempt customized restoration of damaged organs. This eliminates immune rejection reactions and allows for personalized regeneration treatment.

One of the key achievements of ROKIT’s technology is the practical application of bio-printing technology from the laboratory to the operating room for actual patient treatment. This advanced technology combines artificial intelligence and has made it possible to regenerate not only diabetic foot ulcers but also damaged cartilage. In addition, research is being conducted to regenerate kidneys in collaboration with medical staff from Seoul National University Boramae Hospital and Asan Medical Center as part of a national project.

This progress was noted by the Director of the Advanced Regenerative Medicine Department of the Ministry of Health and Welfare, major media outlets, and prominent regenerative medicine scholars in Korea who attended the BRRM symposium.

ROKIT Healthcare has built a skin regeneration treatment platform for diabetic foot and knee cartilage treatment and has conducted clinical trials in dozens of countries overseas. The company is also planning to expand its treatment range to include clinical trials for chronic kidney failure patients.

ROKIT Healthcare President You Seok-hwan spoke at the event about how Korea is differentiating itself in advanced bio fields such as bio-printing and regenerative medicine. ROKIT Healthcare is proud to be part of this effort to advance the field and improve patient outcomes.

Together with BPRM, ROKIT Healthcare has made a meaningful first step towards creating an open innovation collective intelligence for the development of technology and the practical application of bio-printing regenerative medicine and advanced bio for patient treatment.

Anti-aging

The science behind NMN

NAD+(Nicotinamide Adenine Dinucleotide) is one of the keys to maintain healthy mitochondrial functions and steady energy output. Unfortunately, when we age, NAD+ levels decrease, causing aging-related symptoms and diseases. However, David Sinclair, a NAD+ researcher from Harvard, says the NAD+ molecule itself cannot readily cross cell membranes to enter cells. Instead, precursor molecules to NAD+ must be used to increase bioavailable levels of NAD+. Providing NAD+ precursor such as NMN, NR(Nicotinamide Riboside), niacin(vitamin B3) can increase NAD+ levels so that our cells become healthier, our organs become healthier and we become healthier. As an NAD+ precursor, we believe that NMN is more readily absorbed and is more effective as a supplement.

NMN Benefits

Many studies showed that NMN can prevent the reduction of NAD+ levels, helping alleviate aging-related disease. Therefore, clinical trials with NMN have been shown that it increases insulin sensitivity, improve sleep, strength and skin health in older adults. Recent study has shown that taking NMN reduces blood vessel stiffness in middle-aged adults with high blood-glucose and body mass index.

The following graph showed a reduction in blood vessel stiffness after taking NMN. Participants treated with NMN (gray) have significantly lower brachial-ankle pulse wave velocity (baPWV) values than untreated participants (Placebo) in the right and left leg, indicating reduced blood vessel stiffness.

In order to see the impact of NMN on the aging of blood vessels, it’s conducted to see the stiffness of blood vessels (arteries) in a group of 30-40 healthy adults between the ages of 40 and 59 who took 250 mg of NMN for 12 weeks. The assessment of blood vessel stiffness was conducted by observing the speed of blood flow through an artery located near the ankle.