July 1, 2020 by admin 0 Comments

ROKIT HEALTHCARE PRESENTS WORLD’S FIRST ALL-IN-ONE BIOPRINTING PLATFORM

HIGHLIGHTS
  • Launched by ROKIT Healthcare, Dr. INVIVO 4D6 this is a bioreactor-based bioprinting platform.

  • This platform is unique due to built-in cell incubator and low-temperature plasma sterilizer.

ROKIT Healthcare has launched the Dr. INVIVO 4D6, a bioreactor-based bioprinting platform. This platform has a built-in cell incubator and low-temperature plasma sterilizer. The plasma….

June 29, 2020 by admin 0 Comments

Bioprinted Skin Patches for Diabetic Foot Ulcers Commercialized by Rokit Healthcare

After years of investigating ways to manage treatment for diabetic foot ulcers (DFU), Korean 3D bioprinter manufacturer, Rokit Healthcare finally announced the success of a new DFU regeneration platform based on its 4D bioprinting technology for customized tissue regeneration. This new and alternative method for chronic wound healing promotes a mechanism of skin reconstruction for DFU treatment that was successfully tested on patients and will be globally commercialized this year.

To find an advanced treatment method, particularly for wound healing, Rokit tested the DFU therapy with its own 4D bioprinting system, using a personalized bioink developed with the patient’s own adipose tissue that had no immune rejection.

With diabetes on the rise in most countries, patients require targeted therapies and effective solutions for pain management. Today, over 460 million adults have diabetes, that’s roughly 6% of the global population, and it is expected to reach 700 million patients by 2045. Furthermore, diabetes can damage eyes, kidneys, and nerves, cause heart disease, stroke, and even the need to remove a limb. In fact, diabetic foot ulcerations are one of the most common complications associated with diabetes, as an estimated 50% of diabetic ulcers become infected and could result in amputation.

Rokit’s mission is to decrease the rate of amputation for patients with DFU, by offering safe and effective regenerative therapy based on 4D bioprinting technology. As part of one of their continuing studies, a global Rokit team successfully tested its DFU regeneration platform on patients in India and will continue clinical trials in South Korea, Europe, North America, and East Asia.

The process begins with fat tissue taken from a patient (for example through liposuction), which is then used to prepare an autologous extracellular matrix (ECM) mixture to form a bioink that is loaded into Rokit’s INVIVO 4D bioprinter to produce a dermal patch. The autologous patch is finally implanted at the wound site after the damaged tissue has been removed.

The results of the study, published in the American Diabetes Association‘s journal Diabetes, describe how the autologous ECM patch, applied onto the chronic wound site of DFU patients, resulted in a significant wound size reduction after only a one-time treatment.

During the tests, most of the patients showed complete closure of the wound in only two to five weeks. In fact, after a 14-day skin wound healing process, the treated wound area had more effectively reconstructed epidermal and dermal structures when compared to the non-treated wound areas.

▲ After the process, the treated wound area has more effective reconstructed epidermal and dermal structure compared to the non-treated area (Credit: Rokit Healthcare)

“My team recently focused on skin regeneration, especially for caring diabetic foot ulcers. Using our 4D bioprinting system with patient’s autologous fat tissue, diabetic foot ulcers were successfully healed after getting only one treatment during the clinical trials. Rokit’s DFU regeneration platform will provide a safe, fast, and cost-effective solution for curing diabetic wounds,” said Jeehee Kim, president of Rokit Healthcare’s DFU and Skin Regeneration Strategy Business Unit and author of the published paper.

Currently, diabetic foot ulcers are treated with dressings, negative pressure, and skin grafting, but according to Rokit, these treatments have proven ineffective, costly, and time-consuming for patients, moreover, they do not provide the correct therapeutic approach as regenerative medicine and tissue engineering would. Instead, the company’s alternative treatment solution to promote skin reconstruction, along with its use of biomaterials and bioink designs, can hold a lot of promise for future effective customized 4D bioprinting to regenerate human tissues and organs.

▲ DFU treatment process (Credit: Rokit Healthcare)

To find an advanced medical solution, particularly for diabetic wound healing and skin regeneration, Rokit used its 4D bioprinting platform along with the minimally manipulated autologous fat tissue. According to the company, INVIVO was key to its success, provided a fast regeneration effect and customized treatment that fits the skin loss area.

“Dr. INVIVO is what we believe to be a scientific breakthrough. It’s the world’s first clean bench hybrid 4D bioprinter. When creating a regenerative patch on diabetic foot ulcer patients, Dr. INVIVO plays a mayor role. With its precise and rapid manufacturing capabilities, Dr. INVIVO helps create a personalized therapy solution by building patient specific designs,” explained one of Rokit Healthcare’s R&D engineers, Jaeyong Shin One.

As reported by MK’s Maeil Business Newspaper, Rokit Healthcare has begun commercializing in 48 countries its DFU treatment platform that uses 4D bioprinter Dr. INVIVO. To that end, the company signed a per region export business cooperation agreement and expects the number of sales for this year alone to reach 424 million dollars and well over one billion dollars by 2022. For now, the contract enables commercialization of the platform to India, countries in Europe, Latin America, the Middle East, and North Africa. However, the company already has plans to expand, launching the platform in other regions, like North America, Japan, China, and Australia.

The platform includes all of the procedures required to treat DFU, including 3D scanning of the affected area, diagnosis, bioprinting with personalized bioinks, and a procedure kit. 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.

The company’s INVIVO bioprinting technology has already been acquired by research labs and institutions in more than 25 countries, specializing in tissue and material engineering, drug testing, 3D tissue, and disease modeling. Dr.INVIVO is the world’s first sterile, all-in-one 4D organ regenerator. Rokit’s autologous skin regeneration procedure using Dr.INVIVO already received regulatory approval for non-advanced therapy medicinal products (ATMP) by the EMA for the treatment of diabetic ulcers, pressure ulcers, scar revision, and burn wounds, meaning immediate access to the operating room.

▲ Dr. INVIVO (Credit: Rokit Healthcare)

“Imagine that you get a 3D bioprinting service in a hospital to renew your damaged body parts. The human body is composed of cells, proteins and extracellular materials that we can also use a bioink to regenerate organs, which means regrowing the injured body back to its original shape and function,” Kim went on. “4D bioprinting technology is the best method to create human organs, such as skin, cartilage and bone tissue. We live in the era of the fourth industrial revolution that will ideally change human lifestyle, including our healthcare service. Now, Rokit Healthcare leads the advanced cutting edge 4D bioprinting technology as a pioneer.”

Ulcer healing usually takes weeks or even months, with many ulcers never healing and resulting in amputations. By promoting mechanisms of skin reconstruction, this alternative method could be essential to reducing the risks associated with DFU’s, as well as help lower therapy costs, and lead to a better quality of life for patients. By attempting to cure the inevitable development of diabetic ulcers, Rokit Healthcare is pioneering the foot regeneration treatment market thanks to its innovative development. However, healing diabetic ulcers is only the beginning, the company’s unique treatment platform is already moving into cartilage regeneration and other skin wounds and disease.

June 25, 2020 by admin 0 Comments

ROKIT Healthcare Reveals World’s First All-in-One Bioprinting Platform with Built-in Bioreactor Chamber, Plasma Sterilizer and 6 Rotary Printheads: Dr. INVIVO 4D6

ROKIT Healthcare announced the launch of the Dr. INVIVO 4D6, a bioreactor-based bioprinting platform with a built-in cell incubator and low-temperature plasma sterilizer as the first of its kind. It is designed and built with the vision of in-hospital manufacturing and offers a controlled cellular environment in aseptic conditions in combination with the complex biofabrication technologies of six rotary printheads. ROKIT Healthcare is a South Korea-based regenerative medicine solutions company that develops hardware, software, and clinical application platforms employing 4D bioprinting technology for customized human organ and tissue regeneration.

Chief Executive Officer at ROKIT Healthcare, Seok Hwan You, explains: “Bioprinting right by the bedside inside the operating theatre means minimized time, risks, and costs in the transfer of patient cells to the bioprinter and in the transfer of printed tissues back to the patient. It is a new kind of point-of-care, personalized healthcare solution that maximizes the benefits of autologous regenerative medicine technologies. Dr. INVIVO 4D6, which we call the Organ Regenerator, is designed to pave the way with features that have been added after feedback from physicians and scientists.”

Features on the Dr. INVIVO 4D6 from ROKIT Healthcare

Achieving three-dimensional architecture is just one of several factors to consider in tissue engineering. Cell environment factors, like incubation temperature, oxygen/carbon dioxide level, and humidity are key to successful human tissue and organ development with optimal cell viability and functionality. Moving beyond the capacity to dispense cells and biomaterials with multiple printheads, Dr. INVIVO 4D6 offers an integrated system to meet clinical needs in human tissue engineering and its translational applications.

Dr. INVIVO 4D6 optimizes tissue engineering and regenerative medicine research with:

  1. Built-in cell incubator with temperature, humidity and CO2 control
  2. 6 printheads for complex tissue fabrication with hydrogels, filaments, polymer pellets, and diverse FDA-approved materials
  3. Complete particle control with circular air flow generation technology, much like a biosafety cabinet
  4. High-throughput to the max with up to 384-well tissue screening and assay development

Translation of Bioprinting in the Operating Room

In addition to being a bioprinter manufacturer, ROKIT Healthcare works as a medical contractor that partners with state agencies, biotech firms and academic research centers to develop applications for bioprinting technology in the hospital operating room. ROKIT Healthcare has been awarded a $3 million grant by the South Korean government to co-develop an in-situ 3D bioprinting system for skin regeneration. Since 2019, ROKIT Healthcare has partnered with specialty plastic surgery hospitals around the world to offer 3D scan-print skin regeneration platforms for patients suffering from chronic diabetic foot ulcers and burns. The company has completed clinical studies in India and Korea.

Founded in 2012 and active in more than 50 countries, the company is advancing the scientific and healthcare revolution in regenerative medicine by providing on-demand human tissue manufacturing solutions in vivo and in vitro.

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