January 19, 2021 by admin 0 Comments

Treatments for Diabetic Foot Ulcers with Bioprinted Skin Patches

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. 

December 21, 2020 by admin 0 Comments

ROKIT America, developed NMN supplement product

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)

December 21, 2020 by admin 0 Comments

ROKIT Healthcare’s wellness anti-aging center is to be opened in Hungary

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).

December 21, 2020 by admin 0 Comments

ROKIT Healthcare Organ Regeneration Publications and Posters

  • 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.

December 21, 2020 by admin 0 Comments

ROKIT Healthcare Organ Regeneration Clinical Trials

  • 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.