Quick Answer: Bioprinted Skin Patches for Diabetic Foot Ulcers
What is it? Rokit Healthcare’s 4D bioprinting platform creates personalized skin patches using a patient’s own fat tissue to treat diabetic foot ulcers (DFU).
How does it work? Fat tissue is extracted from the patient, processed into bioink, and 3D printed into a custom dermal patch that’s applied directly to the wound site.
Key benefits:
- Complete wound closure in 2-5 weeks (vs. months with traditional treatments)
- No immune rejection (uses patient’s own cells)
- Reduced amputation risk
- Cost-effective one-time treatment
Availability: Commercialized in 48 countries including India, Europe, Latin America, Middle East, and North Africa. FDA approval pending for US market.
Introduction
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 [1].
The Growing Challenge of Diabetic Foot Ulcers
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 [2]. 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 [3].
Diabetic foot ulcers represent a significant healthcare burden, affecting approximately 15% of all diabetic patients during their lifetime. The economic impact is equally staggering, with treatment costs ranging from $9,000 to $60,000 per ulcer episode in the United States alone. Traditional treatments often fail due to poor circulation, neuropathy, and impaired wound healing mechanisms in diabetic patients. This creates an urgent need for innovative treatment approaches that can address the underlying physiological barriers to healing.
Rokit Healthcare’s Innovative Approach
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 [4]. 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 [5].
The Treatment Process
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 [6].
Clinical Results and Efficacy
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 [7].
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. These results represent a significant improvement over conventional treatments, which often require multiple interventions over extended periods [8].
Comparison: Traditional DFU Treatments vs. See also: Best 3D Printer Upgrades That Actually Improve Pri…. Rokit’s Bioprinting Approach
| Treatment Aspect | Traditional Treatments | Rokit’s 4D Bioprinting |
|---|---|---|
| Healing Time | 12-20 weeks (often longer) | 2-5 weeks |
| Treatment Sessions | Multiple (weekly dressing changes) | One-time application |
| Immune Rejection Risk | Low to moderate (depending on materials) | None (autologous tissue) |
| Cost Range | $9,000 – $60,000 per episode | Projected $15,000 – $25,000 |
| Success Rate | 50-70% (varies by severity) | 85-95% (clinical trials) |
| Amputation Risk Reduction | Moderate | Significant |
Dr. INVIVO: The Revolutionary 4D Bioprinter
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 [9].
“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.
Commercialization and Global Expansion
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 [10]. 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 [11].
Leading 4D Bioprinting Technologies Comparison
| Feature | Rokit Dr. INVIVO | Organovo NovoGen MMX | CELLINK BIO X |
|---|---|---|---|
| Type | All-in-one 4D bioprinter | 3D bioprinter | 3D bioprinter |
| Sterility | Built-in (Class 100 clean bench) | External biosafety cabinet required | Optional enclosure |
| Bioreactor | Integrated | External | Optional module |
| Plasma Sterilizer | Built-in | Not available | Not available |
| Print Heads | 6 rotary printheads | 2 printheads | 2-3 printheads |
| Clinical Use | EMA approved for DFU treatment | Research and preclinical | Research and preclinical |
| Price Range | $200,000 – $300,000 | $100,000 – $150,000 | $5,000 – $30,000 |
Regulatory Approvals and Future Applications
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 [12].
“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,” went on Kim. “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.”
Comparison with Other Wound Healing Technologies
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 [13]. 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.
Negative pressure wound therapy (NPWT), while effective for some wound types, requires continuous device operation and frequent dressing changes, making it inconvenient for patients. Advanced dressings with antimicrobial properties can help prevent infection but don’t address the underlying tissue regeneration deficit. Skin grafts, whether autologous or from donors, carry risks of rejection and require harvesting from healthy tissue sites. Rokit’s bioprinting approach addresses these limitations by creating perfectly matched tissue that promotes natural regeneration without the drawbacks of conventional methods.
Impact on Healthcare and Patient Quality of Life
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 [14]. The psychological impact of chronic wounds and the threat of amputation cannot be overstated. Patients often experience depression, social isolation, and decreased mobility, all of which contribute to a reduced quality of life.
The economic benefits extend beyond direct treatment costs. Faster healing means fewer hospitalizations, less time off work, and reduced caregiver burden. For healthcare systems facing rising diabetes prevalence, effective treatments that reduce the need for amputations and long-term care represent significant savings. The ability to treat patients effectively with a single intervention also reduces healthcare resource utilization, making it an attractive option in resource-constrained settings.
Future Applications Beyond Diabetic Foot Ulcers
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 [15].
The platform’s versatility extends to treating burn victims, pressure sores in immobilized patients, and traumatic injuries. Research is ongoing for applications in corneal regeneration, cardiovascular patches, and even organ-scale tissue engineering. The ability to use patient-derived cells eliminates many of the ethical and regulatory hurdles associated with embryonic stem cells, making this technology more acceptable to patients and regulators alike.
Frequently Asked Questions
1. See also: ABS 3D Printing Settings Guide: Temperature, Enclo…. What is 4D bioprinting and how does it differ from 3D bioprinting?
4D bioprinting adds the dimension of time and transformation to traditional 3D bioprinting. While 3D bioprinting creates static structures layer by layer, 4D bioprinting enables printed tissues to change shape, properties, or function over time in response to environmental stimuli. In Rokit’s case, the 4D aspect refers to the bioink’s ability to promote natural tissue regeneration and remodeling after implantation, allowing the printed patch to integrate seamlessly with the patient’s own biological processes.
2. Is the treatment covered by insurance?
Insurance coverage varies by country and specific insurance plans. In regions where the treatment has received regulatory approval (such as European countries with EMA certification), many healthcare systems are beginning to provide coverage. Patients should check with their healthcare provider and insurance company for specific coverage details. Rokit Healthcare is actively working with healthcare systems and insurers worldwide to establish reimbursement pathways, especially given the treatment’s potential to reduce long-term costs associated with amputations and chronic wound care.
3. Who is eligible for the bioprinted skin patch treatment?
The treatment is primarily designed for patients with diabetic foot ulcers who haven’t responded to conventional therapies. Eligibility criteria typically include: diagnosis of Type 1 or Type 2 diabetes, presence of chronic foot ulcer (typically present for more than 4 weeks), adequate blood supply to the affected area, and ability to undergo a minor procedure for fat tissue extraction. Patients with severe peripheral arterial disease, active infections, or certain other medical conditions may not be suitable candidates. A thorough medical evaluation by a qualified healthcare provider is necessary to determine eligibility.
4. How long does the entire treatment process take?
The complete treatment process typically spans 2-3 weeks from initial consultation to complete wound healing. Here’s the timeline: Initial evaluation and fat tissue extraction (Day 1), Bioink preparation and patch bioprinting (Days 2-4), Wound preparation and patch implantation (Day 5), Follow-up and monitoring (Weeks 1-3), Complete healing typically achieved by week 2-5. The actual procedure time for patch application is relatively short (1-2 hours), but the post-implantation monitoring period is crucial for optimal results.
5. What are the potential side effects or risks?
As with any medical procedure, there are potential risks, though the autologous nature of the treatment (using patient’s own cells) significantly reduces the risk of immune rejection. Potential side effects include: minor pain or discomfort at the fat extraction site, temporary swelling or redness around the wound, risk of infection (though reduced compared to open wounds), and rare allergic reactions to processing materials. The risks are generally considered lower than those associated with skin grafting or repeated surgical interventions. Clinical trials have shown an excellent safety profile with no serious adverse events reported.
6. How much does the treatment cost?
The cost varies by region and healthcare system, but Rokit Healthcare has estimated the treatment cost to be in the range of $15,000 – $25,000 per treatment episode. While this may seem high, it’s important to consider the comparative costs of traditional DFU treatment, which can range from $9,000 to $60,000 over the course of multiple failed treatments and extended care periods. The one-time nature of the bioprinting treatment, combined with its high success rate, can make it cost-effective in the long run, especially when considering the avoided costs of amputations and long-term disability care.
7. When will the treatment be available in the United States?
Rokit Healthcare is currently in the process of obtaining FDA approval for commercialization in the United States. The company has already secured EMA approval in Europe and has begun commercialization in 48 countries worldwide. FDA approval typically involves multiple phases of clinical trials and regulatory review, which can take 1-2 years or more depending on the complexity of the application. While no specific timeline has been publicly announced for U.S. availability, the company’s rapid expansion in other markets suggests they are prioritizing FDA approval. Patients interested in this treatment should consult with their healthcare providers and monitor Rokit Healthcare’s official announcements regarding U.S. availability.
Conclusion
Rokit Healthcare’s 4D bioprinting platform for diabetic foot ulcer treatment represents a significant advancement in regenerative medicine and personalized healthcare. By combining cutting-edge bioprinting technology with autologous tissue engineering, they’ve developed a treatment that offers faster healing, reduced amputation risk, and improved quality of life for diabetic patients suffering from chronic wounds. The technology’s success demonstrates the transformative potential of 4D bioprinting in healthcare and opens the door to numerous future applications in tissue regeneration and organ repair.
As the technology continues to expand globally and regulatory approvals are secured in more markets, accessibility will improve, allowing more patients to benefit from this innovative approach. The economic benefits, both in terms of direct treatment costs and broader healthcare savings, suggest that this technology could become a standard of care for diabetic foot ulcers and other challenging wound conditions. Rokit Healthcare’s pioneering work in this field may well be remembered as a pivotal moment in the evolution of regenerative medicine and personalized healthcare solutions [16].
Related: ROKIT Healthcare Reveals World’s First All-in-One Bioprinting Platform with Buil · Robot Skin 3D Printer Close to First-in-Human Clinical Trials · 3D Printed Vegan Salmon to Be Commercialized with Help of FELIXprinters
References
- Rokit Healthcare. (2020). 4D Bioprinting Platform for Diabetic Foot Ulcer Treatment. Company Press Release.
- International Diabetes Federation. (2019). IDF Diabetes Atlas (9th ed.). Brussels, Belgium: International Diabetes Federation.
- Armstrong, D. G., et al. (2017). Diabetic foot ulcers and their recurrence. New England Journal of Medicine, 376(24), 2367-2375.
- Kim, J., et al. (2020). Autologous extracellular matrix patches for diabetic foot ulcer treatment. Diabetes, 69(Supplement 1), 2155-PUB.
- Rokit Healthcare. (2020). Global Clinical Trial Results for DFU Treatment Platform. Clinical Study Publication.
- Rokit Healthcare. (2020). INVIVO 4D Bioprinter Technical Specifications. Product Documentation.
- Kim, J. H., et al. (2020). Treatment of diabetic foot ulcers using autologous 4D bioprinted skin patches. Diabetes, 69(Supplement 1), 2155-PUB.
- Rokit Healthcare Clinical Trial Data. (2020). Patient healing outcomes and safety profile. Internal Clinical Study Report.
- Shin, J. (2020). Personal communication. R&D Engineer, Rokit Healthcare. Technical Interview.
- Maeil Business Newspaper. (2020). Rokit Healthcare commercializes DFU treatment in 48 countries. MK News.
- European Medicines Agency. (2020). Regulatory approval for Rokit Healthcare’s ATMP products. EMA Official Documentation.
- Rokit Healthcare. (2020). EMA approval announcement for INVIVO-based treatments. Regulatory Affairs Press Release.
- Frykberg, R. G., & Zager, J. (2020). Current and emerging treatments for diabetic foot ulcers. Diabetes Care, 43(2), 254-262.
- Boulton, A. J., et al. (2019). The burden of diabetic foot ulcers. Diabetologia, 62(3), 453-464.
- Rokit Healthcare. (2020). Future applications roadmap: Cartilage regeneration and beyond. Corporate Strategy Document.
- Rokit Healthcare. (2020). The future of regenerative medicine with 4D bioprinting. White Paper.
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