[Asia Economy Reporter Hyunseok Yoo] Global bio-specialized company Rokit Healthcare announced on the 4th that its ‘personalized 4D printing kidney failure treatment patch’ has completed approval from the European Medicines Agency (EMA).
Kidney failure is a disease in which the kidney’s filtration function is impaired due to chronic complex diseases such as diabetes and hypertension, causing waste products to accumulate in the blood. Depending on the speed of kidney function decline, it is classified into acute kidney failure and chronic kidney failure.
A company official explained, “When chronic kidney failure progresses to end-stage kidney failure, alternative therapies such as dialysis or kidney transplantation are performed to replace kidney function, but these are not fundamental treatments. Currently, there is no treatment method that can restore kidney function with existing technology.”
Rokit Healthcare developed a new treatment technology that outputs autologous tissue made with bioink into a homogeneous patch form through a 4D bioprinter (Dr. INVIVO) with minimal manipulation and attaches it laparoscopically to the kidneys of chronic kidney failure patients. Since it uses the patient’s own tissue, there is no immune rejection reaction, and it can be applied to patients using minimally invasive methods in the operating room, making it a safe procedure.
The company expects that if this technology is applied in actual treatment, it could delay the start of kidney hemodialysis by several years or reduce the frequency of dialysis, thereby improving the quality of life for kidney failure patients. A company official stated, “In kidney failure animal models, the treatment patch prevented glomerular fibrosis and renal cell necrosis and regenerated damaged kidney cells, thereby preventing the progression of chronic kidney failure to end-stage kidney failure. The goal is to delay the progression of kidney failure by applying the treatment patch, postpone the start of hemodialysis, and ultimately improve kidney function.”
Rokit Healthcare is also developing a ‘special organ regeneration decellularization and recellularization device’ that decellularizes donated organs such as kidney, liver, and heart, then re-transplants donor cells onto the scaffolded kidney without immune rejection.
Yuseok Hwan, CEO of Rokit Healthcare, said, “Following approval from the European Medicines Agency, we are proceeding with certification procedures in multiple countries. We are pleased that the path to kidney regeneration has opened with our kidney failure patch technology following diabetic foot regeneration and cartilage regeneration using our 4D bioprinting technology, and we hope this technology, which can improve patients’ quality of life and extend lifespan, will be introduced to more countries.”
Meanwhile, the company has completed domestic patent applications for its kidney failure treatment film technology. Following the EMA approval, it is currently pursuing necessary approvals and certifications by country, including the U.S. FDA.
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