Miracell Receives FDA 510(k) Clearance for SMART M-CELL PRP Concentration System and SMART M-CELL Bone Marrow Concentration System

Blood- and bone marrow-based efficient growth factors extraction system demonstrates substantial equivalence and high cell viability

SEOUL, South Korea, April 10, 2026 /PRNewswire/ -- Miracell, a leading stem cell technology company, announced that it has obtained U.S. FDA 510(k) clearance for its stem cell extraction system, SMART M-CELL, along with its dedicated kits, the BSC Blood Kit and BMSC Bone Marrow Kit.

The clearance was granted based on demonstrated substantial equivalence to SmartPReP, a globally recognized standard system originally developed by the Institute for Immunological Research (IDI) at Harvard Medical School. This milestone underscores the international credibility of Miracell's technology in terms of cell quality and performance.

The cell concentration technology utilizing SmartPrep has been continuously validated through a wide range of studies and comparative analyses, with approximately 100 related publications and review articles reported to date.

Notably, in patients with knee osteoarthritis, BMAC injections have demonstrated reductions in pain and improvements in function. In cases of rotator cuff tears, the application of BMAC and BSC has been associated with increased cell proliferation, as well as pain relief and functional recovery. Additionally, studies in cartilage defects and bone injury sites have reported tissue regeneration and histological improvements following the use of BMAC or BSC.^[1,2]

Beyond musculoskeletal indications, the biological efficacy and broader applicability of cell concentration technologies have been explored across multiple therapeutic areas, including skin regeneration and aesthetics, diabetic ulcers, chronic wound healing, vascular and cardiovascular regeneration, and immune-related conditions.

While SmartPReP has been widely recognized as a high-performance concentration system, SMART M-CELL represents a significant advancement.

Miracell's technology maximizes cellular activity during the extraction process, maintaining cell viability.

This breakthrough is the result of hundreds of experimental iterations

SMART M-CELL is an automated system that selectively separates and concentrates Efficient Growth Factors from blood and bone marrow. Beyond Efficient Growth Factors, it produces a multi-cell composition that includes growth factors, white blood cells, and SDF-1α, supporting tissue regeneration and functional recovery. The system is designed to maximize clinical applicability with high recovery rates and operational stability.

Notably, this FDA clearance validates not only individual components but the entire integrated system—combining both centrifuge and kit—demonstrating its performance and effectiveness as a unified solution. This distinguishes Miracell from conventional centrifuge devices, which have typically been classified as lower-risk, notification-only products.

Efficient Growth Factors extraction technology requires more than simple physical concentration; it demands the preservation of cellular sensitivity and biological characteristics. Achieving higher purity levels requires exponentially greater engineering precision. Through its unique system and kit design, SMART M-CELL delivers world-class cell recovery rates and purity. Miracell previously secured a U.S. patent in February 2024 for its centrifuge container (kit) used in SMART M-CELL.

SMART M-CELL is currently the only FDA-cleared Efficient Growth Factors extraction system from Korea. The FDA clearance, along with U.S. patent recognition, validates Miracell's differentiated approach from Harvard-based systems and confirms its superior extraction performance and product stability.

Miracell emphasized that as cell purity increases, performance improves exponentially, noting that this FDA clearance reflects the culmination of its intensive R&D efforts to enhance purity—even by just 1%. With both U.S. patent protection and FDA 510(k) clearance, SMART M-CELL is positioned to become one of the most trusted regenerative medicine solutions in the clinical field.

While treatment has traditionally focused on symptom relief through pharmacological approaches, there is a growing shift toward biologic therapies based on the body's intrinsic healing capabilities. Advances in regenerative medicine—particularly those leveraging autologous cells and growth factors—are driving new treatment paradigms aimed at fundamental tissue repair and functional restoration, rather than simple symptom management.

Miracell also noted that it has already obtained regulatory approvals in multiple countries and is currently supplying SMART M-CELL and related kits to approximately 40 countries worldwide, including across Europe. The company added that regulatory approvals are underway in markets such as Brazil and Taiwan, and that, following the recent FDA clearance, it plans to aggressively expand into the global market, including the United States.

Meanwhile, Miracell is a regenerative medicine company that has successfully awarded four stem cell-based new medical technologies in Korea, including treatments for cartilage defects, acute myocardial infarction, critical limb ischemia, and knee osteoarthritis. The company is also advancing efforts to expand its treatment portfolio, including the registration of a new medical technology involving concentrated autologous bone marrow stem cell injections for intervertebral disc pain.

SOURCE Miracell