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

SEOUL, South Korea, April 10, 2026 — Miracell, a premier stem cell technology firm, has announced the U.S. FDA 510(k) clearance of its stem cell extraction platform, SMART M-CELL, and its associated kits, the BSC Blood Kit and BMSC Bone Marrow Kit.

The FDA authorization was awarded following a demonstration of substantial equivalence to the globally recognized standard system, SmartPReP, which originated from the Institute for Immunological Research (IDI) at Harvard Medical School. This achievement reinforces the international standing of Miracell’s technology regarding cell quality and efficacy.

The cell concentration technology underpinning SmartPrep has been consistently verified through extensive research and comparative studies, with around 100 related publications and review articles documented so far.

In clinical applications, BMAC injections have shown pain reduction and functional enhancement in knee osteoarthritis patients. For rotator cuff tears, the use of BMAC and BSC has been linked to greater cell proliferation, alongside pain alleviation and functional improvement. Furthermore, research on cartilage defects and bone injuries has indicated tissue regeneration and histological betterment after treatment with BMAC or BSC.^[1,2]

Apart from musculoskeletal uses, the biological effectiveness and wider potential of cell concentration technologies have been investigated in diverse therapeutic fields such as skin rejuvenation and aesthetics, diabetic ulcers, chronic wound care, vascular and heart regeneration, and immune disorders.

Although SmartPReP is acknowledged as a high-performance concentration system, SMART M-CELL marks a considerable step forward.

Miracell’s innovation optimizes cellular activity throughout the extraction procedure, ensuring cell viability is preserved.

This advancement comes after numerous experimental trials.

SMART M-CELL is an automated platform that selectively isolates and concentrates Efficient Growth Factors from blood and bone marrow. In addition to these factors, it generates a multi-cell mixture containing growth factors, white blood cells, and SDF-1α, which aids tissue repair and functional restoration. The system is engineered for optimal clinical use, offering high recovery yields and reliable operation.

Significantly, this FDA clearance certifies the complete integrated system—the centrifuge and kit together—proving its capability and efficiency as a cohesive product. This sets Miracell apart from traditional centrifuge equipment, usually categorized as lower-risk devices requiring only notification.

Extracting Efficient Growth Factors involves more than mere physical concentration; it necessitates maintaining cellular sensitivity and biological properties. Attaining higher purity demands a substantial increase in engineering accuracy. With its distinctive system and kit architecture, SMART M-CELL achieves top-tier cell recovery and purity. Miracell had earlier obtained a U.S. patent in February 2024 for the centrifuge container (kit) employed in SMART M-CELL.

SMART M-CELL is now the sole FDA-cleared Efficient Growth Factors extraction system from South Korea. The FDA clearance, combined with U.S. patent approval, affirms Miracell’s distinct methodology compared to Harvard-derived systems and verifies its exceptional extraction capability and product reliability.

Miracell stressed that performance grows exponentially with increased cell purity, highlighting that this FDA clearance is the outcome of dedicated R&D work to boost purity—even marginally. With both U.S. patent safeguards and FDA 510(k) clearance, SMART M-CELL is set to emerge as a leading and dependable regenerative medicine solution in clinical practice.

Whereas therapy has historically aimed at symptom control via drugs, there is an increasing move toward biologic treatments that harness the body’s innate healing processes. Progress in regenerative medicine—especially using a patient’s own cells and growth factors—is fostering new treatment models focused on underlying tissue repair and functional recovery, rather than just managing symptoms.

Miracell further stated it has already secured regulatory approvals in numerous nations and is presently distributing SMART M-CELL and its kits to about 40 countries globally, including throughout Europe. The company mentioned that regulatory processes are ongoing in markets like Brazil and Taiwan, and that, after the recent FDA clearance, it intends to pursue vigorous global expansion, including in the United States.

Additionally, Miracell is a regenerative medicine enterprise that has successfully attained four stem cell-based new medical technology certifications in Korea, covering therapies for cartilage defects, acute myocardial infarction, critical limb ischemia, and knee osteoarthritis. The company is also progressing initiatives to broaden its treatment offerings, such as registering a new medical technology for concentrated autologous bone marrow stem cell injections to address spinal disc pain.

 

SOURCE Miracell