Miracell Receives FDA 510(k) Clearance for SMART M-CELL PRP Concentration System and SMART M-CELL Bone Marrow Concentration System
Miracell has received FDA 510(k) clearance for its SMART M-CELL blood and bone marrow concentration systems and kits, an automated platform the company says uses patented separation technology to preserve cell viability while concentrating growth factors and stem cell-rich regenerative components for applications including orthopedics, wound healing, and regenerative medicine.
Key findings
- Miracell has received FDA 510(k) clearance for its SMART M-CELL system and its blood and bone marrow kits.
- The clearance was based on substantial equivalence to SmartPReP, a cell concentration system originally developed at Harvard Medical School.
CORRECTION: One of our readers, Scott Bruder, M.D., Ph.D. of Dark Horse Consulting, had some important nuance to share about the FDA 501(k) clearance.
Dr. Bruder pointed out that these products have a Class I clearance as “laboratory-use only” devices. The authorization language from the FDA states, “It is for in vitro use only. The safety and effectiveness of this device for in vivo indications for use has not been established.”
This means the product cannot be marketed or promoted for use in treating any condition, such as osteoarthritis, rotator cuff repair, or cartilage repair. If physicians or companies promote the use of a product with just this type of Class I clearance, they are subject to laws regarding “misbranding” and possibly “adulterated use”. It is not considered “off-label” use in humans because there is no “on-label” use for treating humans with these Class I-cleared devices. Dr. Bruder said he shares this information in the spirit of keeping the clinical community of practitioners out of trouble!
Miracell has received FDA 510(k) clearance for its SMART M-CELL extraction system, along with the BSC Blood Kit and BMSC Bone Marrow Kit. The company says the automated platform separates and concentrates regenerative components from blood and bone marrow while maintaining cell viability.
What the system does
SMART M-CELL selectively concentrates what Miracell calls Efficient Growth Factors from blood and bone marrow. According to the company, the output also includes a multi-cell composition containing growth factors, white blood cells, and SDF-1α (stromal cell-derived factor 1 alpha, a signaling protein involved in cell trafficking and tissue repair), intended to support tissue regeneration and functional recovery.
The company says the system is designed for high recovery rates and operational stability. The FDA clearance covers the integrated system, including both the centrifuge and the kit, not just individual components.
Regulatory and technical context
The clearance was granted based on substantial equivalence to SmartPReP, a concentration system originally developed by the Institute for Immunological Research at Harvard Medical School. Miracell says SmartPReP-based cell concentration technology has been supported by about 100 related publications and review articles.
Miracell also says preserving cellular sensitivity and biological characteristics during processing requires more than simple physical concentration. SMART M-CELL uses a proprietary system and kit design aimed at improving cell recovery and purity, and notes it previously received a U.S. patent in February 2024 for the centrifuge container used in the system.
Clinical context
The company points to published work around bone marrow aspirate concentrate (BMAC) and blood stem cell concentrate (BSC) in musculoskeletal care.
- In knee osteoarthritis, BMAC injections have demonstrated pain reduction and functional improvement.
- In rotator cuff tears, BMAC and BSC have been associated with increased cell proliferation, pain relief, and functional recovery.
- In cartilage defects and bone injury sites, studies have reported tissue regeneration and histological improvement following use of BMAC or BSC.
Beyond musculoskeletal uses, cell concentration approaches have also been explored in skin regeneration and aesthetics, diabetic ulcers, chronic wound healing, vascular and cardiovascular regeneration, and immune-related conditions.
Global rollout
Miracell says SMART M-CELL is currently the only FDA-cleared Efficient Growth Factors extraction system from Korea. The company adds that it has already secured regulatory approvals in multiple countries and is supplying SMART M-CELL and related kits in about 40 countries, including markets in Europe.
According to Miracell, additional regulatory approvals are in progress in Brazil and Taiwan, and the company plans to expand further in the U.S. following the FDA clearance.
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