At BPB MEDICA™, we believe in evidence—not assumptions. That’s why the performance of our MARROW-STEM™ device was rigorously validated under the standards of EU Regulation 2017/745, ensuring both safety and clinical efficacy.
A Closer Look at the Validation Process:
To evaluate the device’s ability to efficiently harvest mesenchymal stem cells (MSCs), we conducted flow cytometric analysis on bone marrow samples taken from orthopaedic patients with preserved hematopoietic profiles.
Key steps included:
• Treating marrow samples to lyse red blood cells and isolate the nucleated cell fraction.
• Using a precise antibody mix to identify the non-hematopoietic stromal fraction containing MSCs.
• Quantifying the MSC population via fluorescence-activated cell sorting (FACS).
Results That Speak for Themselves:
• 98% cell viability in the collected samples.
• ~0.093% of cells were confirmed to be MSCs—remarkable, considering these cells typically represent only 0.001–0.1% of bone marrow mononuclear cells.
• High reproducibility and consistent performance across samples.
The Added Value of Selective Aspiration:
Compared to traditional centrifuge-based systems (internal benchmark data):
• MARROW-STEM™ delivered over twice the concentration of colony-forming MSCs (CFU-f) per ml.
• Peripheral blood contamination was significantly lower.
• The entire procedure is performed within a sterile field, reducing infection risks and avoiding the loss of valuable biological material.
Conclusion:
This validation confirms what our engineers designed MARROW-STEM™ to do: maximise MSC yield with minimal invasiveness, while improving sterility and preserving ease of use. The device not only performs reliably but also represents a smarter, cleaner, and more efficient alternative to centrifugation-based bone marrow harvesting.
