Regenerative Medicine
Pure BMC Kit
Autologous bone marrow concentrate system for regenerative procedures.
Manufacturer
EmCyte®
Classification
FDA 510(k) Cleared
Storage
Refrigerate 2–8°C
Aspirate Volumes
| Aspirate | Concentrate |
|---|---|
| 30 mL bone marrow | ~3 mL BMC |
| 60 mL bone marrow | ~6 mL BMC |
Overview
The Pure BMC Kit is an FDA 510(k) cleared autologous bone marrow concentrate system by EmCyte®. It enables point-of-care processing of bone marrow aspirate to produce a concentrated preparation rich in progenitor cells, platelets, and growth factors for use in regenerative procedures.
Key Features & Benefits
- FDA 510(k) cleared bone marrow concentrate system
- Point-of-care processing of bone marrow aspirate
- Concentrates progenitor cells and platelets
- Closed-system design for sterility
- Compatible with Sapphire Series centrifuge
- Autologous preparation from patient’s own marrow
Indications for Use
Autologous bone marrow concentrate preparation for use in regenerative medicine procedures as directed by a licensed healthcare provider. For professional use only. Requires trained clinician for marrow aspiration.
Mechanism of Action
The Pure BMC Kit is an FDA 510(k) cleared medical device. The kit uses centrifugation to concentrate nucleated cells and platelets from bone marrow aspirate. Ridge Biologics does not make clinical efficacy claims. Use should be based on healthcare provider judgment and manufacturer labeling.
Regulatory & Compliance
Regulatory Framework
FDA 510(k) Cleared
Application
Autologous bone marrow aspirate processing
Handling
Aspirate: room temp; concentrate: 2–8°C
Distributor License
Ridge Biologics, Utah DOPL
Refer to the manufacturer’s package insert for complete indications, contraindications, warnings, precautions, and instructions for use. Ridge Biologics is an authorized distributor and does not modify, manipulate, or repackage products. Distribution to licensed healthcare providers only.