The European Medicines Agency’s Committee for Advanced Therapies has issued a scientific recommendation that adult autologous regenerative cells for subcutaneous administration does not fall within the definition of an advanced therapy medicinal product as provided in article 2(1)(a) of regulation (EC) No 1394/2007. This is because the cells are not being manipulated during the process and the MatraseTM Enzyme Blend is removed during processing. This makes the system ready for applications in the wound care as well as aesthetics and reconstruction field in Europe. Further certifications underline InGeneron’s commitment to high-quality standards and safe treatment processes.
The SmartGraft™ 30 and SmartGraft™ 200 system have clearance under section 510(k) of the FDA. All other medical devices can be used for research in a laboratory setting. InGeneron is registered with the FDA for laboratory and research use under the FDA registration number 3009742429.
InGeneron’s devices all carry the CE mark including devices with sterile disposables for cell and tissue collection, processing and characterization including the processing unit.
- Transpose® RT System: “The intended purpose of the Transpose® RT System is the processing of tissue from a patient for extraction of a regenerative cell preparation for re-administration to the patient upon prescription of a physician. This CE mark is applied per Directive 93/42/EEC as amended, Annex V.”
- SmartGraft™ System: “The intended purpose of the SmartGraft™ 30 system is the processing of tissue from a patient for re-administration to the patient upon prescription of a physician. This CE mark is applied per Directive 93/42/EEC as amended, Annex V.”
InGeneron, Inc., headquartered in Houston, Texas is a medical device company that designs, develops, manufactures and services devices with sterile disposables for cell and tissue collection, processing, and characterization. InGeneron, Inc. has a quality management system that is EN ISO 13485:2012 certified.