EMCM has developed a resorbable collagenous membrane for dental and periodontal applications for an important player in the dental market. The membrane functions as a barrier between soft and hard tissue to support Guided Bone Generation and Guided Tissue Generation surgical techniques to direct growth of bone or gingival tissue. The starting material is derived from an animal source and is processed into a decellularised and delipidised membrane using Leader Biomedical proprietary eCOO® Technology which employs supercritical carbon dioxide (scCO2) for the effective removal of unwanted substances. The multi-staged manufacturing process has been validated and regular production batches have been manufactured for European markets. The manufacturing process aims to preserve the natural porous and interconnected structure of the native tissue.
Recently, EMCM and Leader Biomedical initiated a collaboration focusing on Design & Development for a similar device aiming for US FDA registration of NovoMem using the 510(k) regulatory pathway based on substantial equivalence to predicate devices.
Currently under development for Leader Biomedical, NovoMem is an acellular, resorbable collagen membrane. This membrane is produced from porcine pericardium and processed with our proprietary eCOO® Clean process, which uses supercritical carbon dioxide (scCO2) to clean human and animal derived bone and soft tissue. NovoMem is designed to function as a cell occlusive barrier membrane for dental applications.
The membrane is intended for use during guided bone regeneration (GBR) and guided tissue regeneration (GTR) procedures as a biodegradable barrier for:
- Simultaneous use with implants
- Augmentation around implants placed in immediate extraction sockets
- Augmentation around implants placed in delayed extraction sockets
- Localised ridge augmentation for later implantation
- Alveolar ridge reconstruction for prosthetic treatment
- Filling of bone defects after root resection, cystectomy, removal of retained teeth
- Guided bone regeneration in dehiscence defects
- Guided tissue regeneration in periodontal defects
Project for a Dutch life sciences company
For an other customer EMCM will impregnate (spray-coat) an identical eCOO® processed membrane with pharmaceutical active ingredients, such as a hormone, in a newly built facility.
The impregnated membrane will be used in both dental and orthopedic applications.
The newly built facility has a different pressure regime and building structure and is separated from EMCM’s other activities.
Therefore it is suited to work with small amounts of hormones.