Bone are able to regenerate in response to injury. However, there are limitations to their regenerative potential.
Current bone regeneration enhancing therapies include allografting, autografting, applying vascularized grafts, and other bone transplant techniques. Although commonplace in orthopedic surgery, these treatments have many limitations since a significant number of fractures show either delay in healing or failure to heal.
A good example of the need for efficient bone regeneration is to allow stable placement of dental implants after a tooth loss (Periodontal Disease).
Periodontal Disease (PD)
Periodontal Disease (PD) is a pathological inflammatory condition of the gum and bone support surrounding the teeth caused by bacteria proliferating in the dental plaque. In its more serious form the gums pull away from teeth, bone is lost, and the teeth loosen or fall out. Periodontal disease is the leading reason for tooth loss. According to the World Health Organization (WHO) data in 2012, several periodontal disease, which results in tooth loss was found in 15% to 20% of middle-aged adults.
The standard treatment is Guided bone regeneration (GBR) that aims to regenerate bone and allow successful implant placement. It can be achieved by implanting a barrier membrane that prevents the gingival epithelium and connective tissue cells from invading the bone cavity during the healing process. Resorbable or non-resorbable barrier membranes are commercially available. The main disadvantage of resorbable membranes are the unpredictable resorption time and the release during degradation of toxic substances that may affect bone formation. Most frequently used are non-resorbable membranes (Gold Standard in GBR) that require of a second surgical intervention to remove them. This may result in an injury of the regenerated tissue. None of the two classes of membranes are bioactive (able to activate bone-forming cells) or possess antibacterial activity. Their poor efficacy results in a high degree of relapse.
Which technologies, which products?
Tiss®-Active are Zinc and/or Doxycycline functionalized nanostructured membranes that have as main features:
- Highly bioactive and contribute to fast bone regeneration by enhancing the precipitation of natural minerals onto their surfaces and bone-forming cells activity.
- They are non-resorbable but get fully integrated in the tissue (post-treatment surgery is not needed).
- Antibacterial activity.
Major expected advantages of Tiss®-Active versus the main competitors (a Teflon non-resorbable membrane) are activation of bone-forming cells, fully bone integration and antibacterial activity. Moreover, the enhanced osteogenesis and also bioactivity showed by Tiss®-Active open a promising door to other applications which can be successfully addressed with this membrane (e.g. reconstruction of large bone defects or new coatings for metal implants).
From a regulatory standpoint, Tiss®-Active could be developed as a Medical Device. Our objective is to complete the development of this product in order to move to the market. To this end we are going to start soon the regulatory and clinical efficacy studies. We can carry out these studies in collaboration with a partner specialized in GBR or by ourselves if we obtain financial support. We are open to discuss in licensing/investment terms.
Do you wish to get further information of this technology? It will be a pleasure to sign a CDA with you and send confidential information about this technology.
Contact with our COO, Mr. Angel Valero-Navarro email@example.com