Community Research and Development Information Service - CORDIS


CHARME Report Summary

Project ID: 674282

Periodic Reporting for period 1 - CHARME (Growing bone fast and cost-effective)

Reporting period: 2015-07-01 to 2016-06-30

Summary of the context and overall objectives of the project

Yearly, 3 million bone grafting procedures are performed to improve the quality of life young and old patients suffering musculoskeletal diseases. In individuals of working age, musculoskeletal problems such as backache are one of the most common causes of sick leave and long-term work disability and therefore have serious economic consequences for society. The prevalence of many of these musculoskeletal problems increases markedly with age. The increasing number of older people and the changes in lifestyle throughout the world mean that the burden of musculoskeletal conditions on people and society will increase dramatically, and thus result in rising public healthcare issues.
The excellent bone healing and regeneration properties of EpitaxOs make it superior to the current bone graft products. EpitaxOs is a synthetic biomaterial with specific surface structural properties controlled at the nanoscale level triggering bone regeneration after implantation (in situ tissue engineering). Safe, effective, less burdensome, off the shelf and cost effective, EpitaxOs improves the quality of life of old and young patients, addresses the societal economic burden of healthcare costs and allows faster work reintegration.
The CHARME project aims at bringing this unique but cost-effective EpitaxOs bone graft to a successful production and commercial launches implying a robust production process, clinically relevant efficacy data and regulatory approvals

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The activities carried out the first year of the project met all pre-set objectives. The main results are the following:
• Regulatory approval obtained in Europe, allowing commercialization and clinical use in this geographic area,
• Regulatory submission in the US, an important key market where the largest bone graft industries are located,
• Improved production yield of >90% achieved, with a yearly production capacity for worldwide distribution,
• Completion of preclinical studies showing rapid spine fusion compared to classical bone graft products.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

EpitaxOs has the same performance as golden standard autograft (patient’s own bone) and other bone graft materials from biological origins, without their disadvantages:
• no autograft harvesting required, and thus extra operative procedure and donor side pain;
• available in unlimited quantities,
• reproducible, no lot-to-lot variation,
• no risks associated with immune reactions, disease transfer, or supra-physiological growth factors concentration;
• affordable technology compared to other osteoinductive treatments.
EpitaxOs improves the patient’s quality of life with an overall reduction of medical care costs
• EpitaxOs reduces healthcare costs as it is more affordable but as effective as growth factors
• Relieving back pain encountered in 50% of the younger and middle aged working population will enhance the patient’s quality of life, reduce sick leaves and long-term work disabilities and thus be advantageous to the economy and society as a whole
• Ensuring long term stability of dental implants and widening the applications or larger maxillofacial defects will result in more comfort for the patient.

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