Report

Teaser, summary, work performed and final results

Periodic Reporting for period 2 - CHARME (Growing bone fast and cost-effective)

Teaser

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...

Summary

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 brought this unique but cost-effective bone graft to a successful production and market approval for the largest market segment in the EU and US. Thanks to CHARME project, a successful business alliance has been concluded to launch the product worldwide under the name MagnetOs.

Work performed

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.

Final results

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.

Website & more info

More info: http://www.charme-horizon.nl.