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Advanced Synthetic Bone Grafts by Supercritical Technology

Country of Origin: Spain
Reference Number: TOES20181106001
Publication Date: 8 November 2018

Summary

A Spanish university developed a technology for the manufacturing of new synthetic bone implants. The implants have adequate osseointegration and bone regeneration capacity. The technology allows the manufacture in a single step without post-processing at a suitable temperature for the incorporation of labile components at high yields and in the absence of organic solvents that may compromise its biocompatibility. The university is looking for license agreements with bone implant suppliers.

Description

Regenerative medicine offers new possibilities in the treatment of pathologies of bone tissue that, although it has a capacity for spontaneous regeneration, cannot reconstruct large defects or congenital deformities. Available bone implants cannot respond to the demands of current social context in terms of availability to satisfy the growing demand, as well as efficacy to respond to the increase in life expectancy due to a limited time-in-use and/or poor osseointegration.

All these drawbacks have led to an intensification in the design and development of advanced synthetic implants that act as three-dimensional scaffolds that actively participate in the regeneration of tissue, act as a platform for the release of bioactive substances, and guide the growth of tissue.
The implants developed by the Spanish university have adequate osseointegration and bone regeneration capacity, with a defined composition and use, and have been protected by a patent. Likewise, a clean technology with high capacity for process integration has been developed, which is also protected by a patent and which is the only one that allows obtaining a synthetic scaffold with the previously mentioned requirements. The synthetic bone implant has a scaffolding format with porosity analogous to that of trabecular bone (between 50 and 90%) and biodegradable relying on controlled-degradation biopolymers, and which is suitable for incorporating biologically active substances that are released in a controlled manner over time, and an agent modulator of the release pattern. The main component of the matrix will be poly(D,L-lactic-coglycolic acid) (PLGA), widely accepted polyester for biomedical applications, with modulable biodegradation profiles and production with high reproducibility control.
All these above mentioned components have been individually accepted by the regulatory agencies in at least one drug product or medical device registered to date. From the point of view of manufacturing, supercritical CO2 technology is used as an innovative, original, reproducible and environmentally friendly alternative to obtain scaffolding and scaffolding components free of traces of solvents by applying moderate processing conditions.

The technology used by the Spanish university is the first of its kind capable of preparing a PLGA scaffold with degradation time in the range of 8 to 10 weeks and in the absence of solvent.

Given the global market of the product, potential clients will be the suppliers of bone implants at international level.

The university is looking for license agreements with customers with experience in the bone implant manufacturing business and with capacity for distribution and commercialization in different world regions. These customers will have the capacity to negotiate the patent licensing of the technology, to carry out the clinical trials and to bring the product to market.

Advantages and Innovations

The manufacturing technology is unique in terms of processability windows, quality of the product and respect for the environment. The modulation of the degradation rate of the product to biorelevant periods of time and / or the efficient use of biologically active agents of autologous origin are other competitive advantages compared to the rest of commercial alternatives.

Stage Of Development

Field tested/evaluated

Requested partner

The university is looking for license agreements with customers with experience in the bone implant manufacturing business and with capacity for distribution and commercialization in different world regions. These customers will have the capacity to negotiate the patent licensing of the technology, to carry out the clinical trials and to bring the product to market.

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