Abstract

The University of Minho has developed an injectable biodegradable adhesive foam solution for spinal interbody fusion, providing instant stabilization of the vertebrae without instrumentation and promoting favorable biomechanical conditions for bone growth.

Tecnology Description

BioLIF represents a disruptive and paradigm shifting approach to spinal fusion and a range of other bone repair applications. The technology relates to a synthetic, injectable and biodegradable bone adhesive foam that provides instant stabilization of the bone without instrumentation, and a favourable biomechanical environment for bone growth. The biopolymer, composed of PCL pDA and pMAA (FDA approved for several medical applications), is produced into a foam through a dedicated portable and disposable high-pressure device, using CO2 as foaming agent, for in situ application/extrusion in bone defects filling/fusion.

Innovative Aspects and Main advantages

Currently available synthetic adhesives have high adhesion strength, however, they present crucial disadvantages such as poor biocompatibility and limited biodegradability. On the other hand, biologically inspired materials raise less biocompatibility concerns and may overcome the ability of synthetic adhesives to adhere in a wet environment, but are not able to provide the mechanical integrity required for bone tissue applications and are instead more suitable as soft tissue adhesives.
BioLIF is a synthetic bone adhesive that satisfies all the desired and required properties for a bone adhesive: it’s injectable, provides mechanical stability (adhesion strength 120 N/cm2), is osteoinductive and biodegradable.

Market Applications

BioLIF is a bone adhesive platform technology. Although it has been validated for use in spinal fusion, the biomaterial has the potential to be used across various other orthopaedic applications, as well as for veterinary and cosmetics applications.

Stage of Development

In vivo studies using adult pigs were conducted (interbody fusion procedure) to evaluate performance of the material for a period of 6 months. The intervertebral disk was surgically removed and PCL pDA pMAA foam was extruded by the device to fill the void site. Immediate hardening of the material and adhesion to surrounding tissues occurred and no spinal instrumentation was used for stabilization. By avoiding instrumentation, the procedure requires half the surgery time, which has an extraordinary economic impact in terms of healthcare costs.

Intellectual Property Rights

Patent granted in the US (US20210187159) and EU (EP3743122) – INJECTABLE AND EXPANDABLE COMPOSITION, DEVICES, KITS, METHODS AND USES THEREOF.

Collaboration Details

The team is looking for medical devices’ companies willing to discuss research collaborations and licensing arrangements for commercial exploitation of the technology.