Biowool(TM)- A Versatile Platform Technology with Dental and Orthopaedic Applications

Over 800,000 sinus lift procedures are performed annually within a £2.3billion dental and orthopaedic bone graft substitute market.

In dental grafting, patients' own bone (autograft) gives the highest success (98.5%, 1-5-year follow up) however, limited availability, increased operative time and patients suffering from blood loss and morbidity means grafts derived from animals (xenograft) are the standard of care. Xenografts also suffer from the lowest success rate (73%) for 1-3-year follow up.

In addition, failure in sinus lifts often occurs due to granular xenografts perforating and tearing the sinus membrane (10-20%), leading to severe complications including infection (3%) and significant pain. The sinus bone grafting market is dominated by two large companies; Botiss and Giestlich.

Their market occupancecan hinder market entry but there is a clear clinical and patient need for better solutions in sinus lift bone grafting.

We have developed a synthetic fibrous material; Biowool™ which is a 2nd generation bioactive glass to be constructed into cotton-wool-like structure. Its 3D form is a unique selling point for sinus lift procedures giving a competitive advantage over other products.

Whilst the market leaders, Bio-Oss® and maxresorb® are granular and non-resorbable, Biowool™ is fully resorbed in <8 weeks.

Its cotton-wool-like nature makes application easy within a sinus lift procedure, reducing the chances of perforation of the sinus membrane giving significant patient benefit.

This MRC DPFS project will enable setting up of a QMS, produce Biowool™ to scale at an ISO 13485 certified facility and to develop protocols for GLP preclinical product safety assessment via CROs.

We have provisionally mapped suitable partners and clinical champions for Biowool™ to successfully deliver this project.