• Minicabecera3



"Advanced material for the regeneration of oral mucosa injuries"

Call Identifier: SMEInst-02-2016-2017
Grant agreement no.: 763090

This project has received funding from the European Community's Horizon 2020 Programme under grant agreement no 763090.

The project NEOFIBRIN was submitted to the Horizon 2020 program call SME Instrument Phase 1 with the aim of evaluating technical, industrial scale-up and market feasibility of the novel tridimensional scaffold for restoring masticatory oral mucosa functional activity.

Patented and produced by Histocell S.L, HR018-NEOFIBRIN is an innovative absorbable matrix for application in lesions of the oral mucosa with the ability to promote the regeneration of soft tissues as well as to treat localized mucosal damage. The product is composed of fibrin, obtained from coagulation of the fibrinogen present in the plasma, and agarose. Briefly, fibrin creates a highly compatible three-dimensional matrix which promotes regeneration of the lesion and agarose confers consistency. This unique combination of natural components brings up a new exclusive matrix design which provides mechanical support to cells to migrate and restore functional activity of mucogingival tissue.

Considering only the 5% of the identified severe recession cases, it is estimated a market size of almost 8 Million cases for HR018–NEOFIBRIN per year in seven of the major markets (Germany, France, UK, Spain, Italy, Japan and USA). This market is anticipated to increase if severe periodontitis cases are also included.

Industrialization barriers have been properly identified in terms of tentative prices of the main raw materials per HR018–NEOFIBRIN unit, and establishing a manufacturing capacity of the new demonstration plant. In addition, the necessary approach to guarantee viral safety of plasma source has been developed.

Although commercial barrier analysis identified various competing products, none of them has still demonstrated to be effective enough, and periodontists confirmed the need of innovative matrices with higher resistance capable of being left exposed in the oral cavity such as HR018–NEOFIBRIN.

All the above mentioned tasks have resulted in an improved business plan for industrial-scale advanced manufacturing, clinical trial development, financing, and commercialization of HR018-NEOFIBRIN for oral mucosa injuries.