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Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2011.2.3.1-5 | Award Amount: 4.03M | Year: 2012

With a share of 38%, orthopaedic and traumatology (O&T) are the worldwide leading markets of implanted biomaterials, involving millions of new patients each year at an increasing trend. Infection related to implanted medical devices is directly related to bacterial capability to establish multilayered, highly structured biofilms on artificial surfaces. Bacterial infections due to implanted biomaterials represent the most devastating complication in O&T, involving millions of European citizens. Aim of the present research is to develop, validate and bring to the market a disposable coating of implanted biomaterial (Implant Disposable Antibacterial Coating, I.D.A.C.). The device, based on a novel, proprietary, resorbable hydrogel, would act as a fast resorbable local delivery carrier of antibiofilm and antibacterial compounds. The active drug (antibiofilm and antibiotic agents) will be mixed at the time of the hydrogel application, allowing the correct choice for any given patient, reducing regulatory requirements, improving storage life and versatility. In particular, I.D.A.C. will be tested as a resorbable carrier of drugs (e.g.: N-acetylcisteine and its derivatives, serratia peptidase and other peptides, etc.) already known from our studies for having excellent antibiofilm properties, while others are able to by-pass the intact biofilm barrier and kill the underlying bacteria, when locally administered. The final purpose of the present research is to set a novel approach to early control of biofilm formation,to prevent bacterial colonization of implanted material and to treat established implant-related infections and chronic wounds, without any risk of inducing new drug resistance and alter the environment. The research will be conducted under the aegis of the European Bone and Joint Infection Society and the European Hip Society, through a network of upper standard European research and clinical centers and experienced SMEs from eight Countries around Europe.

Agency: Cordis | Branch: H2020 | Program: SME-1 | Phase: BIOTEC-5a-2014-1 | Award Amount: 71.43K | Year: 2015

The aim of the ADHESION Project is to strengthen the anti-adhesion and anti-bacterial characteristics of a NOVAGENIT proprietary product (DAC), by tuning and validating a new more competitive solution targeted to the orthopaedic and cardiovascular surgery. NOVAGENIT will take the opportunity to expand its own business in the anti-adhesion market by taking advantage of the intrinsic barrier effect of the DAC hydrogel. A new formulation of the DAC product will add an anti-bacterial power to the anti-fouling/anti-adhesion intrinsic action. This could be due to a combination of silver nano-particles and to Vitamin C added to the derivatized hyaluronan based gel original formulation. The new formulation, comprising a lyophilized membrane, will increase the usability for the end user, and will prolong the shelf life of the biotech, advanced material product.NOVAGENIT intends to address both the adhesion and infection issues, as it is a complete novelty in the market of anti-adhesion products. Specifically the business opportunity consists in the combination of the three key product features (anti-fouling, antibiotic and usability) into a novel product not yet market available, and to target two surgery markets (cardiovascular and orthopaedic ones) in order to generate the appropriate return on the investment. This phase 1 consists in the feasibility study devoted to assess the economic/technological viability of the innovative idea and to generate its business plan. It will be followed by a phase 2 where the product will be industrialized and make ready for sales through a targeted marketing plan. The envisaged advantage for the European Health-care system from the results of the ADHESION Project is to spare the costs of re-interventions, both for the post-surgical adhesions (about 2 billion Euros/year), and the post-surgical infections (about 3 to 5 billion Euros/year). Future opportunities of this product on different markets will be exploited.

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