E!12852 A novel bio-material is to dramatically decrease the cost of treatment of severe wounds and burns.

The outset outcomes when starting the project were met as originally planned despite Covid 19. However, due to the Covid 19 pandemic and lock down period there was a delay in achieving these goals. This affected, however, mostly our partners CICA and IMREDD and to a less degree Biovotec. The project was managed according to Biovotec risk management procedures assuring a good risk balancing. All approvals for the pre-clinical trials were readily achieved and a comprehensive review of recent advancements in wound, ulcer and burn treatment was conducted to be able to set the R&D performed in the context of the most recent developments. Biovotec has focused to develop 3-dimensional scaffold. This was an obvious extension of the use of the use of PEP (purified eggshell membrane) form Biovotec?s two-dimensional film product. Valuable information and limitations were obtained during the many cells and pre-clinical trials leading also to the development of a completely soluble form of PEP. This proved to be quite challenging and lead after succeeding to filing of a patent for the formulation and production of this form of PEP. This soluble form of PEP was then shown to be an ideal component for the Bio Ink used by our cooperation partner to 3-d print prototypes which then were assessed in cell and preclinical trail with great success. Overall, the project has resulted into two patent applications and at least 2 concrete product development efforts.

The project has allowed the development of different scaffolds which are aligned with the need of costs of treatment and the potential savings for the health system. In addition we have been able to develop and patent a new bioink with the potential to be cost effective compared to the current bioink. This is mainly due to the cost of our biomaterial. In addition, we have developed and apply for a patent of new form of PEP (Purified eggshell protein) which can have a distinct impact on treating burns where one wants to achieve a controlled healing to avoid scaring. Based on these studies it is likely that both products have the potential to compete to the current products on both price and efficacy.

The loss of skin can occur for many reasons, including genetic disorders (bullous conditions), acute trauma, chronic wounds or even surgical interventions. Chronic wounds and burns sometimes can result in rapid, extensive, deep tissue loss which cannot be successfully treated with common techniques and can lead to traumatic surgery such as amputation and in certain cases death. Treatments are a major healthcare cost for all developed countries. Currently, the clinical ‘gold standard’ in full thickness injuries treatment is split-thickness autologous skin grafting, however, more techniques and products are becoming available because donor sites are extremely limited. New products/structures, such as collagen derived – 3 D matrix materials which are incorporated into the wound are becoming more popular. Ideally, wounds at-risk of becoming chronic in high-risk patients should be treated from the outset with the most effective products (such as collagen/protein-based dressings), however, due to cost considerations, this is not the case. Biovotec has developed and validated a 2D medical device DermaRep which is a dissolvable film based on PEP for chronic superficial wounds only. We have developed a 3D product, patent: Tissue engineering scaffolds comprising particulate eggshell membrane) and have completed a pre-clinical feasibility study. Now, Biovotec would like to expand the knowledge from the 3D product development and deliver a novel 3D medical device product for deep/severe wounds and burns incorporating PEP which will have a unique, superior position in respect to functionality and an unprecedented competitive price. During the project, we will develop and optimize our current 3D product (scaffold) based on the feedback from laboratory measurements/specifications. Both in vitro and in vivo tests will be carried out to prepare for the post-project final pre-clinical (efficiency test in pig model) and clinical studies and the subsequent product launch.