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

Målsettninger for prosjektet ble oppfylt som opprinnelig planlagt til tross for Covid 19. På grunn av Covid 19-pandemien og nedstengningsperioden var det imidlertid en forsinkelse å oppnålese av disse målene. Covid 19 påvirket for det meste våre partnere CICA og IMREDD, men også i mindre grad Biovotec. Hele prosjektet ble styrt i henhold til Biovotecs risikostyringsprosedyrer som sikret en god risikobalansering. Godkjenninger for de prekliniske studiene ble oppnådd raskt, og en omfattende gjennomgang av nylige fremskritt innen sår-, og brannsår behandling ble utført for å kunne sette FoU utført i sammenheng med den siste utviklingener. Biovotec har fokusert på å utvikle 3-dimensjonalt scaffold. Dette var en åpenbar forlengelse av bruken av PEP (renset eggeskallmembran) fra Biovotecs todimensjonale filmprodukt. Verdifull informasjon og begrensninger ble oppdaget i løpet av de mange cell og prekliniske studier som også førte til utvikling av en helt løselig form for PEP. Dette viste seg å være utfordrende, men etter å ha lyktes ledet det til en utvikkling av et patent for formulering og produksjon av denne formen for PEP. Denne løselige formen for PEP viste seg da også å være en ideell komponent for Bio Ink som ble brukt av vår samarbeidspartner til 3D-trykte prototyper som deretter ble vurdert i celle- og preklinisk forsøk med stor suksess. Samlet sett har prosjektet resultert i to patentsøknader og minst 2 konkrete produktutviklingstiltak.

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.