Periodic Reporting for period 3 - DERMAREP (Clinical validation and production upscaling of a novel product for healing of Pressure Ulcers, Leg Ulcers and Diabetic Foot Ulcers.)
Reporting period: 2021-10-01 to 2022-09-30
Wound treatment is a major healthcare cost for all developed countries. In the UK for example, it is estimated that up to 4% of all health care costs are due to wounds . However, this represents only some 15-20% of the overall cost of wound treatment, where hospitalization and nurse time represent the remaining costs. The main driver for growth is the treatment of chronic and complex wounds in an aging population, complicated by the increase in diabetes and other metabolic disorders. 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 based dressings), however, due to cost considerations, this is not the case. This was confirmed through extensive interactions with KOLs in the UK and France which also stated that wound care for chronic wounds is still an unsolved matter.
The direct and societal cost in the treatment of delayed and chronic wounds is a significant problem in all major developed countries. Efficiency in wound healing is now a critical element in the struggle to maintain service levels in face of an aging population with its increased level of complex illnesses such as diabetes and venous insufficiency both of which lead to chronic leg wounds and ulcers. At the same time the National Health Service budget assumption is for zero budget growth between 2015 and 2020 in real terms. The conflicting trends in the UK are typical of that of all EU countries. Clearly, costs must be reduced per patient in this scenario. In most socialized medicine countries, presently most pressure is applied to driving down consumable costs.
Wound healing products have remained largely unchanged for the last 20 years. Collagen products today have limited use as they are seen as expensive (up to 10 times as expensive as non-collagen products ). Supply and safety of mammalian derived materials have also limited the usage of such products. In this scenario, effective wound care products, such as collagen based dressings, but with a significantly lower cost, become an attractive solution.
The concept behind DermaRep – the only EggShell Membrane (ESM) based wound dressing - directly addresses the healthcare industry needs by providing a novel wound care product that it as effective as the existing collagen based dressings, but it is also:
- significantly lower in cost (at least 3 fold lower cost)
- much more easily scalable,
- significantly safer
The combination of product scalability, effectiveness and cost represent a breakthrough in the wound healing market. This will allow for the first time an advanced product to be become the standard of care, reducing both product cost and nursing time. With DermaRep, BIOVOTEC will, therefore, be in a privileged position to seize a major market opportunity within the healthcare sector.
The direct and societal cost in the treatment of delayed and chronic wounds is a significant problem in all major developed countries. Efficiency in wound healing is now a critical element in the struggle to maintain service levels in face of an aging population with its increased level of complex illnesses such as diabetes and venous insufficiency both of which lead to chronic leg wounds and ulcers. At the same time the National Health Service budget assumption is for zero budget growth between 2015 and 2020 in real terms. The conflicting trends in the UK are typical of that of all EU countries. Clearly, costs must be reduced per patient in this scenario. In most socialized medicine countries, presently most pressure is applied to driving down consumable costs.
Wound healing products have remained largely unchanged for the last 20 years. Collagen products today have limited use as they are seen as expensive (up to 10 times as expensive as non-collagen products ). Supply and safety of mammalian derived materials have also limited the usage of such products. In this scenario, effective wound care products, such as collagen based dressings, but with a significantly lower cost, become an attractive solution.
The concept behind DermaRep – the only EggShell Membrane (ESM) based wound dressing - directly addresses the healthcare industry needs by providing a novel wound care product that it as effective as the existing collagen based dressings, but it is also:
- significantly lower in cost (at least 3 fold lower cost)
- much more easily scalable,
- significantly safer
The combination of product scalability, effectiveness and cost represent a breakthrough in the wound healing market. This will allow for the first time an advanced product to be become the standard of care, reducing both product cost and nursing time. With DermaRep, BIOVOTEC will, therefore, be in a privileged position to seize a major market opportunity within the healthcare sector.
BIOVOTEC has now completed all validation tests of the process line for harvesting of eggshell membrane. This material is the source material for producing PEP which then within the scope of this project is used for the production scale up further downstream. In addition, extensive upscaling and validation work has been done to ensure an industrial production of PEP. This PEP has then be used to investigate the possible process parameters and process optimizations to produce the final wound care device DermaRep. Within this first period of the project, our production partner has been able to find and verify those parameters.
In addition, extensive testing of different packaging and suppliers was carried out in order to be able to select the best quality / price package for DermaRep. We can now confirm that DermaRep can be produced at a very competitive price which is essential for its entry on the market in Europe. The work done so far has allowed us to start with process validation and technology transfer which will be the main focus during the second year of the project.
Our clinical study has been completed successfully and has been reviewed by several KOLs giving a strong recommendation of its clinical effect. This has allowed Biovotec to apply for CE mark. However, our CE mark application for DermaRep has taken longer time than expected. Here the “state of emergency “in the health systems in Europe and especially in the UK in addition the shift of the regulatory bodies towards Covid 19 devices has affected the progress of the CE marking. Which forced Biovotec to change Notify Boby to secure progress. The CE mark is essential in order to start the planned clinical trial post CE mark with our CRO partner Cromsource. Due to this delay imposed to us mainly by the Notified Body, it was decided to strengthen our application by additional clinical analysis and third-party evaluations by Key Opinion leaders in Europe. This work has been done and DermaRep CE mark has been filed the 21st of September.
In addition, extensive testing of different packaging and suppliers was carried out in order to be able to select the best quality / price package for DermaRep. We can now confirm that DermaRep can be produced at a very competitive price which is essential for its entry on the market in Europe. The work done so far has allowed us to start with process validation and technology transfer which will be the main focus during the second year of the project.
Our clinical study has been completed successfully and has been reviewed by several KOLs giving a strong recommendation of its clinical effect. This has allowed Biovotec to apply for CE mark. However, our CE mark application for DermaRep has taken longer time than expected. Here the “state of emergency “in the health systems in Europe and especially in the UK in addition the shift of the regulatory bodies towards Covid 19 devices has affected the progress of the CE marking. Which forced Biovotec to change Notify Boby to secure progress. The CE mark is essential in order to start the planned clinical trial post CE mark with our CRO partner Cromsource. Due to this delay imposed to us mainly by the Notified Body, it was decided to strengthen our application by additional clinical analysis and third-party evaluations by Key Opinion leaders in Europe. This work has been done and DermaRep CE mark has been filed the 21st of September.
The DermaRep project is expected to have several impacts which are divided into 3:
Environmental impact:
DermaRep is now converting eggshell residues – namely, the eggshell membrane – into a commercially valuable by-product – a biomaterial and novel wound healing solution. The waste valorization will have a significant impact in the egg processing industry by reducing the costs with waste disposal and minimizing associated environmental problems. Finally, the BIOVOTEC process is based mainly on mechanical and heat energy and does not create significant chemical residues unlike the current animal collagen extraction industry.
Economical impact:
The conflicting trends in the UK are typical of that of all EU countries. The National Health Service budget assumption is for zero budget growth between 2015 and 2020 in real terms. A model of wound resource requirements has estimated a year on year increased requirement of 1-2% for wound care services (Dowsett et al 2014). The total expenditure in 2014 is estimated at £2.16 billion compared with 3.37 billion in 2019 with the dressing’s budget increasing from £420 million to £461 million over the same period (Dowsett et al, 2014). Clearly, costs must be reduced per patient in this scenario. In most socialized medicine countries, most pressure is applied to driving down consumable costs.
DermaRep is developing cost-effective wound dressings that can be used for initial treatment of all wounds at risk of delayed or non-healing, reducing the incidence of chronic wounds, such as venous, pressure and diabetic ulcers which will address this problem and will positively impact hospitals and all payers through a highly significant reduced treatment costs per wound.
Health Impact:
Treatment of delayed and chronic wounds is a significant problem in all major developed countries. Efficiency in wound healing is now a critical element in the struggle to maintain service levels in face of an aging population with its increased level of complex illnesses such as diabetes and venous insufficiency both of which lead to chronic leg wounds and ulcers.
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 based dressings), however, due to cost considerations, this is not the case.
Our medical device is being specifically developed to address this problem: The combination of product scalability, effectiveness and cost represent a breakthrough in the wound healing market.
Environmental impact:
DermaRep is now converting eggshell residues – namely, the eggshell membrane – into a commercially valuable by-product – a biomaterial and novel wound healing solution. The waste valorization will have a significant impact in the egg processing industry by reducing the costs with waste disposal and minimizing associated environmental problems. Finally, the BIOVOTEC process is based mainly on mechanical and heat energy and does not create significant chemical residues unlike the current animal collagen extraction industry.
Economical impact:
The conflicting trends in the UK are typical of that of all EU countries. The National Health Service budget assumption is for zero budget growth between 2015 and 2020 in real terms. A model of wound resource requirements has estimated a year on year increased requirement of 1-2% for wound care services (Dowsett et al 2014). The total expenditure in 2014 is estimated at £2.16 billion compared with 3.37 billion in 2019 with the dressing’s budget increasing from £420 million to £461 million over the same period (Dowsett et al, 2014). Clearly, costs must be reduced per patient in this scenario. In most socialized medicine countries, most pressure is applied to driving down consumable costs.
DermaRep is developing cost-effective wound dressings that can be used for initial treatment of all wounds at risk of delayed or non-healing, reducing the incidence of chronic wounds, such as venous, pressure and diabetic ulcers which will address this problem and will positively impact hospitals and all payers through a highly significant reduced treatment costs per wound.
Health Impact:
Treatment of delayed and chronic wounds is a significant problem in all major developed countries. Efficiency in wound healing is now a critical element in the struggle to maintain service levels in face of an aging population with its increased level of complex illnesses such as diabetes and venous insufficiency both of which lead to chronic leg wounds and ulcers.
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 based dressings), however, due to cost considerations, this is not the case.
Our medical device is being specifically developed to address this problem: The combination of product scalability, effectiveness and cost represent a breakthrough in the wound healing market.