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Novel Biomaterial for Improved and Cost-efficient Wound Healing

Periodic Reporting for period 5 - BIOCURE (Novel Biomaterial for Improved and Cost-efficient Wound Healing)

Reporting period: 2018-02-01 to 2018-07-31

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 . The global market for advanced wound care products was projected to be $ 3 billion in 2012, with an annual growth above 10% and representing one of the leading medical product sectors . However, this represents only some 15-20% of the overall cost of wound treatment, where hospitalisation 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.

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. Recently, enhanced products based on bovine collagen or porcine materials have shown to be more effective than the traditional dressings based on natural materials such as cellulose and cotton. Collagen products today have limited use as they are seen as expensive (up to 10 times as expensive as non-collagen products ). In 2011, total collagen product sales worldwide were only USD$91 m even though have increased significantly afterwards. 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 BIOCURE – 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 BIOCURE, BIOVOTEC will, therefore, be in a privileged position to seize a major market opportunity within the healthcare sector.

BIOCURE aims at developing a cost-effective wound dressing based on a novel biomaterial derived from eggshell membrane to be used as first-line treatment in all wounds at risk of delayed or non-healing, reducing the incidence of chronic wounds, such as venous and diabetic ulcers.
BIOVOTEC has now completed all validation tests of the new process line which allows the harvesting of eggshell membrane at industrial scale, a by-product of industrial egg production which is a source of valuable proteins and collagen. The fabrication of the innovative medical device derived from eggshell membrane has been achieved at industrial scale which confirms the possibility of producing at high volume under GMP conditions in facilities meeting the ISO medical device standard.
Our pre clinical tests have been completed successfully and has allowed Biovotec to apply for the human clinical trial.
Biovotec has now received the approval from both the health Authority (MHRA) and the Ethic Committee in the UK and has initiated its first human trials which will allow Biovotec to CE mark its medical device in 2019.
BIOVOTEC does not want to report its development progress in details as the information still is confidential.
BIOVOTEC has participated in two of the world wide known conference on wound healing in the US and EU and has also been in contact with several Hospitals and Keep Opinion Leaders in the field. Patents, Publications and Posters have also been submitted which strengthen Biovotec position.
The Biocure project is expected to have several impacts which are divided into 3:

Environmental impact:
BIOCURE 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.
BIOCURE 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 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. This will allow for the first time an advanced product to be become the standard of care, reducing both product cost and nursing time for the benefit of the patients, this will have a high significant impact on patient health.