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Novel Biomaterial for Improved and Cost-efficient Wound Healing

Periodic Reporting for period 1 - BIOCURE (Novel Biomaterial for Improved and Cost-efficient Wound Healing)

Reporting period: 2015-03-01 to 2015-08-31

BUSINESS CONCEPT: 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 and Negative Pressure Wound Therapy), however, due to cost considerations, this is not the case.

SOLUTION: BIOVOTEC aims to pursue a major market opportunity by 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. BIOCURE is based on a novel biomaterial derived from eggshell membrane (ESM) – a by-product readily available in egg industry. BIOCURE range products will be safer, potentially more effective, much more easily scalable and significantly lower in cost when compared with the available animal tissue based advanced wound healing products, such as bovine collagen and porcine materials which are expensive to derive and have potential safety concerns . Nevertheless, despite the benefits of using ESM based wound dressings, it is crucial to validate and demonstrate the benefits of ESM based wound dressings before large-scale commercialization.

The key expected outcome of this overall innovation will be a range of cost-effective wound care products which: a) Manage wound moisture content b) Provide an anti-microbial barrier and wound covering c) Prevent or reduce bacterial growth d) Most importantly, provide a biological stimulus to wound healing and tissue repair. As first application, we will focus on clinically validating the product for treatment of venous ulcers and diabetic ulcers, which are major unmet medical needs. Clinically, our goal is for BIOCURE to be used as a first-line treatment in all chronic and at risk wounds.
In line with the objectives of the SME instrument phase1 project, the focus of phase 1 has been on delivering the following:
1. Analyse existing players’ product portfolio and identify gaps in product lines, which could be strengthened by the BIOCURE range.
2. Perform end user needs analysis using value proposition canvas for UK market and find how these needs can solved by Biovtec wound care products
3. Perform pre-clinical studies to minimize investment risk on R&D and scaling of the product
4. Development of prototype formulations to assess manufacturing feasibility with different product presentations based on the user and product requirements.
5. Definition of product development schedule and costing for EU and development of a regulatory strategy for EU and US approval and establishment of Biovotec Quality System.
6. Perform financial and product development risk analysis

The work during six month feasibility study has lead us to below conclusions:

The wound healing market is dominated by a group of established multinationals and there is no room for another “me too” generic product to be successfully launched with similar features and cost. Collagen products are effective but increase the costs of standard of care in VLU’s by approximately 6 fold and are therefore limited to wounds that have failed and are at a “salvage” stage. The costs and difficulties of conducting clinical studies to show cost effectiveness to the standards required by UK NICE for existing collagen products will hinder their wider market adoption. The incidence and prevalence of VLU’s is increasing worldwide due to the ageing population. A product with significantly reduced cost and similar effectiveness to collagen products would be highly attractive in the EU and US payers in reducing overall costs of VLU treatment. BIOCURE will increase the product costs of standard of care by approximately 100% per dressing change but reduce the number of dressings to healing. This compares with a 600% increase per dressing change with a collagen based product such as Promogran. BIOCURE has the potential to be a disruptive technology solution and has the potential to become the standard of care in all developed markets due to its price versus effectiveness position.

The objectives set out in our SME 1 application have been achieved and our business hypothesis has been verified. ESM is an effective material for enhancing wound healing and at a significantly lower cost compared to the existing competition. The lower cost will remove the barriers for adoption by payers and clinicians and Biocure has the potential to become the new standard of care for chronic wounds and wounds at risk.