CORDIS - EU research results

Development of manufacturing process for a novel multi-layer film comprising of a water-soluble polymer and a bio-compostable polymer to enable flushable ostomy pouches

Periodic Reporting for period 1 - BioStomy (Development of manufacturing process for a novel multi-layer film comprising of a water-soluble polymer and a bio-compostable polymer to enable flushable ostomy pouches)

Reporting period: 2015-05-01 to 2015-10-31

The Biostomy Feasibility project is underway to understand the commercial viability of the production of a fully flushable biodegradable ostomy bag. We are carrying out freedom to operate work, market reviews and manufacturing process reviews and will produce a business plan for taking Biostomy to market.

Our objectives are to understand the market dynamics, the IP landscape, manufacturing cost issues and our route to market. We have completed out report and have achieved all our goals.
We have carried out a detailed patent search and identified the top 5 competing patents. the detailed patent survey was undertaken by our IP consultants Cresco Innovation Ltd.

Whilst initially this topic appeared to be a busy space in terms of patent filings, in fact there are groups of patent families and only a very small number of filings that are relevant to the ACEDAG patent.

The patent landscape is heavily dominated by 3M with four out of the top 5 most relevant patents either filed by or assigned to 3M or companies within their group. The other relevant patent (US5142010A) by Olstein is lapsed.
Our initial search, conducted through the European Patent Office, was based on the following key words:

• ‘ostomy’
• ‘disposable’
• ‘dissolve’
• ‘degradable’
• ‘water soluble’
• ‘anti-bacterial’
• ‘extruded film’

This search returned 65 results. However, many of these filings were part of patent families derived from the same invention, and we have therefore only listed each patent family once in our report. Many of the results concentrated on methods of drug delivery, or catheter function, and were unrelated to the ACEDAG invention. We also conducted a search by category and obtained 72 results, which broadly concurred with the key word search. The idea of dissolvable ostomy bags exists in the market and there have been filings related to this for over 20 years. We have included lapsed patents in our findings as these are relevant to prior art considerations. We have determined the top 9 nearest competing patents

We have carried out extensive market research and prepared a competitor analysis, technology analysis, risk review and created route to market strategy and financial forecasts. We have concluded ACEDAG’s BioStomy offers an innovative solution into a mature market. Market growth is ca. 5% per annum driven by an ageing population. We are not aware of any technological approaches which are disruptive to the market. Through careful alliances ACEDAG will be able to provide a product which will improve the quality of life for ostomates and represent a viable business proposition.
We have completed our business plan and have a detailed sales forecast including a profit and loss calculation. We anticipate creating new jobs.

Business aims
Ostomy drainage pouches are medical devices made of heavy-duty plastic used to collect waste from a surgically diverted colon, ileum or urinary system. Their disposal can cause users psychological, social, and work-related problems, negatively affecting their quality of life. Soiled ostomy devices become domestic waste and the heavy-duty plastic is not biodegradable and ends up at landfill sites. Our proposed ostomy pouch product - BioStomy - seeks to address challenges faced by ostomates by providing an industry first – a fully flushable ostomy pouch using an advanced water soluble and biodegradable polymer material manufactured by an innovative co-extrusion process.
We intend to partner with an established manufacturer of ostomy bags to exploit their customer base. We will supply the material (extruded laminated polymer) for final finishing, and sale. To achieve this we will need to invest in the development of an extrusion process, clean room facilities, and staff to produce the required material – ca. 224 tonnes p.a. by 2022 .

Financial summary
The sale of materials will provide an operating profit of €76.3 m over 5 years, an RoI of 9770% from an investment of €773k. Returns are high as the investment required is kept low, as our partners will met the majority of sales and marketing costs.
Ostomy cycle