AnastomoSEAL Importance

Social and economic impact on European level

The success of the project will have significant economic and social impact.

WHO estimates that each year 1,234,000 new cases of CRC occur in the world, of which 60% occur in developed countries; the European Union ranks top with about 48 new cases of CRC per 100,000 (54% in men and 46% in women).

The number of new cases of early CRC is expected to rise considerably in the future years as national screening programs have been introduced among the different States of Europe in accordance with the "European Guidelines for Quality Assurance in Colorectal Cancer screening and Diagnosis" and as life span and aging of population are increasing. Figure 11 reports the growing incidence rate of CRC in some EU states from 1975 to 2005 for both men and women.

Men Women

Figure 1: Trends in incidence of colorectal cancer in selected countries: age-standardised rate (W) per 100,000. GLOBOCAN 2008 (IARC) , Section of Cancer Information (18/4/2011)

The divergence between incidence (upward trend) and mortality rates (downward trend from the mid-1990s onwards) suggests an increase of early detection of the disease with a corresponding shift to an earlier stage and improvements in therapy, but at the same time this trend is having important consequences in the disease prevalence. In fact, the incidence of Stage I disease in the USA has increased over the past years due to better screening and is currently nearly 30%. In spite of the improvement of the surgical technique and accumulated experiences, AL is still one of the most severe complications, with up to 21% incidence rate. As a reference, in the Swedish Rectal Cancer Registry the AL rate was just below 10%. No tendency towards improvement was found throughout a ten-year period from 1995 to 2004. At present, AL leads to a prolonged initial hospital stay (average of 71 days), possible re-admissions and sometimes repercussions extending over several years; it requires urgent return to the operating room, repeated surgical operations and death is not uncommon. The mortality rate for an AL in the literature typically is in the 10% to 15% range. Further, AL has been associated with increased local recurrence and diminished survival after colorectal cancer surgery.

The quality of life of a colorectal cancer patient and his/her family is deeply modified when faced with this diagnosis and it worsens even more when complications occur. A study published in 2008 described how patients with AL had a clearly poorer quality of life, lower body image, poor social activity and also had significantly higher depression and anxiety. Patients requiring a stoma face problems including adapting to the new anatomy, managing the stoma and continuing normal activities in their socio-cultural environment. The level of disability related to multiple abdominal operations or again the presence of a stoma has a strong impact also on the work productivity of these patients.

The biomaterial developed within AnastomoSEAL project will cause faster regeneration of the intestine thus preventing AL. It will then have a great impact on the quality of life of patients subjected to colorectal surgery for cancer resection. This will make it possible for patients to return to normal life earlier than before. The quality of life will be enhanced in terms of patient comfort since the proposed material will reduce the complications of actual surgical proceedings like a long duration drainage. It will reduce the number of additional surgical procedures needed and all the related medical and psychological morbidities. This material will lead to a reduction of the anastomotic leakage cases meaning a shorter hospital stay, a quick return to daily activity and work and good quality of life. It also could allow the patient to start chemotherapy earlier and potentially prolong long-term survival.

In clinical research, surgeons need to widen their scope of practice, thus further research and trials are required to overcome "dogmas" in traditional colorectal practice: this project is supposed to have an impact also on the scientific community by enhancing collaborations and knowledge sharing between academic, industrial and medical world in Europe, with the final aim to improve the quality of patient care.

Also the economic impact of the project is significant, especially in relation to the cost of health care and to the global growth potential of the European biomaterials industry.

The management of anastomosis leakage by the health care system is presently very onerous. AL generates a very considerable demand for hospital resources and diverts these resources from the hospital population at large. This economical cost will increase in a linear fashion because of the aging of the population. As an example, only in one EU country (France) the cost of health care for AL has been estimated to be € 63,000 for a single patient. In USA the average number of cases of AL is 24'000 per year with an estimated cost of 1.2 billion USD.

The new biomaterial has the potential to decrease the cost of health care by decreasing the number of CRC patients suffering from this complication.

Significant contributions to the cost build-up are prolonged hospitalization, radiographic studies during and after the admission, consultation services, more extended use of the operating room, stoma-related complications, re-intervention for ostomy closure, longer nursing care, materials (e.g. antibiotics, ostomy bags). No attempt was made to assess the total cost involved for a sample case of colorectal leak because public hospitals do not have a scale of charges for the individual consultations and services involved and, in any case, charges generally do not reflect actual costs. Moreover, the costs of rehabilitation, physiotherapy, prolonged absence from work of the patients and sometimes of members of the family who become caregivers and nursing homes must be considered. A literature search failed to identify any studies which have quantified the variety and volume of these resources. Nevertheless, it is self-evident that a reduction of the anastomotic leak rates by AnastomoSEAL would produce huge health savings by increasing the cost-effectiveness ratio.

AnastomoSEAL project will respond not only to expectancy of patients in general, but also to specific policies of stakeholders, calling for better medical and technological solutions for CRC patients (e.g. Europacolon, which is committed to preventing deaths from colorectal cancer and improving the quality of life and support for those affected by the disease). Due actions to ensure effective communication to-and-from stakeholders will be planned in the Dissemination activities.

The global economic growth potential of the biomaterials industry is huge. Many of the current leading treatment concepts and surgical techniques have been originally invented in Europe but the manufacturing and worldwide marketing of biomedical devices is centered mainly outside Europe. This project aims to satisfy a widespread clinical need by specifically designing a resorbable biomaterial for colorectal anastomoses. Currently, materials and medical supplies specifically devoted to this aim are not present on the world market, although both public and private research is likely to be moving fast in this direction. The introduction on the market of such innovative product by the European industry has the potential to spin it into significant economical growth, therefore enhancing the global competitive position of Europe in this field. The possibilities for the European biomaterials industry to cover markets other than EU with a successful product are high. Areas like Australia and New Zealand, as well as Canada and the U.S.A., present high incidence rates of CRC, to which high mortality rates of countries like the Russian Federation, Ukraine, Belarus and South Africa should be added.

Impact on European Policy

  1. The potential social impact of AnastomoSEAL project is clearly addressing to the Community societal objectives related to the quality of life and health, in particularly the topics stated in the EC Communication COM(2009) 180 fin: "Dealing with the impact of an ageing population in the EU (2009 Ageing Report)".  CRC is a cancer of the elderly and with increasing aging of the population the number of cases may be expected to rise further in spite of decreases in incidence and mortality rates (2,3). The highest age-adjusted rates for incidence, mortality and hospitalization are in the oldest age group, >80 years, although the largest number of new cases and hospitalizations occurred in the 60–69 and 70–79 year age groups. Overall, more than 80% of cases arise in people who are older than 60. It has been estimated that in Europe by 2015 there will be a 22% increase in the population aged >65 years and a 50% increase in the number of persons aged >80 years.The project fully responds to some main topics reported in the EC Communication COM(2009)180 fin. In particular AnastomoSEAL tackles the challenges of reducing the economic impact of ageing on healthcare systems (mainly for long-term care), of improving the health and providing new or adapted goods and services for elderly population.  The level of disability related to multiple abdominal operations or the presence of a stoma have a strong impact also on the productivity of patients. Since the retirement age is increasing, more and more elderly people is needed as an active worker. Therefore, a healthier elderly population means more work power and productiveness. Reducing complication-related disabilities for colorectal patients may respond also to the EC Communication COM(2009) 180 fin aim of "raising the employment rates of older workers". Another point of interest of this Communication is the healthcare spending related to technological progress: in this sense AnastomoSEAL Project is cost-saving in a long-term analysis.
  2. Although the specific target of the AnastomoSEAL project directly deals with neither prevention nor care of CRC, still any positive achievement would contribute to limitation of its negative medical, social and economic impact, in line with major actions of the EU against Cancer at large (European Partnership Action Against Cancer and CRC in particular (e.g. Speech on European colorectal cancer policy delivered by John Dalli, Member of the European Commission, responsible for Health and Consumer Policy, in a roundtable debate at the European Parliament, Brussels, Belgium, 02 March 2011)).
  3. According to the Strategic Research Priorities identified by Nanomedicine European Technology Platform, AnastomoSEAL project is aimed to "create regenerative medicine products and procedures capable of dramatically improving patients' mortality and morbidity caused by major diseases". The developed biomaterial will be "tailored for specific patients and disease states" and it will be designed to be "time programmed" in order to provide "temporary support of a damaged tissue" promoting at the same "time tissue growth and regeneration".
  4. The project AnastomoSEAL aims at fully integrating within the scopes of two Innovation policies of the EU:
    – Lead Market Initiative for Europe, the European policy that supports actions to lower barriers to bring new products or services onto the market with specific reference to the Sector: Bio-based products andKnowledge and Technology Transfer which supports activities aimed to generate new knowledge and to turn it into new commercial products through the promotion of collaboration and the transfer of knowledge between public research and industry, as one of ten key areas for action in order for Europe to operate as a single market for knowledge.
  5.  The economical benefits for healthcare and social systems derived by a potential success of AnastomoSEAL project clearly follow the European Economic Recovery Plan 4 (EERP) outlines that indicate all the activities "geared at putting age-related spending on a sustainable path" as a major tool to overcome the economic recession.
  6. Moreover, the strong involvement of SMEs in AnastomoSEAL is fully adherent to the concepts of the "Small Business Act" for Europe (SBA), which reflects the Commission's political will to recognize the central role of SMEs in the EU economy and for the first time puts into place a cmprehensive SME policy framework for the EU and its Member States.

 

Impact on SMEs and Industries.

SMEs and Industries involved in the Project

The direct and indirect economic benefits are significant to the industrial partners of the AnastomoSEAL Consortium. The networking value of the consortium is enabling the SMEs to increase their business opportunities in the biomaterials sector. The expected benefits brought by the project to the individual companies are hereafter described.

FMC

FMC BioPolymer/NovaMatrix manufactures ultrapure alginate, chitosan, and hyaluronic acid for biomedical applications. As such, the AnastomoSEAL project represents an opportunity to further develop biomedical applications for our ultrapure biopolymers. This is "business critical" to FMC as increased use in advanced biomedical applications will demonstrate that there is a market for these high-added value bio-based products. FMC anticipates that ultra-pure alginates and hyaluronates will be utilized in the Project giving FMC additional experience in new medical fields. FMC also has background patents in alginate technology areas such as gelation and foams.  FMC is directly involved in the development of Standards and Guidelines for biopolymers used in biomedical applications. The company's efforts through the American Society for Testing and Materials (ASTM) have generated industry-wide consensus standards also recognized by the U.S. FDA. FMC will contribute to further guidance documents in the field of biomedical biopolymers through the participation in AnastomoSEAL. This is important for acceptance of alginate and hyaluronate in the medical device community. Finally, FMC looks forward to having interaction with Sigea regarding hyaluronan and hyaluronan derivatives. The two Companies may certainly develop collaborations in other non-Project related areas due to their involvement in AnastomoSEAL. The project will facilitate visiting each other's facilities and learning more about potential common business opportunities and research capabilities.

Impuls

The AnastomoSEAL project represents an opportunity for this company (already present in the medical market sector in Europe, Asia, Africa and the Americas) to develop a new branch in its health-related activities.

The peculiar location of the Company can be regarded as a small but concrete effort within the EU Strategy for the Baltic Sea Region. This is the first time that a comprehensive Strategy, covering several Community policies, is targeted on a 'macro-region'. Several convergence, competitiveness and co-operation programmes are co-financed from the European Regional Development Fund (ERDF) in the Baltic Sea Region in the period 2007-2013.

Among them, the European Commission approved an Operational Programme for Poland, the "Innovative economy". Specific objectives of the Operational Programme include improving enterprise innovativeness, strengthening economic development through good science, increasing the international market share of innovative products made in Poland, creating permanent and better places to work.

The "Innovative economy" Operational Programme is structured along the following priority axes:

Research and development of new technologies;

Capital for innovation
(the objective of this priority axis is to increase the number of enterprises using innovative solutions and to improve access to external financial resources that encourage innovative undertakings);

Investments in innovative undertakings
(this priority axis seeks to increase the level of competitiveness of enterprises through the application of new solutions. In terms of development trends and advanced globalisation, sustainable growth can only be guaranteed by enhancing competitive advantages based on innovative solutions);

Diffusion of innovation (e.g. strengthen the competitive position of enterprises through the development of cooperative relationships, know-how exchanges, resources utilisation improvement);

Polish Economy on the International market.

Due to intense and constant contacts of its management, I.E. Impuls will provide a privileged access to the Russian Medical Device Market. This market is potentially huge, given its population and potential wealth of natural resources. A system of medical insurance is in place, but it is badly managed and the quality of treatment varies from region to region. However, the government's national "Health" project aims to improve healthcare standards. In 2011, the Russian market for medical equipment and supplies is estimated at US$ 5'961.3 million.. This is despite rapid growth, especially of imported products, in the 2006-08 period.
Russian medical device manufacturers are generally small and undercapitalised, and tend to produce obsolete products; they can only compete with Western products in terms of cost. The country has a strong scientific research base but has no experience of commercializing new products. Exports are low and centered on other former USSR markets. Around 73% of the market is supplied by imports. Germany, the USA and Japan were the leading suppliers in 2009, accounting for 55% of imports between them. Notwithstanding the sharp fall in 2009, the value of imports has greatly increased over the last five years.

The possible outcome of the innovative product is expected to spread sales into foreign markets (including the expanding markets in Central and Eastern Europe), to increase the company know-how, the turnover and the work-place opportunities.

Rescoll

The AnastomoSeal project is extremely important for RESCOLL's development strategy for the following reasons:

•    As a service company RESCOLL needs to broad its competences; as AnastomoSeal deals with adhesion and interphases in the biomedical sector it fits very well to RESCOLL's historical expertise: adhesion phenomena.

•    Marketing aspects are also important for us. RESCOLL's market share in biomaterials passed from 5 to 20% and a team of 5 experts in the area is now in place.

•    Recognition: A project as AnastomoSeal indirectly generates more turn over for us. In the past, other framework projects brought us new customers looking for similar expertise.

•    As a research company RESCOLL has been involved in several projects and has developed plenty of products and techniques. It is foreseen to create a company exploiting these technologies.

Sigea

Sigea Srl is a research-oriented Company whose main goal is the development for biomedical applications of new polysaccharide derivatives conjugated with functional moieties to combine two different properties in a single molecule.

This proprietary technology will be applied in the AnastomoSEAL project to generate molecules characterized by specific properties useful for the specific biomedical applications described in the Project. While the existing background of Sigea's technology supports the rationale for using the proposed molecule, the presently proposed application actually opens up a totally new biomedical field for the Company. The participation to this Project will dramatically increase the know how correlated with the molecule that will be developed and, furthermore, will open new perspectives on the potential application of this technology for additional new molecules and new biomedical applications.

Also, Sigea expects that the collaboration with other Institutions/Companies, due to exchange of different experiences and knowledge, will open new horizons for its scientists and growth.

SMEs and Industries in Europe

Besides directly foreseen benefits for the industrial partners of the project, AnastomoSEAL will have a positive impact on the European biomedical device industry in general.

To take care of this aspect, reference has been made in the preparation of AnastomoSEAL project to the outcome of the Exploratory process on the future of the medical devices sector, set up to map the existing public health and industrial challenges in the sector and investigate possible topics of reflection at the European level (Exploratory Process on the Future of the Medical Devices Potential themes for further reflection at the European level and Issues identified by the Members). Focus themes of the latter will be hereafter used to highlight the potential relevance of AnastomoSEAL results for the European medical device industry.

Focus Themes AnastomoSEAL Highlights
Future challenges and opportunities for public health and medical technologies developments.
… future challenges of public health systems and how the medical devices industry could respond to them, with a particular focus on … societal changes (e.g. ageing society)….
A success in combating AL with a new medical device will result in an adequate answer of the European industry to a societal problem due to increase because of demographic trends.
Competitiveness and Innovation of the medical devices industry.
This work stream investigated what are the global innovation and competitiveness challenges faced by the medical devices industry, including aspects of R&D, emerging technologies and green economy.
AnastomoSEAL brings R&D innovation into an effective answer to a presently unsolved medical problem.
The primary challenge for access to medical devices is the availability on the market of safe, innovative, useful and affordable products. [There is] the need to develop incentives to drive and reward investment in green technology. AnastomoSEAL combines already proven abundant natural products (polysaccharides, butyric acid) in a new and novel assembly at the cross point of nanotechnology and green
chemistry.
The assessment of the value of a medical device often lacks a holistic approach as it does not always consider the whole clinical pathway and the full life-time of a product when it is justified. It is a challenge to take into account the impact of the different and variable clinical applications of relative importance of the same medical device. AnastomoSEAL will respond to a specific medical need, but at the same time it will be very easily adapted to answer to a much larger range of clinically relevant issues, thereby enormously amplifying the technological life-time of the new medical device.
Other aspects such as non-monetary improvements linked to societal aspects (e.g. quality of life, reduced hospital stay for patients, social inclusion, etc.) are rarely considered. AnastomoSEAL will positively affect the quality of life of the patients. It will contribute to a better appreciation of the role of the medical device industry by both the general public and the health decision makers. AnastomoSEAL will successfully undergo any health technology assessment, used by decision makers as a useful tool to better ensure a fair access to medical interventions making the best use of scarce resources.
Industrial challenges
The Members of the Exploratory Process identified the main industrial challenges in the medical devices sector. The Members of the Process underlined the importance of SMEs in the medical devices sector and the fact that the sector depends on a healthy stream of SMEs to develop new ideas and create new technologies. Medical technology in Europe is a substantial industry, with sales of €95 billion and employing nearly half a million people. Yet it is an industry built upon Small and Medium Sized enterprises (SMEs). These companies, which employ less than 250 people, are responsible for 80% of total sales. In fact, there are around 18,000 of these companies in Europe, more than half of which employ ten people or less.
The number and role of industrial partners (and of SMEs in particular) in AnastomoSEAL project clearly points to a special attention given to the sector. However, it is expected and desired that the number of SMEs potentially interested and/or directly involved in industrialization, expansion to new clinical targets and to wholly different application sectors is much larger than presently achieved. The European SMEs dealing with bio-based products (in particular with polysaccharides and natural polymers) will benefit from the application of their core-business products in a high-added value area. This will certainly stimulate the strive for similar new applications, thereby expanding their potential market.

European SMEs will be offered a new and novel medical device as a combination of:

  1. technological product and process up the final sterilization step,
  2. already successfully tested in pre-clinical trials,
  3. properly protected by IP actions and benchmarking regulatory issues,
  4. ideally suited as a candidate for innovation in public sector procurement.
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