Community Research and Development Information Service - CORDIS

H2020

CerISMA Report Summary

Project ID: 698263

Periodic Reporting for period 1 - CerISMA (Cerenkov Imaging for Surgical Margin Assessment)

Reporting period: 2015-12-01 to 2016-11-30

Summary of the context and overall objectives of the project

Cancer is not only a leading public health challenge in Europe, it is also a growing economic challenge. Over three million cases are currently diagnosed each year across the continent. Forecasts show that by 2020 almost half of the population will be diagnosed with the disease in their lifetime. The cost of cancer for the EU is €126 billion per year and rising. The health and economic implications of cancer therefore provide a compelling opportunity for technologies that can improve health outcomes and reduce treatment costs.

Surgery remains one of the primary treatments for cancer, yet surgeons lack the tools to identify accurately and remove cancer during an operation, resulting in costly re-operations and negative health ramifications. Lightpoint Medical Ltd has developed a molecular imaging camera (LightPath™) based on a breakthrough imaging modality, Cerenkov Luminescence Imaging (CLI). The technology can provide surgeons with real-time intraoperative analysis of cancerous tissue to ensure the complete removal of cancer in a single operation. The device provides the potential for a dramatic reduction in costly reoperations and follow-up treatments across a wide range of major cancer indications, proving not only an innovative solution for healthcare providers, but also a tool to substantially reduce cancer care costs.

The CerISMA project is critical to underpinning the success of Lightpoint Medical Ltd’s ambitious sales and marketing strategy for LightPath™ in mainstream clinics in Europe and North America with a particular focus on initial strategic territories of the UK, France, Germany, Netherlands and the US. The project will consist of a multi-centre, multi-national (EU) clinical trial to comprehensively validate the clinical performance of LightPath™ and provide health economic data. The study will focus on the company’s first target cancer indication, which is breast cancer. Breast cancer is one of Europe’s most common cancer indications and is the leading cancer-related cause of death for women in the EU. The project’s clinical data and results from the CerISMA project will be critical in supporting the commercial exploitation of LightPath™ technology and in understanding the potential impact of the technology on patient outcomes and health service costs.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Over the first year of the grant, the project team has worked hard to secure regulatory and ethical approval for the study and to set up the clinical sites. Good progress has been made against these objectives with regulatory submissions made on time in the UK and Germany. Both UK regulatory and ethical approval have been obtained and the first UK clinical site has been set up. Sufficient progress has now been made for patient recruitment to commence to deliver the clinical data in the second project year necessary to achieve the objectives goals of the project.

The achievements obtained during the first year include:
• All regulatory and ethics applications submitted;
• UK regulatory and ethics approval obtained;
• UK and German clinical sites confirmed;
• First UK clinical site set up;
• First device built and installed at clinical site;
• User feedback questionnaires completed;
• Website developed;
• Initial press release distributed and press coverage secured.

In addition, over the first project year, the company has worked hard to begin the commercialisation of the technology, including undertaking market access research, initiating discussions with distributors, building relationships with key opinion leaders, publishing clinical data from pilot trials, securing funding for research in other cancer indications and initiating relationships with early adopters. As a result, early orders are at a contract stage with delivery expected in Y2 and the company has received industry recognition and media coverage for the technology.

Therefore, in summary, the project team has delivered all the necessary work to correctly, ethically, and practically set up the study. Everything is now in place for patient recruitment to commence and begin delivering clinical data to achieve the deliverables in the second year of the project. The company has established itself in a strong position to fully commercialise the technology once the clinical data is available.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

LightPath™ promises to dramatically improve detection of cancerous tissue during cancer surgery. It is expected that the device will provide the diagnostic performance comparable to the current gold-standard histopathology whilst, in addition, reducing re-operation rates (>50% reduction), reducing critical delays in follow-up treatment and a significant improvement in cosmetic outcomes (decrease in patients undergoing subsequent mastectomy). The consequent reduction in costs will provide substantial benefits to healthcare providers and society. The competitive advantage of the LightPath™ device is that it will provide oncology surgeons with real-time intraoperative imaging of cancerous tissue in an operating theatre.

When data is available from the project's clinical study, the project team will be able to begin demonstrating the impact of the technology outlined above. Such data is anticipated in the second year of the project. However, during the course of the first year, Lightpoint Medical Ltd published clinical data from the pilot trial for the technology in breast cancer surgery at Guy’s & St Thomas’ Hospital. The results were published in the Journal of Nuclear Medicine (Grootendoorst MR et al. Intraoperative Assessment of Tumor Resection Margins in Breast-Conserving Surgery using 18F-FDG Cerenkov Luminescence Imaging - A First-in-Human Feasibility Study. J Nucl Med Published December 8, 2016 as doi:10.2967/jnumed.116.181032). Results were disseminated at the Association of British Surgeons Annual Conference and the British Association of Surgical Oncologists. This has helped Lightpoint Medical Ltd to advance key commercial objectives over the course of the first year. Such progress will aid the immediate impact of the CerISMA project results by enabling the rapid translation and commercialisation of the technology. The first year progress includes:
- The initiation of discussions with regionally-exclusive medical device distributors with agreements intended to be signed in the first half of the second year;
- Submission of draft application to the FDA for regulatory approval of LightPath™ in the US;
- Key Opinion Leaders secured to help market the technology once the clinical data is available. This includes two in the UK, one in Germany and one in US;
- Relationships initiated with early adopters and collaborative research partnerships developed. As a result, early orders are at a contract stage with delivery expected in the second year;
- Industry recognition received, including the British Engineering Excellence Awards, The Institution of Engineering and Technology Innovation Awards, The Great British Entrepreneur Awards and The Microsoft Accelerator;
- Funding secured for the development of a second product for laparoscopic key-hole cancer surgery. This device will be complementary to LightPath™ and will help to ensure the long-term sustainability of the company.

Related information

Record Number: 198387 / Last updated on: 2017-05-19
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