Community Research and Development Information Service - CORDIS

H2020

CerISMA Report Summary

Project ID: 698263

Periodic Reporting for period 2 - CerISMA (Cerenkov Imaging for Surgical Margin Assessment)

Reporting period: 2016-12-01 to 2017-11-30

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 second year of the grant, the project team has worked hard to revise the study in line with a significant amendment approved by the European Commission in July 2017. The project was amended in light of delays incurred over the first year, particularly delays in receiving national and local ethical and regulatory approvals for the study.

Following the approval of the amendment in July 2017, the project team has achieved the following:
- Successfully amended the study protocol and all study paperwork, in close collaboration with the clinical partners;
- Submitted and secured ethical, regulatory and local R&D approval for the revised changes in the UK and Poland;
- Secured three new sites in Poland to accelerate patient recruitment.

Therefore, at the end the second year, the project is ready to initiate patient recruitment under the new study protocol in the third year with the aim of concluding the study in the summer of 2018 and the grant in November 2018.

Once again, the company has made good progress over the past year on the commercialization of the device, including the placement of the LightPath™ in leading research institutes in the US and Europe, deepening relationships with distributors, building relationships with key opinion leaders, initiating clinical trials in other cancer indications, securing early adopter sales and building a pipeline of future sales prospects. The company has continued to receive industry recognition and media coverage for the technology.

Therefore, in summary, despite the project delays in the first year, the project team has successfully amended the study and secured all the necessary approvals and resources to begin delivering the clinical data in the third year. It has effectively used the time over the course of the past year to optimize the device and introduce a new innovation to further aid commercialization. The company has also worked to further establish itself in the market, placing itself in a strong position to fully commercialize 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 third year of the project. However, during the course of the first and second 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) and in year 2 featured as the cover article in the June issue of the Journal of Nuclear Medicine. Results have been disseminated at the Association of British Surgeons Annual Conference, British Association of Surgical Oncologists and the Optical and Molecular Imaging Strategies in Surgery meeting in Las Vegas.

The pilot study has helped to advance key commercial objectives over the course of the first and second year, including:
- Signature of four distributor contracts in European territories;
- 15 Key Opinion Leaders in the US and Europe secured to help market the technology once the clinical data is available;
- The first two sales of the device achieved with two additional orders received and three pending;
- Industry recognition received, including the British Engineering Excellence Awards, The Institution of Engineering and Technology Innovation Awards, The Great British Entrepreneur Awards, The Microsoft Accelerator; The European Venture Contest, The Royal Academy of Engineering, SME Leaders Programme; UK Private Business Award for Technology Innovation of the Year; Medilinks Innovation Award; Mayor of London International Innovation Programme.
- Funding secured for two clinical studies in prostate cancer surgery;
- Funding secured for the development of a second product for laparoscopic key-hole cancer surgery;
- Funding secured from the European Commission's ACTPHAST programme for photonics innovation.

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