ENDObronchial microWAVE Ablation for the minimally invasive treatment of lung cancer

Project Information

ENDOWAVE

Grant agreement ID: 888193

DOI

10.3030/888193

Project closed

EC signature date 3 December 2019

Start date 1 November 2019

End date 29 February 2020

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

ENDOWAVE LIMITED
Ireland

Periodic Reporting for period 1 - ENDOWAVE (ENDObronchial microWAVE Ablation for the minimally invasive treatment of lung cancer)

Reporting period: 2019-11-01 to 2020-02-29

Summary of the context and overall objectives of the project

Lung cancer is the leading cause of cancer deaths worldwide. Currently, over 1000 patients die from lung cancer every day in Europe. In 2018, it was estimated that there were more than two million new cases worldwide, representing 11.6% of all new cancers, with someone dying of lung cancer every 30 seconds globally. In the EU, lung cancer causes 267,700 deaths annually, which is more deaths than that caused by the two most common cancers, breast and colorectal, combined. The high mortality rate is demonstrated by its dismal 5-year survival rate of just 18%, compared to 89% for breast cancer and 65% for colorectal cancer.

Surgery is recognised as the gold standard curative treatment, but it is invasive with long recovery times and expensive to deliver. ENDOWAVE, with funding support through H2020, are developing a minimally invasive treatment for early stage lung cancer that will both improve patient outcomes and reduce treatment costs.

The ENDOWAVE system uses microwave energy, that is delivered using a long and flexible catheter through the patient’s airway directly into the target tumour. Microwaves are emitted from an antenna located at the distal tip of the catheter to heat the lesion and the diseased tissue, whilst sparing surrounding healthy lung. This approach is less invasive and expensive than surgery, and is well suited for treatment of early stage tumours.

The overall objective is to bring ENDOWAVE’s pioneering technology to patients. This will require significant investment to complete product development work, conduct clinical trailing and obtain approvals for market launch.

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

Funding provided to ENDOWAVE Ltd. through H2020-SMEINST-888193 has enabled the team to prepare material that has formed part of a business case document. This has included developing a road map to commercialization and work to identify and develop relationships with key suppliers that will form the technology supply chain. ENDOWAVE have reviewed the design with input from industry leading suppliers to ensure manufacturability. The team have also analyzed in detail the regulatory part required for approval in both the EU and US. This information will allow the team to plan on cost in detail the next steps required to achieve the approvals for market launch. The SME Instrument funding has also allowed and a way to work with clinical advisors to develop plan for first human clinical trialing. A draft protocol has been prepared and the study has been costed. Completion of these tasks has provided the inputs required for drafting a robust business plan that meets the requirements for investment from med-tech investors. The team has already engaged with a number of potential investors and corporate partners using this plan, and there has been significant interest. They will continue to work with investors to finalize funding that will enable the technology to move forward to the market as quickly as possible.

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)

ENDOWAVE is developing a minimally invasive microwave thermal ablation technology that can be delivered through the patient’s airways. The needle tip is inserted into the centre of the targeted tumour. The catheter tip contains a microwave antenna that has been designed to deliver controlled heating to surrounding tissue. This process is used to heat and destroy the tumour whilst sparing healthy tissue. Our technology provides a minimally invasive and cost effective treatment for lung cancer, which when combined with early diagnosis achieved through screening programmes, has the capability to significantly improve lung cancer survival rates for patients and to reduce costs for payers.

The pioneering ENDOWAVE technology includes an advanced antenna design, which is small enough to be navigated through the torturous path in lung. It also includes a micro “choke” to ensure that the ablation delivery is controlled and safe. The microwave system has been integrated into a fully flexible catheter, designed to ensure ease of delivery and maximize usability. During the SME Instrument project the team had further advanced this technology with significant “design for manufacture” input and from key suppliers in the microwave electronics industry.

ENDOWAVE have achieved the aim of the SME Instrument project to generate a business plan, which included a road map to commercialization, formal arrangements with suppliers, a regulatory approval strategy and a first in human clinical trial plan. The team are on course to raise investment in 2020, which will enable product development work to be completed and first in human trialing to commence.

ENDOWAVE flexible microwave ablation catheter for treatment of lung cancer

Lung cancer statistics and delivery of Endowave system through airway to tumour