Business plan optimisation and preparation for scaling of a transcatheter heart valve replacement manufactured using automation

Project Information

LIFELET

Grant agreement ID: 101114117

DOI

10.3030/101114117

Project closed

EC signature date 26 May 2023

Start date 1 June 2023

End date 31 March 2024

Funded under

• European innovation ecosystems

Total cost

No data

EU contribution

€ 75 000,00

Coordinated by

LIFELET MEDICAL LIMITED
Ireland

Periodic Reporting for period 1 - LIFELET (Business plan optimisation and preparation for scaling of a transcatheter heart valve replacement manufactured using automation)

Reporting period: 2023-06-01 to 2024-03-31

Summary of the context and overall objectives of the project

Lifelet Medical is an Irish startup with a vision of one valve for life for patients suffering from heart valve disease. Lifelet has developed a novel polymeric material aiming to make heart valve replacement more sustainable for patients and the planet. Specifically, Lifelet is developing a transcatheter aortic valve replacement (TAVR). At Lifelet we have a particular heart for the treatment of women with severe aortic stenosis. Historically, fewer women are represented in clinical trials for TAVR than men. Second, women tend to have small aortic anatomy which can lead to poor outcomes because commercial device manufacturers do not make small enough sizes for these women due to supply and demand pressures and the heavy device costs. Because we transcend all the costly tissue sourcing and burdensome manufacturing, we have a vision to manufacture valves more efficiently. And with automation, Lifelet aims to manufacture more patient specific device sizes to impact upon the €5B transcatheter aortic valve replacement market.

Heart valve replacement falls under the category of a regulated Class III medical device and, as such, requires a substantial amount of data to safely and effectively treat patients in the future. The Women TechEU project objectives centered around mapping out a regulatory pathway, developing an understanding of market access for European countries, as well as developing a business plan and funding strategy to finance the critical activities required to bring the device to commercialisation and impact upon patient's lives.

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

The work plan aimed to define robust strategies to attract funding and deliver the technology to patients.
Task 1: Regulatory and Clinical Pathway
Task 2: Defining market access strategy for Europe
Task 3: Updated business plan and fundraising strategy

Main achievements:
1. Developed a robust clinical evidence generation strategy as well as overall regulatory strategy for US and Europe
2. Defined top 5 target countries for European market access
3. Successfully prepared a data room, pitch deck, and raised a Seed financing round during the Women TechEU project

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)

A Seed financing was raised to enable the hiring of a team and to enable key bench and in vivo studies. Key needs to ensure further uptake and success include additional funding and access to capital to finance the execution of the clinical evidence generation strategy, additional filing of patent applications, and continued guidance on EU MDR regulatory complexities.