LYMPHIT: an innovative easy-to-use and cost-efficient diagnostic microneedle patch for the early detection of Lymphedema

Project Information

Lymphit

Grant agreement ID: 836091

DOI

10.3030/836091

Project closed

EC signature date 19 November 2018

Start date 1 December 2018

End date 31 March 2019

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

DICRONIS SAGL
Switzerland

Periodic Reporting for period 1 - Lymphit (LYMPHIT: an innovative easy-to-use and cost-efficient diagnostic microneedle patch for the early detection of Lymphedema)

Reporting period: 2018-12-01 to 2019-03-31

Summary of the context and overall objectives of the project

Lymphedema is a chronic condition which may be inherited (primary) or caused by injury to the lymphatic vessels (secondary). It is often-ignored and misunderstood condition but affects up to 250 million people throughout the world. Cancer survivors run a lifelong risk of secondary lymphedema, a disease with no known cure which is caused by damage to or removal of the lymph nodes because of surgery, chemotherapy and radiotherapy and characterized by swelling due to a marked accumulation of fluid in the limb. Although most cancer survivors developing secondary lymphoedema do so within the first three years following treatment, there is no standardized protocol for monitoring patients nor are there efficient, cost-effective methods for early detection of lymphedema. Diagnostic methods are highly inaccurate, can only detect the disease at an advanced and potentially irreversible stage, greatly decreasing patients’ quality-of-life and increasing healthcare costs. This project reviewed the technical and business feasibility of Lymphit. The first solution able to track the lymphatic activity and detect lymphedema at the earliest (sub-clinical) stage.

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

Dicronis completed a full analysis of the technical and business potential of their Lymphit technology. The project allowed Dicronis to formalize a sound technical development plan that forms the foundation for Lymphit’s commercialization. The next critical step for commercialization is to complete a period of clinical studies. This includes a first in-human study that will validate Lymphit’s ability to measure lymphatic activity and prove its safety. Following the study’s successful conclusion, Dicronis will conduct a larger clinical study which will enable commercialization of Lymphit as a diagnostic tool for lymphedema. During the project, Dicronis spoke to commercialization partners and discussed distribution of Lymphit following the completion of the clinical trials. Dicronis developed a go-to-market strategy with a European focus and investigated their internationalisation to the US and Japan.

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)

Our innovative integrated system provides clinicians with a reliable, affordable diagnostic method to identify subclinical signs of lymphedema at least six months earlier than current diagnostic procedures. Lymphit reduces treatment costs by up to 50% by identifying the condition at a reversible stage. Medical practitioners can quickly and selectively prescribe conservative treatment, avoiding progression of the disease and enabling the patient to carry on everyday life as far as possible, thereby effecting a tenfold reduction in social costs associated with loss of productivity.

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Lymphedema external signs