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

Descrizione del progetto

Monitorare il sistema linfatico tramite la fluorescenza

L’organismo contiene una rete di vasi, noti collettivamente come sistema linfatico, che hanno la funzione di raccogliere e filtrare il fluido in eccesso e di reimmetterlo in circolazione. In seguito a un trattamento antitumorale, il fluido linfatico potrebbe accumularsi in uno degli arti, comportando l’insorgenza di una condizione denominata linfedema. Al fine di migliorare la diagnosi del linfedema allo stadio precoce, il progetto Lymphit, finanziato dall’UE, ha sviluppato uno strumento innovativo a microago per la valutazione del sistema linfatico mediante un colorante fluorescente. Il monitoraggio quantitativo del colorante fornisce informazioni sullo stato del sistema linfatico, consentendo così l’avvio del trattamento quando la condizione si trova a uno stadio reversibile.

Obiettivo

Lymphedema is a chronic condition, outlined by a progressive accumulation of fluids in a limb, leading to great physical and psychological debilitation of the affected patient and often occurring secondary to oncologic treatments. There is not early diagnosis for lymphedema. Current diagnostic methods are highly inadequate and detect the disease only at an advanced stage, leading to serious complications, greatly decreasing quality-of-life of the patients while increasing healthcare costs. In response to this challenge, Dicronis has developed a diagnostic tool (LYMPHIT) based on a painless and minimally-invasive delivery of ICG, an FDA approved fluorescent agent, with an extremely high safety profile, integrated into polymeric dissolving microneedles patches which allows determining the status of the lymphatic system by optically measurement of the fluorescence decay. LYMPHIT enables patients and clinicians the earliest possible detection of lymphedema, by quantitatively tracking the function of the lymphatic system in a painless, easy-to-use and highly-scalable manner. LYMPHIT will be disrupting in the market by empowering medical practitioners to timely and selectively prescribe conservative treatments, which can contain or avoid a worsening of the swelling in the affected limb. Therefore, LYMPHIT will reduce lymphedema treatments costs up to 50% and reduce 10-fold the social costs associated to productivity loss, both of them associated with late stage lymphedema. Upon completion of the project, LYMPHIT will boost the growth of our company generating additional 64 FTEs, revenues of €398M and a ROI of 10.25 by the fifth year after Phase 2 execution. With the help of the SME instrument, Dicronis aims to complete the product optimization and clinical validation so that it can be commercialized across European markets first, and global markets later on, improving the quality of care of healthcare systems worldwide as well as the lymphedema patient´s quality of life.