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FORNY20-FORNY2020

PaCRTool: Verification- proof of concept

Alternative title: Pacertool Commerc

Awarded: NOK 4.7 mill.

Project Number:

321638

Project Period:

2021 - 2022

Funding received from:

Organisation:

Location:

This project aims at introducing precision medicine for improvement of cardiac resynchronization therapy (CRT) for heart failure. Heart failure is the leading cause of death and morbidity in the western world. 30% of all patients with heart failure need treatment with CRT caused by conduction defects in the conduction system in the heart. The conduction defect generates an ineffective pump function in the heart chambers. The conduction defect can be treated with CRT by placing pacemaker leads in the left and right heart chambers and thereby restoring a synchronous and effective pump function. More than 100000 patients receive such treatment every year in the US and Europe, however, more patients need treatment. Despite the treatment being effective, more than 30-50% of all patients treated have no effect of the treatment but are still lifelong exposed to unwanted negative effects. The prognosis of this group of patients remains poor. CRT may improve with increasing the treatment precision. Pacertool has developed technology to identify patients who will respond to treatment and those who will not. The technology is both precision medicine and personalized treatment. We have had the opportunity through this verification project to analyze the market and increase our understanding of product and market fit. We have improved the business model after having completed market investigations and reimbursement landscaping. We have improved our regulatory strategy in the USA and EU and further developed our clinical strategy to enable market approvals and adoption. The project has promoted product finalization of the cardiac catheter, the signal amplifier, and the software with the user interface. The project has in large contributed to the verification of the targeted market and product fit, as well as contributed to establishing a solid ground for commercialization.

Gjennom dette prosjektet har vi nå oppnådd en klarere forståelse for markedsgodkjennings prosessen og forretningsplanen. Vi har et klarerer bilde av refusjonsordninger i USA og i Tyskland. Vi har oppnådd kontakt med potensielle strategiske partnere og utviklet forståelse for hva de er opptatt av og hvordan man skal kunne lykkes med å komme i dialog og partnerskap med disse. Vi har videre fortsatt utvikling av produkter og har nå produkter som er funksjonelle prototyper som har blitt testet i henhold til krav og standarder. Vi har fått tilbakemeldinger på produktet fra brukere, både gjennom direkte kontakt og gjennom markeds analyser. Gjennom prosjektet har vi kommet nærmere målet om nå markedsgodkjenning av produktene slik at disse skal kunne brukes for presisjonsmedisin og persontilpasset behandling av pasienter med hjertesvikt. På denne måten vil vårt mål om forbedret behandling med redusert ressursbruk kunne nåes.

Funding scheme:

FORNY20-FORNY2020