Pilloxa, CE-marking and clinical trial
| Reference number | |
| Coordinator | PILLOXA AB - Pilloxa |
| Funding from Vinnova | SEK 200 000 |
| Project duration | July 2016 - May 2017 |
| Status | Completed |
| Venture | Medtech4Health: Competence Enhancement in SME |
Purpose and goal
The aim and goal of the project is to CE mark the product and prepare for a clinical study where the product is to be tested on transplanted patients. These goals are partially met due to that the product will receive CE-marking by the end of this month and the preparation for the clinical study is in place. The transplantation clinic that we will collaborate with are very committed to the trial that will begin after the summer of 2017.
Expected results and effects
The result of the project would be a CE-marked product and preparation for the clinical study. This is partially met when the product is CE marked within the next few weeks and the study is prepared. The effects of having a CE-marked product is that it allows Pilloxa to start selling it (to pharmaceutical and insurance companies). The effect of the clinical trial is to verify clinically that the product leads to better adherence, which results in the effect that patients feel better and have fewer complications. The data can also be used for public procurement.
Planned approach and implementation
The project took longer to implement than originally intended (which I suppose is not uncommon). But we have also been able to build a large knowledge base internally within the company regarding regulatory and study-related matters, which we consider to be very positive for the future.