A new instrument for endoscopic tumor biopsy sampling
| Reference number | |
| Coordinator | BibbInstruments AB |
| Funding from Vinnova | SEK 2 000 000 |
| Project duration | February 2014 - December 2015 |
| Status | Completed |
Purpose and goal
The purpose of the project was to verify the technique and instrument in a clinical setting and to see if it could deliver diagnostic biopsy material that could be used for evaluation of cancer. To protect the technique and instruments immaterial rights.
Results and expected effects
The instrument can deliver diagnostic biopsy material that can be used for histopathological evaluation of cancer suspicious lesions in the stomach. The technique was technically and clinically verified in a pilot study where several both benign and malignant diseases could be diagnosed. A sterile re-usable instrument was constructed and CE-marked. The patent application regarding the instrument was approved in Sweden and so was the following PCT application. National applications have been filed for the 8 largest markets and we are waiting for the respective evaluation.
Approach and implementation
The entire project was divided into 6 month long periods and the progress was reported to Vinnova at the end of each milestone. The instrument was validated through an ethical committee approved clinical pilot study of 10 patients. The sterile re-usable instrument was constructed, tested and CE-marked. The immaterial rights work was performed in conjunction with Lund University and the patent firm Awapatent.