2019-08-29 08:00
Significant events during the first quarter Significant events after the end of the period CEO’s comments Commercialization of DiviTum® for breast cancer During the first quarter of the new financial year, we achieved several important milestones...
2019-08-28 07:55
Based on the feedback from the FDA, Biovica has now a clear path to a 510(k) submission and clearance for DiviTum. In the supplement II process, topics such as intended use, clinical validation plan and predicate device were discussed. This is the third...
2019-07-25 12:16
On the 22nd of July, Biovica had fruitful meeting with the FDA regarding Supplement II that discusses the approach for clinical validation of DiviTum. Next step is to document the conclusions from the meeting, which the FDA will review and signoff. This...
2019-06-28 08:00
”A very positive fiscal year 2018/2019 is summarized in the annual report. For example, we have presented positive results from clinical trials in collaboration with leading oncologists, that has highlighted the value of DiviTum before and during...
2019-06-14 08:00
Significant events during the fourth quarter Significant events after the end of the period CEO's comments Commercialization of DiviTum® for breast cancer During the fourth quarter, we achieved several important milestones for launching DiviTum®...
2019-05-22 09:45
DiviTum® has to date been investigated in seventeen clinical studies, of which eight were within the breast cancer area. In breast cancer, over 1,000 patients have participated, where the majority have been patients with metastatic breast cancer (n=845)...
2019-05-08 11:09
ASCO brings together more than 32,000 oncology professionals from across the globe to share the latest clinical cancer research impacting patient care. The Biovica team will attend the ASCO (American Society of Clinical Oncology) Annual Meeting in Chicago...
2019-05-06 08:00
The study, which evaluated standard hormonal therapies in metastatic breast cancer, used the DiviTum® blood test as a non-invasive tool to monitor therapy efficacy. A total of 244 patients had their blood samples analyzed with DiviTum® and the...
2019-05-02 13:30
In accordance with previously announced information, the board of directors resolved on 9 April 2019 on a new share issue, with deviation from the shareholders' preferential rights, subject to the extraordinary general meeting's subsequent approval...
2019-04-10 14:00
The agreement gives IBL-America non-exclusive rights to sell DiviTum® to pharmaceutical companies, Contract Research Organizations and research institutes in the US. The collaboration will further increase the commercial activities for this customer...
>4,500
Numbers of patients in studies
28
Publications
22
Pharma Projects