Regulatory

Biovica, active in cancer diagnostics, today announced that the US Food and Drug Administration (FDA) has indicated that its previously communicated reallocation of resources to address COVID-19 continues to impact the timeline for completion of the review of Biovica’s 510(k)-submission for DiviTum®TKa. The FDA currently estimates that the reallocation will last another 90 days, approximately, during which time the FDA will not be able to continue reviewing Biovica’s submission.

Convincing study results and application submitted to the FDA – commercialization just around the corner

Biovica, active in blood-based cancer diagnostics, today announced that the company’s 510(k) submission to the US Food and Drug Administration (FDA) for the blood test DiviTum®TKa will proceed to substantive review when the COVID-19 related pause ends.

Biovica, active in cancer diagnostics, today announced that the US Food and Drug Administration (FDA) has indicated that it is reallocating resources to COVID-19 impacting the timeline for completion of the review of Biovica’s 510(k)-submission for DiviTum®TKa. The FDA currently estimates that the reallocation will last approximately 90 days during which time the FDA will not be able to continue reviewing Biovica’s submission.

Biovica, active in blood-based cancer diagnostics, today announced that the company has filed a 510(k) submission with the U.S. Food and Drug Administration (FDA).

The following resolutions were passed at the annual general meeting of Biovica AB (publ) on 27 August 2020 in Uppsala.

Clinical validation completed, work with the FDA submission in the final phase

Biovica International AB (“Biovica” or the “Company”) has successfully completed a directed share issue of 4,700,000 Class B shares corresponding to approximately SEK 148 million (the “Directed Issue”). The subscription price in the Directed Issue has been determined to SEK 31.5 per share through an accelerated book building procedure performed by Pareto Securities AB (“Pareto Securities”). Due to significant demand, the gross proceeds in the Directed Issue was increased from the SEK 110 million indicated in the Company’s press release earlier today. A number of Swedish and international institutional investors participated, including Andra AP-fonden, Coeli Asset Management and Lancelot Asset Management.

Biovica International AB (”Biovica” or the ”Company”) has engaged Pareto Securities AB (“Pareto Securities”) to explore the conditions for carrying out a directed share issue of Class B shares, corresponding to approximately SEK 110 million through an accelerated bookbuilding procedure (the “Directed Issue”).

Biovica today announces that the clinical validation of the blood test DiviTum® TKa has been completed, demonstrating the clinical value of the product. The clinical validation is the final part of Biovica’s application for US market approval. Biovica remains on schedule to submit its regulatory filing during September 2020.