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    BIOVIC B   SE0008613731

BIOVICA INTERNATIONAL AB (PUBL)

(BIOVIC B)
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Biovica International : successfully completes clinical validation for DiviTum« TKa FDA submission

08/26/2020 | 11:34am EDT

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.

“We are very pleased that we have successfully completed the clinical validation in accordance with our timeline. DiviTum® TKa has met its predefined criteria. In the clinical validation, more than 1.700 samples from over 400 patients were analyzed. This is an important step towards finalizing our 510(k) application. This is a major milestone in making the product available for monitoring treatment of metastatic breast cancer and our intention is that DiviTum® TKa should be available to patients in the US early next year," said Anders Rylander, CEO of Biovica.

© Modular Finance, source Nordic Press Releases

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Financials
Sales 2021 3,00 M 0,35 M 0,35 M
Net income 2021 -40,0 M -4,72 M -4,72 M
Net cash 2021 133 M 15,7 M 15,7 M
P/E ratio 2021 -30,7x
Yield 2021 -
Capitalization 1 239 M 146 M 146 M
EV / Sales 2021 369x
EV / Sales 2022 29,5x
Nbr of Employees 20
Free-Float 41,9%
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Mean consensus UNDERPERFORM
Number of Analysts 2
Last Close Price 43,60 
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Managers and Directors
NameTitle
Anders Rylander Chief Executive Officer & Director
Cecilia Driving CFO, Head-Human Resource, IR & EVP
Lars Erik Holmqvist Chairman
Mattias Bergqvist Director-Clinical Development
Otti Bengtsson Gref Director-Research & Development
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