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BioPorto is focused on flagship NGAL acute kidney-injury test but also looking at coronavirus test

Last updated: 14:42 05 Dec 2022 EST, First published: 17:25 03 Nov 2021 EDT

Snapshot

  • BioPorto beefs up management team ahead of NGAL tests with the appointment of Nis Kruse
  • BioPorto discusses key takeaways from interim analysis of data of trial to evaluate its NGAL Test
human kidneys

About the company

BioPorto A/S is an in-vitro diagnostics company that provides healthcare professionals in clinical and research settings a range of diagnostic tests and antibodies. Its pioneering product portfolio includes assays for underserved disease states such as NGAL for acute kidney injury. The company sells its products in more than 80 countries through diverse sales channels and partners. BioPorto has its headquarters in Copenhagen, Denmark and is listed on the Nasdaq Copenhagen stock exchange.

How it is doing

05 Dec 2022

BioPorto (NASDAQ COPENHAG:BIOPOR) A/S has appointed Nis Kruse as Executive Vice President of Strategic Partnerships and General Manager of EMEA & APAC as the company gears up for the prospective global launch of its neutrophil gelatinase-associated lipocalin (NGAL) tests.

 “We are preparing for the prospective global launch of NGAL tests, having submitted our De Novo application to the US Food and Drug Administration to aid in identifying pediatric patients at risk of moderate to severe acute kidney injury,” said Tony Pare, BioPorto (NASDAQ COPENHAG:BIOPOR)’s CEO.

“Nis’ experience in strategic partnership development, distributor management, and building commercial teams will be a welcome addition to the BioPorto executive team,” he added.

Kruse most recently served as SVP and chief commercial officer at SSI Diagnostica A/S, an in vitro diagnostics company focusing on infectious diseases, having delivered substantial top-line growth in the company during the pandemic.

10 Nov 2022

BioPorto (NASDAQ COPENHAG:BIOPOR) A/S announced it has submitted a De Novo application to the US Food and Drug Administration (FDA) of a neutrophil gelatinase-associated lipocalin (NGAL) test to help identify pediatric patients at risk of moderate to severe acute kidney injury (AKI).

Results from the in vitro diagnostics company’s recently completed GUIDANCE trial, which exceeded the company’s prespecified targets for test performance, supported the application, according to a statement from BioPorto (NASDAQ COPENHAG:BIOPOR).

09 Nov 2022

BioPorto (NASDAQ COPENHAG:BIOPOR) has reported a 16% revenue increase in the first nine months of 2022 over the prior year, and maintained its revenue guidance of 24 to 27 million Danish kroner (DKr).

For the nine months ended September 30, the Copenhagen and Boston-based company reported a total revenue of DKr 20.3 million (US$2.9 million), and said it has a cash equivalent of DKr 98.9 million (US$13 million) as of September 30, 2022, up from the DKr 59.6 million (US$9.3 million) it posted the same time last year. It also announced an adjusted EBITDA loss of DKr 49.5 million (US$7.2 million).

For the third quarter ended September 30, the company reported total revenue of DKr 5.3 million (US$0.7 million), a 0.4% decrease over the prior year and an adjusted EBITDA loss of DKr 17.1 million (US$2.3 million).

What management says

02 Sep 2021

BioPorto (OTC:THOXF, NASDAQ COPENHAG:BIOPO) A/S Chief Medical Officer Christopher Bird spoke to Proactive New York about the Danish group's interim analysis of data from the pediatric clinical trial being conducting to evaluate The NGAL Test as a tool for risk assessment of moderate to severe acute kidney injury.

Bird says he believes the final results will provide strong support for the value of The NGAL Test as a biomarker to identify risk of AKI in critically ill children. The interim analysis includes data collected from six different leading US children’s hospitals over a twelve-month period.

BioPorto (NASDAQ COPENHAG:BIOPOR) intends to continue expanding patient enrollment in order to maximize the study’s statistical power for the upcoming US Food & Drug Administration (FDA) submission.

BioPorto discusses key takeaways from interim analysis of data of trial to...

BioPorto (OTC:THOXF, NASDAQ COPENHAG:BIOPO) A/S Chief Medical Officer Christopher Bird spoke to Proactive New York about the Danish group's interim analysis of data from the pediatric clinical trial being conducting to evaluate The NGAL Test as a tool for risk assessment of moderate to severe...

on 09/02/2021