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Analyst Comment

Bioporto: Wrap up from Q3 event

By Claus ThestrupCEO, Sweden
BioPorto

Bioporto: Wrap up from Q3 event with CEO Tony Pare and VP Controlling and Reporting George Rosa.

CEO Tony Pare gave an in depth explanation of The FDA process and the 510K application. When NGAL is approved by FDA, what will happen with reimbursement? Bioporto partner in US is Roche.

NGAL sales increased 20% in Q3 on a YoY comparison. 

CEO Tony Pare mentioned the following priorities going forward - Gain FDA approval, expand TAM in the US and grow the business in ROW.

Listen to full interview here: Q3 event

Disclaimer:  HC Andersen Capital receives payment from Bioporto for a Digital IR/Corporate Visibility subscription agreement. /Claus Thestrup 1:00 PM 02-11-2023.

 

BioPorto

1.73DKK02.11.2023, 17.20

BioPorto is a Danish in-vitro diagnostics company with headquarters in Copenhagen, Denmark. The company was founded in 2000. BioPorto has one marketed product, the NGAL test, for early diagnosis of acute kidney injury (AKI), which is commercially available in Europe, Canada, Asia, and Israel. It has received breakthrough designation from the FDA for AKI in the pediatric indication, for which it is currently conducting data analysis following the completion of enrollment of patients for its Phase 3 study which will lead to an expected application to FDA. Future plans include further FDA submission for adult indication as well as other markets.

Read more on company page

Forum discussions

Hej Andreas, Jeg kan godt forstår, at det kan være svært at holde hoved og hale på det hele. Det er ikke unormalt i en godkendelsesproces med...
10/12/2023, 11:36 AM
by Claus Thestrup
0
Har I noget overblik over deres tidslinje for ansøgningen ved FDA - Efter ændringen og spørgsmål fra FDA, så kan jeg ikke længere finde hoved...
10/12/2023, 11:28 AM
by Andreas
0
BioPorto præsenterede i går deres Q3 regnskab i samarbejde med HC Andersen Capital. Der blev snakket om alt fra nøgletallene fra det seneste...
11/10/2022, 10:06 AM
by Asbjorn Scheller
1
Husk at læse hele vores research disclaimer på https://www.inderes.dk/disclaimer. Dansk: BioPorto er et dansk In-vitro diagnostisk (IVD) selskab...
10/17/2022, 8:02 AM
by Olivier A. de Goeij
0
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