Company News
PRESS RELEASE | September 11, 2023
Update on NGAL Test Regulatory Pathway
Based on direction from the US Food and Drug Administration (FDA), BioPorto decided to change the regulatory pathway for the Company’s NGAL test from a De Novo to a 510(k). This is not expected to impact the FDA’s ongoing review process. Read More
PRESS RELEASE | March 15, 2023
Update From CEO Tony Pare
Preliminary 2022 financials, the status of US Food and Drug Administration (FDA) review, and a focus on European expansion. Read More
PRESS RELEASE | November 10, 2022
FDA De Novo Submission with Breakthrough Device Designation
BioPorto submitted an FDA De Novo application with Breakthrough Device Designation for an NGAL test to aid in identifying pediatric patients ≥ 3 months to < 22 years at risk of moderate to severe acute kidney injury. Read More
PRESS RELEASE | June 28, 2022
BioPorto Achieves Targeted Enrollment in Clinical Study
This is the third part of a 3-part clinical study to support a US FDA De Novo submission for use of The NGAL Test in identifying patients under the age of 22 years at risk for acute kidney injury. Read More
PRESS RELEASE | June 20, 2022
BioPorto Appoints Dr. Prasad Devarajan as New Senior Medical Director
World-renowned pediatric nephrologist and NGAL expert Dr. Prasad Devarajan will join the BioPorto team effective July 1, 2022. CEO Tony Pare notes that “Dr. Devarajan’s unparalleled reputation, knowledge, and expertise will be a tremendous gain for BioPorto.” Read More
PRESENTATION | May 11, 2022
Strong Performance of The NGAL Test Drives Revenue Growth
CEO Tony Pare attributes BioPorto’s Q1 2022 17% growth to strong sales of The NGAL Test and ELISA kits. View the investor presentation at https://bit.ly/3Nb4no4