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Landmark FDA CiPA publication officially validates the use of Ncardia Cor.4U®

26 September, 2018

The multi-site CiPA Phase II Myocyte Validation report by Blinova et al. is now available!

We are delighted that the results of this study validate the use of Ncardia's Cor.4U® cardiomyocytes for regulatory safety pharmacology.

Highlights: ·

  • 28 drugs classified by Torsades-proarrhythmic risk studied in blinded experiments.
  • Two commercial human cardiomyocyte lines used with 5 devices across 10 sites.
  • Repolarization effects evaluated using microelectrode array & voltage-sensing dyes.
  • Statistical model predicted proarrhythmic risk from electrophysiologic responses.

 

Stefan Braam, Ncardia CEO, said: "This is a landmark paper. It is probably one of the most extensive cardiac safety pharmacology validation studies ever performed and definitely a key milestone in the history of iPSC technology..."

For more information and to read the Validation Study please visit our CiPA landing page.

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