• (PLX AI) – Bonesupport shares are expected to drop at least 10% today after a major setback in the company's FORTIFY study, analysts said.
  • • Bonesupport announced inconclusive results for the Investigational Device Exemption (IDE) study, as the drop-out rate was very high in the study with only 143 qualified subjects of 201 enrolled for the composite efficacy endpoint at 12 months
  • • The very high drop-out rate has led to the FORTIFY study not qualifying to the requirements of a PMA application
  • • This is a big setback for Bonesupport, as it means it will not be able to file the large trauma indication for PMA approval, Carnegie said
  • • The shares will take a hit, as the market may have underestimated the risk to this trial, Carnegie said
  • • Bonesupport was cut to hold from buy at SEB
  • • We anticipate a 2-year delay in U.S. approval for the indication trauma, until the end of 2024, SEB said

Quelle: PLX AI