Integra LifeSciences Recalls CereLink Intracranial Pressure Monitors, Revises Guidance

  • Integra LifeSciences Holdings Corporation IART initiated an immediate voluntary removal of all CereLink intracranial pressure monitors after customer reports about monitors whose pressure readings were out of range. 
  • The company believes that out-of-range readings are principally caused by electrical interference from the external environment and/or interference from a component on the monitor's circuit board. 
  • These out-of-range readings have occurred at a low incidence rate and at a limited number of sites; however, the company has decided to remove all CereLink monitors out of caution.
  • Related: Piper Sandler Cuts Price Target For Integra Lifesciences As It Divests Wound Care Portfolio.
  • The company is continuing its investigation and plans to resume shipment of the CereLink monitors as soon as any such issues have been resolved.
  • Integra estimates a returns provision of approximately $9 million in Q3 of 2022 and has adjusted its third quarter and full year 2022 guidance accordingly. 
  • It forecasts Q3 adjusted EPS of $0.69-$0.73 (consensus of $0.84) and sales of $374-$382 million ($398.66 million), down from previous guidance of $0.78-$0.82 and $383-$391 million.
  • For FY22, Integra has revised its sales guidance to $1.55-1.57 billion (consensus of $1.59 billion) from $1.56-$1.58 billion and adjusted EPS of $3.12-$3.20 (consensus of $3.31) versus the previous outlook of $3.21-$3.29.
  • Price Action: IART shares are down 1.22% at $51.22 during the premarket session on the last check Wednesday.
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