Clinical Results

Exceptional clinical results support global approvals

Successful clinical trials in Australia…

Trials were conducted in Australia with exceptional results:

1

…paved the way for a successful US trial

XPAND TRIAL RESULTS
Patients enrolled 150
Implanted AeroForm® 168
AdverseEvents 4*
Successful Expansion 96.1%
Patient satisfaction 84%
Physiciansatisfaction 89%
Average Expansion time (days) 21

* Events addressed and solved in final device version that completed trial

trial results

  • Patients enrolled
  • Implated AeroForm®
  • Successful Expansion
  • Adverse Events (device related)
  • Average Expansion time (days)
  • Overall patient & physician satisfaction

PACE1

  • 7
  • 10
  • 100%
  • 0
  • 15
  • 100%

PACE2

  • 33
  • 61
  • 100%
  • 0
  • 17
  • 98%

Aspire

  • 21
  • 34
  • 94%
  • 0
  • 22
  • 95%

trial progress

  • Patients enrolled
  • Implated AeroForm®
  • Adverse Events (device related)
  • Average Expansion time (days)
  • Patients complete

xpand study progress

  • 150
  • 168
  • 2*
  • 17
  • 150

* Events addressed and solved in final device version that completed trial