Clinical Results
exceptional clinical results support global approvals
2009
- Pre-clinical trial Completed
- PACE 1 study complete
2012
- PACE 2 study completed
- CE approval secured
2014
- US XPAND trial enrollment completed
- PACE 2 study results published
- Radiaton Phantom Study published
- US XPAND preliminary results published
2011
- PACE 1 study results published
- FDA approves commencement of US XPAND trial
- First patient enrolled in XPAND study
- PACE 2
2013
- ASPIRE study completed
- TGA approval secured
- Testing
- Radiation Study published
- In Vivo Radiation Paper published
2015
- ASPIRE study published
- US XPAND study results presented (ASPS)
- Altitude testing published
- Australian initial Release
- Australian Full Market Release
…Paved the way for a successful US trial
US XPAND Pivotal trial:
- FDA reviewed study
- prospective , multi-center randomized
- 150 patients, full enrollment
- Interim results published in
plastic & reconstructive surgery in 2014
Successful clinical trials in Australia…
Trials were conducted in Australia with exceptional results:
61 patients
devices
implanted
105
98%+Success rate
day average
expansion time
18
High satisfaction
from patients & physicians
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
