Clinical Results
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…
…Paved the way for a successful US trial
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
Australia Trial Results
- Patients enrolled
- AeroForm®
- Success Rate
- Expansion time (days)
PACE 1
- 7
- 10
- 100%
- 15
PACE 2
- 33
- 61
- 100%
- 17
Aspire
- 21
- 34
- 94%
- 22
US Trial Results
- Patients enrolled
- AeroForm®
- Success Rate (Primary Endpoint)
- Expansion time (days)
Multi-Center Randomized 2:1
- AeroForm
- 98
- 168
- 96.1%
- 21
- Saline
- 52
- 88
- 98.8%
- 46
