2. Safe Harbor Statement
This presentation may contain certain ‘forward-looking statements’. All
statements, other than statements of historical fact, that address activities,
events or developments that we intend, expect, project, believe or
anticipate will or may occur in the future are forward-looking statements.
Such statements are based upon certain assumptions and assessments
made by our management in light of their experience and their perception
of historical trends, current conditions, expected future developments and
other factors they believe to be appropriate.
The forward-looking statements included in this presentation are also subject
to a number of material risks and uncertainties. We caution investors not to
place undue reliance on the forward-looking statements contained in this
presentation.
We would advise reading our annual report filed with the United States
Securities and Exchange Commission on Form 10-K for a more detailed
description of these risks.
2
9. Cardiovascular Trials- PRECISE (Chronic Ischemia)
Change in mV02 from baseline to 6 and 18 months
The PRECISE Trial
20.0
19.0
P < 0.05 P < 0.05
18.0 17.2
mVO2 (L/min)
17.1
16.0 16.6
15.5 15.3
14.0
Transplantation ADRCs
Placebo
Baseline 6 mo 18 mo
9
10. Cardiac Development Status
EU Chronic Myocardial Ischemia
Clinical Data Regulatory
Reimbursement
CE Mark Application Filed 2011 (2012)
EU Acute Myocardial Infarction
Clinical Data
Pilot complete Regulatory Reimbursement
Pivotal began 2011
US Chronic Myocardial Ischemia ATHENA
Clinical Data
PRE-IDE Q4 ‘11 Regulatory Reimbursement
Initiate 2012
10
12. Cell Enriched Grafting for Breast Reconstruction
RESTORE 2: Reconstruction in BCT (lumpectomy and RTx)
Study design • Prospective, single-arm, EU study of cell enriched fat grafting after
BCT
• Baseline performance study, no control group
• Seven centers, 70 patients
Co-primary • Patient satisfaction with functional and cosmetic results and
endpoints improvement in overall breast deformity at 12 mo
• Physician satisfaction with functional and cosmetic results and
improvement in overall breast deformity at 12 mo
Secondary • Change in breast volume and shape (MRI)
endpoints • Improvement in breast deformity
• Number of treatments required to achieve positive changes in
selected endpoints
• Improvement in patient Quality of Life scores
Patient • Quadrantectomy for ≤ T2N0M0, up to 3 cm
selection • Min of 12 mo from last treatment to enrollment, no recurrence
• Mild to moderate breast damage with ≥ 2/3 of the breast
mound remaining
12
13. Cell Enriched Grafting for Breast Reconstruction
Pre Tx 12 months
Post Op
100cc defect
60 Gy
Single treatment
150 cc wet CEFG
150cc defect
No RT
Two treatments
150/100 cc wet
CEFG
13
14. Cell Enriched Grafting for Breast Reconstruction
Co-primary Endpoints
Endpoint Outcome
Physician and patient • Physician- 78% (6 mo), 85% (12 mo)
satisfaction with overall • Patient- 70% (6 mo), 75% (12 mo)
treatment
Secondary Endpoints
Endpoint Outcome
Change in breast volume & • MRI volumetric analysis ineffective in these lesions
contour (MRI) • Improved or much improved- 77% (6 mo), 83% (12 mo)
Improvement in soft tissue (Lent • Improvement in fibrotic indices but not in pain
Soma and cutaneous scoring) and coloration
Adverse Event profile • Safe, no cancer recurrences, benign lipid cysts were
reported as adverse events in 10 patients (14.9%)
Number of treatments required • 1.35 (24 of 67 had second procedure)
Improvement in patient Quality No improvement detected with SF-36. This instrument is now
of Life scores known to lack sensitivity in breast reconstruction. New
instrument (breast-Q) is more sensitive in this population.
Resource utilization Average LOS was 7 hours-2 days, inpatient treatment 41/68
(60%) at baseline 19/24 (79%) at optional
6-month treatment
14
15. Breast Reconstruction Development Status
2006 2007 2008 2009 2010 2011
• RESTORE 1 • CE Mark for •Cytori begins • RESTORE 2 • Breast • UK NIC
Initiated in general RESTORE 2 trial enrollment reconstruction identifies cost-
Japan processing in EU complete added to CE effective-ness
• RESTORE 1 Mark • Complete
data reported RESTORE 2
data reported
15
16. Wound Healing
• 90 yr old Female
• 2 year chronic wound
• Spine exposure
Urethral Lumen • Radiation Tx > 40 yrs
• Single treatment
• Complete healing
Pre-Treatment 1 year Post-Treatment
Day 0 Day 14 Day 21 Day 68 Day 89
Dr. Akita
Nagasaki, Japan
WHO Center for Advanced Nuclear &
Radiation Medicine
17. Key Milestones 2012
Initiate ATHENA trial in U.S. – done
CE Mark for Chronic myocardial ischemia
Publication of key EU breast and CV data
Breast reconstruction technology evaluation in UK
Japanese and other non US regulatory approvals
Expand our commercial scope via partnerships
17