2. Safe Harbor Statement
This presentation contains certain âforward-looking statementsâ about Cytori Therapeutics, Inc. 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 involve known and unknown risks that relate to
Cytoriâs future events or future financial performance and the actual results could differ materially from those
discussed in this presentation. Risks and uncertainties that may cause Cytori's actual results to differ
materially from those discussed in the presentation can be found in the "Risk Factors" section of Cytoriâs Form
10-K, Forms 10-Q and other filings with the United States Securities and Exchange Commission. We would
advise reading our most recent annual report on Form 10-K and quarterly report on Form 10-Q filed with the
United States Securities and Exchange Commission for a more detailed description of these risks.
The forward-looking statements contained in this presentation represent Cytoriâs estimates and assumptions
only as of the date of this presentation and Cytori undertakes no duty or obligation to update or revise publicly
any forward-looking statements contained in this presentation as a result of new information, future events or
changes in Cytoriâs expectations.
3. Overview
Transformative technology platform
â⯠Cell therapy regulated as a device
â⯠Business model: single use consumables
Clinical experience in thousands of patients
Strong IP protection
Near term value drivers
â⯠U.S. government contract milestones (BARDA)
â⯠Phase II U.S. cardiovascular trial data
â⯠International approvals and revenue growth
4. Easily Accessible in Hospital & Clinic
Proprietary Formulation of Cells
â˘âŻ Autologous
(Patientâs own cells)
â˘âŻ Point-of-care availability
(no offsite manufacturing)
â˘âŻ Patented Technology
â˘âŻ Virtually âoff the shelfâ â
ideal for physician workflow
5. Commercial Model & Economics
Cell therapies offered via device & single-use consumableâŚ
allows for favorable pricing, reimbursement, and margins
System:
â˘âŻ
â˘âŻ
Low six figure ASP (current generation)
Next-generation system: smaller, faster, cheaper
& higher cell yields
Per-procedure consumable:
â˘âŻ
â˘âŻ
â˘âŻ
$8,000-$12,000 for vascular indications
$2,000-$3,000 for soft tissue
>80% GM
6. Broad & Deep Intellectual Property
DEVICES
CURRENT
DEVICES
NEXT GENERATION
COSMETIC & RECONSTRUCTIVE
SURGERY
CARDIOVASCULAR THERAPIES
PIPELINE THERAPIES
US: (6)
CELUTION DEVICE (â484)
CELUTION DEVICE PLUS ADDITIVES (â420)
STEMSOURCE DEVICE (â115)
CELUTION DEVICE PLUS SENSORS FOR
CLINICALLY SAFE OUTPUT (â670)
BEDSIDE COMPREHENSIVE
DEVICE (â059)
CELUTION DEVICE CD31 POSITIVE CELLS
(â276)
US: (1)
CELUTION & FUTURE GENERATIONS
(â075)
US: (7)
CELUTION FOR MIXING ADRCS PLUS FAT
(â488)
CELUTION OR NEXT GEN DEVICES FOR SOFT
TISSUE DEFECTS (â684)
ADRCS PLUS FAT PLUS ADDITIVES (â795)
ADRCS PLUS FAT (â672)
ADRCS PLUS FAT
COMPOSITION (â121)
CURRENT CELUTION DEVICE
PLUS FAT (â947)
ADRCâS PLUS FAT PLUS
BUFFER (â834)
EUROPE: (2)
ADRCS FOR CARDIAC (â382) OPPOSED
DEVICE FOR RESTORING BLOOD FLOW (â575)
US: (4)
CELUTION FOR BONE (â043)
CELUTION OUTPUT PLUS
JAPAN: (2)
CELUTION DEVICE (â952)
CELUTION FOR CLINICALLY SAFE OUTPUT
(â556)
KOREA: (3)
CELUTION DEVICE (â995)
STEMSOURCE DEVICE (â812)
CELUTION DEVICE (â139)
CHINA: (1)
CELUTION & FUTURE
GENERATIONS (â241)
HONG KONG (1)
CELUTION & FUTURE GENERATIONS
(â322)
INDIA: (1)
CELUTION WITH
FILTER (â529)
CENTRIFUGE OR
AUSTRALIA: (1)
CELUTION WITH CENTRIFUGE OR
FILTER (â937)
INDIA: (1)
CELUTION DEVICE (â706)
SINGAPORE: (1)
CELUTION & FUTURE GENERATIONS
(â683)
AUSTRALIA: (2)
CELUTION DEVICE (â135)
STEMSOURCE DEVICE (â901)
ISRAEL: (1)
CELUTION WITH CENTRIFUGE OR
FILTER (â800)
CHINA: (1)
CELUTION DEVICE (â689)
MEXICO: (1)
CELUTION & FUTURE GENERATIONS
(â348)
OLYMPUS-CYTORI PATENTS
NEXT GENERATION DEVICE - JAPAN
KOREA: (1)
CELUTION WITH CENTRIFUGE OR
FILTER (â305)
CENTRIFUGAL CONTAINER (â020)
DIGESTIVE ENZYMES (â861)
JAPAN: (1)
CELUTION BUSINESS METHOD
JAPAN: (1)
CELUTION AND NEXT GEN DEVICES FOR
MIXING ADRCS PLUS FAT (â041)
KOREA: (3)
ADRCS PLUS FAT (â454)
CELUTION OR NEXT GEN DEVICES FOR SOFT
TISSUE DEFECTS (â508)
ADRCS PLUS FAT METHOD
(â666)
OPPOSED
AUSTRALIA: (1)
ADRCS FOR CARDIAC (â858)
ADRCS FOR REMODELING (â046)
SINGAPORE: (1)
ADRCS FOR RESTORING BLOOD FLOW(â309)
CHINA: (1)
ADRCS FOR RESTORING BLOOD FLOW (â104)
HONG KONG: (1)
ADRCS FOR RESTORING BLOOD FLOW (â085)
RUSSIA: (1)
CELUTION FOR RESTORING BLOOD FLOW (â924)
SOUTH AFRICA: (1)
ADRCS FOR CARDIAC (â446)
MEXICO: (1)
CELUTION FOR RESTORING BLOOD FLOW (â775)
ISRAEL: (1)
ADRCS FOR CARDIAC (â354)
CANADA: (1)
ADRCS FOR RESTORING BLOOD FLOW(â510)
JAPAN: (2)
RESTORING BLOOD FLOW(â787)
CELUTION FOR REMODELING (â155)
CELUTION FOR
PROSTHETIC
FOR BONE RELATED DISORDERS
(â716)
CELUTION FOR TREATING WOUND
HEALING (â580)
ADRCâS FOR RENAL
(â229)
EUROPE: (2)
CELUTION FOR ACUTE
TUBULAR NECROSIS (â834)
ADRCS FOR WOUND
HEALING (â833)
JAPAN: (3)
ADRCS FOR WOUND HEALING
(â699)
CELUTION OUTPUT PLUS
PROSTHETIC
FOR BONE RELATED DISORDERS
(â119)
CELUTION FOR PERIPHERAL
VASCULAR DISEASE (â511)
INDIA: (1)
ADRCS FOR WOUND HEALING
(â580)
KOREA: (1)
ADRCS FOR WOUND
HEALING (â909)
CARDIAC CONTINUED
KOREA (1)
ADRCS FOR VENTRICULAR
DILATION (â170)
7. Adipose Derived Regenerative Cells
â˘âŻ More than just âstem cellsâ
â⯠Device output yields multiple cell types
â⯠Benefit from multiple mechanisms-of-action
Primary Mechanisms
â˘âŻ Improve blood flow
â˘âŻ Modulate inflammation
â˘âŻ Wound healing
8. Areas of Focus
Cardiac
â˘âŻ Completed proof-of-concept trial
â˘âŻ Enrolling U.S. Phase II HF trial
â˘âŻ Data in 2014
Soft Tissue
â˘âŻ Up to $106 MM in development
funding
â˘âŻ Commercial preparedness
contract with U.S. Government
â˘âŻ PMA for burns
Commercial
Research Market
â˘âŻ Japan approval
â˘âŻ EU âVascularâ approval
â˘âŻ Clinical experience in
thousands of patients
11. Ischemic Heart Disease: Market Size
Ischemic heart disease in the United States
â˘âŻ
â˘âŻ
â˘âŻ
â˘âŻ
Direct & indirect costs of heart failure estimated at $19.5B (2009)
$11.7B paid to Medicare beneficiaries (2006)
Medical costs of IHD expected to double 2013 to 2030
Estimated incidence is 200,000 â 500,000 patients/year in the U.S. alone
Ischemic heart disease in Europe
â˘âŻ IHD expected to cost EU economies âŹ60B/yr
â˘âŻ Estimated that 34.4M and 12.1M disability adjusted life years are lost in Europe
and the EU respectively each year due to IHD
Few, if any, new pharmaceutical approaches for IHD
12. US Regulatory Path for Heart Failure
Development Pipeline
Chronic
Pilot Complete
U.S. Phase II
(ATHENA)
Pivotal
2015
Pilot trial:
â˘âŻ Cells shown to be safe; no adverse effects on rhythm at 6 & 18 months
â˘âŻ Statistically significant stabilization in VO2Max vs placebo
Phase II ATHENA trials:
â˘âŻ 90 patients, multi-center, double blind, placebo-controlled
â˘âŻ Advance to pivotal in 2015
13. PRECISE Trial Showed Proof-of-Concept
Objective
Safety and feasibility of intramyocardial injection in
patients not amenable to revascularization
Design
Double-blind, randomized, parallel group, placebo-controlled
Size
27 patients (Spain, Netherlands, Denmark; 21 Treated, 6 Placebo)
Procedure
â˘âŻ Electromechanical mapping (NOGASTARÂŽ)
â˘âŻ ⤠15 intramyocardial injections of cells (median dose = 42 x 106 per
subject) or placebo (indistinguishable solution) in the area with
inducible ischemia via MYOSTARÂŽ Injection Catheter
14. PRECISE Trial: Data
Summary Results
â˘âŻ No safety issues
â˘âŻ No adverse effects on rhythm at 6 and 18 months
â˘âŻ VO2Max: improvement (p<0.05 vs. placebo)
â⯠Supported by NYHA improvement trend
â˘âŻ MRI: reduction in infarct size (p<0.05 vs. placebo)
â˘âŻ Mortality [36 months]: placebo 33% (2/6) , ADRC 14% (3/21)
15. PRECISE Trial: Exercise Tolerance
Change
 in
 VO2Max
 at
 6
 and
 18
 Months
20
VO2 Max
18
16
ADRCs
14
Placebo
12
Baseline
6
 months
18
 months
16. ATHENA Trials (USA)
â˘âŻ Heart failure due to ischemic heart disease
â˘âŻ Phase II trial design based on PRECISE
â˘âŻ Prospective, randomized, double-blind, placebocontrolled trials
â⯠90 patients: 30 patients at low dose, 30 patients at high dose, 30
placebo control
â⯠Up to 10 centers
â˘âŻ First data readout targeted for 2014
â˘âŻ Potential for pivotal trial initiation in 2015
17. ATHENA Trial
Safety
â˘âŻ Treatment emergent Serious Adverse Events (SAEs)
â˘âŻ Arrhythmia assessment via 24-hour Holter monitoring
â˘âŻ MACE defined as Cardiac Death or Hospitalization for Heart Failure
Efficacy
â˘âŻ VO2 Max (treadmill) (6 mo)
â˘âŻ LVEF, LVESV/LVEDV assessed by Echo (6 mo)
â˘âŻ Perfusion defect by Rest/Pharmacologic Stress SPECT (6 mo)
â˘âŻ Heart failure symptoms, angina, and quality of life (3, 6, 12 mo):
â˘âŻ NYHA and CCS classifications
â˘âŻ Minnesota Living with Heart Failure Questionnaire (MLHFQ)
â˘âŻ SF-36 Health Survey
18. BARDA Contract
Contract objective: National preparedness contract worth up to $106 million in
reimbursed development funding to create a treatment
for thermal burns combined with radiation
Clinical development:
⯠PMA-based pathway for traditional burns
⯠Development from preclinical to FDA approval fully funded
⯠Cytoriâs first U.S. soft tissue indication
Commercialization & Procurement
⯠Cytori maintains commercial rights for approved label
⯠Government can make direct purchases or facilitate orders
from hospitals for preparedness purposes
⯠Procurement potential is above and beyond contract funding
19. BARDA Contract
Discussions
Begin
2010
Award
3 Proof-of-concept Objectives
Announcement Ongoing
Fall, 2012
Cell viability
Pre-Award, White Papers,
Proposal, Negotiation
3 Objectives Trigger
Option 1 & 3
Q1, 2014
Option 1 Objective
Triggers Option 2
Q4, 2015
$32.6 M Option 1
Animal model POC
$45.5M Option 2
Next Gen device feasibility
$4.7M Phase 1 Proof of Concept
$23.4M Option 3
Commercial Acquisition at
BARDAâs Discretion
20. Commercialization
Emphasis: Researchers performing independently funded studies
⯠50+ studies worldwide completed, in process or planned using CelutionŽ
Rationale:
New indications & approvals expand pipeline and opportunities
I.⯠BARDA contract worth up to $106 MM (Sep. 2012)
II.⯠Lorem Vascular: $24 MM equity, $500 MM milestones (Nov. 2013)
III.⯠Japan DIET passes new Regenerative Medicine Law to Fast Track Technology
Growth:
International regulatory approvals and partnerships
I.âŻ
Japan Class I clearance achieved
II.⯠Europe: Vascular delivery & ischemic tissue muscle approvals
III.⯠Asia Pacific:
ÂťâŻ
Australia & Singapore approvals
21. RECOVER Trial (US)
Objec&ve
Â
â˘âŻ evaluate
 the
 safety
 and
 feasibility
 of
 ADRC
 injected
 into
 tears
 of
 the
Â
hamstring
 muscle
Â
Â
Trial
 Design:
Â
â˘âŻ Randomized,
 double-Ââblind,
 placebo-Ââcontrolled
Â
â˘âŻ Part
 A:
 10
 paBent
 open-Ââlabel,
 safety,
 feasibility
 &
 dose-ÂâescalaBon
Â
Â
â⯠Low
 Dose:
 5
 paBents,
Â
 High
 Dose:
 5
 paBents
Â
â˘âŻ Part
 B:
 60
 paBent,
 double-Ââblind,
 placebo-Ââcontrolled
 safety,
 feasibility
 &
Â
dosing
 study
Â
Â
â⯠Low
 Dose:
 20
 paBents,
Â
 High
 Dose:
 20
 paBents,
 Placebo:
 20
 paBents
Â
â˘âŻ Safety
 &
 funcBonal
 end-Ââpoints
Â
21
22. Lorem Vascular Partnership
CelutionÂŽ System Commercialization rights
Territories:
Australia, China, Hong Kong, Malaysia, & Singapore
Indications:
All indications w/initial focus on cardiac, diabetes and renal
Agreement Terms
Equity:
Milestones:
$24 million; 8 million shares at $3.00 per share
Up to $500 million in commercial milestones
Supply agreement:
Cytori receives transfer margin on long-term agreement
Partner
Lorem Vascular:
Distribution Plan:
Newly formed company dedicated to CelutionÂŽ products
Combination of direct sales and distributors
23. Upcoming Milestones
ATHENA
â⯠Complete enrollment in the U.S. ATHENA trial
â⯠Report six-month outcomes from the U.S. ATHENA trial
â⯠Publish PRECISE chronic ischemic heart failure trial long-term data
BARDA
â⯠Achieve proof-of-concept objectives
â⯠Qualify for up to $56 MM in further development funding
â⯠Define & Initiate US Burn Pilot Trial (IDE)
COMMERCIAL
â⯠Growth in product & contract revenues in 2014
â⯠Obtain product registration for the CelutionÂŽ System in China
RECOVER
â⯠Initiate enrollment in US trial (Part A) for hamstring injury