2. Safe Harbor Statement
This presentation contains certain ‘forward-looking statements’ 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
Cytori’s 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 Cytori’s 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 Cytori’s 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 Cytori’s expectations.
3. Cytori Technology
Therapeutic, Regulated as a Device
•
•
•
•
Regulatory Path: US PMA Device (CBER), EU-Device (Notified body)
Per treatment consumable MSRP $2,000 - $10,000
Cells processed available at bedside in about 1 hour
Adipose tissue yields unique mixed cell population
4. Cytori Priorities: Leverage
Transformative Technology Platform
Cardiac
• Completed proof-of-concept trial
• Enrolling US Phase II Heart Failure trial
USA / BARDA
New opportunities
leveraging the
platform
• Up to $106 in development funding
• Commercial preparedness contract
with US Government
• Potential to fully fund PMA for burns
Commercial
• Japan approval
• EU ‘Vascular’ approval
• Clinical experience in thousands of patients
5. Cytori’s Cardiac Cell Therapy
• Completed proof-of-concept trial
• Enrolling ATHENA I & II US Phase 2 heart failure trials
7. Cardiac Cell Therapy
PRECISE Pilot Showed Proof-of-Concept
Proof-ofObjective:
• safety and feasibility of ADRCs delivered via intramyocardial injections in
patients with chronic myocardial ischemia not amenable to revascularization
Study Design:
• double-blind, randomized, parallel group, placebo-controlled
Sample Size
• 27 subjects (Spain, The Netherlands, Denmark) (21 ADRC, 6 Placebo)
Procedure
• electromechanical mapping (NOGASTAR®)
• ≤ 15 intramyocardial injections in the area with inducible ischemia via the
MYOSTAR® Injection Catheter :
– ADRCs (n=21, median dose of ADRCs 42 x 106 per subject)
– Placebo (n=6: indistinguishable solution)
9. Cardiac Cell Therapy
PRECISE Trial: Data Summary
Results
• Holter: no adverse effects on rhythm at 6 and 18 months
• VO2max: improvement (p<0.05 vs. placebo)
– Supported by NYHA improvement trend
• MRI: reduction in infarct size (p<0.05 vs. placebo)
• No safety issues
• Mortality [36 months]: placebo 33% (2/6) , ADRC 14% (3/21)
10. Cardiac Cell Therapy
ATHENA I & II US Heart Failure Trials
• Heart failure due to ischemic heart disease
• Phase II Trials based on EU Pilot (PRECISE)
• Prospective, double-blind, placebo-controlled trials
– 90 patients: 45 patients at low dose, 45 patients at high dose
– Up to 10 centers
• First data readout targeted for 2014
• Potential for pivotal trial initiation in 2015
11. Cardiac Cell Therapy
ATHENA Endpoints
• Safety
• Treatment emergent Serious Adverse Events (SAEs)
• Arrhythmia assessment via 24-hour Holter monitoring
• MACE defined as Cardiac Death or Hospitalization for Heart Failure
• Efficacy
•
•
•
•
VO2 max (treadmill) (6 mo)
LVEF, LVESV/LVEDV assessed by Echo (6 mo)
Perfusion defect by Rest/Pharmacologic Stress SPECT (6 mo)
Heart failure symptoms, angina, and quality of life (3, 6, 12 mo):
• NYHA and CCS classifications
• Minnesota Living with Heart Failure Questionnaire (MLHFQ)
• SF-36 Health Survey
12. 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
BARDA’s Discretion
13. Commercial
• Emphasis:
Currently selling systems and consumables primarily
for researchers conducting independently funded
clinical studies.
• Rationale:
Expand Cytori’s bandwidth to validate new indications;
Build brand presence with leading physicians;
Offset burn as revenues grow.
• Driving Growth:
Japan Class I designation / pending legislation;
Approval in Australia;
Intravase (cardiac reagent) approval in Europe;
Ischemic tissue and muscle CE Mark claim expansion.
14. Commercial
Research Customers Worldwide
50+ investigator studies (in process or completed)
SUI data published
Aug. 2013
USA
EU
AP
3
34
11
Positive scleroderma data Sep 2013
Diabetic ulcer data published May 2013
Soft Tissue
Wound
Ischemia
Ortho/Sport
Vital Organ Australian approval July 2013 based
on extensive clinical case work
EM
3
15. Cytori Cell Therapy: Intellectual Property
Meg
64 Patents Issued Worldwide; More than 75 Pending Applications
DEVICES
CURRENT
DEVICES
NEXT GENERATION
COSMETIC & RECONSTRUCTIVE
SURGERY
CARDIOVASCULAR THERAPIES
PIPELINE THERAPIES
US: (6)
CELUTION DEVICE (‘484)
CELUTION DEVICE PLUS ADDITIVES (‘420)
STEMSOURCE DEVICE (‘115)
CELUTION DEVICE PLUS SENSORS FOR
CLINICALLY SAFE OUTPUT (‘670)
BEDSIDE COMPREHENSIVE
DEVICE (‘059)
CELUTION DEVICE CD31 POSITIVE CELLS
(‘276)
US: (1)
CELUTION & FUTURE
GENERATIONS (‘075)
EUROPE: (2)
ADRCS FOR CARDIAC (‘382) OPPOSED
DEVICE FOR RESTORING BLOOD FLOW
(‘575) OPPOSED
US: (4)
CELUTION FOR BONE (‘043)
CELUTION OUTPUT PLUS
AUSTRALIA: (1)
ADRCS FOR CARDIAC (‘858)
ADRCS FOR REMODELING (‘046)
(‘716)
CELUTION FOR TREATING
WOUND HEALING (‘580)
ADRC’S FOR RENAL
(‘229)
INDIA: (1)
CELUTION WITH CENTRIFUGE OR
FILTER (‘529)
US: (7)
CELUTION FOR MIXING ADRCS PLUS
FAT (‘488)
CELUTION OR NEXT GEN DEVICES FOR
SOFT TISSUE DEFECTS (‘684)
ADRCS PLUS FAT PLUS ADDITIVES
(‘795)
ADRCS PLUS FAT (‘672)
ADRCS PLUS FAT
COMPOSITION (‘121)
CURRENT CELUTION DEVICE
PLUS FAT (‘947)
ADRC’S PLUS FAT PLUS
BUFFER (‘834)
AUSTRALIA: (1)
CELUTION WITH CENTRIFUGE OR
FILTER (‘937)
JAPAN: (1)
CELUTION AND NEXT GEN DEVICES
FOR MIXING ADRCS PLUS FAT (‘041)
HONG KONG: (1)
ADRCS FOR RESTORING BLOOD FLOW
(‘085)
INDIA: (1)
CELUTION DEVICE (‘706)
SINGAPORE: (1)
CELUTION & FUTURE
GENERATIONS (‘683)
RUSSIA: (1)
CELUTION FOR RESTORING BLOOD FLOW
(‘924)
AUSTRALIA: (2)
CELUTION DEVICE (‘135)
STEMSOURCE DEVICE (‘901)
ISRAEL: (1)
CELUTION WITH CENTRIFUGE OR
FILTER (‘800)
KOREA: (3)
ADRCS PLUS FAT (‘454)
CELUTION OR NEXT GEN DEVICES FOR
SOFT TISSUE DEFECTS (‘508)
ADRCS PLUS FAT METHOD
(‘666)
CHINA: (1)
CELUTION DEVICE (‘689)
MEXICO: (1)
CELUTION & FUTURE
GENERATIONS (‘348)
JAPAN: (2)
CELUTION DEVICE (‘952)
CELUTION FOR CLINICALLY SAFE OUTPUT
(‘556)
KOREA: (3)
CELUTION DEVICE (‘995)
STEMSOURCE DEVICE (‘812)
CELUTION DEVICE (‘139)
OLYMPUS-CYTORI PATENTS
NEXT GENERATION DEVICE - JAPAN
CENTRIFUGAL CONTAINER (‘020)
DIGESTIVE ENZYMES (‘861)
CHINA: (1)
CELUTION & FUTURE
GENERATIONS (‘241)
HONG KONG (1)
CELUTION & FUTURE
GENERATIONS (‘322)
KOREA: (1)
CELUTION WITH CENTRIFUGE OR
FILTER (‘305)
JAPAN: (1)
CELUTION BUSINESS METHOD
SINGAPORE: (1)
ADRCS FOR RESTORING BLOOD
FLOW(‘309)
CHINA: (1)
ADRCS FOR RESTORING BLOOD FLOW
(‘104)
SOUTH AFRICA: (1)
ADRCS FOR CARDIAC (‘446)
MEXICO: (1)
CELUTION FOR RESTORING BLOOD FLOW
(‘775)
ISRAEL: (1)
ADRCS FOR CARDIAC (‘354)
CANADA: (1)
ADRCS FOR RESTORING BLOOD
FLOW(‘510)
JAPAN: (2)
RESTORING BLOOD
FLOW(‘787)
CELUTION FOR REMODELING (‘155)
CELUTION FOR
PROSTHETIC
FOR BONE RELATED DISORDERS
EUROPE: (2)
CELUTION FOR ACUTE
TUBULAR NECROSIS (‘834)
ADRCS FOR WOUND
HEALING (‘833)
JAPAN: (3)
ADRCS FOR WOUND HEALING
(‘699)
CELUTION OUTPUT PLUS
PROSTHETIC
FOR BONE RELATED DISORDERS
(‘119)
CELUTION FOR PERIPHERAL
VASCULAR DISEASE (‘511)
INDIA: (1)
ADRCS FOR WOUND HEALING
(‘580)
KOREA: (1)
ADRCS FOR WOUND
HEALING (‘909)
CARDIAC CONTINUED
KOREA (1)
ADRCS FOR VENTRICULAR
DILATION (‘170)
16. Upcoming Milestones
• Achieve BARDA proof-of-concept objectives
– Qualify for up to $56 MM in further development funding
• Complete enrollment in the US ATHENA trial
• Report six-month outcomes from the US ATHENA trial
• Publish 3-year data from the EU PRECISE chronic ischemic heart failure trial
• Accelerate growth in product and contract revenues
• Additional international approvals and patents