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Cytori Corporate Overview NASDAQ: CYTX January 13, 2014

2014 Biotech Showcase Presentation

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CEO Chris Calhoun presents at the Biotech Showcase on January 13, 2014

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Page 1: 2014 Biotech Showcase Presentation

Cytori Corporate Overview NASDAQ: CYTX

January 13, 2014

Page 2: 2014 Biotech Showcase Presentation

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.

Page 3: 2014 Biotech Showcase Presentation

Overview

Transformative technology platform –  Cell therapy regulated as a device –  Business model: single use consumables

Clinical experience in thousands of patients Strong IP protection Near term value drivers

–  U.S. government contract milestones (BARDA) –  Phase II U.S. cardiovascular trial data –  International approvals and revenue growth

Page 4: 2014 Biotech Showcase Presentation

Proprietary Formulation of Cells •  Autologous

(Patient’s own cells)

•  Point-of-care availability (no offsite manufacturing)

•  Patented Technology

•  Virtually ‘off the shelf’ – ideal for physician workflow

Easily Accessible in Hospital & Clinic

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System: •  Low six figure ASP (current generation) •  Next-generation system: smaller, faster, cheaper

& higher cell yields

Per-procedure consumable: •  $8,000-$12,000 for vascular indications •  $2,000-$3,000 for soft tissue •  >80% GM

Cell therapies offered via device & single-use consumable… allows for favorable pricing, reimbursement, and margins

Commercial Model & Economics

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Broad & Deep Intellectual Property 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) JAPAN: (2) CELUTION DEVICE (‘952) CELUTION FOR CLINICALLY SAFE OUTPUT (‘556) KOREA: (3) CELUTION DEVICE (‘995) STEMSOURCE DEVICE (‘812) CELUTION DEVICE (‘139) INDIA: (1) CELUTION DEVICE (‘706) AUSTRALIA: (2) CELUTION DEVICE (‘135) STEMSOURCE DEVICE (‘901) CHINA: (1) CELUTION DEVICE (‘689) OLYMPUS-CYTORI PATENTS NEXT GENERATION DEVICE - JAPAN CENTRIFUGAL CONTAINER (‘020) DIGESTIVE ENZYMES (‘861)

US: (1) CELUTION & FUTURE GENERATIONS (‘075) CHINA: (1) CELUTION & FUTURE GENERATIONS (‘241) HONG KONG (1) CELUTION & FUTURE GENERATIONS (‘322) INDIA: (1) CELUTION WITH CENTRIFUGE OR FILTER (‘529) AUSTRALIA: (1) CELUTION WITH CENTRIFUGE OR FILTER (‘937) SINGAPORE: (1) CELUTION & FUTURE GENERATIONS (‘683) ISRAEL: (1) CELUTION WITH CENTRIFUGE OR FILTER (‘800) MEXICO: (1) CELUTION & FUTURE GENERATIONS (‘348) KOREA: (1) CELUTION WITH CENTRIFUGE OR FILTER (‘305) JAPAN: (1) CELUTION BUSINESS METHOD

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) JAPAN: (1) CELUTION AND NEXT GEN DEVICES FOR MIXING ADRCS PLUS FAT (‘041) KOREA: (3) ADRCS PLUS FAT (‘454) CELUTION OR NEXT GEN DEVICES FOR SOFT TISSUE DEFECTS (‘508) ADRCS PLUS FAT METHOD (‘666)

EUROPE: (2) ADRCS FOR CARDIAC (‘382) OPPOSED DEVICE FOR RESTORING BLOOD FLOW (‘575) OPPOSED AUSTRALIA: (1) ADRCS FOR CARDIAC (‘858) ADRCS FOR REMODELING (‘046) SINGAPORE: (1) ADRCS FOR RESTORING BLOOD FLOW(‘309) CHINA: (1) ADRCS FOR RESTORING BLOOD FLOW (‘104) HONG KONG: (1) ADRCS FOR RESTORING BLOOD FLOW (‘085) RUSSIA: (1) CELUTION FOR RESTORING BLOOD FLOW (‘924) 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) CELUTION FOR RESTORING BLOOD FLOW(‘787) CELUTION FOR REMODELING (‘155)

US: (4) CELUTION FOR BONE (‘043) CELUTION OUTPUT PLUS PROSTHETIC FOR BONE RELATED DISORDERS (‘716) CELUTION FOR TREATING WOUND HEALING (‘580) ADRC’S FOR RENAL (‘229) 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)

Page 7: 2014 Biotech Showcase Presentation

•  More than just “stem cells” –  Device output yields multiple cell types –  Benefit from multiple mechanisms-of-action

Adipose Derived Regenerative Cells

Primary Mechanisms •  Improve blood flow •  Modulate inflammation •  Wound healing

Page 8: 2014 Biotech Showcase Presentation

Commercial Research Market

Areas of Focus

Soft Tissue Cardiac

• Completed proof-of-concept trial • Enrolling U.S. Phase II HF trial • Data in 2014

• Japan approval • EU ‘Vascular’ approval • Clinical experience in

thousands of patients

• Up to $106 MM in development funding

• Commercial preparedness contract with U.S. Government

• PMA for burns

Page 9: 2014 Biotech Showcase Presentation

Current therapy does not address damage to the heart

Cardiac Cell Therapy

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Damage leads to: reduced function

left ventricular failure . . .

Death

Cardiac Cell Therapy

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Ischemic Heart Disease: Market Size

Ischemic heart disease in the United States •  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 – 500,000 patients/year in the U.S. alone

Ischemic heart disease in Europe •  IHD expected to cost EU economies €60B/yr •  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

Page 12: 2014 Biotech Showcase Presentation

US Regulatory Path for Heart Failure

Development Pipeline

Chronic

Pilot trial: •  Cells shown to be safe; no adverse effects on rhythm at 6 & 18 months •  Statistically significant stabilization in VO2Max vs placebo Phase II ATHENA trials: •  90 patients, multi-center, double blind, placebo-controlled •  Advance to pivotal in 2015

Pilot Complete U.S. Phase II

(ATHENA) Pivotal 2015

Page 13: 2014 Biotech Showcase Presentation

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

•  Electromechanical mapping (NOGASTAR®) •  ≤ 15 intramyocardial injections of cells (median dose = 42 x 106 per

subject) or placebo (indistinguishable solution) in the area with inducible ischemia via MYOSTAR® Injection Catheter

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Summary Results •  No safety issues

•  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)

•  Mortality [36 months]: placebo 33% (2/6) , ADRC 14% (3/21)

PRECISE Trial: Data

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12

14

16

18

20

Baseline 6  months 18  months

VO2 M

ax

Change  in  VO2Max  at  6  and  18  Months

ADRCs

Placebo

PRECISE Trial: Exercise Tolerance

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ATHENA Trials (USA)

•  Heart failure due to ischemic heart disease

•  Phase II trial design based on PRECISE

•  Prospective, randomized, double-blind, placebo-controlled trials –  90 patients: 30 patients at low dose, 30 patients at high dose, 30

placebo control –  Up to 10 centers

•  First data readout targeted for 2014

•  Potential for pivotal trial initiation in 2015

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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

ATHENA Trial

Page 18: 2014 Biotech Showcase Presentation

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 »  Cytori’s 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

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BARDA Contract

Discussions Begin 2010

Award Announcement Fall, 2012

3 Objectives Trigger Option 1 & 3 Q1, 2014

3 Proof-of-concept Objectives Ongoing

Cell viability

Animal model POC

Next Gen device feasibility

$32.6 M Option 1

$23.4M Option 3

Commercial Acquisition at BARDA’s Discretion

$45.5M Option 2

Option 1 Objective Triggers Option 2 Q4, 2015

Pre-Award, White Papers, Proposal, Negotiation

$4.7M Phase 1 Proof of Concept

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Commercialization

Emphasis: Researchers performing independently funded studies »  50+ studies worldwide completed, in process or planned using Celution®

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.  Japan Class I clearance achieved II.  Europe: Vascular delivery & ischemic tissue muscle approvals III.  Asia Pacific:

»  Australia & Singapore approvals

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Objec&ve  •  evaluate  the  safety  and  feasibility  of  ADRC  injected  into  tears  of  the  

hamstring  muscle    Trial  Design:  •  Randomized,  double-­‐blind,  placebo-­‐controlled  •  Part  A:  10  paBent  open-­‐label,  safety,  feasibility  &  dose-­‐escalaBon    

–  Low  Dose:  5  paBents,    High  Dose:  5  paBents  •  Part  B:  60  paBent,  double-­‐blind,  placebo-­‐controlled  safety,  feasibility  &  

dosing  study    –  Low  Dose:  20  paBents,    High  Dose:  20  paBents,  Placebo:  20  paBents  

•  Safety  &  funcBonal  end-­‐points  

21

RECOVER Trial (US)

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Lorem Vascular Partnership

Celution® System Commercialization rights Territories: Australia, China, Hong Kong, Malaysia, & Singapore Indications: All indications w/initial focus on cardiac, diabetes and renal

Agreement Terms

Equity: $24 million; 8 million shares at $3.00 per share Milestones: Up to $500 million in commercial milestones Supply agreement: Cytori receives transfer margin on long-term agreement

Partner

Lorem Vascular: Newly formed company dedicated to Celution® products Distribution Plan: Combination of direct sales and distributors

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Upcoming Milestones

ATHENA

–  Complete enrollment in the U.S. ATHENA trial

–  Report six-month outcomes from the U.S. ATHENA trial

–  Publish PRECISE chronic ischemic heart failure trial long-term data

BARDA

–  Achieve proof-of-concept objectives

–  Qualify for up to $56 MM in further development funding

–  Define & Initiate US Burn Pilot Trial (IDE)

COMMERCIAL

–  Growth in product & contract revenues in 2014

–  Obtain product registration for the Celution® System in China RECOVER

–  Initiate enrollment in US trial (Part A) for hamstring injury

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Cytori Corporate Overview NASDAQ: CYTX

Thank you!