Cell Therapy. Cytori Corporate Presentation January 2012

Transcription

1 Cytori Corporate Presentation January 2012

2 Safe Harbor 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.

3 Our Company Mission To improve the quality and length of life by providing innovative cell therapy products

4 Our Innovation Real-time Access to a Patient s Own Regenerative Cells Syringe of Patient s Own Cells Regenerative Cells Derived from Adipose Tissue (Fat)

5 2011 : Year in Review March Shareholder Letter 12 month milestones Expand CE Mark Claims to include NO-CMI On track for early 2012 claims expansion Report 18 month APOLLO data Reported highly positive long-term Data Expand number of sites & ongoing enrollment of ADVANCE Initiated ADVANCE, 4 sites on-line & 23 in process Define & prepare to initiate a US clinical trial for CMI Successful pre-ide meeting & IDE for CMI filed in Q4 Expand efforts with FDA to gain approval or clearance for Celution 3-510ks, 2 appeals, pre-ide, IDE filing, 3 HUD rounds, ++mtgs CE Mark & European commercial launch for Celution One CE Mark for Celution One received in November Complete development of next generation aesthetics device - Development on hold to focus on cardiac pipeline

6 2011 : Year in Review March Shareholder Letter 12 month milestones Increase system installed base & consumable usage rates Grew installed based of systems, shifted sales to hospitals Increase hospital-based customers, with emphasis on breast recon More than half the systems went to hospital based customers Pursue payment for breast reconstruction in Europe NIC support UK, Italy grant Breast recon, NICE filing Q1 Grow PureGraft product sales More than doubled PG; anticipate ongoing growth in 2012 Expand selectively into emerging markets Opened India, Australia, So. Africa, Bulgaria & Russia

7 2012 : Key steps to increase shareholder value Commercial Business Product Pipeline Corporate

8 2012 : Key steps to increase shareholder value Commercial Business 1. Manage into a profitable segment in near term % annual revenue growth until inflection point 3. Focus reimbursement efforts in UK 4. Building market access for NO-CMI 5. Japan cell therapy guidelines & help dev approved studies for translational applications; MHLW approval for breast reconstruction

9 2012 : Key steps to increase shareholder value Product Pipeline 1. No-option CMI CE Mark (EU) 2. Focus on ADVANCE centers: 30 Centers on-line by year-end 3. Publish results of Apollo, Precise & Restore II 4. Initiate Athena (U.S. Chronic Ischemia)

10 2012 : Key steps to increase shareholder value Corporate 1. Bring in non-dilutive / strategic funding 2. Average Cash Operating Loss to $7 mm / qtr 3. Continue to expand global regulatory approvals

11 via Device 4,000+ Patients Treated Cardiovascular Acute Heart Attack Chronic Heart Failure Soft Tissue Breast Reconstruction Wounds, Fistula

12 Chronic Myocardial Ischemia PRECISE TRIAL Prospective European Multicenter Trial Randomized (3:1) Double Blind Placebo controlled Blinded independent core labs Safety & Feasibility Trial n= 27 (6 placebo, 21 treated) Patrick Serruys, MD, PhD Rotterdam, The Netherlands

13 Chronic Myocardial Ischemia MVO 2 : statistically significant change at 18 months METS: statistically significant change at 18 months Infarct size: 8.2% change at 6 months Cytori procedure safe and feasible through 18-months Lower cardiac mortality rate: At avg. follow up of 28 months: - 1 of 21 treated vs. 2 of 6 placebo Under review by Notified Body For CE Mark claims expansion 28 Month Mortality Rate Treated Placebo 0% 10% 20% 30% 40%

14 No Option Heart Failure Estimated Market Size for No Option Patients in Europe Region # of Patients (Incidence) # of Patients (10-Yr Prevalence) United Kingdom 40, ,000 Italy 40, ,000 Germany 55, ,000 France 40, ,000 Spain 30, ,000 Total G5 205,000 2,050,000 * Estimated price per treatment: $ 10,000 G5 Market $ 20 Billion*

15 ATHENA Trial US FDA Trial Chronic Myocardial Ischemia IDE Filed Q4, 2011 Trial design under negotiation with FDA Anticipate IDE approval Summer, 2012 Emerson Perin, MD Texas Heart Institute

16 Acute Heart Attack APOLLO TRIAL Prospective European Multicenter Trial Randomized (3:1) Double Blind Placebo controlled Blinded independent core labs Safety & Feasibility Trial n = 14 (4 placebo, 10 treated) Eric Duckers, MD, PhD Rotterdam, The Netherlands

17 MIBI SPECT TSS change (matched pairs) Cell Treated: Better Perfusion of the Heart 6 & 18 month follow-up Perfusion defect in LAD territory: Reduction in perfusion defect in patients treated with ADRC compared to placebo patients (9,7-fold improvement in LAD perfusion territory) as analyzed by MIBI SPECT (TSS scores) +867% improvement +800% improvement p=ns All SPECT images were assessed by an independent, blinded core lab (CCL, Boston, MA) Slides & Data provided by: Eric Duckers, MD, PhD

18 change in rel.infarct size (I/LV) (matched pairs) Cell Treated: Reduced Damage by > 50% 6 & 18 month follow-up Percent of Left Ventricle Infarcted: Infarct size normalized to ventricle size (%LVI) improved more in ADRC patients compared to placebo control patients (late enhancement cmri): +5,1% abs. and +59% rel. improvement compared to placebo control, PTE) all pts baseline 6 mo control Tx ADRC Tx 24,7% 24,7% 31,6% 15,4% all patients p=ns matched pairs All MRI images were assessed by an independent, blinded core lab (CCL, Boston, MA) Slides & Data provided by: Eric Duckers, MD, PhD

19 change in ESV (cc, 2D TTE) Cell Treated Not going into Heart Failure 6 & 18 month follow-up Change in ESV ESV was markedly reduced in ADRC patients as compared to placebo control patients (as measured by 2D TTE, cmri and SPECT, PTE) 24,4 cc improvement (-72,2%) All TTE images were assessed by an independent, blinded core lab (CCL, Boston, MA) Slides & Data provided by: Eric Duckers, MD, PhD

20 APOLLO: Arrhythmias 60% 50% 40% 30% 20% 10% 0% Percent of Pa ents with a Signific nt Ventricular Arrhythmias 50% 30% Placebo Group 1 Abnormal ventricular beats occur more often in Control patients More Significant Ventricular Arrhythmias in control patients Higher frequency of recordings with Ventricular Premature Bits (VPB) in Controls Higher number of VPBs per recording in Controls 700 Premature Ventricular Contrac ons - Mean Count per Pa ent 3000 Premature Ventricular Contrac ons - Mean Cumula ve Count control ADRC 1500 control ADRC

21 APOLLO: Summary ADRCs are safe in the treatment of STEMI No safety concerns No new Major Adverse Cardiac Events No Deaths Efficacy Concordant improvement in infarct and ischemia: Mean reduction in Infarct Size is maintained to 18 months Improvement in cardiac perfusion is maintained to 18 months May have positive impact on arrhythmia in cell-treatment patents ADVANCE No changes to ADVANCE trial design are needed

22 Acute Heart Attack ADVANCE TRIAL Currently enrolling & treating sites to treat up to 360 patients 60 sites identified & interested; ½ in G-5 23 sites selected & committed Various states of regulatory process by country Focus in 2012 to bringing sites online by YE Eric Duckers, MD, PhD Rotterdam, The Netherlands

23 Advance Trial Timeline in EU

24 Acute Myocardial Infarction Estimated Market Size for AMI Patients in Europe Annual Heart Attack Incidence (EU) 1.9 million % STEMI (large heart attacks) 38% Target Addressable Procedures 720,000 Estimated Price per Treatment $ 10,000 EU AMI Market $ 7.2 Billion

25 US Regulatory US IDE Trial for Cardiovascular: IDE Filed US IDE Trial for Cardiovascular: Heart Attack to follow European Advance Trial US HUD: Parry Rombergs Disease: Ongoing Process Multiple 510(k) device applications filed in 2011 Filed 2 appeals on 510(k) NSE: Now to Merits Panel

26 38 Worldwide Issued Patents, > 100 pending Devices Next Generation Devices Next Generation Cosmetic & Reconstructive Surgery (CRS) Cardiovascular Therapies Pipeline Therapies US: (1) CELUTION FUTURE GENERATIONS ( 075) India: (1) CELUTION FUTURE GENERATIONS ( 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 US: (1) CELUTION FUTURE GENERATIONS ( 075) India: (1) CELUTION FUTURE GENERATIONS ( 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 US: (4) 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) Japan: (1) CELUTION AND NEXT GEN DEVICES FOR MIXING ADRCS PLUS FAT ( 041) Europe: (1) ADRCS FOR CARDIAC ( 382) <Opposition filed> Australia: (1) CELUTION FOR CARDIOVASCULAR ( 858) Singapore: (1) CELUTION FOR CARDIOVASCULAR ( 590) China: (1) CELUTION FOR CARDIOVASCULAR ( 104) Russia: (1) CELUTION FOR CARDIOVASCULAR ( 924) South Africa: (1) CELUTION FOR CARDIOVASCULAR ( 446) Mexico: (1) CELUTION FOR CARDIOVASCULAR ( 775) US: (2) CELUTION FOR BONE ( 043) CELUTION OUTPUT PLUS PROSTHETIC FOR BONE RELATED DISORDERS ( 716) Europe: (2) CELUTION FOR ACUTE TUBULAR NECROSIS ( 834) ADRCS FOR WOUND HEALING ( 833) Japan: (1) ADRCS FOR WOUND HEALING ( 699) India: (1) ADRCS FOR WOUND HEALING ( 580)

27 Thank You!