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CYTX Corporate Presentation, Biotech Showcase
1. Cell Therapy
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.
Cell Therapy
3. Our Company Mission
To improve the quality and length of life
by providing innovative cell therapy products
Cell Therapy
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)
Cell Therapy
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 Cell Therapy
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
Cell Therapy
7. 2012 : Key steps to increase shareholder value
• Commercial Business
• Product Pipeline
• Corporate
Cell Therapy
8. 2012 : Key steps to increase shareholder value
Commercial Business
1. Manage into a profitable segment in near term
2. 20+% 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
Cell Therapy
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)
Cell Therapy
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
Cell Therapy
13. Chronic Myocardial Ischemia
MVO2: statistically significant change at 18 months
METS: statistically significant change at 18 months Under review by Notified Body
For CE Mark claims expansion
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
28 Month Mortality Rate
Treated
Placebo
0% 10% 20% 30% 40%
Cell Therapy
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 40,000 400,000
Italy 40,000 400,000
Germany 55,000 550,000
France 40,000 400,000
Spain 30,000 300,000
Total G5 205,000 2,050,000
* Estimated price per treatment: $ 10,000
G5 Market
$ 20 Billion*
Cell Therapy
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
Cell Therapy
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
Cell Therapy
17. 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)
MIBI SPECT TSS change (matched pairs)
+867% +800%
improvement improvement
p=NS
Slides & Data provided by:
All SPECT images were assessed by an independent, blinded core lab (CCL, Boston, MA) Eric Duckers, MD, PhD
18. 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)
change in rel.infarct size (I/LV) (matched pairs)
all pts baseline 6 mo
control
Tx
24,7% 24,7%
ADRC
Tx
31,6% 15,4%
all patients
p=NS matched pairs
Slides & Data provided by:
All MRI images were assessed by an independent, blinded core lab (CCL, Boston, MA) Eric Duckers, MD, PhD
19. 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)
change in ESV (cc, 2D TTE)
24,4 cc
improvement
(-72,2%)
Slides & Data provided by:
All TTE images were assessed by an independent, blinded core lab (CCL, Boston, MA) Eric Duckers, MD, PhD
20. APOLLO: Arrhythmias
Percent of Pa ents with Signific nt
a Abnormal ventricular beats occur more
Ventricular Arrhythmias often in Control patients
60%
50%
More Significant Ventricular Arrhythmias
50% in control patients
40% Higher frequency of recordings with
30%
30% Ventricular Premature Bits (VPB) in
20% Controls
10% Higher number of VPBs per recording
0% in Controls
Placebo Group 1
Premature Ventricular Contrac ons - Mean Count per Pa ent Premature Ventricular Contrac ons - Mean Cumula ve Count
700 3000
600
2500
500
2000
400
control 1500 control
300 ADRC ADRC
1000
200
500
100
0 0
0.5 1 2 3 4 8 12 16 25 52 77 0.5 1 2 3 4 8 12 16 25 52 77
Cell Therapy
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
Cell Therapy
22. Acute Heart Attack
ADVANCE TRIAL
• Currently enrolling & treating
• 30 – 35 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
Cell Therapy
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
Cell Therapy
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
Cell Therapy
26. 38 Worldwide Issued Patents, > 100 pending
Devices Devices Cosmetic & Reconstructive Cardiovascular Therapies Pipeline Therapies
Next Generation Next Generation Surgery (CRS)
US: (1) US: (1) US: (4) Europe: (1) US: (2)
CELUTION FUTURE CELUTION FUTURE CELUTION FOR MIXING ADRCS FOR CARDIAC CELUTION FOR BONE
GENERATIONS (‘075) GENERATIONS (‘075) ADRCS PLUS FAT (‘488) (‘382) (‘043)
CELUTION OR NEXT GEN <Opposition filed> CELUTION OUTPUT
India: (1) India: (1) DEVICES FOR SOFT TISSUE PLUS PROSTHETIC
CELUTION FUTURE CELUTION FUTURE DEFECTS (‘684) Australia: (1) FOR BONE RELATED
GENERATIONS (‘529) GENERATIONS (‘529) ADRCS PLUS FAT PLUS CELUTION FOR DISORDERS (‘716)
ADDITIVES (‘795) CARDIOVASCULAR (‘858)
Australia: (1) Australia: (1) ADRCS PLUS FAT (‘672) Europe: (2)
CELUTION WITH CENTRIFUGE CELUTION WITH Singapore: (1) CELUTION FOR ACUTE
OR CENTRIFUGE OR Japan: (1) CELUTION FOR TUBULAR NECROSIS
FILTER (‘937) FILTER (‘937) CELUTION AND NEXT GEN CARDIOVASCULAR (‘590) (‘834)
DEVICES FOR MIXING ADRCS ADRCS FOR WOUND
Singapore: (1) Singapore: (1) PLUS FAT (‘041) China: (1) HEALING (‘833)
CELUTION & FUTURE CELUTION & FUTURE CELUTION FOR
GENERATIONS (‘683) GENERATIONS (‘683) CARDIOVASCULAR (‘104) Japan: (1)
ADRCS FOR WOUND
Israel: (1) Israel: (1) Russia: (1) HEALING (‘699)
CELUTION WITH CENTRIFUGE CELUTION WITH CELUTION FOR
OR CENTRIFUGE OR CARDIOVASCULAR (‘924) India: (1)
FILTER (‘800) FILTER (‘800) ADRCS FOR WOUND
South Africa: (1) HEALING (‘580)
Mexico: (1) Mexico: (1) CELUTION FOR
CELUTION FUTURE CELUTION FUTURE CARDIOVASCULAR (‘446)
GENERATIONS GENERATIONS
Mexico: (1)
CELUTION FOR
CARDIOVASCULAR (‘775)
Cell Therapy