caverstem corporate presentation
TRANSCRIPT
A regenerative medicine
company focused on
virility and fertility
Timothy WarbingtonChief Executive Officer
FEBRUARY 26, 2016
Creative Medical Technologies, Inc.
Forward Looking Statements
The following presentation contains certain “forward-looking statements”relating to such matters as anticipated financial performance, futurerevenues or earnings, business prospects, projected ventures, anticipatedmarker performance and similar matters.
The words “may”, “will”, “expect”, “anticipate”, “continue”, “estimate”,“project”, “intend” and similar expressions are intended to identifyforward-looking statements regarding events, conditions, and financialtrends that may affect future plans of operations, business strategy,operating results and financial position.
The expectations reflected in forward-looking statements involve risksand uncertainties; therefore, such expectations cannot guarantee futureresults, performance or achievements and actual results may varymaterially from projected results.
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Patented, Proprietary Stem
Cell Therapy For Erectile
Dysfunction (ED) Using
The Patients Own Stem Cells
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Outpatient Procedure
Not a drug
1 National Institute of Health (NIH) Consensus Conference. NIH Consensus Development Panel on Impotence. JAMA 1993;270:83-90. (Reported patients seeking various treatments)
Erectile Dysfunction Marketplace
• 9,000,000 POTENTIAL UNSERVED PATIENTS
• Pumps & Prosthetics Only Option for those non-responsive to PDE5 inhibitors
• Invasive Surgery
• Penile tissue removed
• Risk of infection
• 24,000 procedures per year – 0.3% of Population
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• 30 million US men have ED.1
• Growing ED population – Lifestyle & Longevity
• 30% do not respond to PDE5 inhibitors (Viagra, Cialis, Levitra) due to smooth muscle and blood vessel deterioration
1Lin C-S et al. Advances in Andrology 2014.2 Song YS et al. International Journal of Impotence Research
2007;19:378.
• Intense academic interest –Because the technology works
• 20 Published papers in 2012-20131
• All studies reported improved erectile function
• Most reported improved muscle, endothelium and nerve tissue
Proof of Principle2
• Stem cells in an animal model of ED
• Proves stem cells translate into smooth
muscle tissue
Green - Transplanted stem cells in penis
Red - Stem cells expressing markers of smooth muscle cells
Yellow - Stem cells taking the morphology of smooth muscle cells in the penis
Time-Phase Penis Cell Extractions
Proven Science - Animal Research
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Animal Research1
First-In-Human Pilot Study
1Ichim TE et al. Journal of Translational Medicine 2013 Jun 9:11:139
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• Case study published in peer-reviewed journal1
• 35 year-old patient with ED
• Non-responsive to PDE5 inhibitors and injections ineffective
• Patient received Caverstem procedure
• 3 Months Later:
• Marked increase in duration and frequency of erections
• Ability to sustain erections until orgasm
• No treatment-associated adverse events
UCLA Clinical Trial
• Collaboration with Harbor-UCLA Medical Center and LABiomed
• Principal Investigator: Dr. Jacob Rajfer, MD, Chief of Urology at Harbor-UCLA Medical Center (emeritus)
• 40 Subject study using the Caverstem procedure
• Will establish Caverstem procedure as “Standard of Care”
• Milestones:
• Signed Study Contract: July 2015
• IRB Approval: September 2015
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• Start Date: November 2015
• Study Complete: Dec. 2016
Business Model
• Issued Patent
• Validated Science & Credibility
• Exclusive Device/Kits Marketing Contract
• Revenue from Sale of Device/Kits to Urologists
• Competitive Advantage:
• First to market with “Standard of Care” procedure – 2017
• Full package offering – Protocol, Clinical Trial, Device/Kits, Training
• Patent is a barrier to entry
• Competitive Pricing better or equal to other offerings
• Sales Force In Place
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• Handful of practices in the US
• No standard processes or protocols
• Illegal in some cases
• Examples:
• Priapus Shot® (P-Shot) – Illegal – Modified cells
• Smart Choice® Stem Cell Institute
• Phoenix Stem Cell Treatment Center
• DaSilvia Institute
Competition
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Awareness
Sales &
Marketing
Press Releases During Study• Study Launch• 1st Patient In• Interim Results
Publication of Study Results• Journal of Urology• American Urology Association
AUA Conferences – Booth & Presentations• Annual – San Diego – May ‘16• Western – Hawaii – Oct ‘16• New York
Direct Sales to Urologists• Arteriocyte – 18 sales staff• Hire & train internal sales• Call on Urologist Practices
• New England• Central• Southeastern
Advertising – In Clinic• In-clinic hand-outs• Posters• White papers
Advertising – National• Print & Television• DTC• Long-Form Commercials
Physician Seminars & Training (inc. education credits)• Los Angeles• Texas
• New York• Florida
Commercialization Strategy
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1 American Urological Association – 2014 State of the Urology Workforce
and Practice in the United States
2 # of Urologist owner/partners X % Urologist Adoption Rate X % Patients
Benefitting from Caverstem X Patient Adoption Rate
2014 US Urologist Population1
Total Number of US Urologists1: 11,601
# of Urologists Owners/Partners15,944 51% of Urologist Population
Est. # of Owned Practices 2,513 Individual & Partner Practices
# of Sales Staff 18
New Practice Sales Calls / Month 10
# of New Calls Per Year 2,160 86% of Practices Visited in 1 Year
Urologist adoption rate 35%
# of patients / urologist1 2,000
% of patients that benefit
from Caverstem 30%
Patient adoption rate 25%
Number of Potential Treatments2312,060
Sales Roll-Out
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Timothy Warbington – Chairman/CEO
• Owned/operated multi-million dollar businesses over the past 25 years
• Health sciences, international trade, agriculture and transportation sectors.
Amit N. Patel, M.D., B.S., M.S., University of Utah Director & SAB Chairman
• Cardiothoracic surgeon
• Director of Clinical Regenerative Medicine and Tissue Engineering at the University of Utah.
• Accomplished inventor and formulator of the Company’s Bionutraceutical® product lines.
Thomas Ichim, Ph.D. – President - Biotechnology Division
• Accomplished scientist
• CEO of Medistem, Inc. – Public biotech firm, successful exit March 2014
• Numerous executive positions in private and public biotechnology firms.
Donald Dickerson, MBA – Chief Financial / Operations Officer
• 25+ years senior management and accounting positions in public and private firms
• CFO of Medistem Inc. – Public biotech firm, successful exit March 2014
• Experience in the technology, manufacturing and health sciences sectors; JP Morgan, Dell, Boeing.
Annette Marleau, PhD - Chief Scientific Officer
• Director of Tumor Immunology at Aethlon Medical Inc
• Research Faculty at University of Nebraska Medical Center
• Fellow at Scripps Research Institute
Management Team
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