Intellicell Biosciences - Marcum Conference PDF

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Presented by: Steven Victor Chief Executive Officer Regenerative Curative Preventative Investor Presentation

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Intellicell Biosciences (Ticker Symbol: SVFC)Regenerative Curative PreventativeInvestor Presentation:Presented by: Steven Victor Chief Executive Officer (CEO)May 29th 2014www.intellicellbiosciences.com

Transcript of Intellicell Biosciences - Marcum Conference PDF

  • Presented by: Steven VictorChief Executive Officer

    Regenerative Curative Preventative

    InvestorPresentation

  • Safe Harbor

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    Statements in this presentation that are not descriptions of historical facts are forward-looking statements relating to future events, and as such all forward-looking statements are made pursuant to the Securities Litigation Reform Act of 1995. Statements may contain certain forward-looking statements pertaining to future anticipated or projected plans, performance and developments, as well as other statements relating to future operations and results. Any statements in this presentation that are not statements of historical fact may be considered to be forward-looking statements. Words such as "may," "will," "expect," "believe," "anticipate," "estimate," "intends," "goal," "objective," "seek," "attempt," or variations of these or similar words, identify forward-looking statements. These forward-looking statements by their nature are estimates of future results only and involve substantial risks and uncertainties, including but not limited to risks associated with the uncertainty of future financial results, additional financing requirements, development of new products, successful completion of the Companys proposed restructuring, the impact of competitive products or pricing, technological changes, the effect of economic conditions and other uncertainties detailed from time to time in our reports filed with the Securities and Exchange Commission. There can be no assurance that our actual results will not differ materially from expectations and other factors more fully described in our public filings with the U.S. Securities and Exchange Commission, which can be reviewed at www.sec.gov.

  • INTELLICELL BIOSCIENCES

    Research began in 2009 and Company founded in 2010Cellular laboratory in New York and planned location in FloridaNew facilities and planned in major US markets

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  • Cellular Processing Laboratory IntelliCell has first commercial cellular processing laboratory

    integrated into an ASC suite in NYC

    Capability to treat multiple disease and injury states under the practice of medicine

    Facility meets regulatory requirements for cGTP processing Can be deployed in major markets in US and Internationally

  • wHospital/Ambulatory Surgery CenterLabs

    Business Model

  • Business Model

    w The company will install/build a FDA cGTP lab in a 25 x 25 foot room

    w The company will employee a QC technician that it trains and monitors

    w The QA of the lab would be accomplished via NY QA directorw All SOPs would be handled by Companyw The Company would sell cells for $2,500 and the

    physician/hospital would charge patient fee set by them if the hospital pays for the lab BUT if Intellicell pays for lab do a 50/50 revenue share

    w All samples would be total QAw Cells available to all and any specialtiesw Company would arrange CME courses

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  • Why doctors would use cells

  • Continuing Medical Education

    w The company will conduct continuing medical education course to multiple specialties in order to teach physicians about cellular therapy

    w The CME course will also expose the physicians to the availability of Intellicells cellular product to treat their patients under the practice of medicine

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  • Clinical Experience

    Summary of Results for SVF Treatments OVER 400 PATIENTS TREATED WITH SVF NO ADVERSE REACTIONS TO ANY SVF TREATMENT 4 LOCAL INFECTIONS AT PUNCTURE SITE OF HARVESTING

    (DUE TO POOR WOUND CARE BY PATIENT)

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    PHYSICIAN GROUP MEDICAL PRACTICE Cosmetic Dermatologist Cosmetic / Plastic Surgeon Ear Nose & Throat Specialist Internal Medicine Specialist 3 Orthopedic Specialists Neuropsychiatrist

  • Anecdotal Clinical Results

  • ALS- QEEG Scans

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  • MRI Indicating Positive Changes in OA Hip

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  • Skiing fracture

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    MultipleFracturesWastoldneverraceagainBUTracing in6months

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    New York Daily News

  • The Journal of Implant & Advanced Clinical Dentistry

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  • Volume Filling& wrinkles

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    FreshFat+SVFs

  • Treatment for Bells Palsy

    16 Weeks After Treatment

    BellsPalsy

    NerveDroop

    Nomoredroop62yroldType1DiabeticdiagnosedwithpermanentBellsPalsy

  • Currently

    Pre-treatmentSeSe

    One Hour Later

  • MARKET OPPORTUNITY

  • Market Indications $15 billion current market for Regenerative Medicine 1.2 million patients to date treated with RM products and therapies 400 + private and 50 public companies with $4.7 billion in total market cap 175,000 peer-reviewed publications and 10,000 issued or pending patents 400 products in the market today with 600 more in development Proliferation of patient advocacy groups demanding shift to RM $1.5 billion in worldwide research funding projected to $14 billion in 10 years

    Potential market is LARGELY UNTAPPED Projected to reach $300 billion by 2020

    source: US Department of Health and Human Services

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    AND THATS JUST THE BEGINNING

  • Partial List of Potential Treatable Conditions

    Osteoarthritis Internal Medicine Gum Regeneration Periodontal Diabetic Ulcers Wound healing Multiple Sclerosis Parkinsons Internal Medicine Cartilage Regeneration Severe Burns

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    Orthopedic and Sports Medicine Tendon Repair Facial Lines and Wrinkles Aesthetic Medicine Heart Damage Chronic Migraine Headache Nerve Damage Bone Regeneration General Surgery Hair Regeneration Blindness and Deafness

    Regenerative Medicine can offer new options and improved outcomes

  • THE INTELLICELL SCIENCE

  • Stromal Vascular Fraction (SVF) Intellicells therapies use Adult Stromal Vascular Cells Derived from Blood Vessels in adipose tissue Capillaries are primary source Same-day clinical procedure High cell counts

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    Blood vessels

    Adipose (fat) cells

    Capillaries

    SVF cellular composition: Adult adipose stem cellsPre-adipocyte cells Endothelial cells Smooth muscle cells Pericytes Fibroblasts Growth factors Blood Cells from capillaries: B &T cells M2 Macrophages (anti-inflammatory)Monocytes Mast cells Natural killer (NK) cells Hematopoietic stem cells Endothelial progenitor cells

  • The Intellicell Process (patent pending)

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    EnzymaticExtraction

    UltrasonicCavitation

    Typical Method Intellicell Method

    Typical Manufacturing Process: SVF is manufactured from adipose tissue using collagenase enzymes,

    particularly Liberase manufactured by Roche

    Intellicell Innovation: We discovered and pioneered the use of ultrasonic cavitation to

    manufacture SVF from adipose tissue

  • The IntelliCell Ultrasound Cavitation R & D

    Over 3 years in development Over 700 tissue samples studied Several mechanical systems tested, ultrasound emerged as best Significant trial and error required to perfect the process Resulted in a process that yields large cell numbers per cc of

    tissue harvested Resulted in a process that demonstrates high cell viability

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  • Ultrasonic Cavitation Enzymatic Extraction

    Typical Method vs. Intellicell Method

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    Cells per ML: 3-8 Million

    Dead Cells: 15-30%

    Debris: 5-15%

    Total Volume of cells: 20 cc

    Total Dose: 50-70 Million Cells

    Cells per ML: 20-30 Million

    Dead Cells: 5-8%

    Debris: 2-6%

    Total Volume of Cells: 40-50 cc

    Total Dose: 500 Million - 1 Billion

    COSTOFDISPOSABLES:$150

    MANUFACTURINGTIME:45to 60MINUTESCOSTOFDISPOSABLES:asmuchas$1500

    MANUFACTURINGTIME:60to120MINUTES

    Extracting SVF from 60 CC of adipose tissue

  • MANUFACTURING PROCESS

  • IntelliCell Cell Process

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    Inject intosite of ailment

    Administerintravenously

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    Lab Procedures All SVF manufactured under FDA "current Good Tissue Practices" (cGTP) IntelliCell has a Director of QA to ensure all procedures fully compliant Each specimen produced will have to be released by a QA manager For remote sites we will employ a Modular Clean Room set up or build out a

    cGTP labAseptic Containment Isolatormeets all FDA tissue handling requirements

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    Evaluation Using a Flow Cytometerlaser that measures cell count and viability

    Release Criteria for use of SVF

    FLOW CYTOMETRY: 80%+ Viability ENDOTOXIN TESTING: within standards GRAM STAIN: negative

    Additional testing: 14-day sterility assay intra-process plating

  • Patent Granted

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    U.S. Patent 8,440,440 & International Patent Application PCT/US2011/64464"ULTRASONIC CAVITATION DERIVED STROMAL OR MESENCHYMAL VASCULAR EXTRACTSAND CELLS DERIVED THEREFROM OBTAINED FROM ADIPOSE TISSUE AND USE THEREOF"

    U.S. Provisional Application No. 61/674,116 "ISOLATION OF STROMAL VASCULAR FRACTION FROM ADIPOSE TISSUE OBTAINED FROM A NON-LIVING SOURCE USING ULTRASONIC CAVITATION"

    Intellicell will be filing additional patents

  • wCompanys Cellular ProductFDA

  • FDA Major Conclusion Points

    wOur Lab process falls under FDA CFR 1271.10 (a) and therefore we believe PHS 361 exempt

    wAlso the cells are utilized under CFR 1271.15 (b) and any clinical claims are made by the physician under the practice of medicine

    wWe operate a fully validated FDA cGTP laboratory with strict SOPs

    wAll our cellular samples are subject to strict QA release criteria and our product is sterile and traceable

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  • MANAGEMENT&

    ADVISORS

  • Management

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    Dr. Steven Victor, Chairman and CEODr. Steven Victor, founder and CEO of IntelliCell, has been at the forefront of clinical product and process development for over 20 years. The patent pending process that Dr. Victor has developed for IntelliCell has been in research for over 4 years. Dr. Victor is a practicing dermatologist in New York City. Dr. Victor's work in regenerative medicine began over a decade ago upon the start of clinical use of autologous fibroblast cells for the purpose of dermal regeneration. Dr. Victor received his medical degree from New York College and a Bachelor of Arts degree from New York University and has held hospital-based teaching positions. He has been sought after to teach physicians new clinical techniques worldwide for over 20 years. Dr. Victor has also been featured in international and local media as an expert in regenerative medicine, medical aesthetics and dermatology.

    Leonard Mazur, Chief Operating OfficerMr. Mazur also serves as an independent Board of Director and is presently the COO of Akrimax Pharma and former COO of Trimaz Pharma. He was CEO of Genesis Pharma sold to Pierre Fabre. At Medicus Pharma he was Ex VP of Sales and Marketing

    Anna Rhodes, Executive VP OperationsMs. Rhodes has been actively involved in the cosmetic and cosmeceuticals industries for over 9 years. From 2001 through 2009, Ms. Rhodes held various executive sales and marketing positions with Victor Cosmeceuticals, Inc. and Victor Products Inc., developing marketing and collateral materials, formulations and training materials for new product launches as well as managing domestic and international distribution. Prior to 2001, Ms. Rhodes held corporate executive managerial and sales positions in the high fashion industry with companies including Calvin Klein, Alberta Ferretti, Michael Kors and Agnona. She was a Magnum Cum Laude graduate of the University of Texas with a Bachelor of Science degree in Business Administration.

  • Management (cont.)Anna Rhodes, Executive VP OperationsMs. Rhodes has been actively involved in the cosmetic and cosmeceuticals industries for over 9 years. From 2001 through 2009, Ms. Rhodes held various executive sales and marketing positions with Victor Cosmeceuticals, Inc. and Victor Products Inc., developing marketing and collateral materials, formulations and training materials for new product launches as well as managing domestic and international distribution. Prior to 2001, Ms. Rhodes held corporate executive managerial and sales positions in the high fashion industry with companies including Calvin Klein, Alberta Ferretti, Michael Kors and Agnona. She was a Magnum Cum Laude graduate of the University of Texas with a Bachelor of Science degree in Business Administration.

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  • Board of Advisors Dr James Andrews, Sports Orthopedics Andrews Institute for Sports Medicine Dr Joshua Hackel, Andrews Sports Medicine Center, Florida Dr Sydney Coleman, Plastic Surgeon, New York Dr Greg Cavaliere, Orthopedic Surgeon, NY Rangers Dr Anthony Maddalo, Orthopedic Surgeon, NY Rangers Dr Nicholas Toscano, Periodontitis, Editor in Chief JIAD Dr Peter Bruno, Internist, New York City Fred Frank Vice-Chairman PJ Solmon, former Merrill Lynch healthcare banker Jack Schneider, former President Allen & Co. Dr Eric Richter, Neurologist, Chief LSU

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    Board of Directors Dr Steven Victor, Chairman & CEO, IntelliCell BioSciences Leonard Mazur, COO Triax, former EVP Sales & Marketing, Medicis Michael Hershman, Founder and CEO the Fairfax Group Myron Houbliak, former President Roche Therapeutics Inc. Sam Khashman, CEO of Imagine Technologies

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    Scientific Advisory Board (SAB)To assist the company in its clinical development programs, IntelliCell has assembled a scientific advisory board consisting of world-renowned researchers and experts in the field of Regenerative Medicine:

    Professor Joachim Kohn (Rutgers University) Professor Jon Dobson (University of Florida) Professor Jared Bushman (Rutgers University) Professor Laith Jazrawi (New York University)

  • Subject Matter SpecialistsBiologics Consulting Group

    Andra E. Miller Ph.D. - Senior Consultant, Director Cell and Gene Therapies. 9 years experience as a molecular biologist and product reviewer with the FDA.

    Stephen Rhodes M.S. - Senior Consultant. Over 20 years of management experience with the FDA Center for Devices and Radiological Health.

    Holly Scott - Senior Consultant. 20 years of multi-office compliance experience with the FDA, including 4 years as a Consumer Safety Officer with FDA/CBER, and 15 years as a Field Investigator with the FDA Office of Regulatory Affairs/ Florida District Office.

    Buchanan Ingersoll & Rooney, PC

    Edward John Allera focuses on the development of new products and business opportunities in the areas of pharmaceuticals and technology, especially regarding the regulation and promotion of drugs, biologics and devices.

    Theodore M. Sullivan counsels clients subject to FDA regulations, advising in matters related to over-the-counter drug regulation, drug exclusivity issues, food and dietary supplement labeling and advertising and import detention of FDA-regulated products.

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