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Forticell Bioscience, Inc. Forticell Bioscience, Inc. Developing Innovative Products To Advance Regenerative Developing Innovative Products To Advance Regenerative Medicine Medicine COSTA PAPASTEPHANOU, Ph.D. COSTA PAPASTEPHANOU, Ph.D. Chief Executive Officer Chief Executive Officer

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Page 1: Forticell Bioscience, Inc. Developing Innovative Products To Advance Regenerative Medicine COSTA PAPASTEPHANOU, Ph.D. Chief Executive Officer

Forticell Bioscience, Inc.Forticell Bioscience, Inc. Developing Innovative Products To Advance Regenerative Developing Innovative Products To Advance Regenerative

MedicineMedicine

COSTA PAPASTEPHANOU, Ph.D.COSTA PAPASTEPHANOU, Ph.D.Chief Executive OfficerChief Executive Officer

Page 2: Forticell Bioscience, Inc. Developing Innovative Products To Advance Regenerative Medicine COSTA PAPASTEPHANOU, Ph.D. Chief Executive Officer

Safe Harbor Safe Harbor StatementStatement

This presentation contains forward-looking statements, including, without limitation, statements concerning product-development objectives and anticipated timing, clinical trial timing, and expected results, potential market opportunities and revenue models, market development plans, anticipated key milestones and potential advantages and applications, which involve certain risks and uncertainties. Actual results may differ significantly from the expectations contained in the forward-looking statements.

Among the factors that may results in differences are the results obtained from clinical trials and development activities, regulatory approval requirements, competitive conditions and availability of resources.

These and other significant factors are discussed in greater detail in Forticell’s Annual Report on form 10-KSB and other filings with the Securities and Exchange Commission.

Page 3: Forticell Bioscience, Inc. Developing Innovative Products To Advance Regenerative Medicine COSTA PAPASTEPHANOU, Ph.D. Chief Executive Officer

Forticell OverviewForticell Overview

Founded as Ortec in 1991 Lead Product – OrCel®, a “skin substitute” wound care

product Superior efficacy / Ease of Use / Distribution advantages Strong patent coverage Addressable markets in excess of $1 billion Completed Phase III trial for Venous Leg Ulcers (VLU)

PMA filed in October 2007

FDA Approval to initiate Pivotal (Phase III) trial for Diabetic Foot Ulcers

Acquired two advanced biomaterial platform technologies Fibrin Microbeads for adult stem cell isolation and therapy Haptide® peptides for soft tissue augmentation and regeneration

Page 4: Forticell Bioscience, Inc. Developing Innovative Products To Advance Regenerative Medicine COSTA PAPASTEPHANOU, Ph.D. Chief Executive Officer

Clinical Application of Clinical Application of OrCelOrCel®® in VLU in VLU

Page 5: Forticell Bioscience, Inc. Developing Innovative Products To Advance Regenerative Medicine COSTA PAPASTEPHANOU, Ph.D. Chief Executive Officer

• Bi-layered

-optimal growth factor mix• Open collagen scaffold -deposited biomatrix -cell migration -re-vascularization

• Immature cells

-highly productive

-proliferative

-induce rapid regeneration

• Cryopreserved -extended shelf life -ease of distribution

OrCelOrCel®® Provides An Optimal Environment For Provides An Optimal Environment For Stimulating Accelerated Skin Regeneration and Stimulating Accelerated Skin Regeneration and

Wound HealingWound Healing

Unique Characteristics of OrCel®Unique Characteristics of OrCel®

AllogeneicFibroblasts

AllogeneicKeratinocytes

Page 6: Forticell Bioscience, Inc. Developing Innovative Products To Advance Regenerative Medicine COSTA PAPASTEPHANOU, Ph.D. Chief Executive Officer

Cryopreserved vs. Cryopreserved vs. Fresh Fresh

Longer Shelf Life

Guaranteed Quality

Immediately Available to End User

Reduced Cost of Production

Inventory Management

Page 7: Forticell Bioscience, Inc. Developing Innovative Products To Advance Regenerative Medicine COSTA PAPASTEPHANOU, Ph.D. Chief Executive Officer

Overview of OrCelOverview of OrCel®®’s’sVenous Leg Ulcer Pivotal Trial Venous Leg Ulcer Pivotal Trial

ResultsResults

50% of OrCel® treated patients achieved 100% wound closure in

comparison to 31% for SoC patients (p=0.0141) Median time to healing for treated patients was 77 days while

median time to healing was not achieved with SoC patients Mean days to healing was 63.7 days for OrCel® treated

patients and 74.6 days for SoC (p=0.0113) OrCel treated patients had a faster rate of healing at each visit

(p<0.0001) Durability of healing was better in OrCel® treated patients

compared to SoC treated patients (87%) vs. 78%) and

the mean time to ulcer recurrence in the SoC group was

92 days vs. 113 days for the OrCel® group.

OrCel® treated patients healed faster and in larger numbers than Standard of Care (SoC) patients.

Page 8: Forticell Bioscience, Inc. Developing Innovative Products To Advance Regenerative Medicine COSTA PAPASTEPHANOU, Ph.D. Chief Executive Officer

Percentage of Subjects Healed at Percentage of Subjects Healed at Each WeekEach Week

p value=0.0290

Pe

rce

nt

of

Su

bje

cts

He

ale

d

Weeks

Page 9: Forticell Bioscience, Inc. Developing Innovative Products To Advance Regenerative Medicine COSTA PAPASTEPHANOU, Ph.D. Chief Executive Officer

Days to 100% Wound Days to 100% Wound Closure by Investigator Closure by Investigator

AssessmentAssessment

Page 10: Forticell Bioscience, Inc. Developing Innovative Products To Advance Regenerative Medicine COSTA PAPASTEPHANOU, Ph.D. Chief Executive Officer

Chronic Venous Leg Ulcers Chronic Venous Leg Ulcers PrevalencePrevalence

As the US population ages (35.9 million over 65 years of age and 4.7 million over 85), the incidence of chronic wounds is expected to rise significantly, with estimates of 5 to 7 million chronic and complex wounds projected.

Venous leg ulcers are the most common type of chronic wounds with an incidence of 2.5 million each year. The prevalence rises dramatically with age and affects more than 1% of those over 60.

VLU’s account for the loss of 2 million workdays a year. Cost of treating leg ulcers is $2-3 billion/year

$1 billion for out-patient care alone $27,000 per episode

Page 11: Forticell Bioscience, Inc. Developing Innovative Products To Advance Regenerative Medicine COSTA PAPASTEPHANOU, Ph.D. Chief Executive Officer

Achieving Market Achieving Market SuccessSuccess

Established Market – Tissue engineering is now a real option in wound care

Educated Physicians - First entrants paved the way in education

VLU/DFU market still waiting for optimal product

Serious and costly medical issue

Page 12: Forticell Bioscience, Inc. Developing Innovative Products To Advance Regenerative Medicine COSTA PAPASTEPHANOU, Ph.D. Chief Executive Officer

Sales Sales ProjectionsProjections

First year:– ~ 10,000 units ~ $10 mm

Second year:– ~ 20,000 units ~ $20 mm

Third year:– ~ 40 – 50,000 units ~ $40 – 50 mm

Page 13: Forticell Bioscience, Inc. Developing Innovative Products To Advance Regenerative Medicine COSTA PAPASTEPHANOU, Ph.D. Chief Executive Officer

% ofpatients achieving

100% wound closure

Diabetic Pilot Results

47%

23%

OrCel® Standard of Care

Pilot Diabetic Foot Ulcer Pilot Diabetic Foot Ulcer Data - Data -

OrCelOrCel®® Heals Wounds Faster Heals Wounds Faster

Page 14: Forticell Bioscience, Inc. Developing Innovative Products To Advance Regenerative Medicine COSTA PAPASTEPHANOU, Ph.D. Chief Executive Officer

Haptides™ PlatformHaptides™ Platform

Haptides are a soluble synthetic version of the fibrinogen cell attachment

peptide sequence

Page 15: Forticell Bioscience, Inc. Developing Innovative Products To Advance Regenerative Medicine COSTA PAPASTEPHANOU, Ph.D. Chief Executive Officer

Licensing and Co-Development Licensing and Co-Development Opportunities for Haptides™ Opportunities for Haptides™

Technology Technology

Chronic wound healing

Periodontal regeneration

Orthopedic implants

Dermal soft tissue augmentation

Industrial scale microcarrier cell culture

Page 16: Forticell Bioscience, Inc. Developing Innovative Products To Advance Regenerative Medicine COSTA PAPASTEPHANOU, Ph.D. Chief Executive Officer

Haptide Treated CollagenHaptide Treated CollagenPreclinical Validation of Preclinical Validation of

Enhanced Cell AttachmentEnhanced Cell Attachment

Improved cell attachment and growth in vitro by 40-50%

Increased cell migration from surrounding dermis

Very low inflammation

Well integrated into surrounding tissue

Passed all safety, biocompatibility, and toxicology tests (ICH/ FDA)

Promising results in implantation studies in vivo

Peer-reviewed publication

Page 17: Forticell Bioscience, Inc. Developing Innovative Products To Advance Regenerative Medicine COSTA PAPASTEPHANOU, Ph.D. Chief Executive Officer

Fibrin MicroBeads (Fibrin MB): cross-linked, heat-treated Fibrin beads that can be used to isolate matrix-dependent cells, including Mesenchymal-type Adult Stem Cells

In Vitro and In Vivo proof of principle of stem cell isolation, expansion and differentiation

Published data Valuable Unique Intellectual Property

Five U.S. Patents Issued Received notice of allowance for European Patent Five publications in peer reviewed journals

Valuable licensing opportunity Significant advantages over comparable technologies

Fibrin MicroBeadsFibrin MicroBeadsNovel Biomatrix Enabling Stem Cell Novel Biomatrix Enabling Stem Cell

TherapyTherapy

Page 18: Forticell Bioscience, Inc. Developing Innovative Products To Advance Regenerative Medicine COSTA PAPASTEPHANOU, Ph.D. Chief Executive Officer

FMB Stem Cell Enabling FMB Stem Cell Enabling Product and Competition Product and Competition

AdvantagesAdvantages Recovery, expansion, differentiation and

delivery possible on same matrix

Adaptable to all sources of adult MSC Peripheral blood Bone Marrow Adipose tissue Cord Blood

Minimizes complex and costly aseptic culture process

Page 19: Forticell Bioscience, Inc. Developing Innovative Products To Advance Regenerative Medicine COSTA PAPASTEPHANOU, Ph.D. Chief Executive Officer

Projected PMA Projected PMA TimelineTimeline

February 2007: Submission of manufacturing process (CMC)

October 2007: Submission of the clinical data

January 2008: Expected FDA response

June / July 2008: PMA Approval

September 2008: Launch OrCel in US

January 2009: Begin DFU Clinical Trial

Page 20: Forticell Bioscience, Inc. Developing Innovative Products To Advance Regenerative Medicine COSTA PAPASTEPHANOU, Ph.D. Chief Executive Officer

Ortec’s Key Value Ortec’s Key Value ConsiderationsConsiderations

Pre Market Approval (PMA) submission for venous leg ulcer indication completed

Potential initiation of revenue in 2008 upon FDA approval;

 Strong patent position – withstood two patent challenges Limited competition - One direct competitor (Apligraf)

CMS reimbursement in place Reimbursement currently in excess of $1,100 per application

Approval to initiate Phase III clinical for use of OrCel in diabetic foot ulcers.

Potentially two additional valuable technologies applicable to growing area of regenerative medicine including cosmetic applications

Multiple licensing opportunities Valuable IP in adult stem cell space Issued patents for cell attachment technology

Historically low market value

Page 21: Forticell Bioscience, Inc. Developing Innovative Products To Advance Regenerative Medicine COSTA PAPASTEPHANOU, Ph.D. Chief Executive Officer

Capital StructureCapital Structure

Common Shares (Including Restricted and Penny Warrants) 13,561,000

Preferred Share Common Stock Equivalent (upon conversion) 36,420,000

TOTAL 49,981,000

Warrants & Stock Options (Avg exercise price $0.95) 51,183,000

Fully Diluted Common Stock and Equivalents 101,164,000

Stock Price @ November 20, 2007 $0.50

(FORB )

Page 22: Forticell Bioscience, Inc. Developing Innovative Products To Advance Regenerative Medicine COSTA PAPASTEPHANOU, Ph.D. Chief Executive Officer

( F O R B )( F O R B )

www.forticellbioscience.comwww.forticellbioscience.com