forticell bioscience, inc. developing innovative products to advance regenerative medicine costa...
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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
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.
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
Clinical Application of Clinical Application of OrCelOrCel®® in VLU in VLU
• 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
Cryopreserved vs. Cryopreserved vs. Fresh Fresh
Longer Shelf Life
Guaranteed Quality
Immediately Available to End User
Reduced Cost of Production
Inventory Management
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.
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
Days to 100% Wound Days to 100% Wound Closure by Investigator Closure by Investigator
AssessmentAssessment
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
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
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
% 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
Haptides™ PlatformHaptides™ Platform
Haptides are a soluble synthetic version of the fibrinogen cell attachment
peptide sequence
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
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
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
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
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
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
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
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www.forticellbioscience.comwww.forticellbioscience.com