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Forticell Bioscience, Inc

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Presentation on theme: "Forticell Bioscience, Inc"— Presentation transcript:

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

2 Safe Harbor Statement 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.

3 Forticell 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

4 Clinical Application of OrCel® in VLU

5 Unique Characteristics of OrCel®
OrCel® Provides An Optimal Environment For Stimulating Accelerated Skin Regeneration and Wound Healing Unique Characteristics of OrCel® 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 Allogeneic Keratinocytes Allogeneic Fibroblasts

6 Cryopreserved vs. Fresh
Longer Shelf Life Guaranteed Quality Immediately Available to End User Reduced Cost of Production Inventory Management

7 Overview of OrCel®’s Venous Leg Ulcer Pivotal Trial Results
OrCel® treated patients healed faster and in larger numbers than Standard of Care (SoC) patients. 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.

8 Percentage of Subjects Healed at Each Week
p value=0.0290 Percent of Subjects Healed Weeks

9 Days to 100% Wound Closure by Investigator Assessment

10 Chronic Venous Leg Ulcers Prevalence
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

11 Achieving Market Success
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 Market conditions are conducive for us to be successful. Advanced wound care has evolved as the preferred option to treat chronic wounds and we offer the most advanced product. More physicians are aware and educated in the tissue engineered and advanced wound care products which have been introduced into the market place within the last few years. Reimbursement has been achieved making the ability to penetrate much easier than it was for the first entrants into the market. A number of products have been commercialized; some quite successfully, but the market still awaits the optimal product and OrCel fills that niche.

12 Sales Projections First year: ~ 10,000 units ~ $10 mm Second year:
Third year: ~ 40 – 50,000 units ~ $40 – 50 mm

13 Pilot Diabetic Foot Ulcer Data - OrCel® Heals Wounds Faster
Diabetic Pilot Results % of patients achieving 100% wound closure 47% 23% OrCel has shown to be effective in treating DFUs, as well, were OrCel showed a 104% improvement over standard of care in ulcers <6cm2 or less. This was a 40 patient - 12 week study – clinical endpoint was 100% healing. Daily rate of healing was almost double in comparison to the standard of care. These results were published in July 2003 peer reviewed journal “Wounds”. Based on these results, we have obtained approval to begin DFU pivotal trial. We expect to do so upon completion of the VLU confirmatory trial. OrCel® Standard of Care

14 Haptides™ Platform Haptides are a soluble synthetic version
of the fibrinogen cell attachment peptide sequence

15 Licensing and Co-Development Opportunities for Haptides™ Technology
Chronic wound healing Periodontal regeneration Orthopedic implants Dermal soft tissue augmentation Industrial scale microcarrier cell culture

16 Haptide Treated Collagen Preclinical Validation of Enhanced 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

17 Novel Biomatrix Enabling Stem Cell Therapy
Fibrin MicroBeads Novel Biomatrix Enabling Stem Cell Therapy 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

18 FMB Stem Cell Enabling Product and Competition Advantages
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

19 Projected PMA Timeline
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

20 Ortec’s Key Value Considerations
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

21 Capital Structure Common Shares (Including Restricted and Penny Warrants) ,561,000 Preferred Share Common Stock Equivalent (upon conversion) 36,420,000 TOTAL ,981,000 Warrants & Stock Options (Avg exercise price $0.95) ,183,000 Fully Diluted Common Stock and Equivalents ,164,000 Stock November 20, $0.50 (FORB )

22 ( F O R B ) www.forticellbioscience.com


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