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Ortec International, Inc. Developing Innovative Products To Advance Regenerative Medicine.

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Presentation on theme: "Ortec International, Inc. Developing Innovative Products To Advance Regenerative Medicine."— Presentation transcript:

1 Ortec International, Inc. Developing Innovative Products To Advance Regenerative Medicine

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 Ortec’s Annual Report on form 10-KSB and other filings with the Securities and Exchange Commission.

3 Ortec Overview  Founded 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 will be 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 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 OrCel ® Provides An Optimal Environment For Stimulating Accelerated Skin Regeneration and Wound Healing Unique Characteristics of OrCel ® Allogeneic Fibroblasts Allogeneic Keratinocytes

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

7  FDA HDE approval, (fresh) OrCel ® in RDEB hand surgery and chronic wounds (2001)  FDA PMA approval for (fresh) OrCel ® in burn Donor Sites (2001)  IDE to test cryopreserved OrCel ® in VLU (2002)  Completed VLU Phase III clinical trial  Clinical Data will be submitted in October 2007  Strategic alliance with Lonza  Commercial Manufacturing in Walkersville, MD  Reimbursement set at $1,100  Approval to initiate Phase III DFU Trial OrCel ® Overview

8 Overview of OrCel ® ’s Venous Leg Ulcer Pivotal Trial Results OrCel ® shows improvement over standard of care in typical venous leg ulcer (VLU) population  59% of OrCel ® treated patients achieved 100% wound closure in comparison to 36% for the control (p=0.034)  OrCel ® treated patients had significantly faster healing (p=0.017)  OrCel ® treated patients had a faster rate of healing at each visit (p<0.0001)

9 Confirmatory Venous Leg Ulcer Trial  12- week trial designed to confirm the superiority of OrCel ® in healing venous leg ulcers  61 patients – conducted at 12 centers combined with the patients of the original Phase III trial  Combined data evaluated using Bayesian Statistical method requested by FDA  Statistical significance achieved for both primary clinical endpoints  Incidence of 100% wound closure  Acceleration of wound closure

10 Chronic Wounds & Severe Burns – U.S. Market (2004) Total Patients = 3.8 Million Pressure Ulcer Severe Burns Diabetic Foot Ulcer Venous Ulcer Source: CDC, NIH, Published Estimates

11 ® OrCel ® COMPETITIVE LANDSCAPE Dermagraft Integra Regranex Unilayered Dermal or Epidermal Cells Acellular Bilayered Dermal and Epidermal Cells OrCel Apligraf Graftjacket Other: Oasis, Collagen Etc.

12 OrCel  in Donor Site Healing (Independent Physician Evaluation: Donor Site Treated with both OrCel  & Apligraf  ) OrCel  Apligraf OrCel  : Fast healing of acute wounds with less inflammation

13 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  Cost of treating venous leg ulcers approach $1 billion annually

14 % of patients achieving 100% wound closure Diabetic Pilot Results 47% 23% OrCel® Standard of Care Pilot Diabetic Foot Ulcer Data - OrCel ® Heals Wounds Faster

15 Projected PMA Timeline  February 2007: Submission of manufacturing process (CMC)  October 2007:Submission of the clinical data  January 2008:Expected FDA response  April / May 2008:PMA Approval  September 2008:Launch OrCel in US  January 2009:Begin DFU Clinical Trial

16 Ortec’s Key Value Considerations  Near term Pre Market Approval (PMA) submission for venous leg ulcer indication  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

17 Ortec International, Inc. (OTCBB: OTCI.OB)

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