Presentation on theme: "Ortec International, Inc. Developing Innovative Products To Advance Regenerative Medicine."— Presentation transcript:
Ortec International, Inc. Developing Innovative Products To Advance Regenerative Medicine
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.
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
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
Cryopreserved vs. “Fresh” OrCel ® Longer Shelf Life Guaranteed Quality Immediately Available to End User Reduced Cost of Production Inventory Management
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
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)
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
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
® OrCel ® COMPETITIVE LANDSCAPE Dermagraft Integra Regranex Unilayered Dermal or Epidermal Cells Acellular Bilayered Dermal and Epidermal Cells OrCel Apligraf Graftjacket Other: Oasis, Collagen Etc.
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
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
% of patients achieving 100% wound closure Diabetic Pilot Results 47% 23% OrCel® Standard of Care Pilot Diabetic Foot Ulcer Data - OrCel ® Heals Wounds Faster
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
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
Ortec International, Inc. (OTCBB: OTCI.OB) www.ortecinternational.com
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