ortec international, inc. developing innovative products to advance regenerative medicine
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Safe Harbor StatementSafe 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 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
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. “Fresh” OrCel®
Longer Shelf LifeGuaranteed Quality Immediately Available to End UserReduced 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
OrCelOrCel®® Overview Overview
Overview of Overview of OrCelOrCel®®’s’sVenous Leg Ulcer Pivotal Trial Venous Leg Ulcer Pivotal Trial
Results 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 Confirmatory Venous Leg Ulcer TrialUlcer 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)
1%28%
27%
44%
Total Patients = 3.8 Million
Pressure Ulcer
Severe BurnsDiabetic Foot Ulcer
Venous Ulcer
Source: CDC, NIH, Published Estimates
OrCel®®
COMPETITIVE LANDSCAPE
DermagraftDermagraft
IntegraIntegraRegranexRegranex
UnilayeredDermal or Epidermal Cells
Acellular
BilayeredDermal
and Epidermal Cells
OrCelOrCel ApligrafApligraf
GraftjacketGraftjacket
Other: Oasis,
Collagen Etc.
Other: Oasis,
Collagen Etc.
OrCel in Donor Site Healing(Independent Physician Evaluation:
Donor Site Treated with both OrCel & Apligraf)
OrCel
ApligrafOrCel: 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
% ofpatients achieving
100% wound closure
Diabetic Pilot Results
47%
23%
OrCel® Standard of Care
Pilot Diabetic Foot Ulcer Data - Pilot Diabetic Foot Ulcer Data - OrCelOrCel®® Heals Wounds Faster 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 Ortec’s Key Value ConsiderationsConsiderations
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