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

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

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

Ortec International, Inc. Developing Innovative Products To Advance Regenerative

Medicine

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

Clinical Application of

OrCel® 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. “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

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

www.ortecinternational.com