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Quick facts
Corporate Overview
- Founded in 1991 to develop tissue-engineered product
now known as OrCel®
- Publicly traded company since 1996 (OTCBB:OTCI)
- Raised nearly $150 million to fund research and development
efforts
- Fully integrated organization with approximately 40 employees
- FDA approved cGMP pilot manufacturing facility
- Initial focus on treatment of
acute and chronic wounds – granted
two FDA product approvals for non-cryopreserved OrCel®
- Expected near term submission of Premarket Application
(PMA) for cryopreserved OrCel® for use in
Venous Leg Ulcers (VLU)
- Strategic partnership with Lonza (SWX:LONZA) (formerly Cambrex)
- Commercial Manufacturing
- Sales and Marketing
- Ortec retains 66% – 73%
of Sales Revenue
- Recent acquisition of two new patented biomaterial platform
technologies: Fibrin Microbeads and Haptides™ for
broad spectrum applications in tissue regeneration/repair
and stem cell R&D and therapeutics
Recent and Projected OrCel® Milestones
- Completed initial VLU Phase III clinical trial on
136 patients
- Completed 60-patient Phase III confirmatory trial
- Announced positive top line results of the Phase III
data, August 2006
- Received FDA approvable letter to market to EB patients,
September 2006
- Strategic alliance with Lonza (SWX:LONZA)
(formerly Cambrex)
- Reimbursement for OrCel® set
at $1100
- Filed Pre Market Approval (PMA) application for Venous Leg Ulcers (VLU)
- Received FDA approval to initiate Phase
III DFU trial
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