IIP Technologies GmbH, Bonn Our Vision: To become the - PowerPoint PPT Presentation

IIP Technologies GmbH, Bonn Our Vision: To become the market leader of learning implantable medical devices allowing patients to compensate for their loss of vision and other disabling neurological deficits. www.iip-tec.com

The Company • Founded 2002 in Bonn, Germany • Basic research work done in Intelligent Implants GmbH in Bonn (from 1998 - 2002) • Co-Founders: Mr. Steffen Suchert and Prof. Rolf Eckmiller • Human Resources: approx. 25 people - (primarily Ph.D‘s / Engineers) - experienced management team

Unmet Need for Secondary Blindness Normal Retinitis Pigmentosa Age-related Macula Degeneration (AMD)

Current Therapeutic Approaches • Transplantation • Pharmaceutical Therapy • Nutrition / Supplements • Gene Therapy • Visual Prosthetics („Chip“)

History of „Retinal Implant“ • Research efforts started around 20 years ago • Principle: Electrical stimulation of remaining cells • Scientific basis: Experience with Cochlear implants however visual system is much more complex • Larger number of electrodes • Surgical procedure • Biocompatibility • Degree of compensation by the brain • Approx. 10 research groups / companies active worldwide

Market Potential Germany Europe Global Retinitis Pigmentosa 30 000 - 60 000 > 90 000 > 1 million (RP) Thereof blind 10 000 - 15 000 > 30 000 > 300 000 Age-Related Macula > 5 million 230 000 > 500 000 Degeneration (AMD) Thereof blind 25 000 > 55 000 > 500 000

Our Approach – The Learning Retinal Implant System Retina Stimulator Stimulation Data IR-Transmission Energy Transmission Radio Frequency Visual Interface Camera Stimulation Power Wire Data Wire Wire Stimulation Pre- Generation processing Re-chargeable (Algorithms) batteries Parameter table PC (adaptive during learning process) Fitting Pocket Processor Software

The Implant: Extra-occular approach

Clinical Development Strategy Proof of Principle Acute clinical trial (20 patients suffering from Retinitis Pigmentosa) Point 1-2 electrodes Proof of Feasibility Pattern Early Chronic Human Trial (3 to 5 Retinitis Pigmentosa patients) 49 electrodes Pivotal Trial for CE mark and FDA approval Picture Pivotal Trial (approx. 70 patients) 231 electrodes

Point • Acute clinical trial • Successful completion of acute clinical study with patients suffering from Retinitis Pigmentosa (RP) in 2004 • Concept : increasing levels of stimulation triggered several times during a period of 45 minutes to determine stimulation thresholds • Key result : 19 out of 20 patients reported that visual perception had been triggered by electrical stimulation • Proof of principle that epiretinal electrical stimulation works in most patients with RP

Point • PI-foil for the acute clinical trial

Pattern: • Early Chronic Human Trial • Start: Q4-2005, Europe • Concept : long term implantation of implant with 49 electrodes in 3 to 5 Retinitis Pigmentosa patients for up to 18 months (results after 1-2 months) • Key end point of feasibility study: differentiation between simple objects

49 electrode implant Pattern

Picture • Pivotal Trial • Start: Q4-2006 Europe Q2 2007 U.S. • Concept : Multi-center study in EU and U.S. on approx. 70 patients; 3 months enrollment, 3 months surgical procedures, 6 (EU) to 12 months (U.S.) follow-up (safety) • Study endpoint: Test of orientation capabilities of patients in unknown environment (mobility test) • Pre-IDE FDA-Meeting (June 2005): positive feedback on pre-clinical / clinical program

Picture: Simulation of the visual perception

Key Milestones • Early Chronic Human Trail to start by end 2005 • Design freeze for the final Implant system in Q1/2006 • Prototypes of the Entire System available in Q2/2006 • First series production finalized in Q4/2006 • Start pivotal trail end Q4/2006 • CE-Mark: Q IV/2007

Financial Milestones • Funds used: € 20 million • Current burn rate: € 450 k / month • Current capital approx. € 3-5 million increase: • Next capital increase: approx. € 12-15 million

Marketing Strategy • Optimise selection: Competence Patient Small number, high impact, Potential Centre rehabilitation • Clinical trials: Pre-marketing tool Reimburse- • Global approach ment • Strategic partnership (USA)

Thank you IIP-Technologies GmbH � Bonn www.iip-tec.com