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

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

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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

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www.iip-tec.com

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.

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  • 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

The Company

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Unmet Need for Secondary Blindness

Retinitis Pigmentosa Age-related Macula Degeneration (AMD) Normal

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

Current Therapeutic Approaches

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  • 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

  • Approx. 10 research groups / companies active worldwide

History of „Retinal Implant“

  • Larger number of electrodes
  • Surgical procedure
  • Biocompatibility
  • Degree of compensation by the brain
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> 5 million > 500 000 > 500 000 > 55 000 230 000 Thereof blind 25 000

Age-Related Macula Degeneration (AMD) Global

> 1 million > 300 000

Europe

> 90 000 > 30 000

Germany

30 000 - 60 000 Thereof blind 10 000 - 15 000

Retinitis Pigmentosa (RP)

Market Potential

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Our Approach – The Learning Retinal Implant System

Camera Wire Stimulation Data Wire Power Wire Stimulation Data IR-Transmission Energy Transmission Radio Frequency

Visual Interface Retina Stimulator

Pre- processing Stimulation Generation (Algorithms) Re-chargeable batteries Parameter table (adaptive during learning process)

Pocket Processor Fitting Software

PC

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The Implant: Extra-occular approach

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Clinical Development Strategy

Acute clinical trial (20 patients suffering from Retinitis Pigmentosa) Proof of Principle Early Chronic Human Trial (3 to 5 Retinitis Pigmentosa patients) Pivotal Trial (approx. 70 patients) Proof of Feasibility Pivotal Trial for CE mark and FDA approval Point Pattern Picture

1-2 electrodes 49 electrodes 231 electrodes

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  • 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

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  • PI-foil for the acute clinical trial

Point

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  • 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

Pattern:

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Pattern

49 electrode implant

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  • 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

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Picture: Simulation of the visual perception

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  • 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

Key Milestones

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  • Funds used:

€ 20 million

  • Current burn rate:

€ 450 k / month

  • Current capital
  • approx. € 3-5 million

increase:

  • Next capital increase:
  • approx. € 12-15 million

Financial Milestones

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Marketing Strategy

Competence Centre Reimburse- ment Patient Potential

  • Optimise selection:

Small number, high impact, rehabilitation

  • Clinical trials:

Pre-marketing tool

  • Global approach
  • Strategic partnership (USA)
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Thank you

IIP-Technologies GmbH Bonn www.iip-tec.com