The World’s only known robotic, LED based, smear microscope for TB screening!

Facts about TB incidence With 8.8 Mi new cases annually and almost 2 Mi deaths, TB is still a leading mortality factor Overall, one-third of the world's population is currently infected with the TB bacillus. 10% of people who are infected with TB bacilli (but who are not infected with HIV) become sick or infectious at some time during their life. TB is the leading killer of people with HIV 27 countries account for 85% of MDR-TB cases There is huge need for tools that correspond to the medical need at affordable price (WHO report) Annually over USD 1 Bi wss spent on TB diagnostics in 2009, and the sum is increasing Nearly 5,000 people die from TB daily, a curable disease in most cases !! Source WHO

Further Facts The most commonly used sputum smear microscopy is more than 100 years old, but is the most affordable for the majority of HBC countries Traditionally executed, it is also the most ineffective, detects only half of patients tested with currently used manual method, mainly due to low sensitivity, lack of well trained personel, tiring factor. Todays TB drugs are more then 40 years old and have to be taken for 6-9 months Todays TB vaccine is more than 85 years old Delay in assessing proper diagnostics costs time, money and leads to continued transmission of infections TB drains 12 billion USD from the annual incomes of the poorest communities Loss of productivity attributable to TB approaches 7% of GDP in some countries There is urgent need for more accurate and rapid diagnostic tests (WHO, FIND) Source WHO

The Shocking Facts about TB

TB Burden Source WHO

Current market (WHO) Source WHO

Sputum smear diagnosis of TB: Light source microscopy ZN staining The fastest and cheapest available method Good specificity Weak sensitivity Trained staff needed Time consuming,10– 15 min./slide Traditional Fluorescence microscopy Increased sensitivity More expensive Faster, less tiresome Maintenance requirements (mercury vapour lamps)

Current smear market (WHO) Source WHO

The Global Revised WHO Plan 2011-2015

Current smear market Source WHO

- Potential smear market 200 M tests (WHO) Market cont. Current assumptions: Number of microscopy centers ~70K (58K public, 12K private) 20% of microscopes should be replaced by LED by 2015 (WHO) 1 smear laboratory/ 100 000 population should be reached by 2015 (WHO) - Potential smear market 200 M tests (WHO) Source WHO

Fluorobot: the only fully automated, dedicated solution Based on the traditional smear microscopy principle LED fluorescent technique Fully automated Input / output and moving of the slides Image capturing and analysis Intelligent bacterium recognition algorythms Long walk away time Low cost, robust design suitable for high incidence, high burden countires Small footprint High throughput (25 smears/hour) Competitive cost/test

Main Features Illumination system using LED technology, much less sensitive, longer lifetime and cheaper than mercury vapour lamps Robust, cost effective X-Y movement Special, fast focusing system Cost effective, simplified light path, optimised for a single magnification Dedicated image processing and pattern recognition algorithms used for bacteria identification Huge walk away window, batch processing of 100 – 250 slides Standardised quality, no tiring effect No trained microscope reading staff needed

Major milestones Feasibility Study in Q1 2009 Functional Model stage was successfully reached Q4 2009 Laboratory Sample Stage was reached at Q3 2010 „Proof Of Principle” study was conducted at German TB Reference Laboratory, WHO Supranational Laboratory at Borstel led by Dr. Rüsch-Gerdes in September 2010, with positive outcome „Letter Of Intent” was signed with FIND (Foundation for Innovative New Diagnostics, Geneva) in November 2010 Financing Partner is searched in, to carry the project through Prototype Development (Q3 2013) and Validation (Q4 2013) Industrialization and Test Production Planned Q3 2014 GoLive of final product (and disposable) planned Q4 2014

The Road behind our development team Core team has more than 15 years experience in medical imaging and robotic microscopy Main project in the early 90s was the Seditron urine sediment analyzer developed and produced for Boehringer Mannheim

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