The World

1
The Worlds first robotic, LED based, smear
microscopefor TB screening!
The Tireless Technician!
2
Facts about the TB burden

• With 8.8 Mi new cases annually and almost 1,5 Mi
  deaths, TB is still a leading mortality factor
• TB is the leading killer of people with HIV
• 22 HBC (High Burden Country) countries account
  for 80 of the incidence
• Annually over USD 1 Bi was spent on TB
  diagnostics in 2009, and the sum is increasing
• 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
• In 2009 there were 9,7 million orphan children a
  a result of TB deaths

Nearly 4,000 people die from TB daily, a curable
disease in most cases !!
Source WHO
3
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 little more then 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
  infectionsThere is huge need for tools that
  correspond to the medical need at affordable
  price (WHO report)

There is urgent need for more accurate and rapid
diagnostic tests (WHO, FIND)
Source WHO
4
TB Burden in 2009
Source WHO
5
TB Diagnostics market in 2009
Source WHO
6
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)

7
The smear market in 2009
Source WHO
8
The Global Revised WHO Plan 2011-2015
9
Microscopy market in 2009
Source WHO
10
Market cont.

• Current assumptions
• Number of microscopy centers was 70K (58K
  public, 12K private) in 2009
• 1 smear laboratory/ 100 000 population should be
  reached by 2015 (WHO)
• 20 of microscopes should be replaced by LED by
  2015 (WHO)

- Potential smear market 200 M tests (WHO)
Source WHO
11
Fluorobot the only fully automated, dedicated
solution

• Based on the traditional smear microscopy
  principle
• Fully automated
• Input / output and moving of the slides
• Image capturing and analysis
• Intelligent bacterium recognition algorythms
• Low cost, robust design suitable for high
  incidence, high burden countires
• Huge walk away window, batch processing of 100
  250 slides
• Small footprint
• High throughput (25 smears/hour)
• Competitive cost/test

12
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
• Classification follows WHO reccomendation (neg.,
  scanty, , , )
• Standardised quality, no tiring effect
• Images are stored, can be transmitted, archived,
  revisited
• Opening new Quality Control possibilities
• No trained microscope reading staff needed

13
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
• Project was exhibited at MEDICA 2012 Dusseldorf
  and Medical Fair India 2013 in New Delhi, with
  huge success
• Strategic Partner is searched, 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

14
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

15
Your Invitation!
Join the Journey!