Common Sense Ltd.

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Common Sense Ltd. Israeli/UK Healthcare
Opportunities 2008
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• Company
• Established 1999.
• Develops and manufactures diagnostic devices for
  women's health care (OTC, PoC).
• 2 home tests launched in Europe (2005) and in
  the USA (2007) - VI-SENSE, AL-SENSE.
• 2 tests for clinics and hospitals launched in
  Europe (2006)
• VS-SENSE, AL-SENSE for hospital use.
• One site in Israel, Caesarea Industrial Park (20
  employees).

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• IP
• The Innovative polymer which comprises all
  products is defended by 7 sequential patents
  submitted to the US patent office, of which 5
  have been issued, and 2 are pending.
• International PCTs have been submitted to defend
  our Intellectual Property in most of the relevant
  markets.

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• Certification
• CE (IVD) approval for the VI-SENSE and AL-SENSE
  was received August 2004.
• FDA CLIA for the VI-SENSE was received March
  2005.
• CE (IVD) certification of the VS-SENSE-PRO
  received September 2005.
• FDA 510(k) approval for the AL-SENSE was
  received November 2007.
• CE approval for the VA-SENSE was received
  December 2007 (IVD) .
• FDA CLIA for the VA-SENSE, VS-SENSE-OTC and CE
  approval for VS-SENSE-OTC are expected Q2 2008.
• Common Sense holds full certification of ISO
  9001 ISO 13485 (GMP).
• European Notified Body - MDC Germany (CE 0483).

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VI-SENSE Kit
The VI-SENSE is an easy-to-use, panty-liner-based
test, intended for women who sense their vaginal
discharge is abnormal, to give a qualitative
initial indication regarding the potential causes
of their abnormal vaginal discharge. The
VI-SENSE kit holds 1-2 tests.
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Vaginal Infections A Wide Spread Problem

• The Western World Market
• 200 million abnormal vaginal discharge cases per
  year.
• The US Market
• 100 million abnormal vaginal discharge cases per
  year.
• France
• 6 Million Cases
• Israel
• 900,000 Cases

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The Distribution of Common Vaginitis
Typical Distribution of Vaginal Incidents Symptomatic Vaginal Main Condition
20-30 20-30 8-10 Above 20 Only Candida Bacteria Vaginosis Trichomonas Vaginalis Mixed Infections
Only 30 of abnormal vaginal cases are caused by
Candida alone and Candida treatment is sufficient.
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• The VI-SENSE KIT How to Use
• Simple-reading color indicator , assembled on a
  non-intrusive normal panty-liner.
• BLUE STAIN indicates BV or Trichomonas and
  directs the patient to consult a physician for
  antibiotic treatment.
• YELLOW COLOR associated with heavy discharge,
  pain and itching sensation directs the patient to
  seek OTC yeast infection treatment.

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VS-SENSE-OTC Kit
The VS-SENSE - OTC is an in vitro self-test, to
be used by women who sense their vaginal
discharge is abnormal, to give an initial
indication regarding the causes of their abnormal
vaginal discharge. The VS-SENSE kit will hold
1-2 tests.
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AL-SENSE Kit
The AL-SENSE is an easy-to-use, panty-liner-based
test, intended to detect possible leakage of
amniotic fluid when vaginal wetness is
experienced during pregnancy. The AL-SENSE kit
holds 3-5 tests (hospital version holds 50 tests).
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• Amniotic Leak A Major Cause of Stress Among
  Pregnant Women
• Over 20 of women whom reach the hospital as
  they interpret wetness as amniotic fluid leak are
  sent home as this wetness was due to urine.
• On the other hand, many women whom feel wetness
  which is caused by amniotic leak interpret it as
  urine and avoid visiting the hospital. This may
  cause great harm to both mother and baby.
• There are currently no other available home-test
  distinguishes urine from amniotic fluid.
• The AL-SENSE monitors continuously and reacts to
  any small leak.
• The AL-SENSE clearly distinguishes urine from
  amniotic fluid.

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When to Use the AL-SENSE Kit One use of this
detector is for later stages of pregnancy (OTC).
DTC- Woman's Magazines, Pharmacies, Doctors
office, Internet etc. Another use of this
detector is in situations of hi-risk in the
family history, such as pre mature delivery, or
after amniocentesis tests (Rx). Medical
Detailing/Reimbursement A third use is to
continuously test for Amniotic Fluid Leakage once
the pregnant women has arrived at the hospital
(Hospital). Medical Detailing A fourth use is a
stand by kit to be purchased in the early stage
of the pregnancy (OTC). DTC- Woman's Magazines,
Pharmacies, Doctors office, Internet etc.
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AL-SENSE Kit How to Use The AL-SENSE
Kit offers a simple to use classification tool
which uses color identification for
interpretation of the results BLUE COLOR
results indicate possible Amniotic Fluid Leakage
and directs the patient to immediately consult
her physician. YELLOW COLOR indicates urine
presence and requires no treatment.
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The VS-SENSE-PRO Swab
The VS-SENSE Test is a user-friendly swab, used
by clinicians who wish to screen women for
vaginitis,
The VS-SENSE kit holds 8-50 swabs.
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• VS-Sense is a Simple-to-Use,
• Time-Saving Diagnostic Device
• Offers immediate results in the office without
  the need to send a sample to a lab (10 seconds
  test).
• Assists in prescribing full treatment in one
  visit at the clinic.
• Reduces the frequency of return visits, saving
  costs of incorrect/partial medication, and
  improving patient satisfaction.

Negative Result If the swab tip did not change
color, the acidity parameters are in order and
the probability of having a bacterial or
parasitic infection is very low.
Positive Result If any section of the swab tip is
stained blue or green, the acidity parameters are
disordered and the probability of having a
bacterial or parasitic infection is high.
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• Commercialization Patterns
• Clinics/Hospitals Symptomatic patients.
• Niche Screening Before abortion, before intra
  vaginal surgery (hysterectomy, IVF, etc).
• Reimbursed Economic advantage over lab tests
  (costs time).
• Shotgun Versus Sequential Testing -
  Cost-Effectiveness of Diagnostic Strategies for
  Vaginitis
• Phyllis L Carr, MD,1 Michael B Rothberg, MD,
  MPH,2,3 Robert H Friedman, MD,1 Donna
  Felsenstein, MD,4 and Joseph S Pliskin, PhD5
• For patients with vaginitis symptoms undiagnosed
  by pelvic examination, wet mount preparations and
  related office tests, a comprehensive, pH-guided
  testing strategy at the initial office visit is
  less expensive and more effective than ordering
  tests sequentially

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VA-SENSE Kit Monitoring Device to Minimize
preterm delivery in high risk pregnancy
The VA-SENSE Test is an easy-to-use vaginal
acidity home test, to be used by pregnant women
in 1st and 2nd trimester, to give an indication
when the acidity level of their vaginal discharge
is abnormal (Indicating Possible BV infection).
The VA-SENSE kit will hold 12-20 tests.
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Risk of Pre Term Delivery increase following BV
during 1st 2nd trimesters

• 7 folds increase of preterm delivery in women
  with BV before wk 16 of gestation
• Preterm delivery risk increase 4 folds in women
  with BV before wk 20 of gestation
• Leitich H. et al. Am. J.Obstet. Gynecol. 2003 Jul
  189(1)139-147

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Strategies to reduce preterm delivery due to BV -
Past and Present

• Mid 90s Screen treat all pregnant women
• during all pregnancy stages
• 2000 Controversial clinical study conclusions
• applying the 90s strategy
• Recent studies CDC guidelines (2004 and on)
• Target high risk pregnancies
• Focus on trimesters 1,2
• Use systemic antibiotics

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• Cost benefit UK
• Average premature baby hospitalization cost in
  Europe - Euro 10,000
• Preterm deliveries prevented (20 of screened
  patients) 12,000
• Cost saved - 120MM
• Average cost of monitoring and treating - 200
• High risk pregnancies to monitor (10 of 600,000
  Births) - 60,000
• Cost of monitoring treatment - 12MM
• Annual saving 108MM

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Optimal Partnership
Optimal Partner Product
Ability to introduce new OTC products, or Distributors of OTC vaginal treatments VI-SENSE
Ability to introduce new OTC products, or Distributors of OTC vaginal treatments VS-SENSE-OTC
Ability to introduce new OTC products, Strong presence in hospitals and OBGYN clinics AL-SENSE
Strong presence in hospitals and OBGYN clinics VS-SENSE-PRO
Ability to promote prescription drugs (Rx) VA-SENSE