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Common Sense Ltd. Israeli/UK Healthcare Opportunities 2008

Common Sense Ltd. Israeli/UK Healthcare Opportunities 2008. 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.

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Common Sense Ltd. Israeli/UK Healthcare Opportunities 2008

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  1. Common Sense Ltd. Israeli/UK Healthcare Opportunities 2008

  2. 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).

  3. 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.

  4. 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).

  5. VI-SENSE Kit The VI-SENSE is aneasy-to-use, panty-liner-based test, intended for women who sense their vaginal discharge is abnormal, to give aqualitative initial indication regarding the potential causes of their abnormal vaginal discharge. The VI-SENSE kit holds 1-2 tests.

  6. 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

  7. The Distribution of Common Vaginitis Only 30% of abnormal vaginal cases are caused by Candida alone and Candida treatment is sufficient.

  8. 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.

  9. 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.

  10. AL-SENSE Kit The AL-SENSEis aneasy-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).

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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”

  17. 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.

  18. 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

  19. Strategies to reduce preterm delivery due to BV - Past and Present • Mid 90’s– Screen & treat all pregnant women • during all pregnancy stages • 2000 –Controversial clinical study conclusions • applying the 90’s strategy • Recent studies & CDC guidelines (2004 and on) • Target high risk pregnancies • Focus on trimesters 1,2 • Use systemic antibiotics

  20. 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

  21. Optimal Partnership

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