About 20% of pregnant women wrongly diagnose themselves as starting labor with the first sign of wetness, and rush to the hospital prematurely. Common Sense has developed a set of convenient, non intrusive tests that will give women the power to make their own gynecological tests from home. Up until now, tests for abnormal vaginal discharge and for amniotic fluid leakage during pregnancy were conducted by doctors. Common Sense has invented a chemical compound that indicates, by color change, the presence of amniotic fluid or acidity known to accompany bacterial and parasitic infections. The total potential market size for the kits is over $2 billion.
The first product, the VI-SENSE, helps women and doctors to detect bacterial or parasitic infections in abnormal vaginal discharges in order to quickly and accurately diagnose and treat the problem. Often, Trichomonas and Bacterial Vaginosis (BV) which must be treated with antibiotics do not receive proper attention as the symptoms of yeast infection dominate. In addition, doctors and women are subject to many unnecessary recurrent visits and treatments in cases of mixed infections (Candida and BV).
Common Sense has developed a sensitive diagnostic panty liner which changes to a blue color when the risk of having BV and Trichomonas are high. With this information a patient may decide if self-treatment with over the counter medication is possible or show the results to the doctor in order to upgrade the efficiency of the diagnosis and treatment. The VI-SENSE will sell for about $10 a kit containing two tests and will be on the shelves in Europe and Israel soon.
“This product gives the opportunity to finish full treatment in one visit to the clinic,” explained Amir Karp, Marketing and Business Development Manager for Common Sense. He explained that there are over 100 million cases of abnormal vaginal discharge in the U.S. alone and with Common Sense`s panty liner, test results can be brought to the doctor to get complete treatment in the first visit.
Common Sense`s second product, the AL-SENSE, identifies amniotic fluid leakage during pregnancy, especially for later stages. When a women senses any wetness, the test distinguishes between amniotic leakage and urine incontinence, giving the woman a clear indicator about going to straight to the hospital or not. Another use of this detector is after amniocentesis to self-monitor for any amniotic leakage. Current methods that differentiate amniotic fluid from urine are tests are only made in hospitals.
“About 20% of pregnant women wrongly diagnose themselves as starting labor with the first sign of wetness, and rush to the hospital prematurely,” said Karp explaining that this phenomena causes unnecessary burden on the healthcare system and undue stress for pregnant women.
Based on the same pantyliner concept as the VI-SENSE, when worn the pantyliner can determine amniotic fluid traces within minutes based on color change. Each kit containing seven tests retails for about $20 and will be available in Europe this spring.
Common Sense, based in Caesarea, employs 12 people to develop, manufacture and market its products. The company was founded by Prof. Alex Schoenfeld M.D. former head of women`s health department of Rabin Medical Center, Amnon Kritzman, and Prof. Shlomo Mgdassi. To date, the company is worth $20 million, following investments of $4 million by the Fishman family, BMI, Ofer Brothers Group, and I.T.P. The company seeks $2 million to complete FDA trials, upgrade its manufacturing plant and to continue R&D on its future products.
CE approval for both products was received July 2002 and FDA approval is expected third quarter of 2003. Future products include an innovative device for Chlamydia screening. European sales for 2003 are expected to surpass $1 million.