Invent medic Sweden AB (“invent medic”) hereby announces that the analysis of data from the clinical study conducted with the company’s product, TVS, shows that using the TVs provides significant reduction of urinary lekeage. This means that the study reached its primary endpoint. When women used the TVS, their leakage rates decreased by an average of 77%. The results of the final report are thus in line with the previously communicated preliminary analysis.
In the clinical study, the amount of urinary leakage has been studied in a control group and a treatment group that used the company’s product TVS. Invent Medic announced on February 15, 2018 that a preliminary analysis showed significant positive results in a clinical study. Invent Medic has now received a final report from the study, which shows that the study has reached Its primary endpoint, that it is a significant reduction in the urinary leakage in the group that used the TVS compared to the control group. In connection with the use of the TVS, no serious side effects have been reported and the product was perceived as easy to use. The clinical study was conducted at four study clinics in Sweden and was coordinated by senior physician Aino Fianu Jonasson at Karolinska University Hospital in Stockholm. A total of 97 women were included in the study.
Karin Bryder, CEO of Invent Medic, comments:
“The study showed a decrease in urinary leakage by an average of 77% when the TVS was used, this is very gratifying. We continue to work towards the wider launch we have announced, where our goal is to reach out both directly to users and to the health care system. The TVS will be able to make a big difference for women who are affected by single or continuous urinary incontinence. “