The final clinical investigation report from the clinical study with TVS shows significant positive results.
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. "
For more information pleas contact
Karin Bryder, CEO
Phone: +46 (0)70 683 41 44
E-mail: info@inventmedic.com
This information is information that Invent Medic Sweden AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 29 March 2018.
Invent Medic Sweden AB, Company registration number 556682-1046, has developed a medical device for non-surgical relief of female stress urinary incontinence. The inventors behind the product, Jan Clarén and Lars-Olof Henriksson, have been involved in the development and performance of the surgical method TVT, which is now known as the Golden Standard for surgical treatment of female stress incontinence. The product is based on the same scientific basis and has similar mechanism of action as the surgical method but is based on a non-surgical support and is designed so that the woman can use the product when needed. This product has the potential to satisfy a major medical need and could thus have a significant market value. Invent medic's vision is to offer new and innovative medical devices and treatment methods to women with the goal of improving their health and quality of life. The offer shall include safe, effective and safe products and treatment methods that should be easy to use and which will provide health economic benefits to society. Invent Medic Sweden AB is listed on Aktietorget. Ticker is IMS and the share's ISIN code is SE0007603402. For more information see www.inventmedic.com and www.aktietorget.se