Invent Medic announces that the company has submitted an application to FDA for 510(k) market registration of the product Efemia bladder support in the United States. Invent Medic expects to be able to present marketing and sales plans for the product in the United States later in 2021.
The overall plan for the company’s establishment in the United States is proceeding according to plan. The application for market registration is the beginning of marketing activities in the United States for cooperation on the launch of Efemia bladder support. These establishment plans now also include in the long term the Efemia menstrual cup, which is a new product concept under development with planned first market introduction in Sweden in the second half of 2021.
“It is gratifying that the process of obtaining market registration of Efemia bladder support in the US is now taking another step forward. At the same time, I would like to highlight several other activities that are important for our success in the United States. These include our strong commitment to increased marketing and support to our regional partners, which will also include the United States, as well as efforts to identify U.S. partners at different levels.
“In addition to a distributor, we also aim to create relationships with suitable researchers, health care professionals and women’s organisations. In Sweden, we can clearly see that a broad effort involving both health care, women’s organizations and the direct-to-consumer market is optimal for building trust and awareness of us and our products, which in turn drives sales,” says Invent Medic’s CEO Karin Bryder.
More than 20 million women in the United States are estimated to use some form of protection against stress incontinence and thus constitute potential users of Efemia bladder support.
This disclosure contains information that Invent Medic Sweden is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 15-02-2021 07:48 CET.