Invent Medic today publishes a new edition of the company’s newsletter aimed at shareholders, investors, and other stakeholders.
In this edition, CEO Karin Bryder comments that the company has been preparing for the submission for market registration of Efemia bladder support in the United States for a number of months. The first step was made when the company submitted an application to be approved as “Small Business” with the FDA/CDRHs (Center for Devices and Radiological Health) Small Business Program. She further announces that the technical has been adapted to the format that is required by FDA, and that EMERGO is currently doing a preview. This means that the company is in the final phase of preparations and will be able to submit the application as soon as the clearance comes from CDRH.
CEO Karin Bryder goes on to say that the company has chosen to change to German TÜV SÜD as the company’s Notified Body. TÜV SÜD is approved according to MDR and is considered one of the world’s leading players in the field. They also offer services that can facilitate when additional market registrations outside Europe and the US are considered.
The menstrual cup concept that the company acquired earlier in November is discussed briefly and it can be noted that the company is planning an initial market introduction in the second half of 2021.
Invent Medic previously planned to strengthen the marketing and sales organization in 2020 but chose to wait until now to keep the running costs down during the pandemic. The now advertised positions have a clear digital and growth-oriented focus, which the company can benefit from even if the corona pandemic continues to affect the company in 2021.
CEO Karin Bryder also mentions that she will be participating at investor events in connection with the exercise period of the T01 warrants. Finally, merry Christmas and a happy new year.
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The newsletter is published in Swedish and English, with a flexible publishing frequency based on Invent Medic’s news flow. It is produced together with the company’s IR communication partner Honeybadger, http://www.honeybadger.se. Invent Medic encourages feedback and requests on topics for upcoming issues of the newsletter.