The Lund-based development company Invent Medic continues marketing activities for its first product, Efemia bladder support. The company has applied for 510(k) market registration with the FDA and is also starting a subsidiary to bring the product to market in the US. BioStock has spoken to the company’s CEO Karin Bryder to find out more.
Stress Urinary Incontinence (SUI) is a common phenomenon among women, with up to 700 million reportedly suffering to varying degrees worldwide. With its first product, Efemia bladder support, Invent Medic aims to provide women with an easy-to-use and effective aid against the problems.
The company has established several distribution channels in Sweden and in other European countries as well. A first step is now being taken to enter the United States, a market where, according to the company, more than 20 million women suffer from SUI. An application for 510(k) market registration has been submitted to the FDA and the company is currently working on a marketing plan for the product’s launch in the country.
»It is gratifying that the process of obtaining market registration of Efemia continent 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 US. These include our strong commitment to increased marketing and support for our regional partners, which will also include the US, as well as the work to identify US partners at different levels.« – Karin Bryder, CEO Invent Medic.
Establishing US subsidiary
Invent Medic has also signed an agreement with the consulting company MLVC to make the entry into the US as efficient as possible. MLVC specialises in helping Swedish medical device companies enter the US market and will, among other things, help with the setting up of a subsidiary that will drive marketing and sales activities.
Increased investments in marketing
The latest activities are just a few in a long line of initiatives designed to drive the marketing. The company started the new year by announcing two new hires with responsibility for communication toward healthcare professionals and for online marketing. A first step in the effort to enter the US market will be to identify partners. In addition to a distributor agreement, the company will target researchers, healthcare professionals and women’s organisations to build trust and awareness.
The plans also include the introduction of the company’s menstrual cup, which is currently being developed, and which is expected to be launched on the Swedish market in the second half of 2021.
To finance the new investments, Invent Medic has entered into an agreement for subscription and guarantee commitments regarding the warrant TO1. The exercise period runs from February 25 to March 18 and will upon full subscription add 14,9 MSEK to the company The company has secured the issue to 34 percent and has also agreed on a loan facility of 10 MSEK with Råsunda Förvaltning. The capital needs for the next 12-month period are thus secured, regardless of the outcome of the warrant.
BioStock has spoken to Invent Medic’s CEO Karin Bryder to find out more.
Karin, you have now submitted a 510(k) application to the FDA. What does this mean for the company?
– This means that we can seriously talk to contacts that we have established from before. Carina Lindqvist, who responsible for our international expansion, has, among other things, made contacts at the ICS meeting in Gothenburg in 2019. We can now send products for evaluation, which we could not do before.
When can you expect a response from FDA?
– The time for approval of products in our category has historically varied a lot, ranging from four months to just over a year.
You hold a patent for the product in the US where an application for design protection is also under review. Can you tell us more about your intellectual property strategy?
– Invent Medic’s main strategy is to own all intellectual property rights, such as patents, trademarks and design protection, for the products we develop and offer. This creates maximum flexibility when negotiating with potential distributors and licensees, while avoiding ongoing licensing costs.
You are also using MLVC to expand into the country. What does this collaboration mean for the company?
– This means that we have an experienced controller who can streamline the process of starting a subsidiary in the US, and who can handle the transactions we expect.
The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.