In the beginning of the week, the producer of a unique device for breast self-examination sent a request for registration of its product to the American Food and Drug Administration (FDA). The notification is to allow for sale of the Braster system on the American market, which is key from the expansion perspective of a foreign company.
From the outset, the project of the Braster System has been implemented in a way providing its consistency with requirements of FDA, which regulates the medical market in the US. The Company started work on certification in mid-2016. The notification request was prepared on the basis of "Traditional 510(k)" procedure, which consists in demonstrating the substantial equivalence (SE) of the product in terms of purpose and technology to a predicate device previously authorised for marketing by FDA. Typically, these are Class I and II medical devices, which are not subject to the so called "Premarket approval (PMA)" procedure.
BRASTER will be able to introduce its product for sale on the US market after notification from FDA confirming its substantial equivalence to the device indicated in the request. The deadline for FDA to make such decision is 90 days.
"Filing a request and launching the registration procedure at FDA is a key milestone in our Company’s efforts to develop further on the global scale. In the most optimistic scenario, we can be authorised to introduce our product to the American market in three months,” explains President of the Management Board of BRASTER S.A Marcin Halicki. “However, it has to be noted that BRASTER is one of the most advanced devices of this kind in the world. It is also more advanced than the device that we refer to in the request, whereas the last registered device we refer to dates back to the second half of 1980s. Therefore, there is risk that the FDA procedure may be prolonged," he adds.
Currently, the Company is making preparations for global foreign expansion, which is planned to include pilot projects on smaller, European markets, such as Ireland, the Netherlands or Portugal. As previously announced, these projects are to be launched in the beginning of the second half of this year.
Along with the updated strategy for 2015–2021, published in March, the Company plans to make its debut on several foreign markets in 2017–2018. By the end of this year, Braster plans to introduce its product in the UK and the UAE, apart from pilot countries. The Company hopes that if FDA gives its consent, it will manage to introduce the device on the US market. Meanwhile, technical pilot programmes are to be launched in Canada, Brazil, China and India. In 2018, Braster will enter other markets (Germany, Japan, Korea). In Japan, a medical pilot project is planned to be implemented in the third/fourth quarter of this year, before placing the product on the market.
By 2021, BRASTER intends to enter markets allowing for reaching over 21 million people from the strictly defined target group. By this time, foreign sales are to account for 90% of the total sales. Entering foreign outlets, in particular the US market, is intended to contribute to a dynamic increase in the Company’s results.
Development of a global telemedicine platform is another strategic objective of the Company. BRASTER intends to offer unique solutions for two international user groups: B2B – by making an advanced telemedicine platform available for other device producers or medical and paramedical service providers, and B2C – by providing patients with access to online services and doctors’ advice. This vision will be possible to be implemented through an organic growth of the Company and possible acquisitions.
BRASTER plans to gather funds for implementation of this strategy from share issues. Capital needs (including costs of entering the above-mentioned foreign markets, potential acquisitions relating to the planned development of a telemedicine platform and current needs of the Company) have been estimated at PLN 60–70 million.