News on the Company’s activity
The Management Board of BRASTER S.A. wishes to present the Company’s activity in the field of international expansion within the last months and ensure that the financial situation is stable and allows consistent implementation of the Strategy’s objectives (published in the current report no 4/2017/ESPI of 7 March 2017) in the sphere of attracting new partners on the foreign markets.
In July this year, the Company acquired PLN 40.5 million net by issuing series I shares, which significantly strengthened the Company’s financial potential and allowed it to intensify work related to the international expansion. During the first half of 2017, the issuer carried out an in-depth analysis of the possible markets, which contributed both to drawing up a list of potential business partners and determining integrated market strategy for each one of them. In line with the adopted schedule (the current report no 4/2017/ESPI of 7 March 2017) the final contract with a partner in Ireland will be concluded in the near future. In Japan, detailed condition of cooperation in the field of implementation of the complex Strategy preparing the Braster System to be placed on the Japanese market are being negotiated. In addition, there are still discussions being conducted with potential partners in the Great Britain, Italy, China, India, Argentina, Republic of South Africa, Malaysia and Saudi Arabia. Moreover, in relation to the intended start of the Braster device sales on foreign markets, a new version of the Braster website and e-shop has been launched.
Over the last few months, reaching the medical community, both domestic and foreign, has been strongly emphasized. Our increased efforts contribute to creation of a positive image of the Braster System within the medical community as a device complementing standard diagnostic methods and screening. Although the process of reaching physicians is lengthy and time-consuming, the positive effects of many years of work have already become noticeable.
The Company is conducting the Braster System registration processes on previously selected markets. The process has began in i.a. Japan, the United Arab Emirates, Brazil and the USA. In June this year, a request for a permit to market the device on one of the most procedure-wise demanding markets in the world was submitted to FDA. The request was submitted under “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. The Company referred to a device registered by FDA in the 80s, which uses thermography – just like the Braster device. Our device is significantly more advanced and uses computer algorithms which did not exist 30 years ago. Given the above, we are still engaged in dialogue with the American regulator and answer every question asked.
According to the Management Board, fall in BRASTER shares quotation on WSE is unjustified. The Company consistently meets the targets set in the adopted update of the development strategy of the Company, as shown by the above-mentioned events. The share prices are also affected by external factors beyond the Company’s control, such as e.g. uncertain situation on the stock exchange, particularly in relation to small and medium-sized enterprises. A detailed operational and commercial activities as well as the Company’s Strategy implementation overview will be presented in the report for the third quarter of 2017, which will be published on 14 November 2017.