BRASTER S.A. obtained permission from Bioethical Committee of the Regional Medical Chamber in Czestochowa, it will allow to commence in this month observational studies ThermaALG. 130-500 women will be participating in this studies in several clinical centres. Primary aim of this study will be assessment of diagnostic effectiveness and clinical usefulness of the new manual version of algorithm for interpretation of thermographic tests obtained from Braster. Device will get to the market in the second half of 2016.
Manual algorithm is kind of “instruction” for physicians, telling how to interpret thermographic image obtained from Braster. In last months that algorithms were improved basing on results of ThermaRAK studies, which aim was to extend thermographs base. Currently, company possess around 1200 thermographs generated by Braster device.
"The ThermaRAK and ThermaCRAC studies allowed us not only to determine the efficacy of our device, but also to identify the directions for further work on its development. The developed interpretation algorithm will be further used in a clinical trial under the INNOMED project, the aim of which will be to confirm diagnostic efficiency of the Braster device, on a group of approximately 3,000 women. It will also serve to create automatic algorithms for the interpretation of examinations, which are necessary to place the product on the market." – explains Marcin Halicki, President of the Board of BRASTER S.A.
In January this year, BRASTER intensified cooperation with the Warsaw University of Technology in order to develop dedicated algorithms for the automatic interpretation of thermographic examinations from the Tester device and to further increase its sensitivity. According to the experts from the University, this stage will last approximately six to nine months. The initial research project was successfully completed in mid-December last year.
In ThermaALG studies will participate maximum 500 woman. The testing size will depend on efficacy of patients recruitment for studies. According with extended protocol at least 50 patients with malignant breast cancer have to participate in this studies. During studies thermographic imagines and results of imaging studies with histopathological data obtained during diagnosis and differentiation of breast cancer will be collected. Predicted termination of project is 6 months from the starting date. Thanks to the ThermaALG studies Company will be able to compare improved algorithm for interpretation and classification of new result of the thermographic test generated by BRASTER TESTER with results obtained from the previous clinical study ThermaCRAC.
The ThermaALG trial will allow the company to compare the improved algorithm for interpretation and classification of new results of thermographic examinations of the breast performed by Braster with the results obtained using the previous version of the algorithm in the previous clinical trial, ThermaCRAC. The clinical trials are an important element of the development strategy of BRASTER S.A. Their aim is to improve the consumer version of the Braster device, which is to be used directly by women.
The ThermaALG trial, although it is not a clinical trial by definition, will be conducted in line with the principles of good clinical and epidemiological practice and all relevant legal regulations. The competent bioethical committee will be notified about the trial and the collection of clinical material.
At the end of May this year, BRASTER successfully completed its share issue, selling all 2.6 million of the shares offered and thus obtaining PLN 39 million. The funds will allow BRASTER to fully implement the strategy aiming at offering the Braster device for direct sale to women in the second half of 2016.