Update on Bolivia and the market introduction of BERA
The ongoing tests in the Bolivia study, with BERA 3.1 on battery power along with the new optimized accessories and updated metering process, show a tremendous improvement on the quality of measurement data with much less interference. The optimization of the process and the new battery powered BERA 3.1 version improves the measurements, stability and security to a degree that has led management to decide to do the whole study on the newer version of BERA. Management has thus decided to extend the study by some months.
The need in the market for tools to support diagnosis is tremendous, which in turn leads to a significant pressure from the market on launching BERA directly. SensoDetect’s plan was to commercialize BERA during 2018, starting in Bolivia. However, the promising preliminary data from Bolivia with the improved BERA 3.1 system, coupled with the optimized accessories and updated process justify ensuring that the entire study is conducted with the BERA 3.1 system, which in turn will postpone the launch somewhat.
"The optimization of the process and the new battery powered BERA 3.1 version improves the measurements, stability and security to a degree that makes us have to do the whole study on the newer version of BERA.
The pressure from the market is large, but I keep stubbornly behind the need to make the studies on "the right" version of the BERA when the results of the study gave such a clear and significant improvement. It shall also be done in a documented and professional way according to all the rules and procedures. Otherwise, we risk being criticized, as previous board and management experienced a few years ago.
I am convinced that we will reach the target of the clinicians that have already signed LOIs and want to get started as soon as possible. I am also convinced that our owners understand that we do not skip the important steps in the process to save any single month in the release. The delay arises as a result of now redoing the study on the new version of BERA and launching it as the only version for regions with unreliable power supply.
When the study has been completed, we will quickly move to a full launch. The delay is limited, and it is therefore not worth the risk of using the material from BERA 3.0 as the only basis in the study. I am disappointed that we are now revising the original time schedule but am convinced that it is the right decision.
Our sales targets going forward remain with the modification that my anticipated 2018 revenue will now instead be added during 2019. Our partner in Bolivia is now working hard to complete the study, with high quality and speed still aiming to complete during 2018, but we still want to be clear that there is a risk of sales starting first next year.
It is critical for us that we deliver a complete and qualitative study before launch; this, in management’s opinion, is the most robust way to building long-term value for patients, physicians and shareholders alike. "says CEO, Johan Olson Sensodetect AB (Publ.).
VD, SensoDetect Aktiebolag (publ)
Phone: +46 705 424600
This information is information that SensoDetect AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on November 7 2018.
SensoDetect highlights through patented equipment brain stem responses to audio stimuli in order to provide health care clear anomalies and patterns for use primarily within psychiatry. The goal is to increase efficiency in Psychiatry and thus the benefits for health care, society, patients and relatives.
Improve the lives of people with mental illness
Making ABR profiling tests with SensoDetect technology an integral part of setting diagnosis for mental illness
Our Value Proposition:
SensoDetect provides a complete audiogram for the brainstem, helping health care professional to set psychiatric diagnoses objectively and
cost effectively. This unique offering improves patients’ quality of life and reduces the economic impact on the health care system and society