Blog

Statement by Clemens Bimek about the current status quo of the project

Bimek SLV Team | 10. October 2016

Dear Bimek SLV Supporters,
 
it is with great pleasure that we’ve received interest in and willingness to participate in our project. Initially we had envisioned the revolution of contraception as a simpler endeavour and for this reason we had laid out a rather enthusiastic timeline. From our current perspective, this was very optimistic. The hurdles we need to overcome have not only grown in height, but also increased in number.
 
In the meantime, and using all of our available tools, we have attempted to obtain the approval for the valve’s trials from the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte / BfArM). Before we can proceed further with the final approval procedure we need the test results of the manufactured and sterile packaged implants and surgical attachments, as well as a positive evaluation from a Notified Body.
 
Considering the global media attention and the consistently positive reviews we’re somewhat surprised that there have still not been enough financial resources generated to commission the manufacturing, cleanroom assembly, packaging, sterilisation and verification of the test products. Offers from all medically certified manufacturers and service providers have already been made available. The costs for this are within the medium six figure category.
 
Furthermore, the Medical Product Act stipulates that we are required to establish a company, certified according to ISO 13485, in order to be regarded as a viable manufacturer. To this date we have been able to use our self-funded starting capital (thanks to Dr Peter Schnückel) with the help of our cost-effective consultants to create the written framework for all of these processes. This was also only possible, because we have covered all expenses ourselves, without taking any remuneration. We would like to continue doing it this way until the successful commercialisation of the Bimek SLV, so that all investor money and donations go directly to the development of the valve.
 
Subsequently, the costs for the clinical trials also need to be considered. Even if the most helpful volunteers only accept the implanted valve as payment for their efforts and sacrifice, there are still the costs for the organisation of the trials, for an independent monitoring of the trials by a Clinical Research Associate (CRA), for the scientific analysis, the surgeries themselves and the insurance prescribed by law that will protect the participants in unexpected circumstances.
 
It is for these reasons that we are currently campaigning to acquire the financial means of a minimum of 600,000 EUR. Support our cause with your ideas, contacts and investor relationships so that we can raise these investment resources as quickly as possible. The lead investor, Dr Peter Schnückel (email: peter.schnueckel@bimek.com), will gladly accept any information and assistance. After all we are willing to offer 20% of the future company, Bimek SLV, for an investment of 600,000 EUR.
 
We won’t give up!
 
We would like to ask for understanding, as we are currently unable to name a date for the beginning of the clinical trials. As soon as we have this information, we will distribute the questionnaires to find our first candidates.
 
Thank you for your patience and confidence in the Bimek SLV!
 
Clemens Bimek
and the Bimek Team