Dear investors, partners, supporters and friends,
we have reached an important milestone and have brought our first product, Tuberculini, to market as a CE-IVD marked medical device.
We have self-certified our product Tuberculini in Germany. It is intended to genotype M. tuberculosis bacteria found in a sample of patients confirmed with tuberculosis. The product can detect resistance mutations against 12 antibiotics from the WHO list of TB antibiotics. It also classifies the M. tuberculosis strain into many (sub-)lineages with a method from a scientific publication.
Our Innosuisse grant extension was approved, including additional budget, which will help us generate more clinical evidence for our tuberculosis product.
We have incorporated a German subsidiary, Clemedi Deutschland GmbH, in order to register our product on the EU market. Due to the uncertainty arising from the end of the mutual recognition agreement between Switzerland and the EU, and uncertainty surrounding the introduction of new IVD regulation in both Switzerland and the EU, we felt this was a necessary step. It will guarantee us access to the EU market and the Swiss market can still be served via our mother company.
We are opening the next funding round to interested parties. We are grateful for introductions to investors and venture capital funds active in the diagnostics and infectious diseases space. Do not hesitate to reach out.