Clemedi Update Q1 2022

Clemedi Update Q1 2022

Dear investors, partners, supporters and friends,

a lot has happened since the year started and in the following update I will briefly inform you of the major developments.

Business Development

We have secured a commercial use agreement with our largest supplier, ThermoFisherScientific. This will allow us to use components from Thermo inside out IVD Kits whilst using our own brand name.

We have found an exiting new market for our tuberculosis product: latent tuberculosis. Did you know that an estimated 25% of the world population is suspected to be latently infected with tuberculosis, and that the disease might break out at anytime, particularly in case of immunosuppression? We spent time conducting expert interviews in the field and building a business model surrounding this new application.

Company Development

Clemedi is grasping the opportunity introduced in December by the European Commission, that has introduced grace periods for IVD products certified under the current IVDD. This mean that such devices can still be sold until 2026, if they achieve market approval by May 25th 2022. We have shifted our resources to bring our first product for tuberculosis to the market until May 25th, one year sooner than expected.
We are creating a German subsidiary, Clemedi Deutschland GmbH in order to ensure access to the EU market after the mututal recognition agreement between Switzerland and the EU has come to an end.

Product Development

After securing the commercial agreement with our supplier we have fixed the supply chain and manufacturing processes. We have selected the packaging and are preparing a pilot batch production. You can see a picture of the full kit in the post header.

Software Development

We have created a stand-alone version of the software for local installation independent of network access. This will enable to support customers without broadband internet as well as customers that keep patient data in a network separate from the interenet. This is also the version that is planned to undergo certification.

Lab Development

We have generated plenty of data for the technical validation of our tuberculosis assay. Formal analytical performance evaluation will start in a few weeks. In particular key results with regards to level of detection and performance are expected very soon.


We have applied for several grants: Eurostars, Uni Bern Post-Doc grant and Wellcome Discovery award with a total grant volume of EUR 500k.

We also secured more funding from our existing investors to finance the production and marketing of our products. We are grateful of their continuing support.