Sebastian Dümcke

Jul 15, 2022

Clemedi Update Q2 2022

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.

Product Development

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.

Business Development

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.

Company Development

Clemedi has been present on many stages this quarter. We presented at the Swiss Startup Days in Bern, and at the Swiss Biotech Association meeting in Basel.

Clemedi was also present with a Video message at the event from the Vetsuisse faculty: Forschung für Tier und Mensch – 200 Jahre Tierarzneischule Zürich. This event was held at Zurich main station on June 29.

Fundraising

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.

Apr 13, 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.

Fundraising

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.

Jan 10, 2022

Clemedi Update Q4 2021

Business Development

We have signed an evaluation agreement with Thyrocare, a large Indian network of diagnostic labs. They will evaluate our tuberculosis diagnostic in the coming year.

Clemedi conducted interviews with key-opinion leaders to validate the product-market fit of current and future products. Also, Niko attended three (virtual) conferences, South Summit, Wolf Summit and DxPx Europe. In total we got 19 interactions to follow-up with.

Company Development

We are happy to have Dr. Turlough Neary join our team in November as Data Scientist. He will support the development of our AI algorithms. Welcome Turlough!

Clemedi has been invited to pitch at the Roche Diagnostics internal startup day. It was a fun event, where we could get an insight on how such a large company operates.

Clemedi has also been featured in the UZH Magazin 3/21 on page 9 (german only).

Product Development

Software Development

Our new user interface is connected to our backend and ready to be tested by user. It is deployed here: http://tuberculini.clemedi.com

Lab Development

Pauline is trained on the use of our sequencer and all aspects of our test and will start generating important data in the first weeks of the new year.

Fundraising

The team has started fundraising of the next financing round, expected to close in the second half of this year.

To close this report, we would like to wish everybody a happy new year full of success. Clemedi is excited about 2022 as we expect a lot of good things to happen.

Oct 13, 2021

Clemedi Update Q3 2021

Business Development

We have been selected by Swissnex to join the India Market Entry camp. Our team will travel to India to strengthen its market entry strategy for this important market.

We are also negotiating OEM agreements with our suppliers, enabling us to sell a Clemedi branded box with all reagents. You can see our current renders for what this box might look like below.

Company Development

We have new team pitcures. During a fun photoshoot we generated picture material for the core team members.

We welcome Pauline as new addition to the team. She will be supporting development in the lab and serve as liaison to the University of Berne.

Product Development

Software Development

Implemented several new features in our software to help physicians interpret our results within known reference points. For this we added a WHO curated list of resistance confering mutations as well as generated known line-probe assay blots in the user interface as seen below.

Lab Development

We kicked off documentation of all product specifications and parameters under an ISO13485 quality management system with the help of Effectum Medical.

Fundraising

We are closing a last addition to our first financing round to further help us reach our goals. Details will follow.

Jul 9, 2021

Clemedi Update Q2 2021

Business Development

We finalised the license agreement with the University of Zurich. This license gives us the exclusive right to use on the patent application necessary to commercialize the Tuberculini product. We have made progress with potential collaboration partners in India, who are interested in our technology.

Company Development

In our last General Assembly we have created the possibility to conduct future General Assemblies in digital format in line with the move to digitize business processes to increase efficiency.

Product Development

Software Development

We have translated the user interface templates that were validated in a small-scale user study into an interactive and clickable online application that can be hosted in the cloud.

Below you can see mockups of the registration screen as well as the dashboard that shows a list of analyses and the menu for the functionality of the application.

Lab Development

Work packages financed by the Innosuisse Grant we obtained last year are on track. Experiments are ongoing at our partner site at the University of Bern. We also have contracted other international sites in Italy, Pakistan and Uganda to support in validating our Tuberculini product.

Fundraising

We were able to close a convertible round of CHF 385k from several Angel Investors end of June. The financing, will enable us to reach our the design freeze of Tuberculini, the first application on our Disease Management Platform as well as plan the upcoming clincial study.