End of May, we closed our seed round with Elaia Partners, heal capital and HTGF to bring precision diagnostics to immune medicine. Anne-Sophie Carrese says, about the deal: "We have been convinced by the founding team, composed of three former entrepreneurs from the same company, with three PhD profiles, at a stage where they are going to scale their go to market, which is coherent with our deep tech seed investment thesis", Managing Partner at Elaia Partners. See tech.eu's press release here.
.. we've achieved FDA-compliance (as a class I device) less than four months after receiving our CE mark. This was made possible by the professionalism and dedication of our team, but in particular by our US regulatory partner QServe Group, and our contact Jennifer Hadfield (left in picture), and our EU regulatory partner Be-on-Quality. The picture shows Aleks and Jennifer registering our device; the following day the FDA sent us the good news.
We're incredibly proud to share that hema.to has been clinically validated in an international, four-center clinical trial! Blood cancer diagnoses weren't just twice as fast, they were made with 8% more sensitivity and 10% more specificity when made with the help of our beautiful, easy-to-use decision-support software. You can download the press release here.
... at the Medical Innovation Night in Nürnberg, where we pitched hema.to in front of an audience an an excellent jury consisting of Medical Valley EMN e. V., Siemens Healthineers, aescuvest, GWQ ServicePlus AG, IONOS andFraunhofer IIS. We'll be using our E20k prize money to explore partnerships with GWQ and Siemens Healthineers.
... we are now compliant with the IVDD. We conform to ISO 13485 (quality management), ISO 14971 (risk management), ISO 62366 (usability), ISO 62304 (software life-cycle management) and IEC 82304 (health software).