Czech medtech startup HTG Medical has raised €450,000 from angel and VC backers, and its proprietary device, the HTG Urogram, has successfully cleared the EU's Medical Device Regulation (MDR) certification, thereby greenlighting its immediate rollout across European and global markets.
The story of HTG Medical began in 2019 at a medtech hackathon hosted by IKEM, where the founders were challenged to digitise urine output tracking. While they narrowly missed first place, the vision and drive to scale the Urogram into a market-ready product remained. Every hour, a nurse in an ICU must physically walk to a patient's bedside, read their urine output from a drainage bag, and manually log the amount. This decades-old, mundane, and time-consuming routine is about to change thanks to HTG Medical. “
"Getting a prototype into the ICU with real patients is one thing. Transitioning it into a certified medical device means perfecting countless details hidden beneath the surface—from measurement accuracy and engineering reliability to secure hospital data integration, a robust quality management system, and an airtight development and testing lifecycle,” says Max Klimeš, CTO and co-founder.
The HTG Urogram tracks fluid output completely automatically, displaying real-time metrics on an integrated screen and transmitting them directly to Hospital Information Systems (HIS). This returns up to one hour of valuable time back to nurses every day, allowing them to focus on direct patient care rather than paperwork. Furthermore, automation eliminates human error; according to external research, the error rate of manual logging and fluid tracking in ICUs can skyrocket up to 26 per cent.
“Securing the CE mark is validation that we built this product the right way. Starting with a deep understanding of the real needs of ICU nurses and doctors, all the way to engineering technical documentation that meets the world’s strictest regulatory requirements. We are now ready to deploy the HTG Urogram where it can truly help and start saving time,” says Tobiáš Vybíral, CEO and Co-founder of HTG Medical.
The journey from initial engineering drafts to a certified product takes years and thousands of pages of documentation, pushing many legacy manufacturers out of the market entirely. HTG Medical managed to navigate this entire process in just 15 months, accelerated by localised European manufacturing and complete component traceability.
“More than a year of intense regulatory work taught us how to build institutional processes that can withstand any high-stakes international market. ISO 13485 and CE marking under MDR aren't just rubber stamps - they are the core foundations upon which we are building a highly scalable company,” adds Krištof Šaman, COO and Co-founder, who steered the certification sprint.
HTG Medical plans to back its international expansion and commercial launch with a fresh capital injection. This second tranche of the pre-seed round was backed by Garage Angels alongside Electron Capital Partners and JIC Ventures, with participation from existing investors Jinej fond and Dendis Capital.
According to Aleš Filipenský, Investment Director at Garage Angels, healthcare is a sector where innovation traditionally scales slowly.
“The HTG Medical team blew us away by taking the Urogram from a rough hackathon concept to a certified product already active in patient care.
The winning combination for us was a stellar founding team, clear MDR clearance, and a highly attractive recurring-revenue business model.”
The investment pushes the company's total funding past the €1 million milestone. Looking ahead, the stringent MDR certification will serve as a regulatory springboard for fast-tracked registrations in regions outside Europe, including Australia, Singapore, Malaysia, and Saudi Arabia.
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