Czech medtech startup HTG Medical has raised €450,000 in new pre-seed financing and secured certification under the European Union’s Medical Device Regulation for its automated urine-monitoring device. The regulatory milestone clears the HTG Urogram for commercial deployment across Europe and gives the company a foundation for registrations in selected international markets. Together, the funding and certification move HTG Medical from product development toward broader commercialization of a system designed to reduce repetitive work in intensive care units.
New Capital Brings Total Funding Above €1 Million
The financing represents the second tranche of HTG Medical’s pre-seed round and lifts the company’s total funding above €1 million. Garage Angels joined Electron Capital Partners and JIC Ventures in the investment, with existing backers Jinej fond and Dendis Capital also participating. HTG Medical plans to use the capital to support production, commercial launch activities, distribution partnerships, and expansion into additional markets.
Automating Urine Output Monitoring
The HTG Urogram continuously measures a patient’s urine output, displays real-time information on an integrated screen, and transfers the data to hospital information systems. In many intensive care units, nurses still check drainage bags at the bedside and manually record measurements at regular intervals, making the task both repetitive and vulnerable to inconsistent documentation. By automating this workflow, HTG Medical aims to provide clinicians with more reliable data while returning valuable time to nursing teams.
Designed Around Intensive Care Workflows
According to the company, the device can save nurses up to 60 minutes per shift by reducing manual checks and charting. HTG Medical says the system records measurements every five minutes and was developed with input from nurses, physicians, biomedical engineers, and other hospital professionals. More than 4,000 hours of bedside testing helped shape a compact device intended to fit into existing clinical routines without requiring complex installation or extensive training.
From Hackathon Project to Medical Device
HTG Medical began in 2019 after its founders participated in a medtech hackathon hosted by the Institute for Clinical and Experimental Medicine in Prague. The founding team consists of CEO Tobiáš Vybíral, CTO Max Klimeš, and COO Krištof Šaman, who turned the initial concept into a product tested in real hospital environments. Their work focused on addressing a routine but important clinical process that had seen limited automation despite the growing digitization of hospital care.
MDR Certification Opens Commercial Path
Achieving certification under the EU Medical Device Regulation required the company to demonstrate the product’s safety, measurement accuracy, engineering reliability, quality controls, and secure integration with hospital systems. HTG Medical completed the certification process in approximately 15 months, supported by localized European manufacturing and component traceability. The company also holds ISO 13485 certification, which establishes a quality-management framework for medical-device development and production.
International Expansion Plans
HTG Medical expects the European approval to support registration processes outside the region, including in Australia, Singapore, Malaysia, and Saudi Arabia. Its immediate priorities include expanding production, establishing distributor relationships, and increasing hospital deployments as the device enters its commercial phase. The company’s progress will now depend on its ability to navigate hospital procurement cycles, meet local regulatory requirements, and demonstrate measurable benefits across different intensive care settings.
HTG Medical’s latest funding and MDR certification mark a significant transition from early-stage development to market entry. The startup is targeting an overlooked but labor-intensive hospital process with a device designed to improve measurement consistency and reduce administrative demands on nurses. Its next challenge will be converting regulatory clearance, clinical testing, and investor support into sustained adoption across European and international healthcare systems.