Czech Medtech HTG Medical Wins EU Certification and Passes €1M to Automate ICU Care

Every hour, in intensive care units around the world, a nurse walks to a patient’s bedside, reads the urine output from a drainage bag, and logs the number by hand. Czech medtech startup HTG Medical wants to end that routine — and it has just cleared two milestones at once to do it.

The company’s device, the HTG Urogram, has passed EU Medical Device Regulation (MDR) certification, earning its CE mark, while closing a new pre-seed round that pushes cumulative funding past €1 million (~$1.1 million). The European-made, ICU-proven hardware is now cleared for immediate rollout across European and global markets.

“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,” said Tobiáš Vybíral, CEO and co-founder of HTG Medical. “We are now ready to deploy the HTG Urogram where it can truly help and start saving time.”

Machines Measure, Humans Heal

The Urogram tracks fluid output automatically, displays real-time metrics on an integrated screen, and transmits them directly into Hospital Information Systems (HIS). HTG says that returns up to one hour per day to each nurse — time redirected from paperwork to patient care, at a moment when European hospitals are grappling with severe staffing shortages.

Automation also cuts error. According to external research cited by the company, the error rate of manual fluid logging in ICUs can climb as high as 26%.

And continuous measurement changes the clinical picture, not just the workload:

“Continuous monitoring of urine output provides something that hourly manual checks never can — a trend,” said Dr. Marek Šramko, Ph.D., FESC, Head of the Cardiovascular ICU at Prague’s IKEM hospital. “Continuous trends can support earlier clinical recognition of changes relevant to assessing Acute Kidney Injury (AKI) and promote more consistent compliance with KDIGO criteria.”

IKEM’s Cardiovascular ICU has been using the system for four months.

Clearing the MDR Marathon

Since its overhaul, the EU’s Medical Device Regulation has become one of the toughest regulatory regimes in the world — a years-long, thousands-of-pages process that has pushed some legacy manufacturers out of the market entirely. HTG says it navigated the whole thing in 15 months, helped by localized European manufacturing and full component traceability.

“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,” said Krištof Šaman, COO and co-founder, who led the certification effort.

From a Hackathon to the Market

HTG Medical traces its origin to a 2019 medtech hackathon hosted by IKEM, where the founders were challenged to digitize urine-output tracking. They narrowly missed first place but kept building. The company was formally founded in late 2021 by Max Klimeš and Krištof Šaman, joined in 2023 by Tobiáš Vybíral.

The latest €450,000 tranche — the second part 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. Demand ran well ahead of the raise.

“Total soft-circled offers in this round exceeded €1 million, more than double our original target,” said Max Klimeš, CTO and co-founder. “Ultimately, we chose to take only a portion of the offered capital, but this immense demand confirms that investors have strong conviction in HTG Medical’s direction.”

The company plans to use the MDR clearance as a springboard for fast-tracked registrations beyond Europe — including Australia, Singapore, Malaysia, and Saudi Arabia.

The Investor Case

Backers pointed to a rare combination in a slow-moving sector: a certified product already in patient use, and a business model designed to slip past hospital budget resistance.

“The winning combination for us was a stellar founding team, clear MDR clearance, and a highly attractive recurring-revenue business model,” said Aleš Filipenský, Investment Director at Garage Angels.

That model is the clever part, according to Miloš Sochor, Managing Partner at JIC Ventures: hospitals “don’t spend more than they currently do on consumables, but they gain seamless automation and actionable data for free. That is a highly disruptive entry strategy.”

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The round at a glance

• Company: HTG Medical s.r.o. (Prague, Czech Republic), founded 2021
• Product: HTG Urogram — automated ICU urine-output monitoring, integrated with hospital IT systems
• Milestones: EU MDR / CE certification cleared (in 15 months); cumulative funding now past €1M (~$1.1M)
• Latest tranche: €450,000, led by Garage Angels with Electron Capital Partners, JIC Ventures, Jinej fond, and Dendis Capital
• Traction: In use at IKEM’s Cardiovascular ICU for four months; claims up to 1 hour/day saved per nurse
• Next: Commercial rollout in Europe; registrations planned for Australia, Singapore, Malaysia, Saudi Arabia