Europe — Efferon's Pediatric Sepsis Blood Filter Clears CE Mark

Efferon, a medical device startup with roots at Moscow State University in Moscow, Russia, has secured Europe's CE mark for Efferon NEO, a device designed to filter toxins from the blood of children in sepsis, according to TechCrunch. The April clearance made it the first multimodal blood-purification device engineered specifically for pediatric sepsis, the outlet reported.

Sepsis, an acute inflammatory response to infection, kills roughly 3 million children under age five each year worldwide, according to the figures cited by TechCrunch. Efferon was named one of TechCrunch Disrupt 2026's Startup Battlefield 200 companies.

How does Efferon NEO work?

When antibiotics and other standard treatments fail to stop the immune system's overreaction to infection, clinicians must filter a patient's blood to remove toxins driving organ failure. Efferon's devices are built to absorb two classes of those toxins at once: endotoxins and cytokines.

Dima Romashin, Efferon's co-founder and chief executive, described the physiology to TechCrunch using an analogy. "In a fire, there are two things: the flame itself and smoke that it produces," Romashin said, likening endotoxins to the flames and cytokines to the smoke. Most competing devices on the market target only one of the two, according to Romashin; Efferon says its mechanism absorbs both simultaneously.

Why do children need a different device than adults?

Efferon already sells absorbers built for adult patients, but the company says children cannot simply use scaled-down versions of adult equipment. Because children have substantially lower circulating blood volume than adults, Romashin told TechCrunch, devices must be engineered specifically for pediatric physiology rather than adapted after the fact. Efferon NEO was built from the outset for that smaller blood volume, according to the company.

Where is the device already in use?

Efferon NEO is operating in intensive care units across 30 countries, TechCrunch reported, including hospitals in Europe, Saudi Arabia, and Thailand. The company has not yet received authorization to sell the device in the United States.

What comes next for Efferon in the U.S. market?

Efferon is preparing to file for U.S. Food and Drug Administration approval, according to TechCrunch, though no filing date was specified. The company is on track to reach $2 million in annualized revenue by the end of 2026, the outlet reported — a pace Romashin has acknowledged falls well short of the growth rates posted by many AI-focused startups today.

Who built the technology behind Efferon?

The underlying science originated with scientists at Moscow State University, including Efferon co-founder Ivan Bessonov, according to TechCrunch. Romashin, described by the outlet as a serial entrepreneur, joined as chief executive earlier this year to commercialize the research.

Romashin told TechCrunch that he does not measure the company's success against venture-backed growth benchmarks. "Every child who gets to go home" is the metric that matters, he said, according to the outlet's reporting.