What happened in this Health story?

Efferon NEO, a startup's pediatric-specific blood purification device for sepsis, became the first multimodal device of its kind to earn a CE mark and is now deployed in 30 countries as the company prepares to file for FDA approval.

What is a key fact in this story? (1)

**Efferon** developed a blood purification device targeting pediatric sepsis, a condition claiming roughly 3 million children under five annually worldwide.

What is a key fact in this story? (2)

Co-founder and CEO **Dima Romashin** said Efferon's device uniquely absorbs both endotoxins and cytokines simultaneously, framing sepsis as 'flames' (endotoxins) and 'smoke' (cytokines) in an immune-system fire.

Efferon NEO gets first pediatric sepsis CE mark — SkimNews

By TechCrunch · Summarized & edited by Kapil Samant · 2026-10-11

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Efferon developed a blood purification device targeting pediatric sepsis, a condition claiming roughly 3 million children under five annually worldwide.
Co-founder and CEO Dima Romashin said Efferon's device uniquely absorbs both endotoxins and cytokines simultaneously, framing sepsis as 'flames' (endotoxins) and 'smoke' (cytokines) in an immune-system fire.
Efferon NEO received a CE mark in April, becoming the first multimodal blood purification device specifically engineered for pediatric sepsis.
The pediatric device is currently used in ICUs across 30 countries, including European hospitals, Saudi Arabia, and Thailand.
The startup is preparing to file for FDA approval and is on track for $2 million in annualized revenue by end of 2026.
The technology was originally developed by scientists at Moscow State University, including co-founder Ivan Bessonov, before serial entrepreneur Romashin stepped in as CEO earlier this year to commercialize it.

Why it matters: With roughly 3 million children under five dying of sepsis each year and most blood-purification devices designed for adult physiology, Efferon NEO's CE mark is a category-first regulatory milestone — and the company's projected $2 million in annualized revenue by end of 2026, across 30 countries, gives it a concrete commercial base ahead of an FDA filing.