Efferon NEO gets CE mark for pediatric sepsis — SkimNews
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- Efferon NEO, the company's pediatric device, received a CE mark in April, becoming the first multimodal blood purification device specifically engineered for pediatric sepsis.
- Sepsis claims roughly 3 million children under the age of five annually, according to the company, which frames Efferon's mission around drastically lowering that figure.
- Efferon devices absorb both endotoxins and cytokines at once — unlike competing devices on the market, per co-founder and CEO Dima Romashin — who likens endotoxins to flames and cytokines to smoke in the body's overwhelming immune response.
- Efferon NEO is already in use in intensive care units across 30 countries, including European hospitals, Saudi Arabia, and Thailand.
- Efferon is preparing to file for FDA approval and is on track to hit $2 million in annualized revenue by the end of 2026.
- The underlying technology was developed at Moscow State University, with co-founder Ivan Bessonov among the scientists; serial entrepreneur Romashin stepped in earlier this year as CEO to commercialize it, noting success is measured by 'every child who gets to go home.'
Why it matters: For the roughly 3 million children under five killed by sepsis each year, Efferon NEO offers a pediatric-specific tool — distinct from the company's adult devices — that simultaneously targets both endotoxins and cytokines, a dual mechanism Romashin says no competitor matches. With the CE mark secured, an FDA filing in progress, and live ICU deployments spanning 30 countries, the device is moving from European clearance into broader market access on a $2 million revenue trajectory by year-end.
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