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Efferon NEO, a paediatric blood purification device, receives CE mark

Efferon NEO, a medical device designed for paediatric sepsis, has received a CE mark, allowing its use in Europe. The device is engineered to filter toxins from children's blood.

  • Efferon NEO is the first multimodal blood purification device specifically engineered for paediatric sepsis to receive a CE mark.
  • The device is currently used in intensive care units across 30 countries, including European hospitals, Saudi Arabia, and Thailand.
  • Efferon is preparing to file for FDA approval and aims for $2 million in annualized revenue by the end of 2026.

Efferon NEO, a medical device developed by the startup Efferon, has received a CE mark, Europe's equivalent to FDA approval. This makes it the first multimodal blood purification device specifically engineered for paediatric sepsis.

The device is designed to filter dangerous cytokines and toxins from a patient's blood when standard treatments, such as antibiotics, cannot stop the immune system's overreaction during sepsis. Efferon NEO is specifically engineered for young children, who have a significantly lower circulating blood volume.

Sepsis, an acute inflammation triggered by infection, is a leading cause of childhood mortality, reportedly claiming approximately 3 million children under the age of five annually. Efferon's co-founder and CEO, Dima Romashin, stated that the company's technology can absorb both endotoxins and cytokines simultaneously, unlike other devices on the market.

Efferon NEO is currently in use in intensive care units across 30 countries, including European hospitals, Saudi Arabia, and Thailand. The company is now preparing to file for FDA approval and is on track to achieve $2 million in annualized revenue by the end of 2026.

Why this matters: The device addresses paediatric sepsis, a leading cause of childhood mortality, by offering a specialized blood purification method.

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