VILLACH, AT / ACCESS Newswire / April 22, 2026 / Efferon, a biotech company manufacturing multimodal hemoadsorption therapeutic devices designed to remove endotoxins and inflammatory mediators directly from the bloodstream, announces receipt of the CE MDR mark for Efferon NEO, making it Europe’s first hemoadsorption device approved for use in neonatal and pediatric patients with sepsis and septic shock. The certification is supported by results of the multicenter LASSO NEO study (NCT05707494), which for the first time demonstrated the clinical efficacy of targeted endotoxin and cytokine removal in children aged between 1 month and 18 years.
“I believe there is a real need to develop devices adapted for children. Children are not simply ‘small adults’: they have different weights, different circulating blood volumes, and different physiological responses,” said Gabriella Bottari, Pediatric Intensive Care Unit, Bambino Gesù Children’s Hospital, IRCCS, Rome, Italy. “Pediatric-specific technologies can improve safety and clinical applicability. I am motivated by the opportunity to give critically ill children a second chance. These patients are extremely vulnerable, and sometimes standard therapy is insufficient. For these reasons, hemoadsorption is an important adjuvant therapy tool. It is crucial to continue research in this area and share our experience worldwide.”
“Receiving CE MDR certification for Efferon NEO marks a pivotal milestone – not just for Efferon, but for critical care as a whole. For the first time, clinicians across Europe have access to a multimodal extracorporeal blood purification device purpose-built for pediatric patients,” said Dima Romashin, CEO and Co-founder of Efferon. “We are entering a $40 billion market that has long been underserved by existing solutions – and we are doing so with a clear mission: to bring the most advanced life-saving technology to the patients who need it most. The standard of care for a child in the ICU should be no less advanced than for any adult. We’re making sure of that with Efferon NEO.”
Sepsis remains one of the leading causes of death in children worldwide, responsible for more than 3 million pediatric deaths annually. Children account for half of all sepsis cases worldwide, with mortality rates among the most vulnerable patients reaching 25-50%. Until now, no extracorporeal blood purification device has been specifically designed and approved for use in this population under the stringent EU MDR regulatory framework.
“Since the effectiveness of Efferon LPS was demonstrated in adult patients with sepsis, it became clear that denying children access to such life-saving therapies would simply be unethical,” said Ivan Bessonov, CTO and Co-founder of Efferon. “That is why we focused our efforts on closing this gap. Now we can share results: we succeeded. Our deepest gratitude goes to the team of researchers who made this possible, patients, and their families.”
About Clinical Data Supporting the EU Approval
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Efferon NEO performs selective adsorption of lipopolysaccharides (LPS/endotoxin) combined with non-selective adsorption of cytokines, myoglobin, cellular debris, and endogenous and exogenous toxic substances. The device is non-pyrogenic, gamma-sterilized, and intended for single use.
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The device is approved for children with lower circulating blood volume, including pediatric patients up to 18 years old (blood priming volume <30 mL).
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Efferon NEO demonstrated a statistically significant reduction in multiple organ failure severity (pSOFA score 4.9 vs. 7.8 in the control group, p = 0.006 on day 7), faster weaning from mechanical ventilation (p = 0.003) and vasopressor support (p = 0.001), and a meaningful decrease in inflammatory markers including CRP, IL-6, and TNF-α.
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The 28-day mortality rate in the Efferon NEO group was 9%, compared to 35% in the control group (p = 0.008, OR = 0.2).
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The CE MDR certification closes a critical gap in pediatric critical care: prior to Efferon NEO, no multimodal hemoadsorption device designed and approved for pediatric patients was available on the market.
About the company
Efferon is a biotech company manufacturing multimodal hemoadsorption therapeutic devices designed to remove endotoxins and inflammatory mediators directly from the bloodstream.
Today, the company’s product line includes two devices: Efferon LPS (the first hemoadsorption cartridge combining endotoxin and cytokine adsorption), and the new Efferon NEO (specifically designed for pediatric use). Efferon’s technology is already approved and used across Europe, with more than 25,000 treatments, distributed in over 40 countries, including Australia, the United Kingdom, Germany, and Saudi Arabia.
Efferon NEO received EU QMS Certificate No. 2024-MDR/QS-024/A under Regulation (EU) 2017/745 (MDR), issued by Notified Body 3EC International (NB 2265) on April 7, 2026.
Media Contact
Zoe Chernova, PR manager
pr@efferon.com
SOURCE: Efferon
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