In February, Newborn Solutions, CataloniaBio & HealthTech members, received official approval from the Moroccan health authorities to carry out its clinical trial in Morocco. The achievement of this milestone allows the inclusion of the Hôpital d’Enfants de Rabat (HER), a reference pediatric hospital in the country.
“The start of the trial is very important to ensure the recruitment of the necessary patients and to increase the diversity of the population to test the efficacy of the Neosonics device in a country with a higher incidence of meningitis than Spain,” said Rita Quesada, Regulatory Lead of Newborn Solutions.
Newborn Solutions has developed Neosonics, a non-invasive medical device that automatically counts white blood cells in the cerebrospinal fluid directly below the infant’s fontanel in a matter of seconds. The device uses high-resolution ultrasound, novel coupling materials and artificial intelligence (AI) algorithms to accurately rule out or confirm meningitis in neonates and infants quickly, easily and cost-effectively.
The safety of the Neosonics device has been validated in an international clinical trial involving three hospitals in Spain and two centers in Mozambique. In the efficacy phase, after receiving authorisation from the Moroccan Ministry of Health, the Hôpital d’Enfants in Rabat will be incorporated. The first results of the clinical trial will be presented during the second quarter of this year. The results of the proof-of-concept test show 100% sensitivity, 90% specificity in vivo and 92% accuracy in vitro.
“This approval represents the overcoming of a high-risk regulatory barrier and says a lot about our ability to adapt to this process and the good work carried out with our partners at ISGlobal”, says Javier Jiménez, CEO of Newborn Solutions.
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