FDA Approves Groundbreaking Technologies for Epilepsy Monitoring: Embrace Smartwatch and Minder Implantable EEG System
• The FDA has approved Empatica's Embrace smartwatch, which uses machine learning and electrodermal activity monitoring to detect generalized tonic-clonic seizures with 100% accuracy in clinical trials.
• Epiminder's Minder system has received FDA De Novo classification and Breakthrough Device designation as the first implantable continuous EEG monitoring system that can track brain activity for months or years.
• These innovations address critical gaps in epilepsy management, potentially reducing the 3,000+ annual deaths from Sudden Unexpected Death in Epilepsy (SUDEP) and improving care for the 3.4 million Americans with epilepsy.
Sensorion's Audiogene Trial Completes First Cohort Enrollment for OTOF Gene-Mediated Hearing Loss
• Sensorion has completed enrollment of the first cohort in its Phase I/II Audiogene trial, evaluating SENS-501 for OTOF gene-mediated hearing loss.
• The trial focuses on infants and toddlers aged 6-31 months without cochlear implants, aiming to restore hearing and speech development during peak brain plasticity.
• Initial data from the first two treated patients indicate that SENS-501 and the surgical procedure were well-tolerated, with encouraging behavioral improvements observed.
• Sensorion plans to host a KOL event in early 2025 to present comprehensive safety and efficacy data, along with next steps for the Audiogene trial.
Sensorion's SENS-501 Shows Promise in Gene Therapy for OTOF-Related Hearing Loss
• Sensorion's SENS-501 Audiogene trial treated its first patient, showing initial safety and behavioral changes, with cohort completion expected by year-end.
• Final data from the SENS-401 Phase 2a trial indicates it preserves residual hearing after cochlear implantation, showing better outcomes at multiple frequencies.
• Preliminary data from the SENS-401 NOTOXIS trial suggests a potential protective effect against Cisplatin-Induced Ototoxicity, especially at higher doses.
• Sensorion's financial position is strong, with approximately €87 million in cash, supporting operations through the end of 2025.
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