Newport Beach, CA – December 5, 2024 – VivoSense Inc. is excited to announce a productive regulatory meeting with the European Medicines Agency (EMA) regarding the qualification of MEADOW-RETT-BR, our innovative digital health technology (DHT)-based measure of apnea events in patients with Rett syndrome. This milestone marks an important step in advancing novel digital evidence tools for rare diseases.
The EMA’s Innovation Task Force expressed openness and provided valuable feedback, recognizing the importance of breathing dysfunction as a meaningful aspect of health for patients living with Rett syndrome. VivoSense appreciates the EMA’s flexibility and forward-thinking approach in addressing challenges related to clinical research in rare diseases. Their support and guidance significantly encourage us as we move toward formal qualification.
“We are extremely grateful for the EMA’s willingness to engage in this dialogue,” said Dr. Ieuan Clay, Director of Science at VivoSense. “Their input has been instrumental, and we are motivated by their encouragement to continue progressing MEADOW-RETT-BR, bringing meaningful, patient-centered measures to the forefront of clinical research.”
VivoSense is committed to working closely with the EMA and our partners at the Rett Syndrome Research Trust (RSRT) and the Boston Children’s Hospital to bring MEADOW-RETT-BR into full qualification, ultimately enhancing the development of new therapies for Rett syndrome.
For further information, please contact: Dr. Ieuan Clay, ieuan.clay@vivosense.com.
Disclaimer: the advice provided by the EU experts during the Innovation Task Force briefing meeting is informal and does not represent the opinions of the regulatory agencies, working parties, committees or organizations with which they are affiliated.