CONTINUOUS AMBULATORY COUGH MEASUREMENT
SIVA is the first continuous ambulatory cough measurement system used in a drug development study, providing cough profiles over several weeks.
WHAT WE PROVIDE
We are a Swiss medical device company in the field of voice biomarkers and collaborate with global healthcare companies, researchers and clinics.
Our patient-centric solution in the field of respiratory diseases is unique.
It provides:
-
Fully automated and real-time objective 24/7 cough profiles
-
High data consistency and data resolution
-
Important patient contextual data
-
A high level of proven convenience for patients and physicians
The outstanding performance of the cough detection algorithm is based on a high-quality data pool and our machine learning capabilities.
HOW IT WORKS
The SIVA Wearable Device will be used 24/7 by the patient. They will wear it on the chest during daytime and keep it by the bed side during nighttime. Cough and patient contextual data are continuously transferred to the study investigator / healthcare professional.
OUR CAPABILITIES IN CLINICAL RESEARCH
At SIVA, we combine the relevant know-how and experience to effectively support pharmaceutical companies in the approval of drugs as well as researchers in answering unsolved questions: clinical and scientific affairs, regulatory affairs, quality management, hardware and software engineering and project management.
Based on close collaboration with clinical drug development, SIVA currently provides the 'SIVA-MVP research tool' with the following intended use:
The SIVA-MVP is intended for data collection in clinical studies to objectively measure cough of individuals. This data is collected to perform basic or applied clinical research, to establish registry data, or to generate evidence for a cough-reduction drug labeling claim. It is not intended for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of a disease.
Note: This is not a medical device. Nothing herein should be construed as a solicitation or promotion of any product or of an indication of any specific use for any product.
SIVA Health AG is certified according to EN ISO 13485:2016.
The final external audit for the European Medical Device Regulation
(EU MDR) along with the 2nd surveillance audit for ISO 13485 was completed. Medical device approval of the full system in the European market is expected soon.
VALIDATION STUDIES
The first Clinical Validation Study (www.ClinicalTrials.gov / NCT04861155) was conducted at the University Hospital Zurich, Switzerland between April 2021 and October 2021. The results are published in ERJ open research.
Another Clinical Validation Study (www.ClinicalTrials.gov / NCT05689307) is currently being conducted in the U.S.
For more information, please contact us via info@siva-health.com
OUR PARTNERS
The SIVA system was developed in close cooperation with drug development in the pharmaceutical industry.
It is now used in drug development studies, usability studies and scientific studies around the world.
Our partners in the pharmaceutical industry and in research value our expertise and commitment in the field of continuous ambulatory cough measurement in clinical trials. We are happy to provide references.