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Continuous Ambulatory Cough Measurement

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We are a digital health startup company in the field of voice biomarkers and collaborate with global healthcare companies, researchers and clinics.

WHAT WE PROVIDE

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 convenience for patients and physicians

 

 

 

 

 

 

 

 

 

The strong performance of the cough detection algorithm is based on a high-quality data pool and our machine learning capabilities.

Longitudinal objectification of cough supports clinical studies and research in generating important patient insights and data from their daily lives.

HOW IT WORKS

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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 physician / study investigator.

OUR CAPABILITIES

Based on close collaboration with clinical drug development, we currently provide the SIVA-MVP research tool with the following intended use:

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.

Our collaboration partner to conduct clinical studies is TMC Pharma.

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SIVA Health AG is certified according to EN ISO 13485:2016.

In November 2023, the final external audit for the European Medical Device Regulation (EU MDR) along with the 2nd surveillance audit for ISO 13485 was completed. This marks a significant step forward towards medical device approval of the full system in the European market.

PROOF OF CONCEPT

Our 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 iERJ open research.

A 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

WHO WE ARE

We love to create patient-centric solutions that add real value for clinicians, researchers and patients.

In our core team, we combine the relevant know-how and experience to turn these solutions into reality: clinical and medical affairs, hardware and software engineering, machine learning, RA and QM, product and project management, business development and corporate governance.

We are Alex, Mitja, Michael (on picture) and Laura, Molly, Simon in the core-team. Supported by more colleagues who work behind the scenes.

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