Company Research Report on SIVA Health AG

Company Overview

• Name: SIVA Health AG

• Mission: SIVA Health AG aims to provide innovative AI-powered solutions in respiratory health to improve patients' lives by offering continuous insights for enhanced patient care and early diagnosis.

• Founding: No information is available regarding the exact founding date.

• Founders:

• Mitja Alge: Co-Founder & Chief Data Scientist

• Dr. Alexander Duschau-Wicke: Co-Founder & CEO

• Michael Häberli: Co-Founder & CFO

• Key People:

• Dr. Laura Kütt: Chief Commercial Officer

• Headquarters: No specific information on the exact headquarters location.

• Number of Employees: No information is available.

• Revenue: No information is available.

• Known For: The company is known for AI-powered respiratory monitoring and cough detection solutions, providing real-time insights for patient care and supporting early diagnosis.

Products

SIVA System

• Product Description: The SIVA System is an advanced patient-centric and fully automated 24/7 cough detection system. It provides comprehensive cough profiles and contextual data for healthcare professionals, pharmaceutical study sponsors, and researchers.

• Key Features:

• Optimal Placement: Cough monitor placed on the chest for high specificity in measurement and data quality.

• Medical Grade: Classified as a class IIa medical device, bearing CE mark approval.

• Easy to Wear: Equipped with convenient neck straps for quick application and comfort.

• Clinically Validated: Proven performance and usability in clinical validation studies.

• Guaranteed Privacy: Ensures end-to-end data encryption, maintaining privacy without human listener involvement.

Recent Developments

• Certifications & Approvals:

• July 2024: Received certification according to the European Medical Device Regulation (EU) 2017/745, marking it as the first fully automated AI-based continuous ambulatory cough monitoring system approved as a medical device.

• Participation in Conferences:

• July 2024: Participated in the London Cough Conference 2024, presenting findings on cough detection algorithm performance.

• Studies and Research:

• November 2023: Employed in a global drug development study; contributed continuous ambulatory cough measurement system to provide cough profiles.

• March 2023: Commenced a clinical validation study at Bellingham Asthma, Allergy & Immunology Clinic, USA.

• October 2022: Published clinical results from the validation study in ERJ Open Research.

• Independence:

• July 2023: SIVA Health AG became a fully independent company, owning all generated intellectual property after Bayer Pharmaceuticals discontinued its drug project.

Legal and Compliance

• Certifications:

• EU MDR Certified

• ISO 13485 Certified

• ISO 27001 Compliant

• Regulatory Compliance:

• GDPR & HIPAA Compliant

End of the Report.

(Note: This report is created based on the information provided within the data, and some sections remain incomplete due to unavailable details.)