Product updates, company news, and strategic insights from Hyfe.
Regulatory agreement, secured with partner KYORIN Pharmaceutical Co., Ltd., marks the first time Hyfe's automated CoughMonitor Suite will serve as a primary endpoint in a pivotal clinical trial - a precedent for objective digital endpoints in regulated drug and device development.
Comprehensive Chronic Cough Report reveals $15B opportunity. 100M patients, zero FDA-approved drugs, positioning digital cough monitoring as essential pharma infrastructure.
Review including Hyfe research evaluates continuous digital cough monitoring as a practical way to address limitations of patient-reported cough data
Study results demonstrate digital Behavioral Cough Suppression Therapy reduced cough frequency by over 40% in patients with refractory and unexplained chronic cough.
“CDRH clearance is neither necessary nor sufficient for CDER to accept a cough monitor as a trial endpoint. The two run on independent tracks.”
