Cough/ Heart rate correlations offer new insights into respiratory and cardiovascular health

Objective cough monitoring
for drug development and clinical trials

Hyfe’s AI-powered cough monitoring is unobtrusive for patients and can monitor continuously for days, weeks or months. For the first time ever, we can unlock the secrets of longitudinal cough patterns for the benefit of healthcare.

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Welcome to the future of cough monitoring

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Continuous

With Hyfe you can monitor cost-effectively for days, weeks or even months; you’re no longer limited to unrepresentative 24 hr periods.

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Unobtrusive

Hyfe works on wearables and smartphones, minimizing the Hawthorne/placebo effect seen with other more intrusive monitoring devices.

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Highly accurate

Hyfe’s software detects 90% coughs, even in noisy everyday acoustic environments, with just 1.1 false positives / hour.

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Real-time

Data is received daily, so you can manage your cohorts and make adjustments fast.

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Insightful

Hyfe has been used in 46 investigator-initiated trials, generating novel insights across 15 indications.

How Hyfe can support better clinical trials

Patient Recruitment

We help you quickly & cost-effectively identify patients who cough, via our global consumer apps.

Patient Selection

We use continuous monitoring to screen for patients with a high cough rate and stable baseline cough rate  to reduce the placebo effect.

Study Endpoint

Our continuous monitoring offers more insights and sensitivity that periodic monitoring cannot match.

Non-Drug Studies

Hyfe’s longitudinal, continuous cough data helps you gain a novel understanding of disease, leading to improved protocols and study design.

Market Expansion

We can help you target your therapies to those who need it most, using Hyfe’s unobtrusive, cost-effective cough-monitoring.

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Current cough measures are scientifically flawed and contribute to large placebo effects in clinical trials

Patient reported outcomes do not accurately reflect cough and are a poor pharmacokinetic endpoint.

Each chart is one patient.  The green line is subjective self-reported daily cough severity score; the blue line is objective cough rate as measured by Hyfe.

Cough is stochastic, with good days and bad days. Selecting the ‘wrong’ 24 hour period can significantly affect trial results.

In the data, each row is a patient and each square is a day of monitoring. Measurements taken on red days do not reflect the cough rate for the month.

Case study: FEND

Hyfe has partnered with FendMed at several points in the development of their promising anti-tussive agent.

FendMed’s inhaled therapy, which provides long-acting laryngeal hydration, is comprised of Hypertonic Divalent Salts. They have used continuous cough monitoring to optimize FendMed's composition, define the pharmacokinetics of FendMed's effect, and show its impact on cough frequency in chronic coughers.

Continuous, unobtrusive, accurate cough monitoring in near real time has been a game changer for the clinical development of FendMed, allowing us to optimize HDS composition and precisely define its efficacy.

David Edwards, Founder/CEO Sensory Cloud
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Hyfe is collaborating with pharma partners on CDER validation for use as a continuous cough monitor for any etiology.

We expect to receive de novo clearance during 2025. (Please note there are currently zero FDA-cleared devices for counting coughs). Hyfe’s indications for use will be for automated counting of coughs of any etiology.

In addition, some partners are choosing to do a small disease-specific validation for their disease of interest, ether separate to, or embedded within, their clinical trial.

Hyfe has pharma partners committed to using Hyfe through to PIII, and whom are already having conversations with CDER.

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