Cordio Medical, an Israel-based medical technology company, has developed HearO, an app that can help monitor congestive heart failure. The technology is based on the phenomenon that patients with congestive heart failure experience changes in their voice as their disease progresses or before the disease exacerbates. This includes lung sounds, such as wheezing and crackles. Indeed, some cardiologists report that they can hear changes in their patient’s voice, but this usually occurs relatively late in the disease exacerbation, making it less useful.
This phenomenon inspired Cordio Medical to develop an AI-powered app that can help patients monitor their condition. AI is well suited to identify subtle changes in a patient’s voice that would be difficult or impossible to identify manually. The procedure involves a patient repeating the same phrase daily, and the app analyzes this recording and compares it to a reference reading. If anything has changed, the app will notify a health care provider.
Medgadget had the opportunity to speak with Tamir Tal, CEO of Cordio Medical, about the company’s technology and its capabilities.
Conn Hastings, Medgadget: Please give us an overview of congestive heart failure and its impact on patients.
Tamir Tal, Cordio Medical: Heart failure (CHF) is a worldwide pandemic and the statistics are alarming; 2% of the world’s population is hospitalized each year due to CHF, and an additional 6.5 million people are diagnosed with an incurable disease. Each year, approximately 1.1 million people are hospitalized with CHF, creating a financial budget of approximately $40 billion in total, making it one of the most common and costly conditions in the world.
CHF occurs when the heart muscle does not pump blood as well as it should, causing blood and fluid to build up in the lungs and legs. This fluid buildup can cause shortness of breath and swelling in the legs and feet. For most people, heart failure is a long-term condition that cannot be cured, but treatments are available to help control symptoms, possibly for many years. One of the main treatments for stabilizing patients with fluid imbalance is diuretics, which allow the body to release excess fluid. The dosage of prescribed diuretics is minimal, so the patient is not at risk of developing kidney failure. Even a slight change in a patient’s condition can lead to hospitalization.
Medgadget: How are these patients currently being followed? Have you identified gaps in this space?
Tamir Tal: Currently, remote monitoring technologies are used to provide clinicians with early indications of CHF decompensation. This technology helps optimize therapy to further prevent HF hospitalizations, but the need for reliable remote monitoring technology has never been greater. Although there have been introductions of wearable devices, invasive sensing devices, or remote testing, the current standard of care is often inaccurate, inconsistent, difficult to use, and costly for patients.
Medgadget: Please give us an overview of HearO and how it works.
Tamir Tal: HearO® is a medical-grade digital platform that enables CHF monitoring through advanced speech analytics technology, transforming standard mobile devices into advanced medical devices. This product will finally close the market gap by introducing a low cost, easy to use monitoring device available to all CHF patients – including Class 1 and 2. HearO® is not universal but personal.
The physician will prescribe the HearO® app when the patient is in remission, using the first 7-10 days to create a patient-specific baseline, allowing for accuracy by learning the patient’s personal speech pattern. If no changes are discovered in the new daily speech samples, the baseline is updated with new data. If a change is discovered, the HearO® sends an immediate notification to the patient’s clinic.
This patient dependent system allows the patient to have more control over their own health using our easy software device. In addition, the system is language independent. We already have it in six languages and can easily extend it to other languages.
Medgadget: How does heart failure affect the voice, and how did you train the software to recognize it?
Tamir Tal: There is a proven relationship between CHF and speech processing. Cardiologists may hear a change in the patient’s speech patterns when the congestion is symptomatic. Unfortunately, this observation often comes too late after the deterioration of the patient’s condition. Breath sounds can provide critical information describing the physiologies and pathologies of lung and airway obstruction. Lung sounds such as wheezing, crackles, and others are commonly monitored during clinical assessments for CHF.
Research has determined that measures of voice quality correlate with improvement in CHF symptoms during decompensation treatment (SOURCE: 1Murton OM et al. J Acoust Soc Am. 2017;142:EL401-7 ). A voice biomarker is associated with clinical outcome in patients with CHF (prediction of increased risk of death) (SOURCE: Elad Maor et al. Mayo Clin Proc. 2018;93:840-7). Additionally, a positive association between a voice biomarker derived from voice signal analysis and pulmonary hypertension has been reported (SOURCE: Sara JDS et al. PLoS ONE. 2020;15:e0231441).
Cordio has successfully developed modifications of existing speech processing models used in apps such as Alexa and Siri, making them viable for CHF detection and monitoring. The basis of this model is the concept that the lungs act as the engine of the speech process. HearO® analysis algorithms were developed by measuring changes in the speech energy generator. An analogy to help understand this technology is a car engine filled with fluids; the car may drive well for a while, but eventually the engine will get congested and the car will stop. The HearO® is a sensor that indicates these changes by analyzing the patient’s speech and detecting events before the patient can feel it and the cardiologist diagnoses it, thus alerting the clinician to temporarily increase the dose of diuretics in case of manifest prolonged hospitalization.
Medgadget: What inspired you to develop this technology? How did it happen?
Tamir Tal: The idea for Cordio came from a cardiologist, who mentioned that although he could hear in his CHF patient’s voice that he was congested, it was often too late. This prompted us to start researching whether speech processing and AI technologies could detect congestion earlier and allow the clinic to intervene in time to slow patient deterioration.
Medgadget: Do you currently have any ongoing clinical studies? Where is the technology at today in terms of clinical, regulatory and commercial journey?
Tamir Tal: HearO® has been tested and validated on more than 700 patients in three different studies. Each study has been published:
- Dialysis Study – Cordio algorithms identify cyclical changes reflecting body fluid level [Amir O et al. ESC Heart Failure 2021; DOI: 10.1002/ehf2.13367]
- Acute study – HearO® identifies differences in patient speech – ADHF patients at admission vs discharge [O. Amir, WT. Abraham at al. ESC-HF abstract EUD ID 933852, 2020]
- Community Study – HearO® System During Remission and Deterioration of Patients Demonstrates 80% Success Rate in Providing 22-Day Notice Prior to CHF Hospitalizations/Events [O. Amir et Al. HFSA, ID: 021-A-1743-HFSA].
The HearO® has received Breakthrough Device designation from the FDA and is currently undergoing a pivotal study in the United States. HearO® already has CE approval and pilots are expected to start in the UK, Germany and Spain in the coming months.