Corventis clinical trial enrollment complete

By Brian Dolan
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Wireless remote monitoring and diagnostics solutions provider Corventis announced today that it has finished enrolling patients into its MUSIC (Multi-Sensor Monitoring in Congestive Heart Failure) program, which includes two trials: the MUSIC Asia (180 patients) and the pivotal MUSIC study (362 patients). The trials aim to develop and evaluate an algorithm to predict heart failure events.

Corventis has already secured FDA clearance for its core sensor technology and just announced that it received a CE Mark, which means doctors and patients in the European Union and other countries that accept the CE Mark, now can potentially use the technology, which Corventis calls its AVIVO Mobile Patient Management System.

The Corventis system monitors respiration rate, patient activity levels, and fluid levels in a patient’s body through a water-proof, adhesive sensor that is applied to the patient's skin. Fluid levels are monitored by the sensor's impedance detector, which measures buildup of body fluid through indirect electrical measurement. That can serve as a proxy for built up fluid levels in the lungs, which leads to shortness of breath and puts pressure on pulmonary arteries. That threatens to cause heart failure and may lead to hospitalization to remove the fluid.

Corventis' primary use case is for using the device to predict heart failure, which has been the aim of is MUSIC clinical trial. The company is also trying to determine if the system can accurately diagnose sleep apnea through changes in respiration and blood oxygen levels — a future version of the device will include a sensor for blood oxygen. Finally, another Corventis sensor hopes to capture more precise heart-rhythm disturbances in an effort to detect arrhythmias associated with stroke risk.

Corventis is the first start-up that the West Wireless Health Institute has committed to after it announced in June it would soon launch a clinical trial with the company. The randomized trial will be supported by the National Institutes of Health Clinical and Translational Science Award (CTSA) National Consortium, which consists of 38 of the most prestigious academic medical centers in the United States. The trial is designed to clinically validate remote wireless monitoring technology in proactively managing heart failure patients and reducing hospital readmissions, according to the Institute's press release.

Corventis was spun out of PhiloMetron, which is a medical technology accelerator focused on developing therapeutic management systems for large unmet quality of life and healthcare needs. Corventis was PhiloMetron's first spin out, and it is financial backed by Kleiner, Perkins, Caufield & Byers, Mohr-Davidow Ventures and DAG Ventures.

For more on Corventis' background story:
Interview with Mohr Davidow Ventures
Remote monitoring will save $20B?
FDA approves Corventis wireless sensor