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Respicardia

Biotech & Life Sciences · Minnetonka, United States · Founded 2006

Respicardia, Inc. operates as a medical technology firm focused on developing implantable therapies for respiratory and cardiovascular conditions. Founded in 2006 and initially known as Cardiac Concepts, the company has centered its efforts on addressing central sleep apnea (CSA), a disorder where the brain fails to signal the muscles that control breathing during sleep. This condition frequently affects patients with heart failure and other cardiac diseases. The company's flagship product is the remedē® System, an implantable neurostimulation device. It is the only device of its kind to receive FDA approval for treating moderate to severe CSA in adult patients. The system functions similarly to a pacemaker and is implanted by a cardiac electrophysiologist in a minimally invasive, typically outpatient, procedure. It consists of a small battery pack placed under the skin in the upper chest and a lead inserted into a blood vessel near the phrenic nerve. The device monitors the patient's breathing patterns during sleep and delivers electrical pulses to the phrenic nerve, which in turn stimulates the diaphragm to restore a normal breathing rhythm. This mechanism treats CSA without the need for external equipment like masks. A significant milestone for Respicardia was receiving initial FDA approval for the remedē System in October 2017, following a pivotal trial published in The Lancet. The company initiated its U.S. commercial launch in early 2018. In April 2021, Respicardia was acquired by ZOLL Medical Corporation, an Asahi Kasei company, which had been a major investor for over three years. The acquisition integrated Respicardia into ZOLL's portfolio of cardiac and respiratory care solutions. Following the acquisition, an updated version of the product, the remedē EL-X system, received FDA approval in August 2021. This next-generation device is about 25% smaller, features a 40% longer battery life, and utilizes a simplified single-lead design. Keywords: central sleep apnea, implantable neurostimulator, phrenic nerve stimulation, remedē System, cardiovascular health, medical device, respiratory therapy, neurostimulation, sleep disordered breathing, heart failure comorbidity, diaphragm stimulation, implantable medical device, ZOLL Medical, Asahi Kasei, transvenous stimulation, sleep apnea treatment, cardiac electrophysiology, medical technology, FDA approved, respiratory monitoring