Respicardia

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.