According to the American Sleep Association, 50 to 70 million Americans suffer from some type of sleep disorder. Sleep apnea affects over 18 million people, many of whom remain undiagnosed. Respicardia, a venture-backed medical technology company based in Minnesota, announced today that it received approval from the FDA for its Remed? System, a new implantable treatment option for patients who have been diagnosed with moderate to severe central sleep apnea. Respicardia’s device stimulates a nerve located in the chest that is responsible for sending signals to the diaphragm to stimulate breathing.
Source: Respicardia, as provided to Diagnostic and Interventional Cardiology
According to the FDA, sleep apnea is a disorder that causes individuals to have one or more pauses in breathing or shallow breaths during sleep. Breathing pauses can last from a few seconds to minutes. Central sleep apnea occurs when the brain fails to send signals to the diaphragm to breathe, causing an individual to stop breathing during sleep for a period of 10 seconds or more before restarting again. According to the National Institute of Health’s National Center on Sleep Disorders Research, central sleep apnea can lead to poor sleep quality and may result in serious health issues, including an increased risk for high blood pressure, heart attack, heart failure, stroke, obesity, and diabetes.
Respicardia’s device undoubtedly be welcomed by patients who have been enduring medication, continuous positive airway pressure machines (CPAPs) or surgery in an effort to combat sleep apnea.
The Remed? System is comprised of a battery pack surgically placed under the skin in the upper chest area and small, thin wires that are inserted into the blood vessels in the chest near the phrenic nerve that stimulates breathing. The system monitors the patient’s respiratory signals during sleep and stimulates the nerve to move the diaphragm and restore normal breathing.
Respicardia, formerly known as Cardiac Concepts, is backed by Sorin Group, the Italian health care conglomerate, according to Twin Cities Business Magazine. Sorin Group invested $20 million in Respicardia in 2014 to gain an exclusive option on the Remed? System. The company raised $5.1 million in a private placement of convertible debt in June 2017 and has previously raised $17 million in venture capital from from firms including Three Arch Partners, Versant, Polaris, Accuitive Medical and Affinity Capital.
CEO Bonnie Labosky has led Respicardia since its inception in 2006. Prior to joining Respicardia, Bonnie served at Welch Allyn as Group Vice President, where she managed a number of business units and international sales and operations. Previously, at Medtronic, as Vice President and General Manager, she managed businesses including Micro Interventional Systems and Heart Failure where the first Cardiac Resynchronization Therapy using an implantable device was developed. Ms. Labosky also led several Medtronic divisions dedicated to developing the technical components of implantable devices including software, batteries and capacitors and leads.
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