Respicardia Raises $5.1M After Positive Results in Sleep Apnea Trial
Respicardia Inc., a venture-backed Minnesota medtech, has raised at least $5.1 million in a private debt placement after publishing positive results in a pivotal trial for its implantable, pacemaker-like device to treat sleep apnea.
The Minnetonka-based company is led by CEO Bonnie Labosky and backed by Italian health care conglomerate Sorin Group, which invested $20 million in 2014 to gain an exclusive option on Respicardia’s Remede sleep apnea system.
The 11-year-old firm had earlier raised $17 million from venture capital backers such as Three Arch Partners, Versant Ventures, Polaris Ventures Partners, Accuitive Medical Ventures and Affinity Capital Management.
The latest financing was revealed in Form D regulatory filing. It shows the firm had raised $5.1 million of an expected total of $6.6 million from 13 investors as of June 14, in the form of promissory notes convertible into equity.
The Remede System is described as an implantable, pacemaker-like device designed for improving central sleep apnea by using a proprietary “respiratory rhythm management” algorithm, which delivers electrical pulses via a unique transvenous implantable lead to one of the body's two phrenic nerves. The therapy is intended to stimulate the diaphragm to restore a more natural, less disrupted, breathing pattern.
Sleep apnea is linked to serious health conditions such as hypertension, stroke, heart disease, arrhythmias, diabetes, depression, and increases the risk of cancer mortality.
The latest funding comes eight months after the results of a four-year-long pivotal trial of the Remede system were published in the British medical journal The Lancet.
The trial was held to evaluate the safety and effectiveness of the device in subjects with moderate to severe central sleep apnea, compared with a control group that had inactive implants. It was led by Dr. Maria Rosa Costanzo, medical director of the Heart Failure Program of Midwest Heart Specialists-Advocate Medical Group in Naperville, Illinois, and Respicardia board member Dr. William Abraham of Ohio State University’s Wexner Medical Center. The effort included 151 patients at 31 hospitals in the United States, Germany and Poland.
The doctors reported the system achieved all of its desired endpoints. At the six-month evaluation, the device reduced the number of sleep apnea events per hour in 35 of the 68 members of the treatment group, or 51 percent. Only eight (11 percent) of those in the control group achieved the same reduction.
Other important sleep measures, such as the amount of time spent with a low blood oxygen level, were also significantly improved, the authors said. About a third of patients in the treatment group reported therapy-related discomfort, which was resolved with some reprogramming of the device.