Clinical study shows chronic respiratory disease patients using wearable ventilation technology achieved significant increase in exercise endurance

Breathe Technologies, a developer and manufacturer of innovative medical technologies for patients with respiratory insufficiency diseases and neuromuscular diseases, have announced new data demonstrating that use of its Non-Invasive Open Ventilation (NIOV™) System in pulmonary rehabilitation was associated with significant improvement in mean exercise duration change (approximately 63 percent) among patients with chronic respiratory disease. Study results were presented during the biennial COPD9USA meeting which took place on June 5-6 in Chicago.

Increased physical activity and exercise capacity are important factors in improving long-term health outcomes among patients with chronic respiratory disease. Exercise has been shown to increase energy to allow continuation of normal day-to-day activities, maintain a healthy body weight to make breathing easier and reduce the frequency of disease-related respiratory exacerbations.

This retrospective case series, designed to evaluate the effect of a wearable noninvasive open ventilation system in subjects with chronic respiratory disease in a pulmonary rehabilitation (PR) setting, enrolled seven patients in the test group (with NIOV) and nine in the control group.

At the end of 36 visits, the mean change in exercise time was significantly higher in the NIOV group vs. the control group (24.3 vs. 15.2 minutes), despite the fact that patients in this group had more severe chronic lung conditions and poorer pulmonary function values at baseline. Additionally, patients in the NIOV group were able to exercise approximately five minutes longer on average (42.3 vs. 37.8 minutes).

"It is well-established that pulmonary rehabilitation programs have been conclusively linked to positive clinical outcomes in dyspnea reduction, increased exercise capacity and reductions in hospitalization, but improvements in physical activity are currently limited by a lack of solutions that can be utilized to promote PR programs within clinical facilities and at home," said Joanne Scasserra, CRT, RPTF, Department of Respiratory Care, Saint Barnabas Medical Center, Livingston, N.J. "The NIOV System is a one-pound wearable ventilator that can be easily integrated in the pulmonary rehabilitation programs in a majority of patients. We believe that this technology has the potential to improve the current paradigm of respiratory care, through improved exercise outcomes, increased ambulation and empowerment for patients to more fully engage in daily activities."

The Breathe NIOV System is an FDA-cleared wearable ventilation system for people with respiratory insufficiency. The Breathe NIOV System provides augmented tidal volume, which reduces the work of breathing for people with respiratory insufficiency. When Breathe Technologies received its first U.S. FDA 501(k) Clearance in 2010 for the NIOV System, it was the first innovation in the ventilation category since 1998.

"We are excited to see an ongoing trend of positive study results that continue to reinforce the clinical value of NIOV in improving exercise endurance in patients with chronic respiratory insufficiency who might otherwise be sedentary due to their conditions," said Larry Mastrovich, president and CEO, Breathe Technologies. "We appreciate the scientific contributions of our research partners at Saint Barnabas Medical Center who are helping us advance more widespread adoption of the NIOV System through demonstrating its benefits to patients and clinicians."

About The Breathe NIOV System

The Breathe NIOV System is a one-pound non-invasive mechanical ventilator that can be used in homecare and institutional settings. The Breathe NIOV System utilizes novel venturi principle technology in a comfortable facial interface that can be worn while talking and exercising. The Breathe NIOV System technology reduces the overall size of the ventilation system and supports patient mobility and independence.

The Breathe NIOV System reduces the work of breathing by unloading the ancillary respiratory muscles.i Data from the seven studies that support the efficacy of the Breathe NIOV System demonstrate that the device reduces dyspnea (shortness of breath), increases oxygenation, enhances exercise endurance, and unloads respiratory muscle activity.