Respinova’s Pulsehaler Device Wins FDA OK

Respinova’s non-invasive Pulsehaler, a medical device meant to ease breathing in patients with airway restrictions, such as in cystic fibrosis (CF), has been cleared for marketing in the U.S.

Pulsehaler was granted 510(k) clearance from the U.S. Food and Drug Administration (FDA) following the company’s submission of a premarket notification. This type of clearance is required when a device is marketed for the first time or when significant changes have been made to an already marketed device.

“We are excited to bring this innovative technology to respiratory patients,” Cliff Ansel, CEO of Israel-based Respinova, said in a press release.

“This FDA clearance for Pulsehaler is an important milestone for the company,” he said.

The buildup of a thick, viscous mucus — meaning a slimy, green-tinged or yellow mucus — in the lungs is one of the hallmarks of CF. Its accumulation leads to breathing problems, as the mucus cannot be properly moved and cleared by the lungs.

Strategies that increase mucus clearance, making it easier to expel through productive cough, help improve lung function and quality of life in people with CF.

Inhaled medications to improve breathing — including so-called muscarinic antagonists (blockers) or beta-adrenergic receptor agonists such as albuterol — commonly target the smooth muscle that surrounds the airways. These are commonly used in people with chronic obstructive pulmonary disease (COPD), a chronic inflammatory disease that makes breathing difficult.

However, according to Respinova, the small airways in the lungs have little or no smooth muscle in their walls, rendering this type of approach ineffective.

“Despite the available pharma treatments, patients with COPD, asthma, CF and other respiratory diseases unfortunately still suffer from poor quality of life,” said Raphael Breuer, MD, former head of the Institute of Pulmonology at Hadassah University Medical Center, in Israel.

Pulsehaler is a non-invasive device that generates unique pulses of air pressure, using Respinova’s dynamic multi-frequency pressure pulse technology.

Built with a turbine and an internal vibration disc, Pulsehaler generates pulses of air directly into the lung. Once there, the pulses of air expand rapidly, generating forces that help open the airways. This result is further achieved through positive pressure when a person breathes out.

According to the company, the pulses of air also help move the mucus along the airways, promoting its clearance, which reduces the risk of the airways closing.

“Pulsehaler brings a novel approach that will help patients with these conditions open their airways, which should improve their symptoms significantly,” Breuer said.

Marketing information for the device has not yet been released.