Respinova Granted FDA 510(k) Clearance for Pulsehaler

Respinova has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market Pulsehaler™. Pulsehaler™ is an innovative device that facilitates the opening of airways and clearance of secretions in patients with respiratory diseases. The device is held to the patient’s mouth, where it delivers pulses of air pressure to gently open collapsed airways. The pulses also help to smooth and spread the mucus which may have built up on the airway walls, making it easier for the lung to clear and reduce re-closing.

“Despite the available pharma treatments, patients with COPD, Asthma, CF and other respiratory diseases unfortunately still suffer from poor quality of life,” commented Professor Raphael Breuer MD, former Head of the Institute of Pulmonology at Hadassah University Medical Center. “Pulsehaler™ brings a novel approach that will help patients with these conditions open their airways, which should improve their symptoms significantly”, he added.

“This FDA clearance for Pulsehaler™ is an important milestone for the company,” said Cliff Ansel, CEO of Respinova “We are excited to bring this innovative technology to respiratory patients”.

Pulsehaler™ is the first device to use patented Dynamic Multi-frequency Pressure Pulse™ technology. Driven by an internal turbine and multi-frequency vibration disc, Pulsehaler™ sends air pressure pulsations directly into the lung, making it easier to use for patients with airway restrictions.

The small airways have no cartilage structural support and are totally dependent on the tethering forces of the surrounding lung. When these forces are diminished, the small airways collapse and do not permit airflow to the gas-exchanging alveolar zone of the lung. When COPD progresses, the airways open only on deep inspiration, and eventually not at all. When the small airways collapse, not only is gas exchange is impaired, but also the cilia clearing mechanism fails, and secretions accumulate to further worsen the situation.

The small airways have little or no smooth muscle in their walls so that drugs can’t open them up, even if the particles manage to be delivered to the small airways.

Pulsehaler™ generates proprietary pressure pulses that travel into the lung which propagate faster inside the airways than in the surrounding parenchyma, thereby creating multiple momentary dilating forces that help gently pry open the collapsed airways. Pulsehaler™ also generates positive pressure on exhalation, which helps with airway opening. The pulses also help in smoothing and spreading the mucus lining layer on the airways walls, which assists in airway clearance and reduces the tendency of airways to re-close.

Respinova’s research is supported by €2.4 million from the EU’s Horizon 2020 SME Instrument program, which backs research and innovation through open competitive calls for proposals. The company is also among a small handful that has also been awarded a Horizon EIC grant. Respinova will be further testing the Pulsehaler™ in a clinical study of COPD patients across several sites, to gather additional efficacy data as part of the project.

Nearly one in five Europeans over 40 live with some form of the disease, which results in 300,000 European deaths each year, according to the European Lung Foundation.

Respinova’s Pulsehaler™, backed by the EU’s Horizon programs, could alleviate the severe suffering arising from this disease, which costs the EU more than €141 billion annually, according to the European Respiratory Society.

“The major unmet need in Europe and around the world is a treatment that addresses the root cause of COPD complications: small airway collapse,” explains Cliff Ansel, CEO of Respinova. “Until you can treat this, you only delay the inevitable. When patients keep getting progressively less oxygen into their bodies, eventually, they’ll wind up in the hospital.”

One third of COPD sufferers will have to go to the emergency room each year, according to the European Federation of Allergy and Airways Diseases Patients’ Associations.

About Respinova Ltd.

Respinova is a privately held medical technology company.. Their team has decades of experience in developing and commercializing innovative medical devices in diverse therapeutic areas. Respinova is a two-time winner of the prestigious European Horizon program (Horizon 2020 SME and Horizon EIC).

Contact: Cliff Ansel, CEO  cliff AT respinova.com +972-58-687-8812  www.respinova.com

Source: Respinova

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