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Synchrony Medical Enrolls First Patients in a US Study Towards Regulatory Submission of Its LibAirty™ Airway Clearance System


News provided by

Synchrony Medical

Feb 16, 2023, 07:00 ET

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CHARLESTON, S.C. and OR YEHUDA, Israel, Feb. 16, 2023 /PRNewswire/ -- Synchrony Medical announced today that the first patients have been enrolled in its single center, randomized-controlled, crossover clinical study of its LibAirty™ Airway Clearance System at Medical University of South Carolina. The study is led by principal investigator Dr. Patrick A. Flume, Director of the Adult Cystic Fibrosis and Bronchiectasis Center.

The objective of the study is to demonstrate the safety and efficacy of the LibAirty™ airway clearance system in patients with Bronchiectasis.

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Synchrony Medical CEO Anat Shani
Synchrony Medical CEO Anat Shani

The LibAirty™System is designed to enable patients requiring airway clearance to clear their lungs with an easy-to-use adaptive wearable device. The system is based on proven principles of airway physiology to enhance secretion movement to thoroughly clear even the smallest, most affected, and difficult to clear airways. A recent case study presented at the North American Cystic Fibrosis Conference demonstrated how the system already saved the life of a patient in a compassionate use case, as she waited for six months for a double organ transplant.

Dr. Flume said, "Patients with bronchiectasis worldwide are at risk for worsening symptoms, or exacerbations, many of which may result in hospitalization, due to poor airway clearance and lung infections. Synchrony Medical's LibAirty™ could provide an effective way to reduce symptoms and prevent exacerbations. For this reason, we are conducting a clinical trial in which we will be enrolling patients with bronchiectasis for whom we have prescribed daily airway clearance, to examine the system in comparison to the current standard of care. If all works as anticipated, LibAirty™ could become an important tool in addressing the significant clinical need for airway clearance."

Synchrony Medical CEO Anat Shani said, "We believe that LibAirty™ brings new concepts for effective and personalized airway clearance treatment to this market, and we hope the US study will  replicate the promising clinical results demonstrated so far and become the new standard of care for airway clearance."

About Synchrony Medical 

Synchrony Medical, a MEDX Xelerator portfolio company, is developing LibAirty™, a next generation, home-use, airway clearance system designed to help patients with chronic lung disease maintain clear lungs with a short, daily, proficient treatment. 

MEDX Xelerator is a leading medical device and digital health-focused incubator operating under the auspices of the Israel Innovation Authority. Current partners and collaborators include: Boston Scientific, Sheba Medical Center, MEDX Venture Group, Consensus Business Group (CBG), West Pharmaceuticals and The Portland Trust.

For more information, please visit, https://synchrony-medical.com/ 

Press Contact 
Marjie Hadad 
General Manager 
Must Have Communication 
917-790-1178 
+972-54-536-5220
[email protected]

Photo - https://mma.prnewswire.com/media/2004155/Anat_Shani_Synchrony_Medical.jpg

SOURCE Synchrony Medical

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Synchrony Medical Receives 510(k) FDA Clearance for LibAirty™ Airway Clearance System for At-Home Respiratory Relief

Synchrony Medical Receives 510(k) FDA Clearance for LibAirty™ Airway Clearance System for At-Home Respiratory Relief

Synchrony Medical, a medical technology company dedicated to advancing respiratory care, today announced that it has received U.S. Food and Drug...

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