ABM Respiratory care, a medical device company focused on developing novel integrated airway clearance and ventilation solutions, announced today that it has received 510(k) clearance to market its innovative cough therapy system.

This product helps remove secretions for people unable to cough or clear secretions effectively due to reduced peak cough flow resulting from high spinal cord injury, neuromuscular deficits or severe fatigue associated with intrinsic lung disease.

“Receiving our first FDA 510(k) clearance is a great achievement for the company,” said Vinay Joshi, ABM CEO. “We can now focus on executing our corporate strategy of integrating additional respiratory therapies into our BiWaze platform system and providing a truly novel approach to respiratory care.”

The BiWaze™ Cough system is the smallest and lightest assisted cough device on the market. The low profile design and touch screen navigation offers a user friendly experience. BiWaze Cough provides a non-invasive solution to clear secretions from the upper airways as compared to invasive suctioning.

It also provides high frequency oscillations to break up thick secretions and help remove them from the lungs. Each therapy cycle can be personalized to provide the most effective therapy for a person’s respiratory condition. In addition to these features, the device leverages an unique BiWaze platform engine that has two separate paths and blowers for managing inhale and exhale breaths which is unlike any other cough device on the market. The unique BiWaze engine also provides an improved control of the airflow through the device and efficient oscillations in all phases of therapy.

“This is an important step for ABM and we are truly excited for what the future holds for our BiWaze™ platform of products,” said Chad Boerst, ABM President and Founder.  “This allows us to continue to build the foundation of the business while we pursue outside investment.”

Source: Company Press Release