Charleston, S.C.-based startup ABM Respiratory Care has received U.S. FDA clearance for its first product, an airway clearance system known as Biwaze Cough. The portable device helps to remove secretions for people who are unable to cough or clear away secretions effectively on their own due to injury or disease.

ABM – which stands for Advanced Bio Machines – based its 510(k) for Biwaze Cough on other predicate mechanical exsufflation and insufflation devices such as Philips Respironics’ Coughassist and Hill-Rom Inc.’s Vitalcough.

The portable, lightweight (less than 9 pounds) system is designed for use in hospitals, institutional settings or at home use on patients with insufficient coughing ability due to reduced peak cough expiratory flow resulting from high spinal cord injuries, neuromuscular deficits or severe fatigue associated with intrinsic lung disease. Cleared for adults and children three years and older, the device uses high-frequency oscillations to break up mucous in the upper airways and remove it from the lungs, offering an alternative to invasive suctioning. Patients may use Biwaze Cough with a facemask, mouthpiece or an adaptor to a endotracheal or tracheostomy tube.

Features include personalized therapy cycles, Wi-Fi and Bluetooth connectivity, touchscreen interface, personalized therapy profiled and a mobile app for remote control. In addition, the system works on a proprietary platform engine that has separate paths for managing inhalations and exhalations. The Biwaze engine also enhances the control of airflow and oscillations.

Ramping up for launch

“We are currently ramping up production to roll the product out into the U.S. and Middle East over the next several months,” Chad Boerst, ABM’s president and founder, told BioWorld. “We expect to launch globally shortly after that with our pending approval and CE mark.”

Founded in 2017, ABM licensed the Biwaze technology from Metrohealth, an integrated health care system serving the Greater Cleveland area, and incorporated it with its own intellectual property. The technology, which provides mechanically assisted coughing and assisted breathing in a single device, was invented by David Birnkrant, director of Metrohealth’s pediatric pulmonary medicine division. “We have an amazing partnership” with Metrohealth and Birnkrant, Boerst said. “Together, we have combined our intellectual property to create what we believe will be a uniquely positioned, innovative portfolio of integrated therapy products.”

Vinay Joshi, ABM’s CEO, called the 510(k) clearance “a great achievement for the company. 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.”

Development of ventilator in high gear

The company’s aim is to build a portfolio of full respiratory assistance with complete airway management, Boerst said, adding that its next product – a ventilator – is in accelerated development as a result of the COVID-19 pandemic.

“We have several prototypes being tests around the clock and are currently negotiating several international contracts to finalize development and ramp up production,” he said. “We are working with the FDA on emergency use authorization, along with several international government agencies to determine a final timeline and commercialization plan.”

Thus far, ABM has been able to finance its work with money from individual angel investments. However, with growth efforts going into high gear, the company is opening a $6 million to $7 million series A round. Boerst said the goal is to “carry us through” completion of the company’s fully integrated product portfolio.

Competition

The global airway clearance systems market is expected to hit $922 million by 2026, up from $652 million in 2018, according to Allied Market Research. Driving growth is a surge in the incidence of cystic fibrosis, asthma and chronic obstructive pulmonary disease.

Among the companies participating in the space is Monaghan Medical Corp., of Plattsburgh, N.Y. The company received FDA approval in January to use its Aerobika hand-held oscillatory positive expiratory pressure (OPEP) device and VersaPAP positive airway pressure device in tandem.

Another contender is Electromed Inc., of New Prague, Minn., which markets the Smartvest airway clearance system. Other companies include Hillrom Inc. and General Physiotherapy Inc.

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