Beyond Air Accelerates LungFit™ BRO COVID-19 Program
March 18, 2020 8:30am EDT
Prepared to test LungFit™ BRO in COVID-19 patients in a clinical study starting in April pending FDA approval of recently submitted IDE (investigational device exemption)
GARDEN CITY, N.Y., and REHOVOT, Israel, March 18, 2020 (GLOBE NEWSWIRE) -- Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled Nitric Oxide (NO) for the treatment of patients with respiratory conditions, serious lung infections, including those suffering from COVID-19, and pulmonary hypertension, as well as gaseous NO for the treatment of solid tumors, today announced that the Company has drawn $5 million from its previously announced $25 million line of credit to provide the resources to more rapidly move the LungFit™™ BRO COVID-19 program forward.
“While we await feedback from BARDA (a division of HHS) and other US and international agencies, this money allows us to accelerate the anticipated COVID-19 clinical study start,” said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “While we anticipate receiving grants on an emergency basis, we have decided that there is an urgent need to commence the study as soon as possible pending IDE approval from FDA.
Revolutionizing the Delivery of Nitric Oxide
Beyond Air is an emerging medical device and biopharmaceutical company with groundbreaking technology. We are developing the LungFit™† platform system, a generator and delivery system that produces nitric oxide from ambient air, eliminating the need for expensive and cumbersome cylinders.
Our delivery system can generate up to 400 parts per million of nitric oxide for delivery to a patient's lung. It can deliver nitric oxide either continuously or intermittently with the ability to titrate on demand.
We believe the LungFit™ system satisfies a strong desire to eliminate cylinders from the hospital, providing significant benefits as a result. LungFit™ may be used anywhere in the hospital setting, providing the opportunity to treat infants with pulmonary hypertension and bronchiolitis. The simplicity and safety of the LungFit™ system may allow self-administration in the home, where we believe there is a high unmet need for patients with severe lung infections.
Beyond Air Speeds Development of Lung-Treatment Device
9:14 am ET March 18, 2020 (Dow Jones) Print
Beyond Air Inc. said Wednesday it will accelerate development of a medical device aimed to help treat patients with lung conditions that could include effects from Covid-19. Beyond Air said it drew $5 million from a $25 million line of credit to speed up progress on the device as it awaits government approvals for trials.
The device, LungFit, delivers nitric oxide to a patient's lungs. Previous trials have experimented with using nitric oxide to help patients with acute respiratory distress syndrome, which can be a result of Covid-19. Beyond Air says that LungFit could also be a treatment for pulmonary hypertension.
(RTTNews) - Beyond Air Inc. (XAIR) has a couple of clinical trial catalysts up its sleeve, making the stock worth watching in the coming months.
Beyond Air is a clinical-stage medical device and biopharmaceutical company developing inhaled Nitric Oxide (NO) for the treatment of patients with respiratory conditions including serious lung infections and pulmonary hypertension.
The lead investigational asset is LungFit PH, a next-generation phasic flow ventilator compatible nitric oxide delivery system. The cylinder free system is proposed for the treatment of pulmonary hypertension for certain ventilated patients in the hospital setting.
The Company is planning to seek FDA approval for LungFit PH next quarter (Q2, 2020). If all goes well as planned, the device may be launched in the fourth quarter of this year. The market potential of LungFit PH in the U.S. is estimated to be over $300 million.
|Target Patient Population ||US Sales Potential* ||WW Sales Potential* ||Launch Year*** |
|Pulmonary Hypertension (in-hospital) ||>$300m ||>$600m ||2020 |
|Bronchiolitis (in-hospital) ||>$500m ||>$1.2b ||2022 |
|Severe Lung Infections (at-home)** ||>$1b ||>$2.5b ||2024 |