Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 511

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 511
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P levels decreased over the treatment period, showing the effect
of NO in the reduction of systemic inflammation. There were no statistically significant or clinically relevant changes in FEV1 over time,
and lung function indices also remained relatively constant throughout the study duration.

In 2016, Rambam healthcare campus
in Israel conducted a compassionate use treatment for two patients with CF who suffer from M, abscessus lung infections. The data
were published in the Pediatric Infectious Disease Journal in 2017. The NO treatment regime, as well as the device for this treatment,
was supplied by BA Ltd. (as defined below), our wholly owned subsidiary. Patients received intermittent 30-minute treatments of 160 ppm
NO, with two different regimes including hospitalization (5 times a day) and ambulatory treatment (2-3 inhalations a day). Treatment was
well tolerated with no evidence of any serious side effects. We observed significant improvement in sputum production (up to 5-10 times
more sputum), and subjective improvement in the well-being of both patients. Significant reduction in systemic inflammation was observed
in the first patient, as observed by reduction of CRP (C-reactive protein, a systemic inflammation marker that rises in response to inflammation)
levels during treatment. In addition, the first patient had a 2 log (100-fold) reduction in M. abscessus during treatment (an effect
that was lost after the treatment regime changed to ambulatory). The second patient showed a significant increase in the 6-minute walk
(“6MW”) test and the sputum culture became negative, which is consistent with eradication of M. abscessus. Further
information is needed, but we believe these results suggest that the treatment of M. abscessus with high-concentration inhaled
NO is effective.

In 2017, we treated one patient
with CF who suffered from NTM infections (specifically, M. abscessus) under compassionate use in the United Sates at the National
Heart, Lung and Blood Institute with our generator based NO delivery system. The patient saw improvements in 6MW, FEV1, most Quality-of-Life
measures and had no SAEs. The bacteria was not eradicated. The patient requested to be treated again and this treatment commenced in February
2018. A total of 38 treatments were administered over 8 days, 29 of them at a concentration of 240 ppm, with no SAEs believed to be