FDA Grants VERO Biotech Expanded Access Emergency Use for the Treatment of Patients with COVID-19, with the GENOSYL® DS, the First and Only FDA-Approved Tankless System for the Delivery of Inhaled Nitric Oxide

The recently FDA-approved GENOSYL® inhaled nitric oxide may have pulmonary and antiviral benefits in treating pulmonary hypertension and acute infectious diseases associated with the novel coronavirus[1]
GENOSYL® DS facilitates outpatient use of inhaled nitric oxide in the treatment of cardiopulmonary symptoms associated with COVID-19

GENOSYL is contraindicated in the treatment of neonates dependent on right-to-left shunting of blood.
• Abrupt discontinuation of GENOSYL (nitric oxide) gas, for inhalation may lead to worsening oxygenation and increasing pulmonary artery pressure.
• Methemoglobin levels in the blood increase with the dose of nitric oxide; following discontinuation or reduction of nitric oxide, methemoglobin levels return to baseline over a period of hours.
• Methemoglobin, NO2, and PaO2 should be monitored during nitric oxide administration.
• In patients with pre-existing left ventricular dysfunction, GENOSYL may increase pulmonary capillary wedge pressure leading to pulmonary edema.
• The most common adverse reaction is hypotension.
• Nitric oxide donor compounds may have an additive effect with GENOSYL on the risk of developing methemoglobinemia.
• GENOSYL must be administered using a calibrated GENOSYL Delivery System. Only validated ventilator systems should be used in conjunction with GENOSYL.
Please visit www.vero-biotech.com for the full Prescribing Information for GENOSYL.
GENOSYL DS is VERO Biotech\’s lead product specifically designed for the hospital intensive care setting. This proprietary delivery system eliminates the need for large nitric oxide tanks and the associated logistical burden. GENOSYL DS is a tankless and portable system engineered with failsafe, redundant backup features, which delivers a constant concentration of inhaled nitric oxide gas to patients and the easy-to-use interface and portability features.
About VERO Biotech LLC
VERO Biotech LLC (formerly known as GeNO LLC) is a biotechnology company focused on the design, development, and commercialization of next-generation products to address the unmet medical needs of patients with a variety of pulmonary and cardiac diseases.
VERO Biotech LLC is dedicated to improving the lives of patients by leading the development of innovative technologies for inhaled nitric oxide delivery in the acute care hospital setting and beyond, wherever inhaled nitric oxide treatment is needed.
Forward Looking Statements
This press release and any statements of representatives of VERO Biotech LLC related thereto that are not historical in nature contain, or may contain, among other things, certain \”forward-looking statements\” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, without limitation, statements with respect to VERO Biotech\’s plans, objectives, projections, expectations and intentions and other statements identified by words such as \”projects,\” \”may,\” \”will,\” \”could,\” \”would,\” \”should,\” \”believes,\” \”expects,\” \”anticipates,\” \”estimates,\” \”seeks,\” \”intends,\” \”plans,\” \”potential\” or similar expressions, including statements with respect to the potential effects of its products and plans to assess and undertake next steps for VERO Biotech LLC. These statements are based upon the current beliefs and expectations of VERO Biotech\’s management and are subject to significant risks and uncertainties. Actual results may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various risk factors (many of which are beyond VERO Biotech\’s control).

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