VERO Biotech Receives US FDA Approval of GENOSYL® for the Delivery of Inhaled Nitric Oxide

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The GENOSYL® inhaled nitric oxide approval represents the first and only FDA-approved tankless delivery system and is an important new development in the clinical application of inhaled nitric oxide.

FOR IMMEDIATE RELASE

December 20, 2019, – VERO Biotech LLC, an Atlanta, Georgia-based biotechnology company focused on saving lives, alleviating suffering and improving the health economics of care, today announced it has received US Food and Drug Administration (FDA) approval of GENOSYL® (nitric oxide) gas, for inhalation.

GENOSYL® is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.

GENOSYL® is contraindicated in the treatment of neonates dependent on right-to-left shunting of blood. (See below for additional Important Safety Information.)

VERO Biotech‘s GENOSYL® Delivery System (DS) is a compact and user-friendly nitric oxide delivery system, that will not only enable hospitals to reduce logistical burden as compared to the cumbersome tank-based systems currently available, but could provide greater patient access to this potentially life-saving drug.

“FDA approval is a major milestone for VERO Biotech and represents an alternative technology within the inhaled nitric oxide market,” said Brent V. Furse, President and Chief Executive Officer. “We look forward to making GENOSYL® DS available to the critical care community and patients who may benefit from treatment. This is the first step towards VERO Biotech executing on its vision to bring innovative, patient-centric therapeutic solutions to market.”

VERO Biotech anticipates launching GENOSYL® DS in US hospitals in early 2020.

“VERO Biotech’s GENOSYL® DS is a truly innovative way to create inhaled nitric oxide without tanks and will improve access to this gas that has improved the outcomes of many neonates,” said Brian K. Walsh, PhD, RRT, FAARC, Past President of the American Association for Respiratory Care and Professor of Health Sciences at Liberty University. “The pediatric respiratory community eagerly looks forward to additional options of inhaled nitric oxide delivery that GENOSYL® DS brings to our standard of care.”

About Persistent Pulmonary Hypertension of the Newborn (PPHN)

Persistent pulmonary hypertension of the newborn (PPHN) with hypoxic respiratory failure is a serious condition in term or near-term newborns. It is estimated to affect 100,000 neonates globally every year. PPHN occurs when an infant’s circulation continues to flow as it did while in the uterus once the baby is born. The result is too much blood flow bypasses the baby’s lungs inhibiting their ability to breathe effectively. Inhaled nitric oxide has revolutionized the treatment of PPHN, providing improved oxygenation and a reduced need for invasive extracorporeal membrane oxygenation. PPHN is currently the only FDA-approved indication for inhaled nitric oxide. Inhaled nitric oxide is recommended as a first-line vasodilator therapy for PPHN in a Consensus Statement from the Pediatric Cardiac Intensive Care Society.

About Inhaled Nitric Oxide

Nitric oxide is a powerful molecule proven to play a critical role in a broad array of biological functions. In the airways, nitric oxide targets the vascular smooth muscle cells that surround the small resistance arteries in the lungs and is used in adult respiratory distress syndrome and persistent pulmonary hypertension of the neonate. Additionally, nitric oxide is believed to play a key role in the innate immune system and in-vitro studies suggest that it possesses anti-microbial activity not only against common bacteria, including both gram-positive and gram-negative, but also against other diverse organisms, including mycobacteria, fungi, yeast and parasites, and has the potential to eliminate multi-drug resistant strains.

Currently, the only way to provide inhaled nitric oxide is via large, pressurized gas cylinders and complicated delivery systems.

About GENOSYL®

Indication

GENOSYL® (nitric oxide) gas, for inhalation is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.

Important Safety Information

  • 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.
  • Methemoglobinemia increases 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®.

About GENOSYL® DS

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 will provide further patient access for the use of inhaled nitric oxide gas.

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).

For information, please visit www.VERO-biotech.com or contact Ray Russo at Ray.Russo@VERO-biotech.com or (908) 313-7172.