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Biopharmaceuticals Drug Delivery FDA

 News Release - March 26, 2020

FDA Grants VERO Biotech Expanded Access Emergency Use for the Treatment of Patients with COVID-19, with the GENOSYL(R) 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


ATLANTA, March 26, 2020 -- (Healthcare Sales & Marketing Network) -- VERO Biotech LLC, an Atlanta, Georgia-based biotechnology company focused on saving lives, alleviating suffering, and improving the health economics of care, today announced that the U.S. Food and Drug Administration (FDA) has granted "expanded access emergency use" allowing its proprietary inhaled nitric oxide (iNO) delivery system, GENOSYL® DS, to immediately be used for the treatment of cardiopulmonary symptoms associated with COVID-19. GENOSYL (nitric oxide) gas, for inhalation, was recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of persistent pulmonary hypertension of the newborn (PPHN) and is the only tankless inhaled nitric oxide device available in the US.

Application of VERO's tankless inhaled nitric oxide system is valuable during a time of crisis when hospital beds and ventilators are in short supply. The ability to have a portable device in either the hospital or home setting enables healthcare providers the flexibility to treat patients with iNO in various settings, and give patients more access to the care they need.

"In this time of a global pandemic and public health crisis, it is critical to explore all potential options for treating both the novel coronavirus and its associated cardiopulmonary conditions," said Brent V. Furse, President and CEO, VERO Biotech. "Inhaled nitric oxide may provide important benefits and we at VERO Biotech intend to expedite and expand our research in this critical area. The application of home use of iNO—which was not been logistically viable until the approval of a tankless and portable system—may itself also play a role in limiting current demand for hospital beds and ventilators by patients suffering from symptoms due to COVID-19."

VERO Biotech is also working with renowned global academic experts in infectious and cardiopulmonary diseases to evaluate the potential clinical benefits of GENOSYL in treating pulmonary manifestations of COVID-19.

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.

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.
   

Prior to the approval of the GENOSYL system, the only way to provide iNO was 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.
  • 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.

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.

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.

References

1. Akerstrom S et. al. Nitric Oxide Inhibits the Replication Cycle of Severe Acute Respiratory Syndrome Coronavirus. J Virol 2005; 79(3):1966-9.


Source: VERO Biotech

Issuer of this News Release is solely responsible for its content.
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