VERO Biotech Inc., a commercial-stage healthcare business dedicated to neonatal intensive care and the acute care hospital community, today announced FDA approval of the newest generation of its tankless inhaled nitric oxide (iNO) delivery system. 

The Third Generation GENOSYL® Delivery System – developed for respiratory therapists by respiratory therapists – has new features that are expected to deliver three key benefits for patients, clinicians and providers:

• Faster dosing, enabled by an adaptive sensor and automated cassette activation that accelerate time to achieve the desired dose.
• Simpler workflow, as clinicians can now work from one console. The new delivery system has a dual cassette bay within each console, and transitions cassettes automatically. Previously, with a single cassette, clinicians needed to transition to a second console.
• Operational efficiency, facilitated by an improved user interface and smaller, lighter disposable cassettes that alleviate storage constraints within hospitals.

“The enhancements to the GENOSYL Delivery System Console will help me to work more efficiently,” said Denise Lauderbaugh, MPH, BSRC, RRT-NPS and Clinical Practice Specialist, Rady Children’s Hospital, San Diego, CA. “It has two cassettes in one console, and they are even smaller than before; it automatically activates and transitions to the second cassette when the first one is depleted; and I no longer have to transition from a primary to a standby console. I can care for my patients through the operation of just one console,” she added.

“The continuous innovation of the GENOSYL Delivery System represents our commitment to neonatal intensive care and the acute care hospital community in providing solutions to the challenges they face,” said Brent V. Furse, CEO and President, VERO Biotech. “We are grateful for the partnership and support we received with the launch of our innovative tankless GENOSYL Delivery System and this collaboration that has and will allow VERO Biotech to continue to expand on its mission to save lives, alleviate suffering and improve the health economics of acute care.”

GENOSYL DS is the first tankless inhaled nitric oxide delivery system approved by the U.S. Food and Drug Administration (FDA). Inhaled Nitric Oxide dilates pulmonary blood vessels and may be used to improve oxygenation in neonates with hypoxic respiratory failure and pulmonary hypertension. Unlike tank-based systems, GENOSYL DS generates iNO at the bedside using a small disposable cassette. This eliminates the need for hospitals to manage large, cumbersome tanks and helps to simplify clinical workflow.

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 or nasal cannulas 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 a tankless and portable system engineered with redundant backup features, which delivers a constant concentration of inhaled nitric oxide gas to patients with an easy-to-use interface and portability features. This proprietary delivery system eliminates the need for large nitric oxide tanks and the associated logistical burden. 

About VERO Biotech

VERO Biotech Inc. is a privately held company headquartered in Atlanta, Georgia focused on saving lives, alleviating suffering, and improving health economics in the neonatal intensive care and the acute care hospital communities.

Forward Looking Statements

This press release and any statements of representatives of VERO Biotech Inc. 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 Inc.  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 the control of VERO Biotech).

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

SOURCE VERO Biotech LLC