VERO Biotech's Second Generation GENOSYL® Delivery System (DS) Receives FDA Approval in Anesthesia in the Surgical Suite

Second Generation GENOSYL® DS is the first and only Inhaled Nitric Oxide delivery system that is FDA-approved for rebreathing anesthesia, which provides a significant advantage in patient comfort, helping patients retain heat and moisture ^1,2,3

ATLANTA, Feb. 2, 2023 /PRNewswire/ -- VERO Biotech Inc., a commercial-stage healthcare business dedicated to neonatal intensive care and the acute care hospital community, today announced FDA approval of its innovative second generation GENOSYL® Inhaled Nitric Oxide (iNO) delivery system for use with rebreathing anesthesia in the operating room setting. Second generation GENOSYL®DS is now the first and only device for iNO delivery that is approved for use in both rebreathing and non-rebreathing anesthesia methods, improving patient care, saving money for the hospital, and reducing environmental pollution from waste anesthetic gas.

The advantages of rebreathing anesthesia have made this method the standard of care for anesthesia administration in the OR setting. There is a significant advantage in patient care, helping patients retain moisture and body heat. The loss of body heat and moisture can be key complications of anesthesia faced by every patient, especially smaller patients.  Rebreathing also allows lower fresh gas flows, which reduces costs for the hospital as well as environmental pollution from anesthetic gas waste.^1,2,3

The expected benefits of the second generation GENOSYL® DS as approved for rebreathing anesthesia include the following:

• Ability to use rebreathing anesthesia: lower gas flows, i.e., less use of costly anesthetic agents and savings for the hospital; increased patient comfort (by preserving patient body temperature and moisture)
• Streamlined process of care: seamless iNO delivery from the ICU through surgery to post-operative care, resulting in process and workflow improvements for the health care organization that reduce overall cost to the hospital
• Set and forget: allows anesthesiologists to continue to use rebreathing anesthesia and therefore could prevent potentially dangerous, cumbersome, and time- consuming workarounds
• Reduced environmental impact of anesthesia delivery: reduction in release of anesthetic to the environment

"Second generation Genosyl DS has proven to be the only iNO delivery system capable of accurately delivering iNO with an anesthesia machine under rebreathing conditions, enabling low flow anesthesia with all its benefits^4,5," commented Mark Twite, MD, Director of Pediatric Cardiac Anesthesia, Children's Hospital Colorado and University of Colorado Anschutz Medical Campus, Aurora, Colorado. "Anesthesia providers can now simply set the iNO dose without adjusting fresh gas flow or anesthetic agent. This decreases provider distractions, maintains focus on the patient, and facilitates the transition of care between the ICU and OR for ventilated patients," he added.

"We believe this new indication for our second generation device will now provide significant benefits to the anesthesiology and surgical care communities whose patients require inhaled nitric oxide in the operating room setting," said Brent V. Furse, CEO and President, VERO Biotech. "We have addressed an unmet need in facilitating rebreathing anesthesia, a further demonstration of our continuous commitment to neonatal intensive care and the acute care hospital community in providing solutions to the challenges they face," he added.

It is important to note the FDA approval of the GENOSYL DS for use with rebreathing anesthesia in the operating room setting is for the second generation device. The recently approved third generation GENOSYL DS has not been tested with rebreathing anesthesia. VERO Biotech is currently in the process of conducting similar validations and expect to have the data available Q1-2023.

If you have questions regarding which GENOSYL DS is in your hospital, please contact your VERO Biotech Representative at 877-337-4118.

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 and delivers 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.

1. Bengtson JP, Sonander H, Stenqvist O. Comparison of costs of different anaesthetic techniques, Acta Anaesthesiol. Scand. 32, 33-35 (1998).
2. Cotter SM, Petros AJ, Dore CJ, Barber ND, White DC. Low-flow anaesthesia. Practice, cost implications and acceptability. Anaesthesia 46, 1009-1012 (1991).
3. Feiss P, Demontoux MH, Colin D. Anasthetic gas and vapor saving with minimal flow anesthesia. Acta Anaesthesiol. Belg. 41, 249-251 (1990).
4. Twite M, Anderson S, Roebuck A. A novel, cassette-based nitric oxide delivery system accurately delivers inhaled nitric oxide via the anesthesia machine at low fresh gas flows [abstract]. In: The Society for Technology in Anesthesia; 2023 Jan 11-14; Las Vegas, Nevada (NV): STA; 2023. Abstract nr 44.
5. Twite M, Anderson S, Roebuck A. A novel, cassette-based nitric oxide delivery system accurately delivers inhaled nitric oxide via the anesthesia machine independent of fresh gas flow rate and volatile anesthetic agent [abstract]. In: The Society for Technology in Anesthesia; 2023 Jan 11-14; Las Vegas, Nevada (NV): STA; 2023. Abstract nr 45.

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.  GENOSYL DS recently received FDA approval for its innovative dual-cassette design and secondary adaptive sensor technology to further optimize patient care.

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 benefits, advantages or market opportunity of the products.  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 [email protected] or (908) 313-7172.

Contact: Ray Russo (908) 313-7172
[email protected]

SOURCE VERO Biotech Inc.