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 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.
VERO Biotech’s Second Generation GENOSYL® Delivery System (DS) Receives FDA Approval in Anesthesia in the Surgical Suite 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:
“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 benefits4,5,” 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
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. 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 Ray.Russo@vero-biotech.com or (908) 313-7172. Contact: Ray Russo (908) 313-7172
SOURCE VERO Biotech Inc. |
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