PEACHTREE CITY, Georgia
,
March 16, 2023
(press release)
–
Important new development in clinical use This inspection was a key step for the approval of the third generation GENOSYL Delivery System (DS). The approval presents an important new development in the clinical use of inhaled nitric oxide, and the pent-up demand for this third generation innovation demonstrates its increasing value to the acute care community. Numerous benefits for patients and medical professionals 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. The recently approved third generation GENOSYL DS also includes an innovative dual-cassette design and secondary adaptive sensor technology to further optimize patient care. Indication Important Safety Information Please visit www.vero-biotech.com for the full Prescribing Informationfor GENOSYL. 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. Gerresheimer is the global partner for pharmaceutics, biotech, healthcare, and cosmetics with a very broad product range for pharmaceutical and cosmetic packaging solutions and drug delivery systems. The company is an innovative solution provider from concept to delivery of the end product. Gerresheimer achieves its ambitious goals through a high level of innovative strength, industrial competence and concentration on quality and customer focus. In developing innovative and sustainable solutions, Gerresheimer relies on a comprehensive international network with numerous innovation and production centers in Europe, America and Asia. Gerresheimer produces close to its customers worldwide with around 11,000 employees and generated annual revenues in 2022 of EUR 1.8bn. With its products and solutions, Gerresheimer plays an essential role in people's health and well-being. Marion Stolzenwald Karin Fischer
The FDA inspection took place from November 17, 2022 to December 12, 2022 at the Gerresheimer facility in Peachtree City. During this time, production at the facility was inspected by drug and device Consumer Safety Officers, who evaluated the management system and production process for disposable cassettes, from incoming raw materials to finished products.
GENOSYL Delivery System (DS) for inhaled nitric oxide was approved by the U.S. Food and Drug administration in December 2019 and was the first tankless delivery system for inhaled nitric oxide. Inhaled Nitric Oxide dilates pulmonary blood vessels and may be used to improve oxygenation in neonates with hypoxic respiratory failure and pulmonary hypertension.About GENOSYL
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.
About Vero Biotech
About Gerresheimer
www.gerresheimer.comPress contact:
Gerresheimer AG
Klaus-Bungert-Str. 4
40468 Düsseldorf
Phone: +49 (0)211-6181246
Fax: +49 (0)211-6181241
E-mail: marion.stolzenwald @ gerresheimer.com
Gerresheimer Regensburg GmbH
Oskar-von-Miller-Strasse 6
92442 Wackersdorf
Phone: +49 (0)9431-639 6140
Fax: +49 (0)9431-79838-6140
E-mail: karin.fischer @ gerresheimer.com
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