FDA Grants Vapotherm Hi-VNI® Technology System a New Product Category

Vapotherm, Inc. (Vapotherm) today announced that the U.S. Food and Drug Administration (FDA) has granted Vapotherm’s latest version of the Precision Flow® product, the Precision Flow Hi-VNI™ system, a new product category and product code (QAV). The FDA also granted an expanded indication for the system that states it may be used to augment breathing of spontaneously breathing patients suffering from respiratory distress in a hospital setting. This patient population is similar to that treated by other forms of non-invasive ventilation, making the Precision Flow Hi-VNI system a viable alternative to Non-invasive Positive Pressure Ventilation (NiPPV) for most patients. The Vapotherm Precision Flow Hi-VNI system is currently the only product in the QAV category. To gain these expanded claims, and first in category grant, Vapotherm submitted substantial clinical data that Hi-VNI Technology can safely and effectively be used in the treatment of undifferentiated respiratory distress in patients, ranging from newborns to adults. The historical standard of care for non-invasive management of such patients has been NiPPV, a pressure-based form of non-invasive ventilation. Vapotherm’s submission included clinical evidence that Hi-VNI Technology, which is incorporated in all of Vapotherm’s Precision Flow products, is non-inferior to NiPPV in preventing mechanical ventilation. Mechanical ventilation substantially increases risk to the patient of infections, ventilator dependence, and mortality, as well as increases costs to the hospital, and is typically used only when other approaches have been exhausted. The clinical evidence demonstrated similar effectiveness to NiPPV in preventing mechanical ventilation in patients regardless of the underlying cause of the respiratory distress, and whether the patient’s primary problem was getting enough oxygen or getting rid of enough carbon dioxide. “We are delighted with the grant of this new product code by the FDA. We believe it clarifies the appropriate clinical use of Hi-VNI Technology and informs clinicians that it is safe to use as a tool to treat undifferentiated respiratory distress,” said Dr. Michael McQueen, Vice President of Medical Education at Vapotherm. “It emphasizes that Hi-VNI Technology has a similar clinical application of ventilatory support to the standard of care of NiPPV, but without the tight-fitting mask.” Clinicians have seen the impact on their patients. “Many patients with respiratory distress have difficulty with the full face mask. They can become claustrophobic, making the respiratory failure worse,” said Aaron Boyd, MBA, M.D., Chief Medical Officer, Norman Regional Health System. “Vapotherm’s technology helps our clinicians safely and efficiently treat these patients much more comfortably and less invasively.” How It Works Hi-VNI Technology flushes the carbon dioxide-heavy and oxygen depleted exhaled air from the respiratory dead space in the upper airway between breaths and replaces it with optimally humidified oxygen-rich breathing gas delivered through a nasal cannula. As a result, it provides non-invasive ventilatory support and reduces the work of breathing. Patient’s symptoms are relieved, and with no mask, they are able to eat, drink, speak, participate in their care, and avoid mask-related risks of claustrophobia, aspiration and pressure ulcers. The Precision Flow Hi-VNI system that has been granted the new product category includes certain updates to the internal electronics to comply with the latest standards for medical device equipment. It also includes updates to software and instructions for use appropriate to this patient population. Vapotherm anticipates that this version of the Precision Flow will be widely available worldwide by January 2019. Hi-VNI® Technology allows for the fast, safe treatment of undifferentiated respiratory distress with one simple tool. Hi-VNI Technology has a simple nasal cannula that delivers warm, humidified air without sealing to the face, making it comfortable for patients and reducing the risks and care complexities associated with mask therapies. While being treated, patients can talk, eat, drink and take medication. Hi-VNI Technology is a front-line tool for respiratory distress—including hypoxia, hypercapnia, and dyspnea. For more information, visit www.vapotherm.com.

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