Vapotherm, Inc., a global medical technology company focused on the development and commercialization of its proprietary Hi-VNI® Technology products that are used to treat patients suffering from respiratory distress, announced a major expansion in its capital equipment manufacturing capabilities. This expansion is expected to enable the company to increase production of its Precision Flow® systems by up to 20X above pre-COVID-19 pandemic levels. At maximum capacity, Vapotherm’s manufacturing increase would create up to an additional 350 manufacturing jobs at its New Hampshire facility. This scaling up is in response to a potential increase in demand for the company’s Precision Flow Hi-VNI® system in the event of additional waves of COVID-19. The Precision Flow Hi-VNI system is an advanced high-flow nasal cannula (HFNC) system using high velocity to treat the respiratory distress experienced by COVID-19 patients.
“The COVID-19 pandemic has greatly accelerated a process we were already seeing of respiratory experts recognizing the benefits of our Precision Flow Hi-VNI system for treating patients with all types of respiratory distress,” commented Joe Army, CEO of Vapotherm. “As hospitals and governments across the United States and around the world prepare for potential future waves of COVID-19 patients and subsequent pandemics involving respiratory disease, we are expanding our manufacturing capabilities to be in a position to meet the needs of hospitals and patients for our therapy. The expansion also provides us with optionality and flexibility when thinking about our ability to bring new products to market faster.”
Since the outbreak of the COVID-19 pandemic, a growing number of public health authorities and medical specialty societies in the United States and around the world have expressed support for the use of HFNC as a first-line therapy for treating the respiratory distress experienced by hospitalized COVID-19 patients over early intubation and mechanical ventilation. For example, the Center for Disease Control (CDC), the National Institutes of Health (NIH), the Society of Critical Care Medicine (SCCM), and the American College of Emergency Physicians (ACEP) recommended HFNC over early invasive mechanical ventilation when possible. Additionally, SCCM further suggests HFNC is preferable to non-invasive positive pressure ventilation (NiPPV) in the management of COVID-19 respiratory distress.
The Company is also seeing expressions of interest from domestic and foreign governments, including a $9.9 million blanket purchase agreement (BPA) from the Department of Defense (DoD) that was awarded on May 22, 2020, to support the acquisition of Precision Flow units by the country’s 51 DoD hospitals. Vapotherm is the only HFNC company eligible under this BPA. DoD hospitals have the option to seek funding, and if approved, place orders against the BPA’s $9.9 million cap to acquire Precision Flow devices for up to one year from the date of issuance.
Michael McQueen, M.D., Vice President of Medical Affairs at Vapotherm, commented, “The U.S. medical community did a phenomenal job of quickly recognizing the limitations and possible issues of early intubation and mechanical ventilation in the management of COVID-19 patients. Along with working tirelessly on the front lines, they were continually communicating, sharing information, and adapting in real-time to changing management paradigms. One of the most visible examples of that has been the complete U-turn from the initial management recommendations of avoiding HFNC and proceeding with early intubation, to the current standards suggesting the opposite – avoid intubation and mechanical ventilation if possible, and utilize HFNC aggressively early in the course of treatment.”
Vapotherm invented HFNC and now sells an advanced form of HFNC that provides high flow at a high velocity, rapidly flushing the dead space in the limited time between breaths when respiratory rates are elevated. The Precision Flow Hi-VNI system also offers a number of additional benefits relative to other conventional HFNC systems, including:
- COVID-19 respiratory distress is characterized in particular by patients needing more oxygen. Vapotherm’s Precision Flow Hi-VNI system provides more precise control over the amount of oxygen being delivered to patients than conventional HFNC systems, as the Vapotherm Precision Flow Hi-VNI allows flow rates and oxygen concentrations to be titrated independent of each other. This is vital in the treatment of the respiratory distress experienced by COVID-19 patients as published data on critical care patients has suggested that the delivery of either too much or too little oxygen can lead to increased mortality rates.
- Vapotherm’s Precision Flow Hi-VNI system, which is clinically proven to treat both Type 1 (hypoxic) and Type II (hypercapnic) respiratory distress, is the only HFNC product listed under the United States Food and Drug Administration’s QAV product code, which was included by the FDA at the outset of the COVID-19 pandemic on a list of devices used to provide ventilation and ventilatory support to patients with respiratory failure or respiratory insufficiency during the COVID-19 public health emergency.
- Vapotherm’s proprietary Precision Flow Hi-VNI system provides optimal humidification of the delivered oxygen. This humidification is important to maintain the integrity and mucous-clearance capacity of the patient’s airways.
- The Vapotherm Precision Flow Hi-VNI system allows for rapid disinfection between patients – less than five minutes, while other conventional HFNC systems may take up to an hour.
- Vapotherm’s Precision Flow Hi-VNI system uses a disposable patient circuit to deliver the humidified oxygen to the patient, with a new circuit being used for each patient, an important characteristic when treating respiratory distress from an infectious cause.