- Increased capacity anticipated to scale capital production by
up to 20X above pre-COVID-19 pandemic levels
- At maximum capacity, increased production could create up to
350 manufacturing jobs in New Hampshire
- Move comes as public health authorities and governments
worldwide identify high flow nasal cannula systems as first-line
therapy for COVID-19 respiratory distress
Vapotherm, Inc. (NYSE: VAPO), 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, today 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 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 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.
Vapotherm, Inc. (NYSE: VAPO) is a publicly traded
developer and manufacturer of advanced respiratory technology based
in Exeter, New Hampshire, USA. The company develops innovative,
comfortable, non-invasive technologies for respiratory support of
patients with chronic or acute breathing disorders. Over 2.2
million patients have been treated with Vapotherm Hi-VNI
Technology. For more information, visit www.vapotherm.com.
Hi-VNI® Technology is mask-free noninvasive ventilation
for spontaneously breathing patients and a front-line tool for
relieving respiratory distress—including hypercapnia, hypoxemia,
and dyspnea. It allows for the fast, safe treatment of
undifferentiated respiratory distress with one user-friendly tool.
Hi-VNI Technology’s mask-free interface delivers optimally
conditioned breathing gases, 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 oral medication.
Website Information Vapotherm routinely posts important
information for investors on the Investor Relations section of its
website, http://investors.vapotherm.com/. Vapotherm intends to use
this website as a means of disclosing material, non-public
information and for complying with Vapotherm’s disclosure
obligations under Regulation FD. Accordingly, investors should
monitor the Investor Relations section of Vapotherm’s website, in
addition to following Vapotherm’s press releases, Securities and
Exchange Commission filings, public conference calls, presentations
and webcasts. The information contained on, or that may be accessed
through, Vapotherm’s website is not incorporated by reference into,
and is not a part of, this document.
Legal Notice Regarding Forward-Looking Statements
This press release contains forward-looking statements,
including statements about our ability to increase production of
Precision Flow® systems by up to 20X above pre-COVID-19 pandemic
levels, the creation of up to an additional 350 manufacturing jobs
and the potential increase in demand for Precision Flow Hi-VNI
systems in the event of additional waves of COVID-19. In some
cases, you can identify forward-looking statements by terms such as
‘‘expect,’’ “guide” or “typically” or the negative of these terms
or other similar expressions, although not all forward-looking
statements contain these words. Each forward-looking statement is
subject to risks and uncertainties that could cause actual results
to differ materially from those expressed or implied in such
statement. Applicable risks and uncertainties include, but are not
limited to, the following: Vapotherm has incurred losses in the
past and may be unable to achieve or sustain profitability in the
future, Vapotherm may need to raise additional capital to fund its
existing commercial operations, develop and commercialize new
products, and expand its operations, Vapotherm’s dependence on
sales generated from its Precision Flow systems, competition from
multi-national corporations who have significantly greater
resources than Vapotherm and are more established in the
respiratory market, the ability for Precision Flow systems to gain
increased market acceptance, its inexperience directly marketing
and selling its products, the potential loss of one or more
suppliers, Vapotherm’s susceptibility to seasonal fluctuations,
Vapotherm’s failure to comply with applicable United States and
foreign regulatory requirements, the failure to obtain FDA or other
regulatory authorization to market and sell future products or its
inability to secure and maintain patent or other intellectual
property protection for its products, the impact of the COVID-19
pandemic on its business, including its supply chain, and the other
risks and uncertainties included under the heading “Risk Factors”
in Vapotherm’s Annual Report on Form 10-K for the fiscal year ended
December, 31, 2019, as filed with the Securities and Exchange
Commission on March 4, 2020 and Vapotherm’s Quarterly Report on
Form 10-Q for the quarter ended March 31, 2020, as filed with the
Securities and Exchange Commission on May 5, 2020 and in any
subsequent filings with the Securities and Exchange Commission. The
forward-looking statements contained in this press release reflect
Vapotherm’s views as of the date hereof, and Vapotherm does not
assume and specifically disclaims any obligation to update any
forward-looking statements whether as a result of new information,
future events or otherwise, except as required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20200604005168/en/
PR and Media: Arik Ben-Zvi, CEO & President,
Breakwater Strategy, arik@breakwaterstrategy.com,
+1-(202)-270-1848
Investor Relations: Mark Klausner or Mike Vallie,
Westwicke, an ICR Company, ir@vtherm.com, +1-(603)-658-0011
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