Pilot Study demonstrates Vapotherm HVNI technology is more effective than standard oxygen therapy for treatment of acute asthma in children
25 Settembre 2023 - 12:45PM
Business Wire
Vapotherm, Inc. (NYSE: VAPO), a global medical technology
company focused on the development and commercialization of its
proprietary Vapotherm high velocity therapy® products, which are
used to treat patients of all ages suffering from respiratory
distress, today announced the presentation of an
Investigator-initiated clinical trial, “High flow humidified oxygen
as an early intervention in children with acute severe asthma - a
feasibility randomized controlled trial” at the European
Respiratory Society International Congress 2023. The study was
conducted through the Brighton and Sussex Clinical Trial Unit at
University Hospitals, Sussex, England under the direction of Drs.
Hector Rojas-Anaya and Paul Seddon.
Children who presented to the Emergency Department with acute,
severe, asthma exacerbations that did not respond to initial
pharmacologic treatment were randomized to either HVNI or standard
nasal oxygen therapy. Eighty-six percent (19/22) of children
treated with standard oxygen required escalation of therapy, while
only 61% (17/28) of children treated with HVNI needed further
escalation. In addition, children treated with HVNI met hospital
discharge criteria in a median time of 29 hours, compared to a
median time of 37 hours for those treated with standard oxygen.
“Anytime a child with severe asthma can get well faster and
avoid more invasive care it is a victory. We are excited and proud
that our technology was utilized in this study and in the care of
these children.” said Dr. Jessica Whittle, Chief Medical Officer of
Vapotherm.
Almost 5 million children in the USA, and 1 million children in
the UK have asthma, according to the CDC and NHS.
(https://www.cdc.gov/asthma/most_recent_national_asthma_data.htm;
https://www.england.nhs.uk/childhood-asthma/) The annual cost for
asthma is estimated to be $56 billion according to the Asthma and
Allergy Foundation of America. Studies of acute asthma and other
emergent conditions are limited, in part, by the challenge of
obtaining informed consent. This study demonstrated the feasibility
of pediatric emergency studies utilizing coordinated care and
delayed informed consent.
“These numbers show that we have an enormous opportunity to help
children all over world breathe better and have better lives with
our technology,” said Joe Army, CEO of Vapotherm.
About Vapotherm
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 4.0 million patients
have been treated with the use of Vapotherm high velocity therapy®
systems. For more information, visit www.vapotherm.com.
Vapotherm high velocity therapy is mask-free non-invasive
respiratory support and is 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 tool. The HVT 2.0 and Precision Flow
systems’ 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
(“SEC”) 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 under the
Private Securities Litigation Reform Act of 1995, including
statements about the benefits of Vapotherm’s products. In some
cases, you can identify forward-looking statements by terms such as
“expect,” “continue,” “plan,” “intend,” “will,” or “typically,” or
the negative of these terms or other similar expressions, although
not all forward-looking statements contain these words, and the use
of future dates. 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: subsequent trials or clinical results could
contradict or call into question the results of the clinical study
discussed above or Vapotherm could be otherwise unsuccessful in
obtaining broad clinical acceptance of the use of its devices in
the treatment of pediatric asthma; Vapotherm has incurred losses in
the past and may be unable to achieve or sustain profitability in
the future or achieve its 2023 financial guidance including reduced
cash burn; risks associated with its manufacturing operations in
Mexico; Vapotherm’s ability to raise additional capital to fund its
existing commercial operations, develop and commercialize new
products, and expand its operations; Vapotherm’s ability to comply
with its financial covenants, execute on its path-to-profitability
initiative, convert excess inventory into cash and fund its
business through 2023; Vapotherm’s dependence on sales generated
from its High Velocity Therapy 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; Vapotherm’s inexperience directly
marketing and selling its products; the potential loss of one or
more suppliers and dependence on its new third party manufacturer;
Vapotherm’s susceptibility to seasonal fluctuations; Vapotherm’s
failure to comply with applicable United States and foreign
regulatory requirements; the failure to obtain U.S. Food and Drug
Administration or other regulatory authorization to market and sell
future products or its inability to secure, maintain or enforce
patent or other intellectual property protection for its products;
the impact of COVID on its business, including its supply chain,
risks associated with the recently consummated reverse stock split,
Vapotherm’s ability to regain compliance with the continued listing
standards of the NYSE, market conditions and the impact of the
reverse stock split on the trading price of Vapotherm’s common
stock, a possible delisting of Vapotherm’s common stock 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, 2022, as filed with the SEC on February 23,
2023, and in its subsequent filings with the SEC, including its
Quarterly Report on Form 10-Q for the quarterly period ended June
30, 2023, as filed with the SEC on August 8, 2023. 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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Investor Contact: John Landry, SVP and CFO 603-658-0011 |
Investor Relations (IR@vtherm.com)
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