Vapotherm® Receives CE Mark for Oxygen Assist Module in the European Union
February 05 2020 - 4:01PM
Business Wire
Vapotherm, Inc. (NYSE: VAPO) today announced that it has
received the CE Mark for its Vapotherm Oxygen Assist Module (OAM).
When used with a Precision Flow® system, the Vapotherm OAM helps
clinicians keep their patients within the target oxygen saturation
range more effectively than with manual control alone. Keeping
babies in the prescribed oxygen saturation range may reduce the
health risks associated with dosing too much, or too little oxygen
– such as visual or developmental impairment in premature
infants.
“Oxygen is a deadly, dangerous, life-giving drug with a narrow
therapeutic index and it can be especially dangerous for babies,”
said Joe Army, President and CEO of Vapotherm. “Too much or too
little oxygen can lead to serious consequences. We are very proud
to be able to offer clinicians a new tool in helping to maintain
appropriate clinical oxygen levels in these babies.”
Clinicians focus significant effort on maintaining blood oxygen
saturation within prescribed ranges in order to address these
potential consequences, which are significant in scope. For
example, more than 180,000 premature babies worldwide develop some
degree of retinopathy of prematurity (ROP)—putting them at risk for
visual impairment, including blindness, due to too much oxygen
exposure. Additionally, the prevalence of ROP is increasing as
infant mortality rate decreases.
The effectiveness of the Vapotherm OAM algorithm was validated
in a 2018 study published by Reynolds and colleagues in the
Archives of Disease in Childhood: Fetal and Neonatal Edition. The
data show that trained staff using manual controls alone were able
to maintain premature infants’ oxygen saturation in the
physician-prescribed target range 49% of the time. When using the
Vapotherm device, the staff were able to maintain the target oxygen
saturation range 80% of the time, while at the same time requiring
significantly fewer adjustments to the equipment. The study refers
to the algorithm in the OAM by its prototype name of IntellO2.
Vapotherm OAM integrates with Vapotherm’s Precision Flow
system. The Precision Flow system provides Hi-VNI® Technology,
which has been clinically proven to be a mask-free and seal-free
alternative to nCPAP as well as noninvasive positive pressure
ventilation (NiPPV) in neonates and adults.
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 2.0
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200205005015/en/
Greg Ramade, VP of Marketing, +1-(603)-658-0011, ext. 188 or
+1-(603)-658-0628, pr@vtherm.com
Vapotherm (NYSE:VAPO)
Historical Stock Chart
From Mar 2024 to Apr 2024
Vapotherm (NYSE:VAPO)
Historical Stock Chart
From Apr 2023 to Apr 2024