FDA Grants Vapotherm® Oxygen Assist Module (OAM™) Breakthrough Device Designation
April 09 2020 - 6:00AM
Business Wire
Vapotherm, Inc. (NYSE: VAPO) (“Vapotherm” or the “Company”), a
global medical technology company focused on the development and
commercialization of its proprietary Hi-VNI® Technology products
that are used to treat patients of all ages suffering from
respiratory distress, today announced that the U.S. Food and Drug
Administration (FDA) recently granted Breakthrough Device
Designation for the Company’s Oxygen Assist Module (OAM).
FDA’s Breakthrough Device Program is intended to help patients
and healthcare providers receive more timely access to breakthrough
technologies that have the potential to provide more effective
treatment or diagnosis of life-threatening or irreversibly
debilitating diseases or conditions. The program creates an
expedited pathway for prioritized FDA review of the OAM.
Separately, Vapotherm submitted an Investigational Device Exemption
(IDE) for pediatric use of OAM to FDA.
“We are delighted that the FDA granted OAM Breakthrough Device
Designation status and look forward to working closely with them to
provide clinicians with a solution to more effectively keep their
patients within the physician-prescribed target oxygen saturation
range with significantly fewer manual adjustments to the
equipment,” said Joe Army, President and CEO of Vapotherm.
Vapotherm OAM is a module for use with most versions of
Vapotherm’s Precision Flow® systems. The Precision Flow system
incorporates Hi-VNI® Technology, a mask-free and seal-free
clinically validated alternative to nasal continuous positive
airway pressure (nCPAP) as well as noninvasive positive pressure
ventilation (NiPPV) in pediatrics and adults. When used with the
Precision Flow system, the Vapotherm OAM assists staff in
maintaining a targeted SpO2 (amount of oxygen in the blood)
range.
The effectiveness of the Vapotherm OAM algorithm was evaluated
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
OAM device, the staff were able to maintain the target oxygen
saturation range 80% of the time, while at the same time requiring
significantly fewer manual adjustments to the oxygen delivered by
the equipment. The study refers to the algorithm in the OAM by its
prototype name of IntellO2.
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 2.1
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20200409005334/en/
Terri Clevenger, Westwicke, an ICR Company, pr@vtherm.com,
+1-(603)-658-0011
Vapotherm (NYSE:VAPO)
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