Nuvaira Announces Four Clinical Abstracts Accepted for Presentation at ERS International Congress
(Thomson Reuters ONE) -
Treating COPD and Asthma with Targeted Lung Denervation is Focus of Mini-
Symposium
MILAN, Italy, Sept. 07, 2017 (GLOBE NEWSWIRE) -- Nuvaira, a developer of medical
devices to treat obstructive lung diseases, today announced that four scientific
abstracts featuring the Nuvaira(TM) Lung Denervation System have been accepted
for presentation at the upcoming 27(th) European Respiratory Society (ERS)
International Congress, to be held Sept. 9-13, 2017, in Milan, Italy. The
abstracts may be viewed through the ERS 2017 website.
Scientific experts will present their findings from studies on the safety and
efficacy of Targeted Lung Denervation* (TLD), a bronchoscopic procedure
developed to relieve obstructive airway disease, during a Thematic Poster
session on "Endoscopic Lung Volume Reduction and TLD" taking place Sunday
afternoon, Sept. 10. The abstracts will share some of the important preclinical
work on the physiological response to lung denervation as well as clinical work
on health related quality-of-life improvements.
In addition, Nuvaira announced it will host an evening mini-symposium at ERS on
the use of TLD for the treatment of chronic obstructive pulmonary disease (COPD)
and asthma. The program will be co-chaired by Alvar Agustí, M.D., Ph.D.,
director of the Thorax Institute at Hospital Clinic in Barcelona, and Professor
Felix Herth, M.D., Ph.D., FCCP, chairman, Division of Pulmonology and
Respiratory Care Medicine, Thoarxklink, at the University of Heidelberg. Five
medical experts will present their findings on topics including: Neural Control
of Airway Smooth Muscle, TLD Mechanism of Action, the AIRFLOW-1 and AIRFLOW-2
trials on TLD for COPD patients, and the RELIEF-1 trial on TLD for severe asthma
patients.
"I am very encouraged by the one-year data from the randomized AIRFLOW-1 Trial
of TLD using the Nuvaira Lung Denervation System in patients with COPD," said
Dirk-Jan Slebos, M.D., Ph.D., study principal investigator, University Medical
Center, Groningen, The Netherlands. "As with earlier feasibility studies, the
AIRFLOW-1 data provides strong evidence that TLD is feasible, provides a
sustained treatment effect, and has evolved into a safe treatment. I look
forward to discussing the findings in further detail during the evening session.
"TLD is the first medical procedure that targets the whole lung by
bronchoscopically disrupting overactive parasympathetic nerves to promote airway
dilatation and make it easier for patients to breathe. This one-time procedure
may provide an important tool for long-term clinical improvement in COPD
patients," continued Dr. Slebos.
Nuvaira recently announced completion of patient enrollment in the AIRFLOW-
2 trial, the first sham-controlled clinical trial of TLD using the Nuvaira
System in patients with moderate to severe COPD. The AIRFLOW-2 (NCT#02058459)
trial, designed to assess safety and efficacy of TLD in patients suffering from
moderate to severe COPD, has been conducted at 16 institutions throughout
Western Europe and includes 82 patients.
"We are excited to share new outcomes data and to be featured in four clinical
abstracts at ERS 2017, the largest meeting of respiratory professionals in the
world," said Shane Gleason, chief commercial officer at Nuvaira. "We are equally
pleased with the positive feedback from the institutions participating in the
AIRFLOW-2 Trial, which will build upon the discoveries and data already
collected regarding the treatment of overactive airways nerves during TLD, and
the potential to provide lasting, whole-lung improvement."
About COPD
COPD is the umbrella term used to describe a group of diseases such as small
airway disease (chronic bronchitis) and emphysema, characterized by chronic and
incompletely reversible airway obstruction that interferes with normal
breathing. It is estimated that COPD affects 4 to 10 percent of all adults in
European countries and more than 300 million people globally(1)(,2).
Pharmacological treatment is the approach for most patients today. Inhaled drugs
are used once or twice daily to relax and temporarily open airways. Other forms
of treatment include pulmonary rehabilitation, oxygen administration and
surgical intervention. These treatments provide temporary relief. The annual
financial burden of lung disease in Europe is ?141 billion and COPD accounts for
almost half(3). In the United States, COPD costs are estimated to be more than
$50 billion annually(4).
About Nuvaira
Nuvaira (formerly known as Holaira) is a privately held company headquartered in
Minneapolis, Minn. The company is developing the Nuvaira(TM) Lung Denervation
System to address chronic obstructive pulmonary disease (COPD) and asthma by
treating the overactive airway nerves during Targeted Lung Denervation* (TLD).
Nuvaira received CE Mark approval for its Nuvaira Lung Denervation System for
use during TLD in January 2016. More information may be found
at www.Nuvaira.com.
Note to Media: The evening mini-symposium will take place on Sept. 12, at 17:30
in Room Blue 2, MiCo- Milano Congressi.
*Targeted Lung Denervation (TLD) is currently under clinical investigation for
chronic obstructive pulmonary disease and is not yet commercially available.
Nuvaira is a trademark of Nuvaira, Inc.
_______________
(1) Global Chronic Obstructive Pulmonary Disease Epidemiology and Patient Flow -
2017. Fore Pharma.
(2) http://www.efanet.org/get-advice/copd
(3) http://www.efanet.org/get-advice/copd
(4) Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017 Report
Media Inquiries:
Amy Wolter
+1 (763) 450-5676
info(at)nuvaira.com
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Nuvaira, Inc via GlobeNewswire
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Datum: 07.09.2017 - 14:00 Uhr
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News-ID 559145
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