Nuvaira Announces Oral Presentation at ERS International Congress Discussing Significance of Targeted Lung Denervation to Treat COPD
Results from AIRFLOW-2 Trial Reveal Reduction in Exacerbations and other Respiratory Adverse Events
PARIS, Sept. 18, 2018 (GLOBE NEWSWIRE) -- Nuvaira, a developer of medical devices to treat obstructive lung diseases, announced the acceptance of a clinical abstract by the European Respiratory Society (ERS) for oral presentation at the 28th International Congress 2018 in Paris. Co-principal Investigator, Dirk-Jan Slebos, M.D., Ph.D., from the University Medical Center Groningen in the Netherlands, today will make the first public presentation of results from the AIRFLOW-2 clinical trial (NCT#02058459), the first multi-center, double-blind, randomized, sham-controlled study of Targeted Lung Denervation (TLD) using the Nuvaira™ Lung Denervation System to treat patients with moderate to severe COPD.
“Results from this phase II trial demonstrate a significant reduction in respiratory adverse events such as COPD exacerbations and hospitalizations of greater than 50 percent,” said Dr. Slebos. “I believe these results may have important implications for COPD sufferers and their overall quality of life, as well as for healthcare costs, as there is significant expense associated with exacerbations and hospitalizations.
“TLD is a one-time medical procedure, and it’s the first to target the whole lung by bronchoscopically disrupting parasympathetic nerves to promote airway dilation to make it easier for patients to breathe,” continued Dr. Slebos. “This novel lung denervation system may offer patients who suffer from COPD a long-term treatment that has added effect on top of medical management.”
The oral presentation entitled, “A double-blind, randomized, sham-controlled study of Targeted Lung Denervation in patients with moderate to severe COPD,” by Dr. Slebos et al., takes place today at 15:00 CEST in room 7.3Z2 as part of the session on “Interventional pulmonology highlights in 2018: ELVR, TLD and BT” (Session 496, Abstract no. OA4929) at the Paris Expo Porte de Versailles.
“We are gratified to have had a clinical abstract on results of the AIRFLOW-2 trial accepted for oral presentation at the ERS International Congress, the largest worldwide meeting of leaders in respiratory medicine,” said Martin Mayse, M.D., co-founder and chief technology officer of Nuvaira. “After proving safety and feasibility of TLD in earlier trials, this sham-controlled trial was the logical next step to further study the potential effectiveness of TLD for patients.”
Nuvaira also hosted an industry mini-symposium at the ERS Congress on Monday evening, which focused on TLD as a one-time treatment for COPD and asthma. The program was co-chaired by Alvar Agustí, M.D., Ph.D., director of the Thorax Clinic Institute at Hospital Clinic in Barcelona, and Professor Felix Herth, M.D., Ph.D., chairman of the Division of Pulmonology and Respiratory Care Medicine at the Thoraxklinik in Heidelberg.
Five medical experts presented clinical findings at the mini-symposium on topics that included: neural control of airway smooth muscle, mechanism of action and the Nuvaira Lung Denervation System, TLD in COPD and data from the AIRFLOW-1 and AIRFLOW-2 trials, TLD in severe asthma, and information regarding the upcoming AIRFLOW-3 pivotal trial, which is planned for sites in Europe, Canada and the U.S.
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 more than 300 million people globally1 ,.
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. The annual financial burden of lung disease in Europe is €141 billion and COPD accounts for almost half3. In the United States, COPD costs are estimated to be more than $50 billion annually4.
The AIRFLOW-2 (NCT#02058459) sham-controlled trial was designed to assess the safety of TLD in patients suffering from moderate to severe COPD. The trial included 82 patients at 15 institutions throughout Western Europe. Enrollment has been completed and long-term follow-up is ongoing. The principal investigators are Dirk-Jan Slebos, M.D., Ph.D., University Medical Center, Groningen, The Netherlands and Arschang Valipour, M.D., Ph.D., Otto Wagner Spital, Vienna, Austria.
Nuvaira is a privately held company headquartered in Minneapolis, Minn. The company has developed the Nuvaira™ 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.
+1 (763) 450-5676
*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.
4 Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017 Report
A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/7a4d08f3-b50c-4544-bc2c-cf5b7041311a
Om Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York
+1 212 401 8700http://www.nasdaqomx.com
NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.
Følg saker fra Nasdaq GlobeNewswire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Nasdaq GlobeNewswire
Ondot Announces Investment from Citi Ventures to Power Enriched Transactions22.10.2018 17:00 | Pressemelding
The investment will fuel Ondot’s international growth and give cardholders accessing info via Ondot’s platform increased control over and visibility into each transaction Santa Clara, Ca, Oct. 22, 2018 (GLOBE NEWSWIRE) -- Ondot Systems, the global leader in mobile payments services, today announced that it has secured a strategic funding investment from Citi Ventures. Ondot works directly with financial institutions to give consumers increased control over and visibility into their personal payment transactions. With Ondot, consumers can manage functions such as fraud alerts, transaction limits and purchase location restrictions, all from the convenience of an app on their smartphone or desktop. This investment will further support Ondot’s efforts to grow its international presence and product offerings. Today’s digitally connected consumers are looking for more ways to access detailed information about their digital lives — including personal payment transactions. Ondot’s platform add
Auth0 Supports Global Growth with Office Expansions in US and UK22.10.2018 15:00 | Pressemelding
New offices accommodate rapid employee growth and reinforce customer commitment BELLEVUE, Wash. and LONDON, Oct. 22, 2018 (GLOBE NEWSWIRE) -- Auth0, a global leader in Identity-as-a-Service (IDaaS), today announced it has moved into larger offices in Bellevue, WA, and London, UK, to accommodate current and future growth. The company’s headquarters in Bellevue has experienced an upsurge in employees over the past year, signalling its continued growth trajectory in the region. Recently named a Gold winner in the Seattle Business Tech Impact awards, along with additional industry recognition as a great place to work, Auth0 is attracting top talent in the area. The new office occupies the entire 6th floor of the U.S. Bank Plaza, located at 10800 NE 8th St. The new London office at 182-194 Union St. is a former Victorian-style warehouse, located in the South Bank district. This opening also launches the new “Auth0 Identity Centre,” a 50-seat event space where the company will host customers
Mitratech Announces TeamConnect Essentials for Mid-Sized Legal Departments22.10.2018 15:00 | Pressemelding
New SaaS Legal Operations Solution Can Save $250,000 Per Year in Staff Time Savings and Reduced Legal Spend AUSTIN, Texas, Oct. 22, 2018 (GLOBE NEWSWIRE) -- Mitratech today announced the launch of TeamConnect Essentials, an easy-to-use, quick-to-implement SaaS legal operations solution designed for legal departments who want to leverage built-in best practices validated by 30 years of Mitratech’s client experience. Essentials is built on Mitratech’s TeamConnect platform and acts as a central hub for all legal operations, including integrated matter management, outside counsel management, e-Billing, Microsoft® Office integration, and reporting, delivered as an adaptable, cloud-based solution. “Thirty percent of FORTUNE 500 companies currently use TeamConnect as a platform for legal department innovation. We’ve taken our experience with those customers and others, coupled it with a streamlined implementation program, and created a unique solution for legal departments earlier in their tr
Paysafe’s Differentiated Solutions and Customer Service Recognized by Independent Research Firm22.10.2018 15:00 | Pressemelding
Recently Published Report Also Acknowledges its Bold Strategy and Vision LONDON, Oct. 22, 2018 (GLOBE NEWSWIRE) -- Paysafe Group (“Paysafe”), a leading global payments provider, has been named a ‘Strong Performer’ in a recently published third party report: The Forrester Wave™: Global Merchant Payment Providers, Q4 2018. In the report, Forrester acknowledges Paysafe’s bold strategy and vision and gives it the highest possible score in the omnichannel solution criterion. It also describes Paysafe as a “best fit for merchants that are positioned to take advantage of its many value-added services and consumer businesses” and states that the Paysafe product offering “is one of the most differentiated solution value propositions” of any provider in the report. The Forrester report also comments on Paysafe’s customer service focus, stating client references “were extremely pleased with Paysafe’s transparency and customer service.” Joel Leonoff, President and CEO, Paysafe Group, commented: “W
INVEX partners with Ondot to Launch the First Instant Digital Card in México22.10.2018 14:00 | Pressemelding
Solution accelerates digital transformation, acquisition and use of payment methods in México Santa Clara, California and Mexico City, Mexico, Oct. 22, 2018 (GLOBE NEWSWIRE) -- INVEX (BMV: INVEX A) Credit Card business, the only monoliner specializing in payments and cobranded cards, with focus on 100% digital customer experience in Mexico, has partnered with Ondot, the global leader in mobile payments services, to deliver full card life-cycle management associated with the ‘Instant Card’ on a single platform. The digital card services solution creates an end-to-end customer journey -from product presentment, selection, digital acquisition to instant issuance and secure payments. Conversational platforms are becoming the new digital banking user interface. As consumers spend more time on messaging apps, IoT devices and social media, they require similar solutions from their financial institutions. INVEX solution is built on Ondot’s mobile card services conversational platform and creat
Spartan Essential Turn-Key Design Significantly Reduces Time-to-Market for Equipment Manufacturers22.10.2018 14:00 | Pressemelding
Compact Design with Exceptional Wi-Fi Performance SAN JOSE, Calif., Oct. 22, 2018 (GLOBE NEWSWIRE) -- Quantenna Communications, Inc. (NASDAQ: QTNA), the innovator and global leader of high-performance Wi-Fi solutions, has introduced Spartan Essential, a fast to market turn-key design to address multiple consumer Wi-Fi applications such as mesh, access point for wired extenders and simple boosters for upgrading existing gateway wireless LANs. This new compact product eliminates the need for lengthy feature developments, testing and qualification by Original Equipment Manufacturers (OEMs), Original Design Manufacturers (ODMs) and software integrators. Spartan Essential is a complete turn-key design that uses Quantenna’s award-winning QSR1000 Wave 2 chipset solution and supports dual-band dual-concurrent 4x4 802.11ac and 2x2 802.11n. The Spartan Essential design offers the following advantages: Compact and aesthetic industrial design High-performance internal antennas Single PCB design fo
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom