Business Wire

UK National Institute for Health and Care Excellence (NICE) Updates Endobronchial Valve Treatment Guidance to Standard Care

Del

Pulmonx® Corp. today announced that the UK’s National Institute for Health and Care Excellence (NICE) has updated its guidance for endobronchial valves used to treat severe emphysema, an advanced form of chronic obstructive pulmonary disease (COPD), and now considers current evidence sufficient to support routine use.

The change in NICE guidance is based on safety and efficacy data from multiple randomized clinical trials evaluating Zephyr® Endobronchial Valves (EBV®), which have demonstrated benefits for patients in quality of life, exercise capacity and lung function, as well as long-term safety. In fact, four randomized controlled trials of the Zephyr EBV (BeLieVeR-HiFI, TRANSFORM, STELVIO and IMPACT) provide a significant body of evidence supporting the ability of the treatment to significantly improve lung function, exercise tolerance and quality of life in emphysema patients with no collateral ventilation, as assessed with the Chartis System.1,2,3,4

“In light of the high burden of symptoms, progressive nature of emphysema and poor prognosis for patients, the NICE decision means that patients with severe emphysema should be referred to specialists to determine if they are good candidates for endobronchial valves or other interventions,” said Pallav Shah, MD, consultant physician in respiratory medicine at Royal Brompton Hospital and Chelsea & Westminster Hospital, London.

The British Lung Foundation estimates that in the UK, 1.2 million people are living with diagnosed COPD and almost 30,000 die from the disease every year.5 Roughly one-third of COPD patients have a form of the disease called emphysema.6 Emphysema causes damage to the alveoli, the air sacs in the lungs, which allows air to escape and prevents patients from taking in full breaths. This chronic breathlessness makes even the simplest daily activities difficult, such as washing, eating, walking and household chores, and often leads to patients becoming housebound and depressed. In fact, the quality of life for emphysema patients is worse than that for lung cancer.7

Zephyr EBVs are tiny, minimally-invasive, one-way valves placed via a flexible bronchoscope in airways in the lungs to occlude diseased regions and reduce lung hyperinflation. As a result, the remaining healthier regions can function more efficiently, enabling better breathing and an improved quality of life for patients.

Zephyr EBVs are routinely used in Europe and Australia as a treatment for severe emphysema. The treatment has been included in influential international guidelines from such groups as the Global Initiative for Chronic Obstructive Lung Disease (GOLD).8 The well-known independent Cochrane Airways Group also published a review of the available evidence earlier this year and concluded that, with proper patient selection, bronchoscopic lung volume reduction techniques – such as the Zephyr EBV – should be considered for severe emphysema patients when medical therapy has failed.9

Germany and Switzerland have supported EBV use in eligible patients for several years, and late last month, the Dutch organization for reimbursement – the Zorginstituut Nederland – ruled that EBVs are considered an effective treatment in adult patients with severe emphysema and will now be covered by the government.10

“These decisions will increase patient access to our proven and minimally-invasive Zephyr technology, which has the potential to significantly improve the quality of life for patients,” said Pulmonx CEO Glen French.

Over the past 10 years, more than 50,000 Zephyr EBVs have been implanted globally in more than 12,000 patients. To view a video of the Zephyr EBV procedure, click here.

About Pulmonx

Based in Redwood City, California, and Neuchâtel, Switzerland, Pulmonx is an interventional pulmonology company focused on developing life-changing, cost-effective technologies that improve the lives of patients suffering from lung disease worldwide. For more information, visit www.pulmonx.com.

The Zephyr EBVSystem is an investigational device in the United States. Limited by U.S. law to investigational use only.

1. Klooster K, Ten Hacken NHT, Hartman JE, Kerstjens HAM, Van Rikxoort EM, Slebos DJ. Endobronchial valves for emphysema without interlobar collateral ventilation. N Engl J Med 2015; 373:2325-2335.
2. Davey C, Zoumot Z, Jordan S, McNulty W, Carr D, Hind M, et al. Bronchoscopic lung volume reduction with endobronchial valves for patients with heterogeneous emphysema and intact interlobar fissures (the BeLieVeR-HIFi study): a randomised controlled trial. Lancet 2015;386(9998):1066-73.
3. Kemp SV, et al. A multicenter RCT of Zephyr Endobronchial Valve treatment in heterogeneous emphysema (TRANSFORM). Am J Respir Crit Care Med 2017;https://doi.org/10.1164/rccm.201707-1327OC
4. Valipour A, et al. Endobronchial valve therapy in patients with homogeneous emphysema. Results from the IMPACT study. Am J Respir Crit Care Med 2016;194(9):1073-1082.
5. https://statistics.blf.org.uk/copd
6. http://www.lung.org/assets/documents/research/copd-trend-report.pdf
7. Gore JM, Brophy CJ, Greenstone MA. How well do we care for patients with end stage chronic obstructive pulmonary disease (COPD)? A comparison of palliative care and quality of life in COPD and lung cancer. Thorax 2000;55(12):1000-1006.
8. http://goldcopd.org/wp-content/uploads/2016/12/wms-GOLD-2017-Pocket-Guide.pdf
9. http://www.cochrane.org/CD012158/AIRWAYS_bronchoscopic-lung-volume-reduction-procedures-moderate-severe-chronic-obstructive-pulmonary-disease
10. https://www.zorginstituutnederland.nl/publicaties/standpunten/2017/09/14/standpunt-endobronchiale-longvolumereductie-middels-eenrichtingskleppen-bij-ernstig-longemfyseem

Contact information

Chronic Communications
Michelle McAdam
(949) 545-6654 or (310) 902-1274
michelle@chronic-comm.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

AURAK Enters into a Memorandum of Understanding with Al-Farabi Kazakh National University22.7.2018 09:52Pressemelding

The American University of Ras Al Khaimah (AURAK) President, Professor Hassan Hamdan Al Alkim, and the Al-Farabi Kazakh National University (KazNU) Rector, Professor Galimkair Mutanov, of the Republic of Kazakhstan, signed a Memorandum of Understanding (MoU), agreeing to exchange students, faculty, and research. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180722005025/en/ The Al-Farabi Kazakh National University (KazNU) Rector, Professor Galimkair Mutanov, of the Republic of Kazakhstan and the American University of Ras Al Khaimah (AURAK) President, Professor Hassan Hamdan Al Alkim, exchange a gift to commemorate their universities uniting in an MoU agreement. (Photo: AETOSWire) In the spirit of fostering a close international relationship between the Republic of Kazakhstan and the United Arab Emirates, developing bilateral relations in educational and scientific fields, and wishing to make their own contributions to the

Philip Morris International Announces Non-Executive Board Chairman Louis Camilleri to Assume CEO Role at Ferrari S.p.A.21.7.2018 18:19Pressemelding

The board of directors of Philip Morris International (NYSE:PM) has its board member, Sergio Marchionne, and his family in our thoughts and prayers during this challenging time. We congratulate our board chairman, Louis Camilleri, as he assumes the role of CEO of Ferrari S.p.A. The long term relationship between our two companies is deep and meaningful and we look forward to continued business collaboration. Mr. Camilleri will continue to serve as non-executive chairman of the PMI board. Philip Morris International: Who We Are We are a leading international tobacco company engaged in the manufacture and sale of cigarettes and other nicotine-containing products in markets outside the United States of America. We’re building our future on smoke-free products. Through multidisciplinary capabilities in product development, state-of-the-art facilities and scientific substantiation, we aim to ensure that our smoke-free products meet adult consumer preferences and rigorous regulatory requirem

Loxam Announces a Conditional Agreement to Acquire UK Platforms20.7.2018 14:51Pressemelding

Loxam Group (“Loxam”) announces that its wholly-owned subsidiary Nationwide Platforms Limited (“Nationwide”) has entered into a conditional agreement with HSS Hire Group plc (“HSS”) with respect to the acquisition of UK Platforms Limited (“UKP”). UKP specializes in renting powered access equipment from its 12 branches located throughout the United Kingdom. The company has approximately 130 employees and operates a fleet of 3,000 units. UKP is controlled by HSS since 2013. As part of this transaction, Nationwide has entered into a commercial agreement with HSS to provide powered access equipment to complement HSS’ existing fleet. The closing of the transaction is subject to the approval by HSS’ shareholders and the confirmation that it will not be referred to the Competition and Mergers Authority. The transaction is expected to close before year end 2018. Don Kenny, CEO of Loxam’s Powered Access Division states: “I am delighted with the acquisition of UKP which will further reinforce NW

Schlumberger Announces Second-Quarter 2018 Results20.7.2018 11:00Pressemelding

Schlumberger Limited (NYSE: SLB) today reported results for the second quarter of 2018. (Stated in millions, except per share amounts) Three Months Ended Change Jun. 30, 2018 Mar. 31, 2018 Jun. 30, 2017 Sequential Year-on-year Revenue $8,303 $7,829 $7,462 6% 11% Pretax operating income $1,094 $974 $950 12% 15% Pretax operating margin 13.2% 12.4% 12.7% 75 bps 45 bps Net income - GAAP basis $430 $525 $(74) -18% n/m Net income, excluding charges & credits* $594 $525 $488 13% 22% Diluted EPS - GAAP basis $0.31 $0.38 $(0.05) -18% n/m Diluted EPS, excluding charges & credits* $0.43 $0.38 $0.35 13% 23% *These are non-GAAP financial measures. See section below entitled "Charges & Credits" for details. n/m = not meaningful Schlumberger Chairman and CEO Paal Kibsgaard commented, “The second quarter was both busy and exciting for Schlumberger as we completed a number of major milestones in preparation for the broad-based global activity upturn that is now emerging. We delivered solid top-line gro

H.I.G. Capital Announces the Sale of KidsFoundation19.7.2018 19:50Pressemelding

H.I.G. Capital (“H.I.G.”), a leading global private equity investment firm with more than €21 billion of equity capital under management, announced today that one of its affiliates has entered a definitive agreement to sell the KidsFoundation Group (“KidsFoundation”), the Dutch market leader in childcare services, to Onex Corporation (“Onex”)(TSX:ONEX). Terms were not disclosed. Headquartered in Almere, the Netherlands, KidsFoundation provides high-quality childcare to nearly 30,000 children between the ages of six weeks and 12 years. H.I.G. created KidsFoundation in 2014 through the acquisition of assets from the estate of Estro Group. During H.I.G.’s ownership, the company has developed strongly with significant capital invested by H.I.G. to create a high-quality childcare offering. H.I.G. worked with KidsFoundation management to optimise the footprint of the company by exiting loss-making locations, introduce new IT systems to drive operational improvement and develop an internal M&

SIG Combibloc Group Holdings S.à r.l.: 2018 Second Quarter Results19.7.2018 16:01Pressemelding

We are pleased to announce our quarterly conference call to discuss the results of SIG Combibloc Group Holdings S.à r.l. for the second quarter ended June 30, 2018. Date: Monday, July 23, 2018 Time: 15.00 CEST / 14.00 BST / 9.00 EDT The call information will be distributed on our secure site. If you would like access to our call, please contact investor.relations@sig.biz . Regards, SIG Combibloc Group Holdings S.à r.l. View source version on businesswire.com: https://www.businesswire.com/news/home/20180719005634/en/ Contact information SIG Combibloc Group Holdings S.à r.l. Jennifer Gough investor.relations@sig.biz