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The New 2020 Address from the Global Initiative for Abiding Adverse Lung Ache (GOLD) Gives Accomplished Affirmation Appraisement to Endobronchial Valves, including the Zephyr Valve, for Assay of Emphysema / COPD (Photo: Business Wire)



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REDWOOD CITY, Calif.–(BUSINESS WIRE)–Pulmonx Corporation, a baton in ameliorative pulmonary accessory technologies, appear today that the 2020 amend from the Global Initiative for Abiding Adverse Ache (GOLD) has upgraded the affirmation akin appraisement for bronchoscopic lung aggregate abridgement (BLVR) with endobronchial valves, including the Zephyr Valve, for the assay of emphysema / abiding adverse pulmonary ache (COPD). In the anew appear report, GOLD upgraded the affirmation appraisement to “A”, the accomplished affirmation rating, for BLVR with endobronchial valves.1 This affirmation appraisement is based on after-effects from well-designed randomized analytic trials with abstracts from added than two analytic trials involving a abundant cardinal of patients, including those advised with the Zephyr Valve. The Zephyr Valve is a minimally-invasive assay advantage that has been apparent to advance affection of activity of emphysema patients by acceptance them to acquaintance beneath conciseness of animation and be added active.2

GOLD’s Global Action for Diagnosis, Administration and Blockage of COPD address is advised and revised annually by arch physicians in the acreage of COPD about the globe. It is acclimated common by healthcare professionals as a “strategy document” and apparatus in the administration and blockage of COPD, a ache that impacts added than 65 actor bodies globally. GOLD aboriginal added acknowledgment of the allowances of broncoscopic interventions for COPD, including endobronchial valves like the Zephyr Valve, in 2017. The 2020 address upgrades endobronchial valves to the best affirmation akin available, authoritative it the GOLD accepted of affliction for condoning patients. The upgraded affirmation appraisement of “A” for endobronchial valves signals that:



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“This GOLD appraisement is actual important because it confirms that the anatomy of affirmation acknowledging endobronchial valves is cogent and supports the use of this action as accepted of affliction for patients adversity from astringent emphysema, a anatomy of COPD. As a physician who treats these patients, the Zephyr Valves are the aboriginal FDA-approved minimally-invasive advantage we accept had to advice patients breathe easier already optimal medical assay is no best able in authoritative their symptoms,” said Dr. Gerard Criner, Professor of Medicine and Chair of the Department of Thoracic Anaplasty and Medicine at Temple University. “Before Zephyr Valves were approved, the alone advantage was above anaplasty which comes with cogent risks. With cogent affirmation now in abode for endobronchial valve treatment, we can now action patients a best in assay options.”

Bronchoscopic lung aggregate abridgement with the Zephyr Valve is a ancient action performed through a bronchoscope, which requires no acid or incisions. During the procedure, an boilerplate of four valves are placed in the airways to block off a afflicted allocation of the lung, which is thereby bargain in size. Reducing hyperinflation and preventing air from accepting trapped in the afflicted genitalia of the lung allows the convalescent lung tissue to aggrandize and booty in added air. This after-effects in patients actuality able to breathe added calmly and acquaintance beneath conciseness of breath. 2 Abounding patients advised with the Zephyr Valves accept appear actual abatement and the adeptness to go aback to accomplishing accustomed tasks with greater affluence aural weeks of treatment.



“GOLD is globally admired for accouterment all-embracing affirmation reviews and recommendations that appulse accommodating assay about the world. We are actual admiring to see GOLD accord endobronchial valves, like our Zephyr Valve, an affirmation “A” appraisement afterwards a absolute assay of appear analytic data, which includes assorted Zephyr Valve randomized analytic trials appear in arch medical journals,” said Glen French, President and Chief Executive Officer of Pulmonx. “This akin of affirmation is an important agency for providers and payers who are gluttonous to bear the best assay options for patients with astringent emphysema, a astringent anatomy of COPD.”

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More on the Zephyr Valve
The Zephyr Valve was accepted advance cachet and accustomed by the FDA in June 2018, because according to the FDA it “represents a advance technology as the accessory offers bronchoscopic lung aggregate abridgement after anaplasty and its associated risks. This accessory offers a significant, clinically allusive advantage over the accepted accepted of affliction and therefore, its availability is additionally in the best absorption of patients.”3 Since 2007 added than 15,000 patients accept been advised with the Zephyr Valve worldwide. The Zephyr Valve assay is recommended at the aforementioned akin as lung aggregate abridgement anaplasty in the UK’s Civic Institute for Bloom and Affliction Excellence (NICE) Guidance on the managed of COPD and the GOLD action certificate for the administration of COPD.

More about COPD and Emphysema
COPD is a progressive, life-threatening lung ache that includes emphysema and abiding bronchitis. Added than 65 actor bodies ache with COPD globally and it is estimated that 3.2 actor deaths were acquired by the ache in 2015 (5% of all deaths globally).45 Despite demography the best accessible medications, abounding COPD and emphysema patients ache affection of hyperinflation, area air becomes trapped in the lungs and prevents beginning air from entering the lungs and thereby causing astringent conciseness of breath. As a result, patients acquaintance conciseness of breath, gradually accident their adeptness to appoint in the best basal circadian activities such as aggressive a flight of stairs, walking or showering. There are few assay options for best patients with emphysema and there is no cure. Until now, above medication therapy, the alone added options for these patients were awful invasive treatments such as lung aggregate abridgement anaplasty or lung transplantation.

About Pulmonx
Pulmonx Corporation is a medical accessory aggregation that provides minimally-invasive solutions to amusement patients with astringent emphysema, a anatomy of COPD. Pulmonx solutions accommodate the Zephyr Endobronchial Valve, a different minimally-invasive assay option, and the Chartis Pulmonary Appraisal System and the StratX Lung Assay Platform, a set of avant-garde appraisal accoutrement that accredit accommodating alternative and assay planning. Pulmonx has a acute anatomy of analytic affirmation based on the appraisal of about 1,000 patients in assorted randomized controlled analytic studies demonstrating cogent improvements in pulmonary function, exercise capacity, dyspnea and affection of life. In June 2018, Pulmonx accustomed pre-market approval, or PMA, through the FDA’s ‘breakthrough device’ alleyway to commercialize our Zephyr Valve. Pulmonx solutions are commercially accessible in added than 25 countries with over 15,000 patients treated. For added information, appointment Media 2020 Report: Media November

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1Global Action for Diagnosis, Administration and Blockage of COPD 2020. Retrieved from: Media
2 Criner G. et al. Am J Respir Crit Affliction Med. 2018; 198 (9):1151–1164.
3 PMA P180002: FDA Summary of Safety and Effectiveness Data. June 29, 2018. https://www.accessdata.fda.gov/cdrh_docs/pdf18/P180002B.pdf.
4 Global, regional, and civic activity expectancy, all-cause mortality, and cause-specific bloodshed for 249 causes of death, 1980–2015: a analytical assay for the Global Burden of Ache Study 2015. The Lancet 2016; 388: 1459-1544.
5 The Apple Bloom Organization: Burden of COPD. Accessed November 2019: https://www.who.int/respiratory/copd/burden/en/

Meghan Oreste, 617-823-1441, Media

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