Business Wire

CA-PULMONX-CORPORATION

26.2.2024 14:01:32 CET | Business Wire | Press release

Share
Pulmonx Announces Treatment of the First Patient with the AeriSeal® System in CONVERT II Pivotal Trial

Pulmonx Corporation (Nasdaq: LUNG) (“Pulmonx” or the “Company”), a global leader in minimally invasive treatments for chronic obstructive pulmonary disease (COPD), today announced the treatment of the first patient in the CONVERT II Pivotal Trial, a multicenter, international study evaluating the safety and effectiveness of the AeriSeal® System in limiting collateral ventilation in severe COPD/emphysema patients. Collateral ventilation is caused by openings in the lung fissures, or walls between the lung lobes. The AeriSeal System is designed to occlude these naturally occurring openings in a lobe targeted for bronchoscopic lung volume reduction (BLVR) and block collateral ventilation. Successful treatment with the AeriSeal System is followed by treatment with commercially available Zephyr® Valves. Pulmonx received a staged IDE approval by the Food and Drug Administration (FDA) to commence the CONVERT II Pivotal Trial for the AeriSeal System in late 2023.

The goal of the CONVERT II Pivotal Trial is to establish the safety and effectiveness of using the AeriSeal System to target and treat the fissural defects that allow collateral ventilation between lung lobes which preclude some severe COPD/emphysema patients from benefiting from BLVR with Zephyr Valves. Severe COPD/emphysema patients with collateral ventilation confirmed with Pulmonx’s proprietary Chartis® Pulmonary Assessment System (Chartis) undergo the AeriSeal System treatment. For those patients who experience conversion (as assessed with the Chartis System 45 days later), Zephyr Valves are implanted per current standard of care for lung volume reduction. Procedural success (lung volume reduction) and other clinical parameters including lung function, quality of life and exercise capacity, will be evaluated at 6 months post-valve treatment. The 6-month results will be used to support a Pre-Market Approval (PMA) application. Up to 200 patients will be enrolled at up to 30 sites in the US, Australia, and Europe (ClinicalTrials.gov Identifier: NCT06035120). The study will complement the positive experience that the Company has already gained with the CONVERT Trial (ClinicalTrials.gov Identifier: NCT04559464)1.

Endobronchial Valves are small, one-way valves used to reduce hyperinflation of the lungs, the primary cause of breathlessness in patients with severe COPD/emphysema. If collateral ventilation is present, the treated lobe will not deflate, and the valves are not effective. AeriSeal Foam is designed to block gaps in lung fissures so that patients may then benefit from treatment with endobronchial valves like the Zephyr Valve. Zephyr Valves have been clinically proven to improve breathing, lung function, and quality of life for patients with advanced disease.2

“This is very promising news for patients with severe COPD/emphysema because as the diseases progresses, medications alone often do not control symptoms sufficiently. We know Zephyr Valves can provide durable improvements in lung function, breathing, and quality of life, but for patients with incomplete fissures the treatment does not work effectively,” explains Dr. Michela Bezzi, Director Interventional Pulmonology - ASST Spedali Civili, University Hospital, Brescia, Italy. “Having a technology to seal openings in fissures means we can improve the lives of many more patients using minimally invasive procedures.”

“Pulmonx remains at the forefront in developing and testing new medical technologies to help patients with severe lung disease breathe easier and have better quality of life,” stated Glen French, President and Chief Executive Officer of Pulmonx. “We hope the CONVERT II Trial will move us closer to the goal of helping patients with collateral ventilation to also receive benefit from our Zephyr Valves.”

About the CONVERT II Pivotal Trial

The CONVERT II Pivotal Trial is designed to evaluate the safety and effectiveness of the AeriSeal System in limiting collateral ventilation in severe COPD and emphysema patients. The study will enroll approximately 200 patients in and outside the United States. Patients who experience conversion following the AeriSeal System treatment will then be treated with Zephyr Valves per current standard of care for lung volume reduction. Procedural success defined as lung volume reduction, and other clinical parameters will be evaluated at six months post-valve treatment and will be used to support the company’s premarket approval application.

About the Zephyr Valve Treatment

The Zephyr Valve is a minimally invasive treatment option for severe COPD/emphysema, a chronic, progressive, and irreversible lung disease characterized by the destruction of lung tissue. The loss of the lung’s natural elasticity and the collapse of airways cause air to become trapped in the lung. This makes breathing inefficient, and patients are always short of breath, making the most nominal physical activities difficult. Placed via bronchoscopy, the valves block off a diseased portion of the lung to prevent air from getting trapped and reduce hyperinflation, which allows the healthier lung tissue to expand and take in more air. This results in patients being able to breathe easier, be less short of breath, and have an improvement in their quality of life2. National and global treatment guidelines for COPD include Endobronchial Valves like Zephyr Valves, with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) giving valves an ‘Evidence A’ rating.

About Pulmonx Corporation

Pulmonx Corporation (Nasdaq: LUNG) is a global leader in minimally invasive treatments for chronic obstructive pulmonary disease (COPD). Pulmonx’s Zephyr Endobronchial Valve, Chartis Pulmonary Assessment System and StratX® Lung Analysis Platform are designed to assess and treat patients with severe emphysema/COPD who despite medical management are still profoundly symptomatic. Pulmonx received FDA pre-market approval to commercialize the Zephyr Valve following its designation as a “breakthrough device.” The Zephyr Valve is commercially available in more than 25 countries, is included in global treatment guidelines and is widely considered a standard of care treatment option for improving breathing, activity, and quality of life in patients with severe emphysema. For more information on the Zephyr Valves and the company, please visit www.Pulmonx.com.

Forward Looking Statements

This release contains forward-looking statements within the meaning of Sections 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are based on management’s current assumptions and expectations of future events and trends, which affect or may affect our strategy, operations, financial performance, or clinical progress and actual results may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements should not be read as a guarantee of future performance or results. These forward-looking statements are based on Pulmonx’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation those related to the safety, efficacy and patient and physician adoption of the AeriSeal System and the Company’s other products, the ultimate outcomes, completion, or success of the CONVERT II Pivotal Trial, the ability to obtain and maintain reimbursement codes for its products, and the Company’s ability to procure and maintain required regulatory approvals for the AeriSeal System and its other products. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in Pulmonx’s filings with the Securities and Exchange Commission (SEC), including the Company’s Quarterly Report on Form 10-Q filed with the SEC on November 3, 2023, available at www.sec.gov. Pulmonx does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.

Pulmonx®, AeriSeal®, Chartis®, StratX®, and Zephyr® are registered trademarks of Pulmonx Corporation.

_________________________

1 Eur Respir J 2022; 60: Suppl. 66, 1231.

2 Criner et al. Am J Respir Crit Care Med. 2018; 198 (9): 1151–1164.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240226048565/en/

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com
DK

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Autonomous University of Sinaloa (UAS) Releases Study on the Positive Economic Impacts of Pacifico Mexinol Project in Northern Sinaloa29.4.2026 00:39:00 CEST | Press release

The study, among other factors, estimates for every one job created by Pacifico Mexinol, eight additional jobs on average are created across the broader economy, and Mexico’s GDP will rise by over $2b USD during construction. The study is the first economic impact study of its kind at a state level in Mexico and the methodology can be replicated globally across other sectors and regions. As part of an ongoing joint effort between the academic and commercial sectors, stemming from a Collaboration Agreement between the Autonomous University of Sinaloa (UAS) and Pacifico Mexinol (a subsidiary of Transition Industries) signed in 2024, UAS released the findings of the economic effects study of the world's largest ultra-low-carbon methanol plant, located near Topolobampo, Ahome, Sinaloa. The Pacifico Mexinol project is aligned with the UN Sustainable Development Goals by promoting the use of clean energy, the utilization of treated wastewater, and climate change mitigation. It protects local

Suzano 2025 Annual Report on Form 20-F28.4.2026 23:32:00 CEST | Press release

Suzano S.A. (B3: SUZB3 | NYSE: SUZ) informs that its 2025 Annual Report on Form 20-F was filed on March 24, 2026 with the U.S. Securities and Exchange Commission. Holders of the Company’s equity securities can receive hard copies of the Annual Report, including its audited financial statements, without charge by request directed to: ri@suzano.com.br. This document is also available on Suzano’s website (http://ir.suzano.com.br/). For further information, please contact our Investor Relations Department: Phone: (+55 11) 3503-9330 E-mail: ri@suzano.com.br View source version on businesswire.com: https://www.businesswire.com/news/home/20260428152792/en/

Laserfiche Introduces AI Agents: The Future of Intelligent Content Management28.4.2026 23:00:00 CEST | Press release

New agentic AI capabilities allow any user to automate intelligent, multi-step workflows using natural language. Today at the Laserfiche Empower conference — the premier event for intelligent content management —Laserfiche announced the release of AI Agents. With simple, natural language prompts, these virtual assistants perform complex, multi-step tasks and work within the framework of Laserfiche’s robust security and compliance controls, transforming how you interact with your organization’s information. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260428506937/en/ Laserfiche AI Agents leverage advanced generative AI reasoning models to perform tasks that bridge the gap between building workflows and time-consuming manual effort. They can take actions based on document data and execute bulk changes from natural language user instructions. “The introduction of AI Agents to content management signals a shift in how we hand

BTG Pactual Timberland Investment Group Raises US$1.24 Billion for Largest Reforestation Fund to Date[1]28.4.2026 17:00:00 CEST | Press release

Milestone positions Latin American reforestation strategy as a leading model for scalable, high-integrity conservation and restoration—combining sustainable commercial reforestation with large-scale ecosystem conservation and restoration to target economic returns, climate and biodiversity gains, and rural community benefits. Conservation International serves as Impact Adviser for social and environmental outcomes. BTG Pactual Timberland Investment Group (BTG Pactual TIG), one of the world’s largest timberland managers, today announced the close of fundraising for its Latin American Reforestation Strategy, reaching US$1.24 billion in commitments. This represents the largest reforestation fund closed to date,1 providing a model for large-scale reforestation and restoration that seeks to deliver durable climate impact, tangible benefits for rural communities, biodiversity outcomes, and sustainable commercial production. Global environmental organization Conservation International serves

Qatar Implements Relief Measures to Support Business Community28.4.2026 16:56:00 CEST | Press release

Qatar has activated a comprehensive package of support measures designed to maintain market stability and reinforce investor confidence amid evolving regional conditions. These measures, delivered through the nation’s foreign direct investment ecosystem, provide immediate financial, regulatory and operational relief to Qatar’s international business community. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260428904909/en/ Infographic highlights key relief measures implemented in Qatar to support the business community (Infographic: AETOSWire) H.E. Sheikh Faisal bin Thani Al Thani, Minister of Commerce and Industry and Chairman of Invest Qatar, stated: “Qatar’s commitment to its business community is unwavering. As regional conditions continue to evolve, we remain fully focused on acting decisively to support companies operating in our market, safeguard business continuity and reinforce confidence. Our approach is grounded i

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye