CA-PULMONX-CORPORATION
26.2.2024 14:01:32 CET | Business Wire | Press release
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
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
SMBC and Toshiba Jointly Develop New Equity Indices Using Advanced Quantum-Driven Technologies28.5.2026 03:00:00 CEST | Press release
Sumitomo Mitsui Banking Corporation (“SMBC”) and Toshiba Corporation (“Toshiba”) today announced the joint development of the SMBC/TOSHIBA Quantum Driven Diversified Japan Equity Index and the SMBC/TOSHIBA Quantum Driven Diversified U.S. Equity Index, new equity indices realized with advanced quantum-driven technologies. Collectively, the indices are referred to as “SMBC/TOSHIBA Quantum Diversified” (the “Indices”). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260519448161/en/ Toshiba’s Simulated Bifurcation Machine 1. Background and Objectives Equity investment is central to asset management, but it also carries the ever-present risk of abrupt and substantial market fluctuations driven by geopolitical developments, changes in economic policy, and other external factors. In uncertain markets, investors are constantly seeking innovations in risk diversification that can protect their assets from unexpected market shocks. SM
BeOne Medicines Announces Phase 3 HERIZON-GEA Data Published in NEJM and Presented at ASCO 202627.5.2026 23:00:00 CEST | Press release
TEVIMBRA plus ZIIHERA and chemotherapy demonstrated statistically significant overall survival benefit with an unprecedented seven-month improvement in first-line HER2+ GEAOral presentation at ASCO highlights benefit regardless of PD-L1 status, including in PD-L1 <1% BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that data from HERIZON-GEA-01 were published in The New England Journal of Medicine and will be presented in an oral presentation (Rapid Oral Abstract: 4010) at the American Society of Clinical Oncology (ASCO) Annual Meeting on June 1, 2026, in Chicago.The HERIZON-GEA-01 clinical trial evaluated ZIIHERA® (zanidatamab) plus chemotherapy, with and without TEVIMBRA® (tislelizumab), compared with the control arm of trastuzumab plus chemotherapy as first-line treatment for advanced/metastatic HER2+ gastroesophageal adenocarcinoma (GEA). Dr. Sun Young Rha, Professor of Medical Oncology at the Yonsei Cancer Center, Yonsei Univ
Stallergenes Greer Foundation Celebrates Excellence in Allergy Innovation With 2025 Awards27.5.2026 17:22:00 CEST | Press release
The Stallergenes Greer Foundation, dedicated to advancing allergy research, fostering innovation and addressing environmental factors which impact allergies, is delighted to announce the recipients of the 2025 edition of its prestigious Science Awards for Allergy. Building on the success of the previous edition, this year’s awards recognise outstanding contributions to allergy research and patient engagement and allocate a total of €100,000 to support these initiatives. Four researchers have been selected by the Board as award recipients, each receiving €25,000 across two categories: Innovation In Treatment Awards Assoc. Professor Alexander Eggel, PhD, Department for Biomedical Research, University of Bern, and Department of Rheumatology and Immunology, University Hospital Bern, Switzerland, recognised for his research: “Improving diagnostic and therapeutic options for allergic patients”; Dr Janice A. Layhadi, PhD, Research Associate, National Heart and Lung Institute, Imperial College
Capchase Secures $200M+, as Demand for Vendor Financing in Enterprise Tech Deals Accelerates27.5.2026 16:00:00 CEST | Press release
As buyers face tighter budgets, Capchase helps technology companies close more deals faster with AI-enabled instant financing Capchase, the leading vendor financing platform for enterprise tech, today announced $200M+ in incremental funding to scale its embedded financing infrastructure globally and deploy more AI-enabled features. The funding, a mix of debt warehouse facilities and equity backed by institutional investors, reflects market validation that vendor financing has become essential infrastructure for enterprise technology companies to sell hardware and software products. As global B2B buyers face tighter budgets and greater scrutiny over large, up-front purchases, financing demand is growing. The Market Shift: Financing as a Growth Lever for B2B Tech Companies The $1.3 trillion vendor financing market has been traditionally dominated by banks and other lenders that utilize multi-thread email chains to manual doc review for underwriting. Capchase replaces those bottlenecks wi
ClickHouse Tops $250M ARR and 4,000 Customers, Launches Claude-Powered Agents at Open House 202627.5.2026 15:00:00 CEST | Press release
Annual run-rate revenue more than tripled year-over-year; new CostBench benchmark shows ClickHouse Cloud at 23x better cost-performance than the nearest cloud data warehouse ClickHouse today opened Open House 2026, its second annual user conference, with a set of announcements that mark one of the company's most active quarters since founding. ClickHouse’s serverless cloud offering has crossed over $250 million in annual run-rate revenue — more than triple a year ago — and added more than 1,000 net new customers since January, bringing its total to 4,000. To meet the demands of AI-era workloads, the company also launched ClickHouse Agents, a fully managed agentic analytics service powered by Anthropic's Claude; published CostBench, an open benchmark comparing the major cloud data warehouses on cost-performance; and introduced House Mates, its first formal partner program. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260527
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
