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
IQM Appoints Craig Ciesla, Former Illumina VP, as CTO; Inés de Vega Becomes Chief Scientist19.6.2026 09:00:00 CEST | Press release
Ciesla is a seasoned deep tech executive with more than 25 years of experience delivering products across industries — from startups to Fortune 500 companies. De Vega brings more than 20 years of experience advancing quantum technologies from fundamental research to intellectual property and industrial applications. IQM Quantum Computers, the global leader in superconducting quantum computers, today announced the appointments of Dr. Craig Ciesla as Chief Technology Officer (CTO) and Dr. Inés de Vega as Chief Scientist, as she transitions from her role as Vice President of Quantum Solutions, deepening IQM´s leadership as the company prepares for its planned Nasdaq listing through a merger with Real Asset Acquisition Corp. (Nasdaq: RAAQ). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260619693929/en/ From left to right: Dr. Inés de Vega, Chief Scientist, and Dr. Craig Ciesla, Chief Technology Officer. Ciesla, an experienced d
Teijin Receives Approval for Additional Indications of XEOMIN® for Cervical Dystonia and Blepharospasm in Japan19.6.2026 09:00:00 CEST | Press release
Teijin Pharma Limited, the core company of the Teijin Group’s healthcare business, and Merz Therapeutics GmbH, a leading player in neurology-focused specialty pharma, jointly announced today that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved the additional indications for XEOMIN® (incobotulinumtoxinA) for the treatment of cervical dystonia and blepharospasm. This approval represents the fourth and fifth indications for XEOMIN® authorized in Japan, alongside its existing approvals for the treatment of upper limb spasticity, lower limb spasticity and chronic sialorrhea. Cervical dystonia is a focal dystonia characterized by involuntary contractions of the neck muscles, resulting in abnormal or repetitive movements and postures.1 Blepharospasm is also a focal dystonia, characterized by excessive involuntary contractions of the muscles surrounding the eye.2 Both conditions significantly impact patients’ quality of life. The approval by MHLW is based on Phase III clinic
Incyte Japan Announces Approval of Minjuvi® (tafasitamab) in Combination with Lenalidomide for the Treatment of Adults with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)19.6.2026 08:00:00 CEST | Press release
Incyte Biosciences Japan G.K. today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Minjuvi® (tafasitamab) in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). “This approval provides a new option for patients in Japan living with relapsed or refractory DLBCL, an aggressive disease with historically limited treatment options,” said Yasuyuki Ishida, General Manager, Incyte Biosciences Japan. “We are committed to helping address critical unmet needs for patients and their families affected by this challenging cancer.” DLBCL is the most common subtype of non-Hodgkin lymphoma and is an aggressive malignancy of B lymphocytes. While many patients respond to initial therapy, outcomes remain poor for those with relapsed or refractory disease, particularly for patients who are not eligible for autologous stem cell transplant.1 The approval is based on results from the MOR208C203 Trial: L
Amazfit Introduces Helio Strap Pro, Bringing Body-Worn Movement Intelligence to HYROX and Hybrid Training18.6.2026 19:07:00 CEST | Press release
New multi-sensor system captures heart rate, movement quality, stability and muscle load to provide a more complete view of performance under fatigue Amazfit, a leading global smart wearable brand owned by Zepp Health (NYSE: ZEPP), today announced Helio Strap Pro, a body-worn training system designed to help HYROX and hybrid athletes better understand how their bodies perform under load. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260618031434/en/ Amazfit Introduces Helio Strap Pro, Bringing Body-Worn Movement Intelligence to HYROX and Hybrid Training Building on the screen-free Helio Strap, Helio Strap Pro adds a dedicated waist-mounted motion sensor that captures core-body movement and stability during training. Combined with upper-arm heart-rate sensing and compatible Amazfit smartwatches, the system provides a more complete picture of cardio effort, movement quality and muscle load than wrist-based tracking alone. Hel
HyperLight Announces $80 Million Series C to Accelerate TFLN Deployment for AI Infrastructure18.6.2026 17:30:00 CEST | Press release
HyperLight Corporation (“HyperLight”), a leader in thin-film lithium niobate (TFLN) photonics, today announced the closing of an $80 million Series C financing round led by MediaTek. The round includes participation from UMC Capital, Jabil, Foxconn, EDBI (arm of SG Growth Capital, the investment platform of the Singapore Economic Development Board and Enterprise Singapore), CDIB-TEN Capital, and Qatar Investment Authority (QIA), as well as strategic investors from leading silicon IC and networking companies. Existing investors Summit Partners, The Engine, Foothill Ventures, and Xora Innovation continue to actively support the company’s growth. The financing brings together companies across the AI infrastructure value chain — including silicon ICs, foundry manufacturing, electronics manufacturing services, networking, and global infrastructure investment — reflecting broad ecosystem support for scaling TFLN photonics into production. “This financing is about more than capital — it is ab
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
