Home collateral CONVERT Clinical Trial Data Presented at ERS Demonstrates Early Success of AeriSeal System in Patients with Advanced COPD/Emphysema

CONVERT Clinical Trial Data Presented at ERS Demonstrates Early Success of AeriSeal System in Patients with Advanced COPD/Emphysema


REDWOOD CITY, CA & BARCELONA, Spain–(BUSINESS WIRE)–Pulmonx Corporation (Nasdaq: LUNG) (“Pulmonx”), a global leader in minimally invasive treatments for serious lung disease, announces the presentation of interim results from the CONVERT study at the 2022 European International Conference Respiratory Society (ERS). Data from the first 40 patients in the study demonstrated that treatment with the AeriSeal System was successful in converting collateral ventilation (CV) status in 78% of patients who were subsequently treated with Zephyr valves.

The AeriSeal System is used to close collateral air channels in a target lung lobe of a patient with severe COPD/emphysema, making the patient eligible to then undergo Bronchoscopic Lung Volume Reduction (BLVR) with valves Zephyr. Patients whose lungs have untreated collateral ventilation (CV+) are not currently eligible for treatment with Zephyr valves and have limited options once medical management alone fails to control symptoms. Once the target lobe is converted from CV+ to CV-, patients can be treated with Zephyr valves, which have been shown to improve lung function, quality of life and exercise capacity in affected patients. COPD/severe emphysema.1

The CONVERT study uses the AeriSeal system to seal collateral airflow. Once the treated lobe is negative for collateral ventilation (CV-), Zephyr valves are implanted to treat hyperinflation of that target lobe to relieve symptoms of emphysema without major surgery. Successfully converted patients who received Zephyr Valves experienced clinically significant target lobe volume reduction (TLVR) with a mean reduction greater than one (1) liter. The CONVERT trial is ongoing and full clinical results of BLVR with Zephyr valves have not been reported at this time. However, recently published results from a single center feasibility study at Macquarie University Hospital in Australia showed that the AeriSeal System successfully closed collateral air channels and achieved positive clinical outcomes after treatment. with Zephyr valves.2 At 6 months, CV+ patients treated with AeriSeal and Zephyr Valve showed clinically meaningful improvements similar to those seen in CV- patients treated with Zephyr Valves alone.2 Improvements included:

  • Pulmonary function (FEV1 19.7% increase, residual volume decrease 16.2%)

  • Quality of life (decrease in SGRQ score of 15.1 points)

  • Exercise capacity (increased walking distance in six minutes by 77.2 meters)

No serious adverse events were reported in patients in the Australian feasibility study; 20% of patients in the CONVERT study experienced an inflammatory response after AeriSeal treatment – ​​all were transient, medically managed and resolved. Available data suggests that patients with collateral ventilation can experience successful BLVR with Zephyr Valves after closure of the fissure space with the AeriSeal System.

“This is very promising news for patients with advanced COPD. We know that treatment with Zephyr valves can provide long-term improvements in lung function, breathing and quality of life, but for patients on collateral ventilation, this minimally invasive treatment is not available as an option. explains Dr. Michela Bezzi, Head of Department and Director Interventional Pneumology – ASST Spedali Civili, University Hospital, Brescia, Italy. “Having technology like the AeriSeal System to convert collateral ventilation positive patients to negative status means we can provide treatment for patients who currently have very few options.”

“This work reflects our ongoing commitment to developing and testing new medical technologies to help patients with serious lung diseases breathe easier and have a better quality of life,” said Glen French, President and CEO of Lungx. “These early study results are encouraging and move us closer to helping patients with severe emphysema who have collateral ventilation benefit from our proven Zephyr Valve therapy.

About the CONVERT Study

CONVERT is a prospective, open-label, multicenter, single-arm study conducted at up to 20 experimental sites. The study plans to recruit 140 subjects with severe emphysema and collateral ventilation in the target lobe. This protocol is designed to evaluate the utility of the AeriSeal System, which uses synthetic polymeric foam to occlude (close) collateral air channels in a target lung lobe and convert the target lung lobe to having little or no collateral ventilation ( RESUME-). Patients will then undergo bronchoscopic lung volume reduction with Zephyr Endobronchial Valves. Zephyr valves are not effective if collateral ventilation (CV+) is present, but once the target lobe is converted from CV+ to CV-, patients can be treated with Zephyr valves which improve lung function, quality of life and exercise capacity for patients with severe COPD/emphysema.1 See https://clinicaltrials.gov/ct2/show/NCT04559464 for more details on the CONVERT study.

The AeriSeal System is not FDA cleared or approved for commercial sale in the United States.

About Zephyr Valves

The Zephyr Valve is a minimally invasive treatment option for severe COPD/Emphysema. Zephyr valves are placed bronchoscopy to block off a diseased part of the lung to prevent air from becoming trapped and reduce hyperinflation, allowing healthier lung tissue to expand and take in more air . This allows patients to breathe better, be less breathless and improve their quality of life.1 National and global treatment guidelines for COPD include endobronchial valves such as Zephyr valves with the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) giving the valves an “Evidence A” rating. Over 25,000 patients have been treated with the Zephyr Valve worldwide.

About Pulmonx Corporation

Pulmonx Corporation (NASDAQ: LUNG) is a global leader in minimally invasive treatments for serious lung disease. Pulmonx Zephyr® Endobronchial valve, Chartis® Lung Assessment System and StratX® The Lung Analysis Platform is designed to assess and treat patients with severe emphysema/COPD who, despite medical management, still have profound symptoms. Pulmonx has received premarket approval from the FDA to market the Zephyr valve following its designation as a “breakthrough device”. The Zephyr valve is marketed in more than 25 countries, with more than 100,000 valves used to treat more than 25,000 patients. For more information on Zephyr valves, please visit https://uspatients.pulmonx.com/. For more information about 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 and Section 21E of the Securities Exchange Act of 1934. We may, in some instances, use terms such as “looking ahead”, “confident” , “promises”, “predicts”, “believes”, “potential”, “anticipates”, “expects”, “plans”, “intends”, “may”, “could”, “might “, “will”, “should”, or other words that convey uncertainty of future events or results to identify such forward-looking statements and include, but are not limited to, statements about Pulmonx’s ability to treating more patients and delivering significant patient benefits. Forward-looking statements should not be construed as a guarantee of future performance or results and are not necessarily precise indications of the times at which or by which such performance or results will be achieved. 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 these forward-looking statements due to such risks and uncertainties, which include, but are not limited to, those related to safety, effectiveness and the adoption by patients and physicians of the Company’s products, the end results and results of clinical trials and studies involving the Company’s products, the ability to obtain and maintain reimbursement codes for its products, and the ability of the Company to obtain and maintain the required regulatory approvals for its products. These and other risks and uncertainties are described in more detail 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 August 8, 2022. , available at www.sec.gov. Pulmonx undertakes no obligation to update any forward-looking statements and expressly disclaims any obligation or undertaking to publicly release any updates or revisions to the forward-looking statements contained herein.

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