Barcelona, Spain & Redwood City, Calif., United States:
Pulmonx Corporation (Nasdaq: LUNG) (“Pulmonx”), a worldwide chief in minimally invasive therapies for extreme lung illness, broadcasts the presentation of interim outcomes from the CONVERT Study at the 2022 European Respiratory Society (ERS) International Conference. Data on the primary 40 sufferers in the research demonstrated that therapy with the AeriSeal System efficiently transformed the collateral air flow (CV) standing in 78% of sufferers who have been subsequently handled with Zephyr Valves.
The AeriSeal System is used to shut collateral air channels in a goal lung lobe of a affected person with extreme COPD/emphysema, making the affected person eligible to then endure Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Valves. Patients whose lungs have untreated collateral air flow (CV+) are at the moment ineligible for therapy with Zephyr Valves and have restricted choices as soon as medical administration alone doesn’t management signs. Once the goal lobe is transformed from CV+ to CV-, sufferers could be handled with Zephyr Valves, which has been proven to enhance lung perform, high quality of life, and train capability for sufferers with extreme COPD/emphysema.1
The CONVERT research makes use of the AeriSeal System to shut collateral air stream. Once the handled lobe checks adverse for collateral air flow (CV-), Zephyr Valves are implanted to deal with hyperinflation of that concentrate on lobe to ease emphysema signs with out main surgical procedure. Successfully transformed sufferers who obtained Zephyr Valves had clinically significant Target Lobe Volume Reduction (TLVR) with a imply discount of higher than one (1) liter. The CONVERT trial is ongoing and full scientific outcomes of BLVR with Zephyr Valves weren’t reported at this time. However, outcomes not too long ago revealed from a single-center feasibility research at Macquarie University Hospital in Australia confirmed that the AeriSeal System efficiently closed collateral air channels and allowed for profitable scientific outcomes after therapy with Zephyr Valves.2 At 6 months, AeriSeal and Zephyr Valve handled CV+ sufferers skilled clinically significant enhancements much like enhancements in CV- sufferers handled with Zephyr Valves alone.2 Improvements included:
- Lung perform (FEV1 enhance of 19.7%, Residual Volume lower of 16.2%)
- Quality of life (SGRQ rating lower of 15.1 factors)
- Exercise capability (Six-Minute Walk Distance enhance of 77.2 meters)
There have been no severe antagonistic reactions skilled by sufferers in the Australian feasibility research; 20% of sufferers in the CONVERT Study skilled an inflammatory response following AeriSeal therapy – all have been transient, medically managed, and resolved. The out there knowledge recommend that sufferers with collateral air flow can endure profitable BLVR with Zephyr Valves following closure of the fissure hole 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 with collateral ventilation, this minimally invasive treatment has not been available as an option,” explains Dr. Michela Bezzi, Department Head and Director Interventional Pulmonology – ASST Spedali Civili, University Hospital, Brescia, Italy. “Having a technology like the AeriSeal System to convert collateral ventilation positive patients to negative status means we can provide a treatment to patients who currently have very few options.”
“This work reflects our continued commitment to developing and testing new medical technologies to help patients with severe lung disease breathe easier and have better quality of life,” states Glen French, President and Chief Executive Officer of Pulmonx. “These early study results are encouraging and move us closer to the goal of helping severe emphysema patients who have collateral ventilation benefit from our proven Zephyr Valve treatment.”
About the CONVERT Study
CONVERT is a potential, open-label, multi-center, single-arm research being carried out at as much as 20 investigational websites. The research plans to enroll 140 topics with extreme emphysema and collateral air flow in the goal lobe. This protocol is designed to judge the utility of the AeriSeal System, which makes use of an artificial polymer foam to occlude (shut) collateral air channels in a goal lung lobe and convert the goal lung lobe to having little to no collateral air flow (CV-). Patients will then endure Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves. Zephyr Valves should not efficient if collateral air flow (CV+) is current however as soon as the goal lobe is transformed from CV+ to CV-, sufferers could be handled with Zephyr Valves which has been proven to enhance lung perform, high quality of life, and train capability for sufferers with extreme COPD/emphysema.1 See https://clinicaltrials.gov/ct2/show/NCT04559464 for extra particulars on the CONVERT Study.
The AeriSeal System is just not authorized by the FDA or authorized for business sale in the United States.
About Zephyr Valves
The Zephyr Valve is a minimally invasive therapy possibility for extreme COPD/emphysema. Zephyr Valves are positioned by way of bronchoscopy to dam off a diseased portion of the lung to stop air from getting trapped and cut back hyperinflation, which permits the more healthy lung tissue to broaden and take in extra air. This outcomes in sufferers having the ability to breathe simpler, be much less quick of breath, and have an enchancment in their high quality of life.1 National and international therapy tips for COPD embrace Endobronchial Valves like Zephyr Valves with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) giving valves an ‘Evidence A’ score. More than 25,000 sufferers have been handled with the Zephyr Valve worldwide.
About Pulmonx Corporation
Pulmonx Corporation (NASDAQ: LUNG) is a worldwide chief in minimally invasive therapies for extreme lung illness. Pulmonx’s Zephyr® Endobronchial Valve, Chartis® Pulmonary Assessment System and StratX® Lung Analysis Platform are designed to evaluate and deal with sufferers with extreme emphysema/COPD who, regardless of medical administration, are nonetheless profoundly symptomatic. Pulmonx obtained FDA premarket approval to commercialize the Zephyr Valve following its designation as a “breakthrough device.” The Zephyr Valve is commercially out there in greater than 25 international locations, with over 100,000 valves used to deal with greater than 25,000 sufferers. For extra info on the Zephyr Valves please go to https://uspatients.pulmonx.com/. For extra info on the corporate, please go to www.Pulmonx.com.
Forward Looking Statements
This launch comprises ahead‐wanting statements throughout the that means of Sections 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. We might, in some circumstances, use phrases reminiscent of “look forward,” “confident,” “promises,” “predicts,” “believe,” “potential,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or different phrases that convey uncertainty of future occasions or outcomes to determine these ahead‐wanting statements and embrace, with out limitation, statements about Pulmonx’s means to deal with a higher quantity of sufferers and ship vital advantages to sufferers. Forward‐wanting statements shouldn’t be learn as a assure of future efficiency or outcomes and should not essentially be correct indications of the instances at, or by, which such efficiency or outcomes might be achieved. These ahead‐wanting statements are based mostly on Pulmonx’s present expectations and inherently contain vital dangers and uncertainties. Actual outcomes and the timing of occasions may differ materially from these anticipated in such ahead‐wanting statements consequently of these dangers and uncertainties, which embrace, with out limitation these associated to the protection, efficacy and affected person and doctor adoption of the corporate’s merchandise, the ultimate outcomes and outcomes of scientific trials and research involving the Company’s merchandise, the power to acquire and preserve reimbursement codes for its merchandise, and the corporate’s means to obtain and preserve required regulatory approvals for its merchandise. These and different dangers and uncertainties are described extra totally in the part titled “Risk Factors” in Pulmonx’s filings with the Securities and Exchange Commission (SEC), together with the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 8, 2022, out there at www.sec.gov. Pulmonx doesn’t undertake any obligation to replace ahead‐wanting statements and expressly disclaims any obligation or endeavor to launch publicly any updates or revisions to any ahead‐wanting statements contained right here/in.
Pulmonx®, Chartis®, StratX®, and Zephyr® are registered logos of Pulmonx Corporation.
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