AeriSeal System Shows Promise in Limiting
Collateral Ventilation, Potentially Enabling a Greater Number of
Severe COPD/Emphysema Patients to Benefit from Treatment with
Zephyr® Valves, a Minimally Invasive Treatment Option
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240226048565/en/
Media Contact: Nicole Young 612-747-1362
nyoung@pulmonx.com
Investor Contact: Brian Johnston Gilmartin Group
investors@pulmonx.com
Pulmonx (NASDAQ:LUNG)
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Pulmonx (NASDAQ:LUNG)
過去 株価チャート
から 12 2023 まで 12 2024
