Inogen Achieves Regulatory Milestones to Support Current and Future Products
January 10 2023 - 8:30AM
Business Wire
Inogen Announces Receipt of EU Quality
Management Certification under the Medical Device Regulation for
Portable Oxygen Concentrators
Inogen Announces U.S. Food and Drug
Administration 510(k) clearance for its Latest Portable Oxygen
Concentrator
Inogen to Launch New Rove Series Portable
Oxygen Concentrators in the US This Year
Inogen, Inc. (Nasdaq: INGN), a medical technology company
offering innovative respiratory products for use in the homecare
setting, today announced that it has achieved regulatory milestones
in the EU and the US to support its portable oxygen concentrator
products.
Inogen received European Medical Device Regulation (EU MDR)
certification from its Notified Body, the British Standards
Institution (BSI) in December 2022, granting permission to sell and
commercialize Inogen One G4 and the updated version of its Inogen
One G5 portable oxygen concentrators in the EU.
Additionally on December 9, 2022, Inogen was granted clearance
for its 510(k) premarket notification by U.S. Food and Drug
Administration (FDA) for a new portable oxygen concentrator, Rove
4, which will take Inogen’s leadership in portability of POCs to
the next level.
These regulatory achievements enhance Inogen’s portfolio of
portable oxygen concentrator products with the addition of the Rove
series. Rove 6, a new and improved 6-setting device has already
been launched in European countries where reimbursement is
grandfathered, and Rove 4, a 4-setting device delivering ultimate
performance and portability, is expected to launch in the US by the
back half of 2023 having received FDA market clearance in December
2022.
“We are pleased to announce the receipt of both the EU MDR
certification and US FDA clearance,” said Nabil Shabshab, President
and Chief Executive Officer. “This is an important next step in
Inogen cementing its commitment to continue leading POC innovations
to serve patients in need of oxygen therapy around the world. The
Rove series will serve as our next generation POC platform with
product launches being planned for 2023. We are excited about these
new products and the progress in the overall innovation roadmap
towards next generation offerings to serve COPD patients and
beyond.”
About Inogen
Inogen, Inc. (Nasdaq: INGN) is a leading global medical
technology company offering innovative respiratory products for use
in the homecare setting. Inogen supports patient respiratory care
by developing, manufacturing, and marketing innovative
best-in-class portable oxygen concentrators used to deliver
supplemental long-term oxygen therapy to patients suffering from
chronic respiratory conditions. Inogen partners with patients,
prescribers, home medical equipment providers, and distributors to
make its oxygen therapy products widely available allowing patients
the chance to remain ambulatory while managing the impact of their
disease.
For more information, please visit www.inogen.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, including, among others, Inogen’s expectations regarding its
plans for future product releases and innovation. Any statements
contained in this communication that are not statements of
historical fact may be deemed to be forward-looking statements.
Words such as “believes,” “anticipates,” “plans,” “expects,”
“will,” “intends,” “potential,” “possible,” and similar expressions
are intended to identify forward-looking statements.
Forward-looking statements are subject to numerous risks and
uncertainties that could cause actual results to differ materially
from currently anticipated results, including but not limited to,
risks arising from regulatory approvals; risks related to the
Company’s supply chain and limited availability of parts used in
our POCs, the risk of further slowdowns or temporary halts to
production, or cost inflation for such components; the impact of
changes in reimbursement rates and reimbursement and regulatory
policies; and the possible loss of key employees, customers, or
suppliers. In addition, Inogen's business is subject to numerous
additional risks and uncertainties, including, among others, risks
relating to market acceptance of its products; competition; its
sales, marketing and distribution capabilities; its planned sales,
marketing, and research and development activities; interruptions
or delays in the supply of components or materials for, or
manufacturing of, its products; seasonal variations; unanticipated
increases in costs or expenses; and risks associated with
international operations. Information on these and additional
risks, uncertainties, and other information affecting Inogen’s
business operating results are contained in its Annual Report on
Form 10-K for the year ended December 31, 2021, Quarterly Report on
Form 10-Q for the period ended September 30, 2022, and in its other
filings with the Securities and Exchange Commission. Additional
information will also be set forth in Inogen’s Annual Report on
Form 10-K for the period ended December 31, 2022, to be filed with
the Securities and Exchange Commission. These forward-looking
statements speak only as of the date hereof. Inogen disclaims any
obligation to update these forward-looking statements except as may
be required by law.
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Agnes Lee ir@inogen.net
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