OpGen Submits Updated 510(k) Summary to FDA and Successfully Completes Move to New Headquarters in Maryland
June 07 2021 - 7:30AM
OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company
harnessing the power of molecular diagnostics and informatics to
help combat infectious disease, today announced that it has
submitted an updated 510(k) summary document to the U.S. FDA for
its Acuitas AMR Gene Panel for Isolates. This document incorporates
all of the FDA’s requested updates to various key documents such as
the Package Insert, Electronic User Guide, and Operator Manual.
Consistent with the FDA’s previously communicated timeline, the FDA
provided substantive feedback on all of these key documents by the
end of May. The FDA previously informed OpGen that it intends to
complete its review by the end of August 2021, but that it cannot
commit to a timeline and that such timeline can be affected by
various factors, including the FDA’s other workload and public
health priorities.
Oliver Schacht, CEO of OpGen commented: “We are
excited to see the excellent progress that we have been able to
make towards completion of our Acuitas AMR Gene Panel for Isolates
filings with the FDA and the nice cadence of FDA responses and
valuable inputs moving us much closer towards reaching a final FDA
clearance decision point in the coming months.”
OpGen recently also completed the move of its
U.S. headquarters, laboratories and operations as well as warehouse
to its new Rockville, Maryland based facility. The Company plans to
register this newly built-out facility with the FDA and other
relevant authorities for the future business operations in the U.S.
The new 10,000 square feet facility marks the completion of the
business integration and will result in net savings of
approximately $600 thousand annually in the coming years in terms
of operating efficiencies and reduced rent.
Given recent new Unyvero installations in Q1 and
2021 year-to-date as well as anticipated strong demand for
additional Unyvero system placements in the upcoming quarters,
OpGen has also ordered an additional 30 Unyvero Analyzers from its
Curetis subsidiary and will be moving these into its U.S. warehouse
facilities in the coming weeks. Going forward, all Unyvero
cartridges as well as Acuitas consumables will be stocked and
shipped directly from the new Rockville based facility.
About OpGen, Inc.
OpGen, Inc. (Gaithersburg, MD, USA) is a
precision medicine company harnessing the power of molecular
diagnostics and bioinformatics to help combat infectious disease.
Along with subsidiaries, Curetis GmbH and Ares Genetics GmbH, we
are developing and commercializing molecular microbiology solutions
helping to guide clinicians with more rapid and actionable
information about life threatening infections to improve patient
outcomes, and decrease the spread of infections caused by
multidrug-resistant microorganisms, or MDROs. OpGen’s product
portfolio includes Unyvero®, Acuitas® AMR Gene Panel and Acuitas®
Lighthouse, and the ARES Technology Platform including ARESdb®,
using NGS technology and AI-powered bioinformatics solutions for
antibiotic response prediction.
For more information, please visit
www.opgen.com.
Forward-Looking Statements
This press release includes statements regarding
a potential FDA clearance decision for OpGen’s Acuitas AMR Gene
Panel for Isolates in the U.S.. These statements and other
statements regarding OpGen’s Unyvero products, their
commercialization and launch, future plans and goals constitute
"forward-looking statements" within the meaning of Section 27A of
the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934 and are intended to qualify for the safe
harbor from liability established by the Private Securities
Litigation Reform Act of 1995. Such statements are subject to risks
and uncertainties that are often difficult to predict, are beyond
our control, and which may cause results to differ materially from
expectations. Factors that could cause our results to differ
materially from those described include, but are not limited to,
our ability to successfully, timely and cost-effectively develop,
seek and obtain regulatory clearance for and commercialize our
product and services offerings, the rate of adoption of our
products and services by hospitals and other healthcare providers,
the fact that we may not effectively use proceeds from recent
financings, including our November 2020 private placement, February
2021 Registered Direct and March 2021 warrant exercise and
exchange, the realization of expected benefits of our business
combination transaction with Curetis GmbH, the success of our
commercialization efforts, the impact of COVID-19 on the Company’s
operations, financial results, and commercialization efforts as
well as on capital markets and general economic conditions, the
effect on our business of existing and new regulatory requirements,
and other economic and competitive factors. For a discussion of the
most significant risks and uncertainties associated with OpGen's
business, please review our filings with the Securities and
Exchange Commission. You are cautioned not to place undue reliance
on these forward-looking statements, which are based on our
expectations as of the date of this press release and speak only as
of the date of this press release. We undertake no obligation to
publicly update or revise any forward-looking statement, whether as
a result of new information, future events or otherwise.
OpGen:Oliver SchachtPresident and
CEOInvestorRelations@opgen.com
OpGen Press Contact:Matthew
Bretzius FischTank Marketing and PR
matt@fischtankpr.com
OpGen Investor Contact:Megan Paul Edison
Group mpaul@edisongroup.com
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