OpGen Enters Into Distribution Agreement for Unyvero in the U.S. with Fisher Healthcare
April 18 2023 - 4:30PM
OpGen, Inc. (Nasdaq: OPGN, “OpGen” or “the Company”), a precision
medicine company harnessing the power of molecular diagnostics and
bioinformatics to help combat infectious disease, today announced
that the Company has entered into a non-exclusive distribution
agreement with Fisher Healthcare, a part of Thermo Fisher
Scientific. The agreement is for the distribution of OpGen’s
Unyvero A50 platform and in vitro diagnostic (IVD) tests for
bacterial pneumonia (Unyvero LRT and LRT BAL) as well as its
research use only (RUO) test for urinary tract infection (Unyvero
UTI).
The Unyvero LRT cartridge for hospitalized
patients with suspected pneumonia is the first ever FDA cleared IVD
product specifically targeting bacterial pneumonia and
antimicrobial resistance markers. The Unyvero UTI cartridge has
recently completed its pivotal clinical trial and OpGen has
recently submitted a De Novo classification request for Unyvero UTI
to the FDA. The Unyvero UTI product is available as a RUO test to
laboratories that do their own validation.
Under the distribution agreement, Fisher
Healthcare will have access to the Unyvero A50 platform and
products to distribute and sell to hospitals and laboratories
across the United States.
Oliver Schacht, Chief Executive Officer of
OpGen, commented, “We are very excited about the strategic
distribution partnership with Fisher Healthcare as we believe the
partnership will increase our Unyvero platform’s commercial
presence and footprint across the U.S. We view this expansion in
our commercial channel strategy as the next step towards driving
commercial adoption of Unyvero in the U.S. and achieving our
revenue growth objectives in the coming years.”
About OpGen, Inc.
OpGen, Inc. (Rockville, Md., U.S.A.) is a precision medicine
company harnessing the power of molecular diagnostics and
bioinformatics to help combat infectious disease. Along with our
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 current
product portfolio includes Unyvero, Acuitas AMR Gene Panel, and the
ARES Technology Platform including ARESdb, NGS technology and
AI-powered bioinformatics solutions for antibiotic response
prediction including ARESiss, ARESid, ARESasp, and AREScloud, as
well as the Curetis CE-IVD-marked PCR-based SARS-CoV-2 test
kit.
For more information, please visit www.opgen.com.
Forward-Looking Statements
This press release includes statements regarding
the Company’s entry into a distribution agreement with Fisher
Healthcare. These statements and other statements regarding OpGen’s
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, the success of our commercialization efforts, 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, the
continued impact of COVID-19 on the Company’s operations, financial
results, and commercialization efforts as well as on capital
markets and general economic conditions, our ability to satisfy
debt obligations under our loan with the European Investment Bank,
the effect of the military action in Russia and Ukraine on our
distributors, collaborators and service providers, our liquidity
and working capital requirements, 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 Investor & Press Contact:Alyssa
FactorEdison Groupafactor@edisongroup.com
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