Curetis
Unyvero HPN Application Receives Singapore Health
Sciences Authority Approval; Updates on Sepsis Host Response
Test
-
Market
authorization paves way for broader Unyvero commercial roll-out in
ASEAN region through partner Acumen Research
Laboratories
-
Near-term
clinical validation study of first cartridge-based molecular test
for Sepsis Host Response panel licensed from Acumen in
preparation
Amsterdam, the Netherlands, and
Holzgerlingen, Germany, February 06, 2018; published at 11:00
EST -- Curetis N.V. (the "Company" and,
together with Curetis GmbH, "Curetis"), a
developer of next-level molecular diagnostic solutions, today
announced that Acumen Research Laboratories Pte Ltd. (Acumen), its
partner for the commercialization of Unyvero in the ASEAN region,
has received approval by the Singapore Health Sciences Authority
(HSA) to market the Unyvero HPN Hospitalized Pneumonia Application
Cartridge in Singapore.
With this approval, Unyvero HPN is now fully
registered as a Class C IVD medical device with the Singapore
Medical Device Register (Device Registration No: DE0501196). After
the initial placement of Unyvero Systems under the GN-27 exemption
at early adopter sites such as Raffles Hospital, Farrer Park
Hospital, and Parkway Laboratories, the HSA approval now allows for
a more comprehensive roll-out in Singapore as a bridgehead to the
ASEAN region. Acumen expects that the approval in Singapore will
facilitate market entry into other countries of the region
including Malaysia, Indonesia, and Thailand going forward.
The HSA review and approval process for the
Unyvero BCU Blood Culture Application Cartridge as a second
application for the Singaporean and ASEAN markets is ongoing.
Acumen and Curetis further intend to submit the Unyvero ITI Implant
and Tissue Infection and Unyvero IAI Intra-Abdominal Infection
Application Cartridges for HSA approval.
Curetis and Acumen also announced that the
development of the Unyvero SHR Sepsis Host Response Application
Cartridge for the rapid identification of patients with bloodstream
infections and sepsis has been completed. The cartridge is based on
a proprietary gene expression biomarker panel licensed by Curetis
from Acumen in 2015. In the coming months, the Companies expect to
initiate clinical validation work on this first cartridge-based
rapid molecular test for sepsis alongside a laboratory-developed
test (LDT) based on the same biomarker panel already offered by
Acumen to hospitals in Singapore. The validation work will focus on
demonstrating concordance of the analytical and clinical
performance of two tests in the same patient population.
"In only four to five hours, the new Unyvero HPN
test enables detection of 21 pathogens and 19 antibiotics
resistance markers that are highly relevant for the diagnosis of
hospitalized patients with suspected pneumonia. This will not only
help to improve outcomes for these patients, but also facilitate
the more prudent use of antibiotics and thereby help mitigating the
growing antimicrobial resistance challenge," commented Siew Hwa
Ong, PhD, CEO of Acumen. "We are also pleased with the progress of
the Unyvero SHR Application Cartridge building on our biomarker
panel, as this rapid and easy-to-use molecular test bears great
potential in addressing the diagnostic challenges clinicians are
facing in treating sepsis."
"This first approval of a Unyvero Application in
an Asian market serves as a bridgehead to the entire ASEAN region
and marks an important milestone in the commercial growth strategy
of Curetis," said Oliver Schacht, PhD, CEO of Curetis. "With an
expected near-term clearance decision from the U.S. FDA for the
Unyvero Lower Respiratory Tract Application and the solid progress
we are making with our partner Beijing Clear Biotech with
regulatory studies in China, we are setting the stage for
significant commercial expansion of Unyvero in the years to
come."
###
About Acumen
Research Laboratories
Acumen Research Laboratories,
based in Singapore, was founded in 2010. The company has strong
capabilities in translational research for developing molecular
diagnostics using gene-based biomarkers, with approaches that focus
on in-depth clinical validation early in the development process.
Acumen is one of the few industry leaders in host-based, gene
expression sepsis diagnostics. Acumen has received strong support
from several Singapore government agencies such as SPRING
Singapore, the country's enterprise development agency, the
National University of Singapore Enterprise Centre and the
Diagnostics Development (DxD) Hub, of the Agency for Science,
Technology and Research (A*STAR).
About Curetis
Founded in 2007, Curetis is a
molecular diagnostics company which focuses on the development and
commercialization of reliable, fast and cost-effective products for
diagnosing severe infectious diseases. The diagnostic solutions of
Curetis enable rapid multi-parameter pathogen and antibiotic
resistance marker detection in only a few hours, a process that
today can take up to days or even weeks with other techniques.
To date, Curetis has raised EUR
44.3 million in an IPO on Euronext Amsterdam and Euronext Brussels
and private equity funds of over EUR 63.5 million. Furthermore,
Curetis has entered into a debt financing facility with EIB for up
to EUR 25 million. The company is based in Holzgerlingen near
Stuttgart, Germany. Curetis collaborates with Heraeus Medical,
pharmaceutical companies, and has entered into several
international distribution agreements covering many countries
across Europe, the Middle East and Asia.
In 2017, Curetis established Ares
Genetics GmbH, a wholly-owned subsidiary of Curetis GmbH in Vienna,
Austria. Ares Genetics is dedicated to maximize the R&D and
related scientific and business opportunities of the GEAR assets
acquired in 2016 for the entire Curetis Group.
For further information, please
visit www.curetis.com.
Curetis' Legal Disclaimer
This document constitutes neither
an offer to buy nor to subscribe securities and neither this
document nor any part of it should form the basis of any investment
decision in Curetis.
The information contained in this
press release has been carefully prepared. However, Curetis bears
and assumes no liability of whatever kind for the correctness and
completeness of the information provided herein. Curetis does not
assume an obligation of whatever kind to update or correct
information contained in this press release whether as a result of
new information, future events or for other reasons.
This press release includes statements that are, or may be deemed
to be, "forward-looking statements". These forward-looking
statements can be identified by the use of forward-looking
terminology, including the terms "believes", "estimates",
"anticipates", "expects", "intends", "may", "will", or "should",
and include statements Curetis makes concerning the intended
results of its strategy. By their nature, forward-looking
statements involve risks and uncertainties and readers are
cautioned that any such forward-looking statements are not
guarantees of future performance. Curetis' actual results may
differ materially from those predicted by the forward-looking
statements. Curetis undertakes no obligation to publicly update or
revise forward-looking statements, except as may be required by
law.
Curetis' Contact
Details
Curetis GmbH
Max-Eyth-Str. 42
71088 Holzgerlingen, Germany
Tel. +49 7031 49195-10
pr@curetis.com or ir@curetis.com
www.curetis.com - www.unyvero.com
Curetis International Media &
Investor Inquiries
akampion
Dr. Ludger Wess / Ines-Regina Buth
Managing Partners
info(@)akampion.com
Tel. +49 40 88 16 59 64
Tel. +49 30 23 63 27 68
Curetis U.S. Media & Investor
Inquiries
The Ruth Group
Lee Roth
lroth@theruthgroup.com
Tel. +1 646 536 7012
Acumen's
Contact Details
Acumen
Research Laboratories Pte LTD.
10 Biopolis Road, #03-01
Singapore 138670
contact_us@acumen-research.com
Tel. + 65 90285892
20180206_Curetis_PR_EN