Valencia, Spain -- June 19, 2018 -- InvestorsHub NewsWire --
Zenosense, Inc. (OTC PINK: ZENO) ("Zenosense", the "Company"), a
healthcare technology company focused on the development and
commercialization of the MIDS Cardiac™ hand-held technology for the
early detection of heart attack at the Point of Care, is pleased to
announce that its MIDS Medical Ltd. joint venture ("MML") has
successfully completed a second testing round of its revised
detection system.
In 2017 the first next generation troponin assay for the early
diagnosis of heart attack was approved for use in the U.S. by the
FDA. High sensitivity (“HS”) troponin assays have been in use in
other parts of the world for over 7 years. These assays are
performed on state of the art central laboratory analyzers, which
are expensive and typically take about an hour to turnaround
results, when minutes are vital. The key to the MIDS technology is
its ground breaking ability to magnetically detect and measure
diagnostic assay beads in low enough numbers to support a HS
troponin assay. MML aims to embody this highly compact technology
into an easy to use, hand-held MIDS Cardiac device for rapid
diagnosis in emergency rooms, or by paramedics responding to chest
pain patients at the scene.
Highlights:
- Extensive revision and improvements to core Hall
effect sensor electronics during H1 2018
- Testing on new electronics which confirms and materially
improves upon the testing results announced in late 2017, with a
near doubling of sensitivity
- Results achieved using two leading brands of
commercially available assay beads
- Assay bead numbers detected are well within the
Limit of Detection (“LoD”) required for a HS troponin assay
2018 Quantitative Testing Results
Quantitative testing was conducted to (a) determine the minimum
number of assay beads that can be detected; and (b) to prove
linearity of detection signal to quantified bead numbers. MML has
been advised by Future Diagnostics Solutions B.V. (a leading assay
developer engaged to MML) that a capability to detect below 200,000
assay beads and preferably less than 110,000 is required to support
a HS troponin test.
Two brands of beads were tested: GE Sera-Mag™ (3μm) and Thermo
Fisher Scientific M-270 Dynabeads® (2.8 μm), both of which are
regarded as suitable for a HS troponin assay and have similar
paramagnetic characteristics.
The MIDS LoD of both these brands was seen on a reliable,
repeatable basis at around 50,000 beads, with good signal linearity
(required for accurate assay quantitation) at higher numbers. This
number of beads detected at the LoD is approximately four times
lower than the maximum threshold and therefore well within the
range advised by Future Diagnostics as suitable for a HS troponin
assay.
MML Managing Director and Chief Scientific Officer Dr.
Nasser Djennati commented: “MIDS is a hugely
challenging development. The results of this second round of
testing are quite extraordinary, as magnetic detection at this
level for this application is unheard of. We can now move forward
and apply the MIDS detection to established assay techniques used
in conventional analyzers as we seek to deliver state-of-the-art
laboratory standard, high sensitivity cardiac troponin testing at
the Point of Care.”
Improved Electronics
MML has revised its core Hall Effect sensor electronics during
the first half of 2018 to further enhance the ability of MIDS to
detect and accurately quantitate the nano-Tesla magnetic signal of
the relatively low numbers of assay beads required for a HS
troponin assay.
MML estimates that compared to the previous electronics, the
sensitivity of the platform has been improved by a factor of nearly
2, as well as materially improving its stability.
Independent, Third-Party SEM Verification of Bead
Numbers
MML has carried out an in-house Scanning Electron Microscope
investigation (“MML SEM”) and has received a confirmatory study
carried out by the Condensed Matter Physics group and Materials
Innovation Factory at the Department of Physics of the University
of Liverpool (“Liverpool SEM”). The MML SEM and Liverpool SEM
indicate that a maximum of around 92,000 beads (Liverpool SEM) were
previously detected at the LoD in 2017.
The recent quantitative testing on the improved electronics has
demonstrated a substantial improvement on the initial testing
results, now indicating that approximately 50,000 beads of a type
suitable for a HS troponin assay can be detected at the LoD.
The Company is delighted that the achieved detection of around
50,000 beads is already considerably lower than the maximum number
suitable for a HS troponin assay. It is confident that a further
material reduction to this number at the LoD can be achieved when
unpackaged Hall effect sensors are used as planned in a production
lab-on-chip test strip.
Next Steps
MML is now planning the next key phase of development to test
microfluidic detection on the revised electronics platform and to
embody a HS assay on a test strip.
Carlos Gil, CEO of Zenosense,
commented: “These results should not be
underestimated. I am not aware of any other detection technology
suitable for use at the Point of Care which comes anywhere close to
achieving these results. We are now so far within the limit of
detection I am extremely confident that high sensitivity rapid
troponin testing can become a reality in emergency settings.
Achieving these results is a huge step towards that. I truly
believe we have a blockbuster technology in the making.”
Dr. Dave Dekkers, Scientist at Future Diagnostics
Solutions B.V. said: “We are impressed by the
achievement of MIDS Medical Ltd. for the detection of 50,000 beads
with their Biosensor. Future Diagnostics will follow MML closely on
their progress with the further development of this sensor.”
About Zenosense, Inc.
Zenosense Inc., through a joint-venture ownership in MIDS
Medical Ltd., is primarily focused on the development of a
cost-effective, hand-held Point of Care rapid cardiac diagnostic
device, MIDS Cardiac. MIDS Medical applies patent-protected
magnetic nanoparticle detection technology and a development team
with world-class technical expertise. The MIDS Cardiac device and
test strip is being designed to support a variety of rapid high
sensitivity cardiac biomarker tests, with a focus on troponin I and
T, to identify or discount Acute Myocardial Infarction with
accuracy equal or superior to high sensitivity assays performed on
laboratory analyzers. To find out more about Zenosense,
visit www.Zenosense.com
Forward-Looking Statement
Statements in this news release that are not statements of
historical fact are forward-looking statements, which are subject
to certain risks and uncertainties. Forward-looking
statements can often be identified by words such as "expects,”
"intends,” "plans,” "may,” "could,” "should,” "anticipates,”
"likely,” "believes" and words of similar import.
Forward-looking statements are based on current facts and analyses
and other information that are based on forecasts of future
results, estimates of amounts not yet determined and assumptions of
management. Actual results may differ materially from those
expressed or implied by forward-looking statements due to a variety
of factors that may or may not be foreseeable or within the
reasonable control of the Company. Readers are cautioned not
to place undue reliance on such forward-looking statements.
Additional information on risks and other factors that may affect
the business and financial results of the Company can be found in
filings of the Company with the U.S. Securities and Exchange
Commission, including without limitation the section entitled “Risk
Factors” in the Company’s Annual Report on Form 10-K for the year
ended December 31, 2017 filed on filed on April 17, 2018, and in
Company reports filed subsequently thereto. Except as
otherwise required by law, the Company disclaims any obligations or
undertaking to publicly release any updates or revisions to any
forward-looking statement contained in this news release to reflect
any change in the Company’s expectations with regard thereto or any
change in events, conditions or circumstances on which any such
statement is based. Respective statements concerning the
development of both MIDS Cardiac™ and other devices under
development have been made based on information obtained from MIDS
Medical Ltd. and Zenon Biosystem, which the Company believes to be
accurate, but have not been independently verified.
Contact:Zenosense, Inc. www.zenosense.com Tel: +34 960 454 202 ir@zenosense.net