MONITOREO GLUCEMICO NO INVASIVO
Una compañía
Israelí esta ensayando un dispositivo para medir glucemia transdérmica en la piel del pabellón auricular, ello evitaría el
constante pero necesario trauma cotidiano de tener que efectuar una
punción digital para monitorear el control glucémico.
GlucoTrack® Maker Submitted Pre-Submission Supplement to US FDA
SHDOD, Israel, June 1, 2016 /PRNewswire/ – Integrity
Applications, Inc. (OTCQB: IGAP), maker of GlucoTrack®, a noninvasive device
for measuring glucose levels of people with Type 2 diabetes, announced that it
has set a conference call with the United States Food and Drug Administration
(FDA), expected to take place in July 2016, for further discussion regarding
the Company’s pre-submission supplement (including clinical trial protocol) for
its GlucoTrack® Model DFF device submitted to the FDA for review on May 10,
2016. Such protocol was modified to reflect FDA remarks and discussions with
the Company during a Pre-Submission meeting which took place in October 2015.
Following the July discussion and subject to FDA approval of the Company’s
clinical trial protocol, the Company plans to initiate the pivotal clinical
study in the third quarter of 2016.
About
GlucoTrack®
GlucoTrack®
is a noninvasive device for measuring glucose levels of people with Type 2
diabetes or at risk of developing diabetes that does not require pricking of
the fingers to draw blood for daily glucose monitoring. GlucoTrack® features a
small sensor that clips to the earlobe and measures the wearer’s glucose level
by taking measurements using three technologies. The measured signals are
analyzed using a proprietary algorithm and displayed on a small handheld device
the size of a mobile phone. The derived glucose measurement is also announced
verbally, facilitating use by elderly and vision-impaired diabetes patients.
The
GlucoTrack® Model DFF is expected to begin clinical trials for United States
FDA approval in 2016, subject to approval of Integrity Applications’ clinical
trial protocol by the FDA. The product is experimental in the United States and
is limited to investigational use.
GlucoTrack®
Model DFF obtained a CE Mark approval in Europe (June 2013) and final CE Mark
approval in March 2014 and recently received approval to market the device also
to pre-diabetics.
About
Integrity Applications, Inc.
Integrity
Applications, Inc. is a medical device company focused on the design,
development and commercialization of non-invasive glucose monitoring devices
for use by people with diabetes. Integrity Applications has developed the
GlucoTrack® model DFF noninvasive glucose monitoring device, which is designed
to help people with diabetes obtain glucose level measurements without the
pain, inconvenience, incremental cost and difficulty or discomfort of
conventional (invasive) spot finger stick devices. Integrity Applications operates
primarily through its wholly-owned Israeli subsidiary, A.D. Integrity
Applications, Ltd. For more information, please visit www.integrity-app.com.
Forward-Looking
Statements
This
news release contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Statements contained in this
news release that are not statements of historical fact may be deemed to be
forward-looking statements. Without limiting the generality of the foregoing,
words such as “expect”, “plan” and “will” are intended to identify
forward-looking statements. Readers are cautioned that certain important
factors may affect Integrity Applications’ actual results and could cause such
results to differ materially from any forward-looking statements that may be
made in this news release. Factors that may affect Integrity Applications’
results include, but are not limited to, the ability of Integrity Applications
to raise additional capital to finance its operations (whether through public
or private equity offerings, debt financings, strategic collaborations or
otherwise); risks relating to the receipt (and timing) of regulatory approvals
(including FDA approval); risks relating to enrollment of patients in, and the
conduct of, clinical trials; risks relating to its current and future
distribution agreements; risks relating to its ability to hire and retain
qualified personnel, including sales and distribution personnel; and the
additional risk factors described in Integrity Applications’ filings with the
U.S. Securities and Exchange Commission (SEC), including its Annual Report on
Form 10-K for the year ended December 31, 2015 as filed with the SEC on March
30, 2016.
Contact:
Eran
Hertz, CFO Integrity Applications,
+972
(8) 675-7878 Ext. 400,
eranh@integrity-app.com
FEBRUARY
16 th, 2017
GlucoTrack®
Maker Presents Scientific Data Demonstrating Reliable Accuracy and Precision
Ashdod,
Israel, February 16, 2017 /PRNewswire/ — Integrity Applications, Inc. (OTCQB:
IGAP), maker of GlucoTrack®, a noninvasive device for measuring glucose levels
of people with Type 2 diabetes and pre-diabetics, announced that it is
presenting this week at the 10th International Conference on Advanced
Technologies & Treatments for Diabetes (ATTD 2017) in Paris, France.
The
company presented findings from research that demonstrate the precision and
accuracy of the GlucoTrack Model DF-F non-invasive glucose monitoring device.
Non-Invasive
Glucose Monitoring Device: Reducing Impact of Postprandial Lagging Effect
During Measurement (A. Gal, A. Drexler et al., E-Poster #160, available from
February 15th, 2017 and E-Poster Discussion Session, Exhibition Area, February
16, 2017, 10:10am)
Key
findings: · The latest
generation GlucoTrack algorithm, which compensates for the tissue-lagging
effect relative to blood glucose changes postmeal intake, significantly
improves GlucoTrack accuracy at different post-prandial (post-meal) states, and
equalizes accuracy for pre- and post-meal glucose readings. · GlucoTrack clinical accuracy as measured by Consensus Error
Grid (CEG) showed 100% of the pre-prandial readings in the A+B zones, and 98.2%
of the post-prandial readings in the A+B zones.
Repeatability
of a Non-Invasive Glucose Monitoring Device (A. Gal, A.
Drexler
et al., E-Poster #61, Exhibition Area, available from February 15th, 2017)
Key
findings: · GlucoTrack
Model DF-F demonstrates consistent glucose measurement repeatability between
different GlucoTrack devices and on each earlobe of the same subject. · The repeatability of different GlucoTrack devices is similar at
all tested glucose ranges and post-prandial time periods. · The GlucoTrack mean precision absolute relative difference
(PARD) of 8.2% is equivalent or better than the independently reported PARD
values of commercially available continuous glucose monitoring systems (CGMs).
The
10th annual conference on Advanced Technologies and Treatments for Diabetes
(ATTD) is expected to attract over 2,500 delegates from over the globe. The
conference is attended by the world’s leading researchers, clinical
practitioners and industry/corporate professionals, and provides a forum for
lively exchange of ideas and research relating to technologies, treatment and
prevention of diabetes related illnesses.
About
GlucoTrack® GlucoTrack® is a non-invasive device that measures and displays an
individual’s glucose level in less than a minute without requiring a finger
stick to draw blood.
GlucoTrack®
features a small sensor that clips to the earlobe and measures the wearer’s
glucose level by taking measurements using three technologies. The measured
signals are analyzed using a proprietary algorithm and displayed on a small
handheld device the size of a mobile phone. The derived glucose measurement is
also announced verbally, facilitating use by vision-impaired diabetes patients.
GlucoTrack®
has received CE Mark and KFDA approvals for Type 2 diabetes and pre-diabetics,
and is currently being commercialized in Europe, South Korea and other
geographical areas.
GlucoTrack®
is expected to begin clinical trials for United States FDA approval in early
2017. The product is currently experimental in the United States and is limited
to investigational use only.
About
Integrity Applications, Inc. Integrity Applications was founded in 2001 and is
focused on the design, development and commercialization of non-invasive
glucose monitoring technologies for patients with diabetes and pre-diabetics.
The company has developed GlucoTrack®, a proprietary noninvasive glucose
monitoring device designed to obtain glucose level measurements in less than a
minute without the pain, incremental cost, difficulty or discomfort of
conventional invasive finger stick devices. Integrity Applications operates
primarily through its wholly-owned Israeli subsidiary, A.D. Integrity Applications,
Ltd. For more information, please visit www.integrity-app.com and
www.glucotrack.com
Forward-Looking
Statements This news release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. Statements
contained in this news release that are not statements of historical fact may
be deemed to be forward-looking statements. Without limiting the generality of
the foregoing, words such as “expect”, “plan” and “will” are intended to
identify forward-looking statements. Readers are cautioned that certain
important factors may affect Integrity Applications’ actual results and could
cause such results to differ materially from any forward-looking statements
that may be made in this news release. Factors that may affect Integrity
Applications’ results include, but are not limited to, the ability of Integrity
Applications to raise additional capital to finance its operations (whether
through public or private equity offerings, debt financings, strategic collaborations
or otherwise); risks relating to the receipt (and timing) of regulatory
approvals (including FDA approval); risks relating to enrollment of patients
in, and the conduct of, clinical trials; risks relating to its current and
future distribution agreements; risks relating to its ability to hire and
retain qualified personnel, including sales and distribution personnel; and the
additional risk factors described in Integrity Applications’ filings with the
U.S. Securities and Exchange Commission (SEC), including its Annual Report on
Form 10-K for the year ended December 31, 2015 as filed with the SEC on March
30, 2016.
Contact:
Sami
Sassoun,
CFO
Integrity Applications
SamiS@integrity-app.com
+972 (8) 675-7878
Ext. 400
