Company Description:
We have developed and are commercializing a patent-pending technology that seeks
to bring laboratory testing capabilities to consumers in a distinctive, easy to
use and affordable way through the use of smartphones such as iPhones and
Androids as well as other mobile devices. In tandem with this
effort, we are
developing a diabetes-related, cloud-based mobile health (mHealth) software
platform designed to facilitate patient insight into how to better manage their
diabetes. We were formed in August 2011 as a Delaware corporation.
We are initially applying our technology to address the more than $10 billion
estimated worldwide market for diabetic self-monitoring of blood glucose, or
SMBG, market. Diabetes is a disease where insufficient levels, or a total
absence, of the hormone insulin produces high levels of glucose in the
bloodstream, which can lead to long term adverse effects on a patient"s blood
vessels, which can lead to heart attack, stroke, high blood pressure, blindness,
kidney disease and nerve damage. As part of controlling blood sugar, many
patients must self- monitor their blood glucose levels using home testing kits
(called glucometers) and treat high and low blood sugar episodes accordingly to
avoid the complications from the disease.
Our first product, DarioTM, is a comprehensive, patent-pending system that
combines an all-in-one SMBG device consisting of a lancet (to obtain a blood
sample), a device-specific disposable test strip cartridge and a
smartphone-driven glucose reader adaptor, coupled with a smartphone app and
cloud-based data services. Roughly the size of a pack of gum, we believe that
Dario has the potential to replace standalone glucose meters and their kits
(lancing , lancets and strips vials) which are the current market standard, most
of which have the necessary testing components separated from one another in
what we believe is a cumbersome design. Moreover, all but a few glucometers lack
an interface with a smartphone, and none will have the software applications
associated with Dario, each of which we believe will distinguish Dario as an
alternative in the marketplace.
On September 23, 2013, we announced our receipt of CE Mark certification to
market Dario. The receipt of the CE Mark allows Dario to be marketed and sold in
32 countries across Europe as well as in certain other countries worldwide. We
expect to commence an initial soft launch of Dario for iPhones and other iOS
devices in Europe during the first quarter of 2014 with the goal of collecting
customer feedback to refine our longer-term roll-out strategy. Further, the
Dario app, which is one of the key components of our all-in-one system, has been
approved by Apple and will be available on December 12, 2013 as a free download
to European iPhone and other iOS devices users. This means that every diabetic
in Europe will be able to experience some of the novel functionality of the
Dario app even without using the Dario device itself. Over time, we expect to
add additional features and functionality in making Dario the new standard of
care in diabetes data management. We expect Dario to be the first truly social
diabetes management system, with communities of users learning to appreciate and
sharing its attributes and benefits.
With CE mark certification in hand, we also plan to accelerate our ongoing
efforts to prepare and file with the U.S. Food and Drug Administration (or FDA)
a 510(k) application for marketing of Dario in the United States. This will be
followed by regulatory programs in Asia and South America.
Currently, we have third-party manufacturing for the Dario device, the
cartridges and test strips and other relevant components in place, and we are
preparing to scale-up manufacturing in a manner necessary to support our
roll-out. We also have secured leading distributors for Dario to help us reach
customers in the U.K., Italy and Belgium in tandem with our online marketing
programs. We are making progress in launching innovative online marketing
strategies in other countries, including Germany. We are also actively pursuing
third-party reimbursement in our key target geographies in Europe, which we
expect to be in place for our software launch to occur in the coming months.
Over time, we expect to add additional features and functionality in making
Dario the new standard of care in diabetes data management. We expect Dario to
be the first truly social diabetes management system, with communities of users
learning to appreciate and sharing its attributes and benefits. More broadly,
our goal is for the Dario software system to become the centerpiece in a new era
of interconnected devices and services that provide healthier and better life
for the diabetic patients worldwide. Dario is designed to be a software driven,
comprehensive data-management system with sophisticated insight and analytical
tools constantly attuned to each individual patient and designed to enable
integration with various devices, including most notably the modern,
user-friendly Dario glucose monitoring device.
Our proprietary technology (incorporated into Dario) provides a novel body-fluid
testing apparatus for performing metered measurement of samples utilizing: (i) a
lancing device to obtain a test sample (blood in the case of Dario); and (ii) an
adaptor specifically designed to connect a stripdesigned to absorb the sample,
which then produces an electric signal indicating the level of the substance
tested for in the sample. The adaptor is then connected to a smartphone via the
headphone jack, which allows the test signal to be transmitted to the
smartphone, which will then utilize our software application to obtain and
display the test result on the device. This is coupled with a set of software
features available via a smartphone application as well as internet-based
services. We are presently pursuing patent applications in multiple
jurisdictions covering the specific processes related to blood glucose level
measurement as well as more general methods of rapid tests of body fluids using
smartphones and cloud-based services.
Although we are initially targeting only the large and growing SMBG market, we
believe our invention has the potential to cover dozens of laboratory tests of
bodily fluids (including blood, urine and saliva) that could potentially be
undertaken using a smartphone, including blood coagulation, cholesterol, HIV and
others.
Read more: www.nasdaq.com/markets/ipos/company/...973-71601#ixzz3CBYkt383
We have developed and are commercializing a patent-pending technology that seeks
to bring laboratory testing capabilities to consumers in a distinctive, easy to
use and affordable way through the use of smartphones such as iPhones and
Androids as well as other mobile devices. In tandem with this
effort, we are
developing a diabetes-related, cloud-based mobile health (mHealth) software
platform designed to facilitate patient insight into how to better manage their
diabetes. We were formed in August 2011 as a Delaware corporation.
We are initially applying our technology to address the more than $10 billion
estimated worldwide market for diabetic self-monitoring of blood glucose, or
SMBG, market. Diabetes is a disease where insufficient levels, or a total
absence, of the hormone insulin produces high levels of glucose in the
bloodstream, which can lead to long term adverse effects on a patient"s blood
vessels, which can lead to heart attack, stroke, high blood pressure, blindness,
kidney disease and nerve damage. As part of controlling blood sugar, many
patients must self- monitor their blood glucose levels using home testing kits
(called glucometers) and treat high and low blood sugar episodes accordingly to
avoid the complications from the disease.
Our first product, DarioTM, is a comprehensive, patent-pending system that
combines an all-in-one SMBG device consisting of a lancet (to obtain a blood
sample), a device-specific disposable test strip cartridge and a
smartphone-driven glucose reader adaptor, coupled with a smartphone app and
cloud-based data services. Roughly the size of a pack of gum, we believe that
Dario has the potential to replace standalone glucose meters and their kits
(lancing , lancets and strips vials) which are the current market standard, most
of which have the necessary testing components separated from one another in
what we believe is a cumbersome design. Moreover, all but a few glucometers lack
an interface with a smartphone, and none will have the software applications
associated with Dario, each of which we believe will distinguish Dario as an
alternative in the marketplace.
On September 23, 2013, we announced our receipt of CE Mark certification to
market Dario. The receipt of the CE Mark allows Dario to be marketed and sold in
32 countries across Europe as well as in certain other countries worldwide. We
expect to commence an initial soft launch of Dario for iPhones and other iOS
devices in Europe during the first quarter of 2014 with the goal of collecting
customer feedback to refine our longer-term roll-out strategy. Further, the
Dario app, which is one of the key components of our all-in-one system, has been
approved by Apple and will be available on December 12, 2013 as a free download
to European iPhone and other iOS devices users. This means that every diabetic
in Europe will be able to experience some of the novel functionality of the
Dario app even without using the Dario device itself. Over time, we expect to
add additional features and functionality in making Dario the new standard of
care in diabetes data management. We expect Dario to be the first truly social
diabetes management system, with communities of users learning to appreciate and
sharing its attributes and benefits.
With CE mark certification in hand, we also plan to accelerate our ongoing
efforts to prepare and file with the U.S. Food and Drug Administration (or FDA)
a 510(k) application for marketing of Dario in the United States. This will be
followed by regulatory programs in Asia and South America.
Currently, we have third-party manufacturing for the Dario device, the
cartridges and test strips and other relevant components in place, and we are
preparing to scale-up manufacturing in a manner necessary to support our
roll-out. We also have secured leading distributors for Dario to help us reach
customers in the U.K., Italy and Belgium in tandem with our online marketing
programs. We are making progress in launching innovative online marketing
strategies in other countries, including Germany. We are also actively pursuing
third-party reimbursement in our key target geographies in Europe, which we
expect to be in place for our software launch to occur in the coming months.
Over time, we expect to add additional features and functionality in making
Dario the new standard of care in diabetes data management. We expect Dario to
be the first truly social diabetes management system, with communities of users
learning to appreciate and sharing its attributes and benefits. More broadly,
our goal is for the Dario software system to become the centerpiece in a new era
of interconnected devices and services that provide healthier and better life
for the diabetic patients worldwide. Dario is designed to be a software driven,
comprehensive data-management system with sophisticated insight and analytical
tools constantly attuned to each individual patient and designed to enable
integration with various devices, including most notably the modern,
user-friendly Dario glucose monitoring device.
Our proprietary technology (incorporated into Dario) provides a novel body-fluid
testing apparatus for performing metered measurement of samples utilizing: (i) a
lancing device to obtain a test sample (blood in the case of Dario); and (ii) an
adaptor specifically designed to connect a stripdesigned to absorb the sample,
which then produces an electric signal indicating the level of the substance
tested for in the sample. The adaptor is then connected to a smartphone via the
headphone jack, which allows the test signal to be transmitted to the
smartphone, which will then utilize our software application to obtain and
display the test result on the device. This is coupled with a set of software
features available via a smartphone application as well as internet-based
services. We are presently pursuing patent applications in multiple
jurisdictions covering the specific processes related to blood glucose level
measurement as well as more general methods of rapid tests of body fluids using
smartphones and cloud-based services.
Although we are initially targeting only the large and growing SMBG market, we
believe our invention has the potential to cover dozens of laboratory tests of
bodily fluids (including blood, urine and saliva) that could potentially be
undertaken using a smartphone, including blood coagulation, cholesterol, HIV and
others.
Read more: www.nasdaq.com/markets/ipos/company/...973-71601#ixzz3CBYkt383
