We will not receive any of the proceeds from the sale of the common stock by the
selling stockholders named in this prospectus. All proceeds from the sale of the
common stock will be paid directly to the selling stockholders.
We would, however, receive proceeds upon the exercise of the warrants registered
hereunder held by the selling stockholders which, if such warrants are exercised
in full (and assuming no “cashless” exercise features are utilized and assuming
that the second and third tranches of our August 2012 Private Placement are
completed), would be approximately $4,700,000. Proceeds, if any, received from
the exercise of such warrants will be used for working capital and general
corporate purposes. No assurances can be given that any of such warrants will be
exercised.
We face competition principally from two arenas:
Direct competition from existing companies in the blood based glucose monitors
market. We will compete directly and primarily with large pharmaceutical and
medical device companies, including, but not limited to, Abbott Laboratories,
Bayer Healthcare Division, Johnson & Johnson LifeScan, Roche Diagnostics and
Sanofi. While the market is highly competitive, we believe that Dario will carry
numerous significant comparative advantages versus other devices in the market.
Some of these devices are now offered as connected devices to smartphones, such
as the Sanofi iBGStar.
Dario device is offering an all in one glucose monitoring system, including a
small form factor glucose reader, lancing device and a strip cartridge
integrated with existing smartphones, which will enable Dario to offer features
that are similar to or superior to the most advanced meters in the market (such
as the Contour and Ultrasmart) while having a smaller form factor than the
compact meters in the market (FreeStyle Lite and OneTouch UltraMini). We believe
this design will be attractive to diabetic patients.
Non-invasive and continuous blood glucose monitors. While there are numerous
continuous blood glucose monitoring technologies in the market, we believe they
are expensive to use and are therefore offered mainly for temporary usage and in
medical settings (such as hospitals). There have been a wealth of attempts for
non invasive glucose monitors, but we are not aware of any that are available in
the market or expected to reach the market with significant presence over the
next few years.
Company Description
We were formed in August 2011 as a Delaware corporation to exploit a new
proprietary technology that is seeking to bring laboratory testing capabilities
to consumers in a distinctive, easy to use and affordable way through the use of
smartphones such as iPhones.
We are initially applying our
technology to address the diabetic self-monitoring
of blood glucose, or SMBG, market. Diabetes is a disease where insufficient
levels, or a total absence, of the hormone insulin produce 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 fully integrated, all-in-one SMBG device
consisting of a lancet to obtain a blood sample, disposable test strip cartridge
and a glucose reader adaptor to hold the strip and interface with the
smartphone, combined with a smartphone application and internet-based data
services. Roughly the size of a pack of gum, we believe that Dario has the
potential to replace stand alone 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.
We expect to launch Dario in the SMBG market after obtaining all applicable
regulatory approvals. We began the regulatory approval process in Europe in
2012, and will commence such process in the United States in 2013. Such
approvals will need to be obtained prior to the anticipated commercial launch of
Dario which is anticipated in 2013, first in Europe and subsequently in the
United States. Based on our discussions with regulatory authorities in Europe
and the knowledge and experience of our management on regulatory matters in the
U.S., we believe that applicable regulatory approvals will be obtained in
advance of our anticipated commercial launches for Dario.
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 strip designed 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 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.
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
(including blood, urine and saliva) that could potentially be undertaken using a
smartphone, including blood coagulation, cholesterol, HIV and others.
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We were incorporated under the laws of the State of Delaware on August 11,
2011. We maintain an address at 40 E. Main Street, Suite 759, Newark, Delaware
19711 and our telephone number is (646) 259-3321. We have one wholly-owned
subsidiary, LabStyle Innovation Ltd., that was incorporated in Israel on
September 14, 2011, with its offices at Menachem Begin 7, Ramat Gan (29th
Floor).