labstyle innovations - glucose monitoring for the mobile age
Today, Zacks began reporting on LabStyle innovation. (NASDAQ:DRIO)
Buy rating.
LabStyle is a super developed
Convenient, affordable, simple-to-
Use your own blood glucose meter
Blood glucose monitoring in type patients-1 or type-2 diabetes.
The device, called Dario, is elegantly designed with excellent availability and accessibility through integrated pockets
Size blood glucose meter with smartphone and mobile app.
Dario combines a funding facility, a disposable belt box, and a glucose monitor with a connection plug inserted into the smartphone\'s audio jack.
Management expects Dario to be listed commercially in the EU in the second half of 2013. A U. S. 510(k)
Application as a class-
II medical equipment is also expected to be approved in the second half of 2013 and, if approved, may result in the United StatesS. launch in 2014.
We believe that Dario\'s blood glucose meter and diabetes management system are revolutionary in design and function.
Dario, along with the sales of one-time test strips, mobile apps, and community and physician interaction software, represents the $1 billion peak opportunity for LabStyle innovation worldwide.
To seize this opportunity, we have built a detailed financial model and concluded that the value of these stocks is much higher than this day.
Our target is $12 per share.
Rapid Diabetes background diabetes, or simply, diabetes, is a group of metabolic diseases characterized by high blood sugar levels due to a deficiency in the body\'s ability to produce and/or use insulin.
This defect usually stems from dysfunction of the pancreas, either because the cells do not respond to the insulin produced.
The main manifestation of this disease is high blood sugar levels
The effects of classic symptoms, including polyurination (
Frequent urination), polydipsia (
Increased thirst)
Overeating (
Increased hunger).
Diabetes is divided into three categories: Type-
Type 1 diabetes
2 diabetes, gestational diabetes.
The fourth class is called pre-
From a clinical point of view, diabetes is also considered important and may be the largest group of patients. Type-
Type 1 diabetes
1 diabetes is usually diagnosed in children and young people, formerly known as adolescent diabetes. In type-
1 diabetes, the body does not produce insulin, the most common is the result of the destruction of insulin by the body\'s own immune system --
Produces pancreatic cells called beta cells.
Under normal circumstances, insulin is secreted by the pancreas.
When you have a meal, sugar (glucose)
Food stimulates insulin release in the pancreas.
The amount of release is proportional to the amount required for the size of this particular meal.
The main role of insulin is to help transfer certain nutrients, mainly sugar, to cells in the body tissue.
Cells use sugar and other nutrients in food as energy sources.
Once Insulin transports sugar into cells, the amount of sugar in the blood decreases. In non-
An individual with diabetes, signals beta cells in the pancreas to reduce insulin secretion, so that hypoglycemia (called hypoglycemia) does not develop.
But beta cell destruction occurring in type patients
Diabetes destroys the process.
Type of person-
1 diabetes, insulin cannot transport sugar into cells.
The result is that blood sugar accumulates in the blood.
The high level of blood sugar is called elevated blood sugar.
Elevated blood sugar can lead to a lack of nutrition in body cells.
Therefore, other systems of the body must provide energy for important body functions.
When the body tries to remove high sugar levels in the body, elevated blood sugar can lead to increased urination and dehydration.
Elevated blood sugar may also lead to weight loss, as frequent urination and insufficient body capacity for sugar intake (calories)
Turn it into energy.
Diabetic ketone disease (DKA)
Is another common side.
The effect of frequent elevated blood sugar, when the body breaks down fat cells to get energy without the ability to convert sugar into energy, results will be produced.
Fat cells contain acidic molecules called ketone.
When the ketone accumulates in the blood, the liver releases sugar to fight against high acid levels.
Unfortunately, this will only exacerbate the problem.
Combination of dehydration, frequent urination and acid accumulation-
What is most in the body is the so-called ketone disease.
Over time, elevated blood sugar and ketone poisoning can cause damage to the nerves and small blood vessels of the eyes, kidneys and hearts.
According to the American Diabetes Association, about 80% of adults with diabetes have eye problems. 1 diabetes.
Kidney damage is also common, about 20-30% of type-
Diabetes over time.
Patients with diabetes are also prone to coronary artery disease and high blood pressure (
High blood pressure)
Two main causes of heart disease and stroke
Nerve damage caused by poor blood circulation and elevated blood sugar levels due to hardening of the arteries leads to foot problems.
This may lead to an increased risk of injury, a decrease in the ability to heal open ulcers and wounds, which in turn significantly increases the risk of diabetic foot ulcers. Type-
Type 2 diabetes
Type 2 diabetes, once called non-diabetes
Insulin dependent or adult
Diabetes is the most common type of diabetes, affecting about 90% of the world\'s diabetes patients.
Similar to Type-
Type 1 diabetes
2 diabetes is a metabolic disorder characterized by elevated blood sugar in the case of insulin resistance and relative insulin deficiency.
This is in sharp contrast to type 1 diabetes, where there is an absolute lack of insulin due to the destruction of insulin cells in the pancreas.
However, the type of symptoms
2 Similar, urine (
Frequent urination), polydipsia (
Increased thirst)
Overeating (
Increased hunger).
However, different from the type
1. obesity is considered the main cause of the type
People who are genetically prone to diabetes.
Gestational diabetes: Gestational diabetes is a disease characterized by elevated blood sugar (glucose)
The level first confirmed during pregnancy.
This happens about 3-
5% of all pregnancies, may improve or disappear after delivery;
Or it may develop
Type 2 diabetes occurs about 25% of the time.
While it may be transient, untreated gestational diabetes can harm the health of the fetus or mother.
The risks faced by babies include the big ones (
High birth weight)
Congenital abnormalities of the heart and central nervous system and skeletal muscle deformity.
The increase of fetal insulin can inhibit the production of fetal surface active substances and cause respiratory distress syndrome.
The destruction of red blood cells may lead to high jaundice.
Diabetes is a chronic disease and there is no cure yet.
The main goal of treating diabetes is to control blood sugar by diet, exercise, or drugs such as supplementing insulin or other anti-diabetic drugsDiabetes drugs.
American Diabetes Association (ADA)
It is recommended that diabetic patients check their blood sugar levels every day, or more depending on the severity of the disease.
ADA also recommends that patients check for A1C (
Average blood sugar control)
Content of ketone
Understanding blood glucose levels and monitoring risk factors are critical to maintaining disease stability.
Insulin supplement is the standard for type care1 and some types-2 diabetics.
There are 20 different types of insulin sold in the United States. S.
They vary in the way they are made, the duration of the action, the way they are administered, and the strategy of administration.
Fast-for example-
Insulin analogs (
Brazil, Brazil)
Start work after 5 to 15 minutes and stay active for 3 to 4 hours.
This may be the ideal choice after dinner.
Other, intermediate-
Action insulin may take 1 to 3 hours before starting work, but lasts 18 to 24 hours in the blood.
This is useful for daily blood sugar control in patients with severe diabetes. Long and ultra-
Long acting insulin (
Gan Jing, di te, de Ludi)
It can last more than 24 hours and provide better blood sugar control and the convenience of less frequent administration.
Lantus in Sanofi (
Insulin ganpin
Leading Dragon
Sales of agent insulin are 4 euros. 9 billion ($6. 1 billion)in 2012.
In addition to insulin, there are many anti-insulin drugs.
Diabetes drugs on the market aimed at lowering blood sugar levels;
Some of them are oral and others are injected.
Metformin was the first.
Line, verbal,
Diabetes drugs that work by suppressing glucose production in the liver.
In addition to stable blood glucose control and excellent safety and tolerance, metformin has also been shown to reduce low-density cholesterol and triacid gan oils and has nothing to do with weight gain.
Therefore, it is the most widely used-
Diabetes drugs in the world. Sulfonylureas (
Glimphen, glimphend)
Is another widely used counter.
Drug therapy for diabetes
These drugs work by stimulating insulin release from pancreatic beta cells.
The drug has moderate efficacy, low incidence of adverse events, but can lead to weight gain and risk of hypoglycemia.
Oxazone (
Metformin, metformin)
In short, TZD is an oral drug that is activated-
G is found in fat and muscle cells.
These drugs, based on low risk and convenient administration of hypoglycemia, gained considerable market share in the year 00 s.
However, TZDs are associated with increased risk of weight gain, edema, anemia and heart failure (rosiglitazone)
And bladder tumors (pioglitazone).
A TZD, qugalenone, withdrew from the market in 2000 due to increased risk of liver toxicity.
Leading TZD, Actos of Takeda (pioglitazone)
Sales are $4.
2011 5 billion.
Dipeptide peptide4 inhibitors (
Sitagliptin, vitagliptin, sartagliptin and litagliptin), or DPP-
In short, four inhibitors are a new class of resistance
Because of the strong efficacy, the convenience of oral administration and the low probability of weight gain, diabetes drugs are becoming more and more popular.
The DPP\'s mechanism
4 inhibitor is to increase the level of intestinal insulin promotion (GLP-1)
It can inhibit insulin secretion, reduce gastric emptying, and reduce blood glucose levels, thus inhibiting blood glucose release. Several DPP-
There are already four agents working together.
Formulated with metformin to improve blood sugar control and improve the convenience of administration. Merck\'s DPP-
4 inhibitor, Januvia (sitagliptin)
Sales are $4.
2012 1 billion.
Combined sales of Januvia metformin products, Janumet, added another $1. 7 billion.
Injection resistance
Diabetes drug GLP-for similar pathways-
1 activation, including the ethene peptide and the Lalu peptide.
Both drugs have a lower risk of hypoglycemia and strong blood sugar control. For both DPP-
4 inhibitors and GLP-
1. there are still problems with the safety and tolerance of the activator.
We talk about insulin therapy and resistance.
The use of diabetes drugs is due to the combination of these drugs with lifestyle management, which is centered on diet and exercise, and blood glucose monitoring is usually carried out by diabetes patients themselves. Self-
Blood glucose monitoring (SMBG)
It is a key part of the current diabetes treatment plan.
Doctors recommend SMBG as a pioneer in taking insulin or other insulin-resistant drugs
Diabetes drugs.
Taking too much insulin, or taking too much on an actor, Januvia, or Byetta can lead to hypoglycemia.
Not enough, patients will also have elevated blood sugar and ketone poisoning.
The key to effective use of all of the above drugs is to understand blood sugar levels in a timely and accurate manner. Self-
Monitoring of blood sugar by American Diabetes AssociationADA)
SMBG is an important part of modern diabetes treatment.
The goal of SMBG is to pass more precisely, in some cases, real
Time information about blood sugar levels.
SMBG can be used to help adjust treatment options based on blood glucose values and to help individuals adjust their dietary intake, physical activity, and insulin doses to improve blood sugar control for the dayto-day basis.
According to the doctorEvan M.
Dr. Benjamin, director of Medical Quality at Baystate Medical Center and assistant professor at the School of Medicine at the University of taftz, FACP, \"using SMBG data wisely helps improve blood sugar control, choosing an-
Diabetes protocol and provide strong feedback to patients who wish to improve metabolic control.
\"In 2008, ADA summarized and published the following conclusions in its health care standards: blood glucose monitoring helps to plan meals, activities, and when to take drugs during the day.
As a result, the use of SMBG devices has surged over the past decade.
About 10-
20% of patients with diabetes use SMBG devices, most of which are type-1 diabetics.
SMBG is achieved by using a blood glucose meter or a blood glucose meter.
A blood glucose meter is a medical device that analyzes a small drop of blood by piercing the skin with a bayonet.
The blood is placed on a small one-time test strip and inserted into the blood glucose meter.
The blood glucose meter test kit includes the ancing device, the blood glucose meter itself, and a one-time Test strip.
The design of the film machine is very simple and has not changed much in the past 30 years.
Since the beginning of the 1980s S, there has not been much innovation in the adhesive meter.
Most of the looks and functions are the same.
While improvements have been made in terms of size, battery power, test strips, sharpener devices, blood sample size and test time, in the last thirty years the advancement of the glers has been more of an evolution than a revolution.
The equipment is getting smaller, lighter and faster, but the equipment on the market today usually runs under the same principle and mechanism as the equipment launched in early 1980s, only more bells and whistles.
But considering the relative lack of difference between software and users --
Experience, the hand-held adhesive meter shown in the above figure, is mainly to compete in price.
When consumer goods begin to be finished in price, profit margins begin to decline.
Innovation has stopped, and products have become common.
They look and function the same.
They are not beautiful, most of them are made of cheap plastic materials, poor ergonomics, and cumbersome software.
Compare the slow development of hand-held glue come in the past two to thirty years, as well as the revolution in the mobile phone industry.
Mobile phones in 1980s and 1990s are large, undifferentiated, bulky, poorly-made electronic devices.
Nokia, Sony, Motorola, Ericsson and Telecom are almost all out of the business as they produce older phones that are equally poorly designed year after year.
New entrants like Apple, Samsung, HTC and Google have revolutionized the industry by combining high-quality, ergonomic-designed devices with excellent software, these software not only greatly improve but also enhance the user experience.
Today\'s phones, now known as smartphones, are ubiquitous devices that compete on technology, aesthetics, and emotional attachment. Enter Dario -
Blood glucose monitoring by mobile AgeLabStyle innovation
A leap forward for the blood sugar and diabetes management system.
The Dario product cleans the United Nations.
The original thinking that plagues the heavy, bulky and tedious adhesive meter in today\'s market.
Dario is a compact, simple, elegant device that combines all the components of the blood glucose meter test kit
Instruments and equipment, test strips and cartridges, blood glucose meterswith play-and-
Integrate with leading smartphones in the market. (1)
Lancing equipment: Dario uses Ultra
The thin bayonet with comfortable blood draw is only 0. 3 ml. (2)
Belt box: Each belt box holds 25 strips.
It\'s easy to pull out one at a time (
Use a built-in roller to allocate one at a time)
, Replace the cartridge with a new cartridge. (3)
Meter: the meter is pulled out of the Dario device and easily connected to the smartphone headphone socket.
Once connected to the smartphone, the meter will automatically sync with the Dario app.
Dario\'s goal is to replace the independent self.
An electric blood glucose meter and kit, usually consisting of three separate components.
We have seen several key advantages of Dario devices in the market relative to traditional adhesive meters :-
Ergonomics: Dario is made of high quality materials with an excellent look and feel.
The whole device is roughly the size of a pack of gum that can be handled in the user\'s pocket or wallet. -
Integration: Dario is made with state-of-the-art electronic equipmentChemistry, blood
Standard glucose display based on measurement technology and provide familiar availability.
Dario is easily integrated with the patient\'s own smartphone (play-and-play)
With the application. -
Convenience: Dario has an integrated knife-pulling device and a disposable cartridge.
This will no longer require a separate glucose monitor, tilt device, and bring bottles, which we believe makes Dario the smallest glucose device on the market. -
Availability: The smartphone app comes with the Dario device (
Available on iOS and Android)
When the meter is plugged into the headphone jack, it starts automatically.
Software applications are key to Dario\'s user experience.
The app contains tools to help people with diabetes manage their disease.
We will discuss this application in more detail below. -
Applicability: 55% of new phone buyers buy smartphones, according to Nielsen.
Almost half of mobile phone users have smartphones, and that number is growing every year.
0. 35 billion people with diabetes worldwide, 10-
Insulin accounted for 20%.
Test their blood with a blood glucose meter every day.
In addition to Dario devices, LabStyle will also provide Dario with integrated applications for smartphones (
Currently available on iOS and Android).
As mentioned above, Dario meters work seamlessly with smartphone apps.
Dario device owners can simply download the app and when the meter is connected through the headphone jack it will automatically sync with the meter.
The application software creates a new ecosystem, similar to Apple\'s (NASDAQ:AAPL)
It has been created around iTunes, which allows users to fully connect to the platform.
Similar to the advantages of the device, the application provides a unique advantage for diabetic patients :-
Results: Dario blood glucose meter and its application made blood glucose monitoring fast and simple.
LabStyle\'s product motto for Dario is \"glucose monitoring in the mobile era \".
\"Smartphone users carry their phones with them.
Small and light Dario supports SMBG-the-go. -
Data Sync: The app records each activity, allowing users to track their blood sugar levels over time.
Logs provide users with valuable information about blood sugar control throughout the day or week or month. -
Tools: in addition to blood glucose monitoring, the app also allows users to input carbohydrates and food consumption and to track drug use and physical activity.
Dario\'s application is intended to become an all-round
Including diabetes management tools. -
Sharing: Cloud included in the app-
Based on the data center, users are allowed access to logs on their desktop, tablet, phone, or sent to their doctor, pharmacist or insurance company by email. Screen-
The photos of the Dario app are as follows :. . . . . . Dario ecosystem . . . . . . Above, we talk about the potential of LabStyle to create an ecosystem around Dario, similar to Apple\'s iPhone and
Dario\'s equipment is so small and compact that we expect users to abide by it will be high compared to independent, self-contained
A separate tilt mechanism and an electric adhesive gauge for the Test strip are required.
Seamless integration with smartphone apps synced through the cloud
Computing based on the data center allows users to store, track and analyze their blood sugar information.
Data can be exported and sent (via email)
For patients, doctors, nutritionists, pharmacists, insurance companies or other carers-giver.
Similar to consumers who accept Apple or Google\'s smartphone platform, we believe that once users enter the Dario ecosystem, LabStyle has the potential to retain users for a long time, far beyond the typical service life of the self.
Electric blood glucose meter.
LabStyle can also earn additional income from patients by selling Dario one-time test strips and patient data.
LabStyle believes that its one-time test strip is one of the best in the market today.
This bar allows blood glucose reading with only 0 in 5 seconds. 3 ml of blood.
Coding is not involved.
The Dario device uses enzyme sensors with extensive analysis (10-600 mg/dl).
Dario cartridges can accommodate 25 test strips.
LabStyle plans to be the only supplier of these proprietary strips and sell them directly to consumers (online)
Cooperate with distributors.
We note that the company has entered into a contract with a Korean supplier to supply test strips, connectors and other related components for Dario equipment.
We believe that management will seek contracts for additional supply in a timely manner.
This razor/razor blade strategy is a proven business model that offers high margin, high customer retention.
Data Display, certain types
1 diabetes test their blood up to 8-10 times a day.
LabStyle will endeavor to obtain full insurance reimbursement for test strips upon approval and will further consolidate the income stream once the patient enters the Dario ecosystem.
We also see the possibility of LabStyle monetizing patient data generated by Dario users.
LabStyle wants to provide information to contract research institutions, pharmaceutical companies and other medical device companies to help with trial recruitment and market analysis, and provide information on food and exercise programmes and their impact on blood sugar levels.
In October 2012, LabStyle completed a clinical trial to test the availability of DarioIn.
The purpose of this trial is to promote regulatory applications in Europe and the United StatesS.
The test is designed to help the first user of the Dario device use it with minimal guidance material (i. e.
Quick User Guide and iPhone app)
To demonstrate how the use of Dario equipment and related software can potentially improve compliance in patient care and in patients with diabetes.
The trial also sought to capture and understand the potential weaknesses of the device and to introduce the user to ways to overcome them and to establish the proposition that, in comparison with other devices on the market, the device can be operated by any user.
The study was carried out in Israel using the prototype of Dario\'s product, and its basic functions are combined with the simulation program of the smartphone.
A total of 61 patients with diabetes participated in the study (ages 8 to 80).
These subjects were recruited from the diabetes clinic at the Wolfson Medical Center in Tel Aviv.
More than 95% of patients completed the study.
. . . . . . Regulatory submissions . . . . . . The data from the above studies were included in the European CE Mark regulatory document held in 2012.
Equipment sold in Europe must display the CE mark prior to import or sale and must comply with the requirements of the European Medical Equipment Directive (MDD)
Or actively implanted medical device instructions/In Vitro Diagnostic instructions (IVDD).
LabStyle believes that both instructions will regulate Dario.
Management must also obtain an international organization for standardizing or ISO-
13485 certification.
ISO is an international recognized quality system and is recognized by the applicable agencies of EU member states.
The first audit of the company was conducted by EU regulators in October 2012 and management is currently completing additional technical documents for review.
The company hopes to obtain eu ce Mark certification around 2013, and plans to launch it for the first time in Germany and the United States. K.
Followed by Belgium and Scandinavia. In the U. S.
LabStyle believes Dario will be eligible to become a class
II medical devices must comply with FDA regulations on product design and development
Clinical and clinical testing, manufacturing, labeling, storage, pre-
Market clearance or approval, advertising promotion, sales and distribution.
We believe that it makes sense considering that all new glue is regulated in a similar way.
Approval of a class
II medical devices are available through 510 (k)
Notify the application before listing or approve the application before listing through section 515th (PMA).
LabStyle believes that they will be able to submit documents for Dario at a shorter, cheaper price below £ 510 (k)pathway. A 510(k)
The submission must provide information in support of its assertion that it is substantially equivalent to the assertion device.
Submissions will also include 61-
The patient study mentioned above.
We think this makes sense because the FDA allows the sale of low-risk medical devices without requiring the manufacturer to submit the PMA.
We expect a review of Dario devices after 510 (k)
Submit to be quick and event-free.
We look forward to submitting this material in the second half of 2013.
However, if the FDA does need to submit a PMA, or regulate Dario as a Category --
III. medical devices (Unlikely)
, LabStyle will require additional U. S. S.
Human clinical trials for compiling necessary data.
This will add a lot of cost and time to the United States. S.
Approval of the product.
Outside of two major markets in the United StatesS.
In the EU, LabStyle may seek regulatory clearance in some attractive markets such as Japan, India, South Africa, Russia and Brazil.
Focus mainly on the huge opportunities in foreign markets such as Japan, India and Brazil.
With respect to Brazil, all imported or distributed medical equipment must first be registered with the National Security Agency of argarcia (also known as ANVISA or the National Health Supervision Agency.
However, only companies in Brazil can apply for visa registration.
Therefore, LabStyle must either create a Brazilian subsidiary or work with Brazil-
Obtain a visa and distribute Dario\'s third party in Brazil.
. . . . . . Marketing and sales . . . . . . LabStyle innovation plans to make Dario the internet --
Direct drive productsto-
Seek to reduce consumer marketing and distribution dependent on traditional retail channels.
Besides cost-
Effective way, it eliminates the battle of shelves
The war of shaping and pricing persists when undivided consumer goods are sold in supermarkets, soups, nuts and classes competing for market share --
Medical devices.
We believe that this strategy makes sense given that Dario was designed for the \"mobile era\" and combined with downloadable smartphone apps and the cloud
Platform based on data hosting and sharing.
We doubt, like in the early days.
Dario users will be the adopters of smartphones --
Face, device and social
Be media savvy and able to adapt to the ecosystem of potential paradigm shifts in managing disease.
Therefore, we believe that Dario is well suited to this online distribution program that is directly aimed at consumers.
LabStyle\'s goal is to create effective brand awareness and significantly reduce the use of our capital resources, rather than the amount needed through traditional offline retail channels.
Having said that, we do want the company to use certain aspects of the dealer network and revenue
Share members.
We suspect this relationship will happen. for-
Including well-known online business sites.
We expect that the initial marketing will focus on the young population of people with diabetes, and then gradually expand the marketing efforts for older people with more general diabetes.
The management plan initially focused on insulin dependence (mainly type-1)
Patients with diabetes
Market research shows that although this population accounts for about 10% of the people with diabetes, it accounts for more than 50% of the income of blood glucose monitoring equipment.
On May 2011, the founder of the company submitted a Patent Cooperation Treaty (PCT)
Application of \"monitor of glucose and other body fluid content based on smartphone (
PCT/IL2011/000369)
Including two of the United States. S.
Provisional patent application filed on 2010.
These applications and all relevant intellectual property rights were transferred to LabStyle Innovations.
October 2011 the company founder
PCT covers specific processes related to blood glucose level measurement, as well as more general methods for rapid testing of body fluids.
PCT has been converted into several national patent applications.
PCT/il201/000369 for two United StatesS.
In the interim patent application, the management requires the patent application number to be the patent priority date of September 5, 2010.
Patent application number: 61/332, 778 and November 1, 201161/431,449.
Management holds advanced patent applications for PCT/il11/000369 outside the United StatesS.
Including Israel, Europe, India, South Africa, Australia, China, Japan and Brazil.
With respect to company technology, management is continuing to pursue patent protection and is preparing to submit regulatory documents in multiple jurisdictions of Dario equipment and related software.
Management is also preparing a large number of additional patent applications related to the core technology of Dario\'s products and expected future generations.
LabStyle is defining the final design of the original Dario product and continuing to develop the software through internal and outsourced resources.
In addition, management is seeking to develop new intellectual property around the next few generations of Dario hardware and software, with the goal of achieving enhanced functionality, user interface and data availability.
However, investors should keep in mind that no patent has been granted by any applicable regulatory authority.
Future product sdario and its associated intellectual property represent a platform for rapid mobile diagnostics.
Many signs are noted in its intellectual property document, each of which represents an important opportunity.
These include blood coagulation tests (PT/INR)
The global $700 market, HIV testing and monitoring, $1 billion opportunities, and other programs such as pregnancy and cholesterol testing, each with more than $1 billion opportunities. Risk -
Competition we think Dario is a big leap forward in diet and diabetes management.
This is an elegant design, thanks to the software applications and ecosystems that management has tried to build around the entire platform, it provides users with a better experience and monitoring capabilities.
Nevertheless, LabStyle is entering a highly stable market, with major market competitors including Roche, Bayer HealthCare, Abbott Labs, all backed by a large amount of marketing funds, production of cheap alternatives
Sales Representative, insurance reimbursement and auxiliary treatment agent.
In addition to these four main participants, there are several small, new entrants to the Glucose Monitoring Market, which will provide competition for LabStyle Innovations Corp.
On the device side.
In terms of application, we found
More than a dozen diabetes apps in the ITunes App Store (or iOS devices).
LabStyle\'s app is designed to work seamlessly with Dario devices.
People with diabetes are free to use other diabetes apps as well as Dario and Dario apps.
However, LabStyle innovation
Not the only company trying to capture a smartphone revolution or take advantage of the cloud
Attract patients and build an ecosystem for patients based on computing and social media/shared applications.
. . . . . . On the device . . . . . . Dario was designed for himself.
Blood glucose monitoring (SMBG).
Despite the elegance of the Dario device, it still requires a balance mechanism and a test strip.
Several companies are conducting continuous blood glucose monitoring (CGM)
Platforms that may make SMBG products less common, or at least both systems have patients who may test their blood less frequently (
Less sales of test strips)
Than those without a CGM system.
Let\'s focus on two of these products.
We don\'t think either of these apps is a \"killer app\" that will make Dario obsolete, but they both represent competition and another potential paradigm shift --
Revolution, not evolution.
For diabetic patients with complete lack of insulin.
That is to say, the two devices below still need to be calibrated regularly and people with diabetes can use SMBG and CGM systems.
Other companies have grown.
Small, stylish gluters using smartphones on iOS or Android operating systems.
However, none of these devices combine all three components of the SMBG test suite, and most require people with diabetes to carry devices other than smartphones and blood glucose meters.
We consider Dario devices to be the leading product in the shift to small, smart SMBG devices.
In addition, the combination of cloud
Computing based on application-driven devices is innovative in this field.
Echo therapy (OTC:ECTE)
It is the prelude to SkinPrep and Symphony iCGM installations in developing countries.
Prelude SkinPrep is a platform technology for painless and significantly enhancing skin penetration.
There are no leverage mechanisms and test strips used for Overture and symphonies.
On the contrary, the skin is prepared with a Prelude device (painlessly)
Remove the top layer of the skin, called the corneal layer.
The Symphony device is worn on the abdomen of the skin area prepared by the prelude.
Symphony measured blood sugar through penetration
Chemical glucose sensor
Symphony contains wireless transmitters compatible with ICU software and paired with remote monitors.
Echo\'s Prelude SkinPrep and Symphony iCGM platforms are mainly aimed at Hospital diabetic patients with severe care, complete insulin deficiency
Or elevated blood sugar.
Echo is preparing to launch its CE mark and the United StatesS. PMA (Key procedures)
This platform.
We don\'t think the Prelude/Symphony platform will pose a direct threat to rabstyle and Dario.
LabStyle has been ahead of Echo for many years, and Echo currently focuses on in-
Hospital intensive care unit.
However, this first
A generation of products offers a glimpse of what glucose monitoring might be heading for the next decade.
8 MediSensors, Inc.
A wearable continuous blood glucose monitor synchronized with a user\'s smartphone is being developed.
Like Symphony iCGM, the optical glucose monitor (OGM)
Blood sugar levels are measured without the need for a lever mechanism or test paper.
The device is worn on the skin and is wirelessly output to a smartphone, providing painless and continuous monitoring of glucose levels.
The c8-medisensors OGM has impressive software and integrates with downloadable applications.
The potential impact on the device is the accuracy of reading glucose levels via skin optics, so the device is being designed by the c8-medisenors with the idea of supplementing conventional glue rather than replacing them.
Another obvious blow to the c8-medisensors OGM is the cumbersome, cumbersome design.
The device is secured in place with a belt/package and Velcro.
It\'s in the middle.
The abdomen, right above the abdomen. button.
The picture above is a relatively healthy individual.
We question the wear resistance of the device in patients with higher BMI.
We can see that the equipment is hot or uncomfortable.
The equipment is currently for research purposes only.
We don\'t expect to see it in the market in a few years.
This is
Generation of products, so the absorption may be very low and retained to the most serious type1 diabetics.
However, like Echo\'s products, the c8-medisensors OGM allows investors to understand the market trends of SMBG.
Telecom Medical Supply Co. , Ltd.
Telcare BGM equipment has been developed.
Telcare BGM offers many of the same features Dario offers, including stylish devices with clouds
Data-based hosting (
Called Telserve Hub)
Syncing with mobile smartphones, data analytics applications, and ecosystems designed to provide test strips and add-ons
Provide services to patients.
It does not require coding, personalized features, rechargeable batteries, small blood samples and quick results.
The problem with Telcare BGM is that it is a device separate from the user\'s smartphone.
It even looks like a smartphone.
We question why users would want to carry two devices the size of their smartphones and a financing mechanism once Dario goes public.
LabStyle\'s Dario product takes the Telcare BGM concept to a new level.
Telcare BGM is currently listed in the United States. S.
The retail price of the product is $149.
95, including equipment, 10 lanc knives and 10 test strips. Sanofi-aventis (NASDAQ:SNY)
Developed a very stylish little device called iBGStar.
The device has dock connector compatible with iPhone or iPod Touch
The USB port of the power adapter or the USB port connected to the PC, with port, and the test result display area.
IBGStar is designed to work with the iBGStar mobile app on the iOS platform.
The mobile app provides only a subset of the Dario app, allowing for the sharing of analysis test results, automatic sync, tracking data, historical data storage, dynamic graphics, home or healthcare.
There are two problems we see on iBGStar. fold. No.
1. the device does not contain lancet.
IBGStar comes with a separate lancing device about the size of a lip balm.
This is an additional device that the patient must carry compared to Dario.
Each time the device is used, a new bayonet and a bayonet cap must be inserted together.
Another shock to iBGStar is that the dock is the old iPhone 30-
Pin dock for IPhone 4 or below.
It has no new Apple lighting connection.
The user must purchase this adapter separately for about $30.
In addition, iBGStar is not compatible with Android devices that account for more than half of the smartphone market.
IBGStar\'s retail price in Walgreens is about $75, and the retail price of proprietary test strips is about $1. 30 each.
Medisana AG has developed GlucoDock, a product very similar to Sanofi\'s iBGStar.
We see that the difference between GlucoDock and iBGStar is very small.
It has the same features and the same features, which will limit use, including Dario\'s lack of advanced software and lifestyle integration such as a food database and insulin dose recommendation.
GlucoDock is currently unavailable in the United States. S.
It is available in parts of Europe and retails for 100 euros.
. . . . . . On the software/application . . . . . . Many of the above products have their own software applications that can be synchronized with the device.
The app is free if you buy the software, and if you don\'t buy the device, the app is of little use.
Our search on the iTunes store found more than 20 separate diabetes apps designed to compete with the Dario app.
None will automatically sync with the device.
However, currently patients with diabetes
A separate glue like a free mini or a one-button Ultra may have downloaded a separate
Apply separately.
Recently published an article on clinical diabetes in the fall of 2012 (Tran et al. , Vol. 30:173-178)
Review several of the leading diabetes apps in the iTunes store.
Most of them spend money.
We have compared these applications to the Dario applications.
It\'s clear that LabStyle \"understands\" what people with diabetes are looking for in the app.
LabStyle\'s management believes that the Dario app contains many other unique add-ons that further differentiate it from existing competitors.
These include the ability to burn calorie trackers, insulin recommendation and dose calculations, generate reports and charts, and other measurement sharing tools, sugar profile plans and alarm systems, and the cloud-
Based on access to patient data.
Market Opportunities and sales forecasts are aimed at huge market opportunities.
The World Health Organization estimates that there are about 0. 35 billion people with diabetes worldwide (~90% type-2 diabetics).
In Europe, there are about 52 people with diabetes.
According to Frost & Sullivan, there were 6 million people in 2011, about 25.
8 million diabetes patients in the United StatesS.
According to data from the American Diabetes Association, 2011.
Another $79 millionS.
Pre for adults-
Diabetes, which makes them at a high risk of developing type 2 diabetes.
There are about 0. 138 billion adult diabetes patients in China and India, and about 10 million in Russia.
The medical journal Lancet reported that the number of diabetes patients worldwide has doubled in the past three decades.
While 70% of the increase is due to population growth and aging, this balance is associated with dietary changes, rising levels of obesity and reduced physical activity.
Diabetes is an increasingly popular disease and there is no cure, but the treatment (
Including frequent blood glucose testing programs)are available.
It is estimated that the cost of diabetes complications accounts for 5% to 10% of the world\'s total health care expenditure.
Early diagnosis of early warning signals and continuous monitoring of diabetes are the key to disease prevention and treatment, blood glucose monitoring is the main method of diagnosis and disease management, blood glucose reading matching food (i. e. , carbohydrate)
And the intake of insulin or other drugs.
Self-blood sugar
Monitoring is a key part of managing diabetes, and there is also a large market for SMBG products needed to provide services to these patients.
According to research firm Visiongain, the global SMBG market is worth $9.
$7 billion in 2011 and $27 in the global diabetes monitoring equipment market.
42 billion to 2022.
The company estimates that the global market for SMBG test products is $1.
1994 7 billion.
By 2000, the market has reached about $3.
Global sales of these products climbed to $8 billion by 2008. 8 billion.
It is estimated that the US economyS.
40% of the SMBG market, about $3.
At 9 billion, Frost & Sullivan estimates that Europe accounts for $3.
In 2011, 97 billion of the market.
According to the available data, the compound growth rate of SMBG market is 12%.
Key factors driving market growth include an increase in the population of diabetes, increased awareness of patients, advances in technology, and more self-control of blood sugar in patients. monitoring.
In addition, the price of blood sugar test paper is reasonable and the daily monitoring is increasing, which is expected to help the market growth.
So we think the SMBG market is a huge and attractive opportunity for a new medical device.
However, with the increase in the number of diabetic patients with smartphones, LabStyle will be limited. In the U. S.
According to Nielsen, 55% of new handset buyers bought smartphones as their new phones.
Total percentage of smartphones
There are nearly 50% old phones.
According to data from international data companies, iOS and Android control 91% of the smartphone market (
As of February 2013).
We also see an increasing number of patients and doctors receiving apps for mobile health or mobile health.
According to a 2010 study by research2 guidance, smartphone applications will bring the mobile healthcare industry to 0. 5 billion.
Global smartphone users reached 4 billion in 2015.
An article published in October 2009 in Diabetes, Obesity and Metabolism (Vol. 11:913-930)
It was concluded that the mHealth app had a positive impact on the use and blood sugar control of many health services (
Polisena et al. , 2009).
We believe that the reasonable assumption is that the percentage of smartphone users with diabetes reflects the percentage of the general population, and Dario was designed to be directly involved in the three trends mentioned above --
More and more people with diabetes, more and more smartphone users, and the rapid adoption of mHealth applications.
We have established a detailed financial model to predict the sales of Dario equipment and related accessories, including test strips and application software add-ons.
Here is our statement on the model of the EU and the United StatesS.
We do not model Dario equipment sales outside the EU or the USS. as of now.
We will add these projections to our model based on regulatory opinions from countries outside these regions.
For sales in Europe, we suspect that the company will sign a distribution agreement with the leading medical supplies company in a countryby-county basis.
For example, on April 25, 2013, the company signed an exclusive distribution agreement with Farah Medical.
Dario\'s distribution in the United StatesK. and Belgium.
For the purpose of modeling the price, we suspect that LabStyle will actually \"give way\" to new users of Dario devices, at least early in the release, to gain market share.
Similar to the \"razor/blade\" model, most of the money is earned on consumables.
Give away a device that could retail for $75 (and costs $25)seems counter-
Intuitive until you realize the test strip, it may be sold for $0. 50-$0.
$75 each, only $0. 10-$0.
When we consider the average type, per is a more profitable business.
1 diabetes patients can use 7 items per day.
We see that LabStyle\'s Dario device has a meaningful absorption.
Only a handful of major companies such as Roche, Johnson & Johnson, Bayer HealthCare, Abbott Labs and Sanofi dominate the sales of glucose measuring instruments and test stripsAventis.
Each of the big players above holds 10-
Market share 15%.
We believe that, given the differentiated features of this device, LabStyle Innovations and Dario can be key players in this area.
In addition, the medical perspective behind the improvement of SMBG is clearly.
A paper published in December 2009 on current medical research and opinions (Vol. 25-No. 12:2903-2913)
Entitled \"self\"
Blood glucose monitoring in non-diabetic patients
Systematic review and meta-analysis of insulin therapy for patients with type 2 diabetes
The conclusion of the analysis \"is that SMBG is compared with non-SMBG
SMBG is associated with significant improvement in non-glucose control
Type of insulin therapy2 diabetes.
We think LabStyle is good.
Be able to take advantage of several emerging trends such as SMBG, more smartphone users and cloud computingbased / app-Based on computing.
For the European market, we assume a distribution model in which companies lose little or break even on equipment and then get about 50-
60% per article. For the U. S.
In the market, we assume that more is the direct sales model, in which the company loses money on the equipment and then gets about 70-
80% per article.
We assume the average Type-
7 Diabetes tests per day, average insulin-dependent Type-
Test 3 times a day.
We note that the company is targeting developed countries with a large population of diabetes such as Japan, China, India and Brazil.
The Middle East and Russia also offer significant opportunities.
Before the United States, it was much harder to predict the market share of these countries. S.
And the start of the EU, so we temporarily postponed modeling sales outside the United States. S. or EU.
We are also delaying modeling sales of data generated by the application software or Dario users until we have a better understanding of the future plans here.
On May 10, 2013, LabStyle announced that it had completed financing of $10 million by selling common shares and warrants to a group of accredited investors.
Company sales 4.
Million units, $2.
Each of the 50 units consists of 1 and 0. 5 warrants.
Warrants can be exercised at $5.
00 per share, due in early April 2016.
The total net process for the issue was approximately $9 million.
We believe the company is good.
For the foreseeable future, finance businesses including the launch of Dario in the EU.
Small boot coverage with the purchase of RatingZacks-
Cap Research is launching a report on LabStyle Innovations.
Buy rating.
We believe that Dario is elegantly designed with excellent usability and accessibility through integrated pockets
Size blood glucose meter with smartphone and mobile app.
Dario combines a funding facility, a disposable belt box, and a glucose monitor with a connection plug inserted into the smartphone\'s audio jack.
This is the first and only product we have seen so far that combines all three components with intuitive and valuable applications.
We believe that Dario\'s blood glucose meter and diabetes management system are revolutionary in design and function.
Dario, along with sales of one-time test strips, mobile apps, community and physician interaction software, represents a $0. 5 billion peak opportunity for LabStyle innovation in the USS. and EU.
We have established a positive sales model for Dario equipment, based on our belief that the company can occupy 5 to 10% of the market share in the United StatesS. and EU.
Based on the significant difference between the product and the product, this seems achievable
It\'s easy to buy today and the price is similar.
Only a few major companies such as Roche and Johnson & Johnson dominate the sales of glue come and test strips (NYSE:JNJ)
Abbott laboratory, Bayer Healthcare (NYSE:ABT), and Sanofi-Aventis.
Each of the big players above holds 10-
Market share 15%.
We believe that LabStyle Innovations and Dario can be major players in this area, taking into account the different features of the above-mentioned devices.
Based on this model, we think these stocks are obviously insufficient.
$12 per share.
Disclosure: I do not have a position in any of the stocks mentioned, nor do I have a plan to start any position in the next 72 hours.
This article was written by myself and expressed my views.
I was not compensated.
I have no business relationship with any stock company mentioned in this article.
Buy rating.
LabStyle is a super developed
Convenient, affordable, simple-to-
Use your own blood glucose meter
Blood glucose monitoring in type patients-1 or type-2 diabetes.
The device, called Dario, is elegantly designed with excellent availability and accessibility through integrated pockets
Size blood glucose meter with smartphone and mobile app.
Dario combines a funding facility, a disposable belt box, and a glucose monitor with a connection plug inserted into the smartphone\'s audio jack.
Management expects Dario to be listed commercially in the EU in the second half of 2013. A U. S. 510(k)
Application as a class-
II medical equipment is also expected to be approved in the second half of 2013 and, if approved, may result in the United StatesS. launch in 2014.
We believe that Dario\'s blood glucose meter and diabetes management system are revolutionary in design and function.
Dario, along with the sales of one-time test strips, mobile apps, and community and physician interaction software, represents the $1 billion peak opportunity for LabStyle innovation worldwide.
To seize this opportunity, we have built a detailed financial model and concluded that the value of these stocks is much higher than this day.
Our target is $12 per share.
Rapid Diabetes background diabetes, or simply, diabetes, is a group of metabolic diseases characterized by high blood sugar levels due to a deficiency in the body\'s ability to produce and/or use insulin.
This defect usually stems from dysfunction of the pancreas, either because the cells do not respond to the insulin produced.
The main manifestation of this disease is high blood sugar levels
The effects of classic symptoms, including polyurination (
Frequent urination), polydipsia (
Increased thirst)
Overeating (
Increased hunger).
Diabetes is divided into three categories: Type-
Type 1 diabetes
2 diabetes, gestational diabetes.
The fourth class is called pre-
From a clinical point of view, diabetes is also considered important and may be the largest group of patients. Type-
Type 1 diabetes
1 diabetes is usually diagnosed in children and young people, formerly known as adolescent diabetes. In type-
1 diabetes, the body does not produce insulin, the most common is the result of the destruction of insulin by the body\'s own immune system --
Produces pancreatic cells called beta cells.
Under normal circumstances, insulin is secreted by the pancreas.
When you have a meal, sugar (glucose)
Food stimulates insulin release in the pancreas.
The amount of release is proportional to the amount required for the size of this particular meal.
The main role of insulin is to help transfer certain nutrients, mainly sugar, to cells in the body tissue.
Cells use sugar and other nutrients in food as energy sources.
Once Insulin transports sugar into cells, the amount of sugar in the blood decreases. In non-
An individual with diabetes, signals beta cells in the pancreas to reduce insulin secretion, so that hypoglycemia (called hypoglycemia) does not develop.
But beta cell destruction occurring in type patients
Diabetes destroys the process.
Type of person-
1 diabetes, insulin cannot transport sugar into cells.
The result is that blood sugar accumulates in the blood.
The high level of blood sugar is called elevated blood sugar.
Elevated blood sugar can lead to a lack of nutrition in body cells.
Therefore, other systems of the body must provide energy for important body functions.
When the body tries to remove high sugar levels in the body, elevated blood sugar can lead to increased urination and dehydration.
Elevated blood sugar may also lead to weight loss, as frequent urination and insufficient body capacity for sugar intake (calories)
Turn it into energy.
Diabetic ketone disease (DKA)
Is another common side.
The effect of frequent elevated blood sugar, when the body breaks down fat cells to get energy without the ability to convert sugar into energy, results will be produced.
Fat cells contain acidic molecules called ketone.
When the ketone accumulates in the blood, the liver releases sugar to fight against high acid levels.
Unfortunately, this will only exacerbate the problem.
Combination of dehydration, frequent urination and acid accumulation-
What is most in the body is the so-called ketone disease.
Over time, elevated blood sugar and ketone poisoning can cause damage to the nerves and small blood vessels of the eyes, kidneys and hearts.
According to the American Diabetes Association, about 80% of adults with diabetes have eye problems. 1 diabetes.
Kidney damage is also common, about 20-30% of type-
Diabetes over time.
Patients with diabetes are also prone to coronary artery disease and high blood pressure (
High blood pressure)
Two main causes of heart disease and stroke
Nerve damage caused by poor blood circulation and elevated blood sugar levels due to hardening of the arteries leads to foot problems.
This may lead to an increased risk of injury, a decrease in the ability to heal open ulcers and wounds, which in turn significantly increases the risk of diabetic foot ulcers. Type-
Type 2 diabetes
Type 2 diabetes, once called non-diabetes
Insulin dependent or adult
Diabetes is the most common type of diabetes, affecting about 90% of the world\'s diabetes patients.
Similar to Type-
Type 1 diabetes
2 diabetes is a metabolic disorder characterized by elevated blood sugar in the case of insulin resistance and relative insulin deficiency.
This is in sharp contrast to type 1 diabetes, where there is an absolute lack of insulin due to the destruction of insulin cells in the pancreas.
However, the type of symptoms
2 Similar, urine (
Frequent urination), polydipsia (
Increased thirst)
Overeating (
Increased hunger).
However, different from the type
1. obesity is considered the main cause of the type
People who are genetically prone to diabetes.
Gestational diabetes: Gestational diabetes is a disease characterized by elevated blood sugar (glucose)
The level first confirmed during pregnancy.
This happens about 3-
5% of all pregnancies, may improve or disappear after delivery;
Or it may develop
Type 2 diabetes occurs about 25% of the time.
While it may be transient, untreated gestational diabetes can harm the health of the fetus or mother.
The risks faced by babies include the big ones (
High birth weight)
Congenital abnormalities of the heart and central nervous system and skeletal muscle deformity.
The increase of fetal insulin can inhibit the production of fetal surface active substances and cause respiratory distress syndrome.
The destruction of red blood cells may lead to high jaundice.
Diabetes is a chronic disease and there is no cure yet.
The main goal of treating diabetes is to control blood sugar by diet, exercise, or drugs such as supplementing insulin or other anti-diabetic drugsDiabetes drugs.
American Diabetes Association (ADA)
It is recommended that diabetic patients check their blood sugar levels every day, or more depending on the severity of the disease.
ADA also recommends that patients check for A1C (
Average blood sugar control)
Content of ketone
Understanding blood glucose levels and monitoring risk factors are critical to maintaining disease stability.
Insulin supplement is the standard for type care1 and some types-2 diabetics.
There are 20 different types of insulin sold in the United States. S.
They vary in the way they are made, the duration of the action, the way they are administered, and the strategy of administration.
Fast-for example-
Insulin analogs (
Brazil, Brazil)
Start work after 5 to 15 minutes and stay active for 3 to 4 hours.
This may be the ideal choice after dinner.
Other, intermediate-
Action insulin may take 1 to 3 hours before starting work, but lasts 18 to 24 hours in the blood.
This is useful for daily blood sugar control in patients with severe diabetes. Long and ultra-
Long acting insulin (
Gan Jing, di te, de Ludi)
It can last more than 24 hours and provide better blood sugar control and the convenience of less frequent administration.
Lantus in Sanofi (
Insulin ganpin
Leading Dragon
Sales of agent insulin are 4 euros. 9 billion ($6. 1 billion)in 2012.
In addition to insulin, there are many anti-insulin drugs.
Diabetes drugs on the market aimed at lowering blood sugar levels;
Some of them are oral and others are injected.
Metformin was the first.
Line, verbal,
Diabetes drugs that work by suppressing glucose production in the liver.
In addition to stable blood glucose control and excellent safety and tolerance, metformin has also been shown to reduce low-density cholesterol and triacid gan oils and has nothing to do with weight gain.
Therefore, it is the most widely used-
Diabetes drugs in the world. Sulfonylureas (
Glimphen, glimphend)
Is another widely used counter.
Drug therapy for diabetes
These drugs work by stimulating insulin release from pancreatic beta cells.
The drug has moderate efficacy, low incidence of adverse events, but can lead to weight gain and risk of hypoglycemia.
Oxazone (
Metformin, metformin)
In short, TZD is an oral drug that is activated-
G is found in fat and muscle cells.
These drugs, based on low risk and convenient administration of hypoglycemia, gained considerable market share in the year 00 s.
However, TZDs are associated with increased risk of weight gain, edema, anemia and heart failure (rosiglitazone)
And bladder tumors (pioglitazone).
A TZD, qugalenone, withdrew from the market in 2000 due to increased risk of liver toxicity.
Leading TZD, Actos of Takeda (pioglitazone)
Sales are $4.
2011 5 billion.
Dipeptide peptide4 inhibitors (
Sitagliptin, vitagliptin, sartagliptin and litagliptin), or DPP-
In short, four inhibitors are a new class of resistance
Because of the strong efficacy, the convenience of oral administration and the low probability of weight gain, diabetes drugs are becoming more and more popular.
The DPP\'s mechanism
4 inhibitor is to increase the level of intestinal insulin promotion (GLP-1)
It can inhibit insulin secretion, reduce gastric emptying, and reduce blood glucose levels, thus inhibiting blood glucose release. Several DPP-
There are already four agents working together.
Formulated with metformin to improve blood sugar control and improve the convenience of administration. Merck\'s DPP-
4 inhibitor, Januvia (sitagliptin)
Sales are $4.
2012 1 billion.
Combined sales of Januvia metformin products, Janumet, added another $1. 7 billion.
Injection resistance
Diabetes drug GLP-for similar pathways-
1 activation, including the ethene peptide and the Lalu peptide.
Both drugs have a lower risk of hypoglycemia and strong blood sugar control. For both DPP-
4 inhibitors and GLP-
1. there are still problems with the safety and tolerance of the activator.
We talk about insulin therapy and resistance.
The use of diabetes drugs is due to the combination of these drugs with lifestyle management, which is centered on diet and exercise, and blood glucose monitoring is usually carried out by diabetes patients themselves. Self-
Blood glucose monitoring (SMBG)
It is a key part of the current diabetes treatment plan.
Doctors recommend SMBG as a pioneer in taking insulin or other insulin-resistant drugs
Diabetes drugs.
Taking too much insulin, or taking too much on an actor, Januvia, or Byetta can lead to hypoglycemia.
Not enough, patients will also have elevated blood sugar and ketone poisoning.
The key to effective use of all of the above drugs is to understand blood sugar levels in a timely and accurate manner. Self-
Monitoring of blood sugar by American Diabetes AssociationADA)
SMBG is an important part of modern diabetes treatment.
The goal of SMBG is to pass more precisely, in some cases, real
Time information about blood sugar levels.
SMBG can be used to help adjust treatment options based on blood glucose values and to help individuals adjust their dietary intake, physical activity, and insulin doses to improve blood sugar control for the dayto-day basis.
According to the doctorEvan M.
Dr. Benjamin, director of Medical Quality at Baystate Medical Center and assistant professor at the School of Medicine at the University of taftz, FACP, \"using SMBG data wisely helps improve blood sugar control, choosing an-
Diabetes protocol and provide strong feedback to patients who wish to improve metabolic control.
\"In 2008, ADA summarized and published the following conclusions in its health care standards: blood glucose monitoring helps to plan meals, activities, and when to take drugs during the day.
As a result, the use of SMBG devices has surged over the past decade.
About 10-
20% of patients with diabetes use SMBG devices, most of which are type-1 diabetics.
SMBG is achieved by using a blood glucose meter or a blood glucose meter.
A blood glucose meter is a medical device that analyzes a small drop of blood by piercing the skin with a bayonet.
The blood is placed on a small one-time test strip and inserted into the blood glucose meter.
The blood glucose meter test kit includes the ancing device, the blood glucose meter itself, and a one-time Test strip.
The design of the film machine is very simple and has not changed much in the past 30 years.
Since the beginning of the 1980s S, there has not been much innovation in the adhesive meter.
Most of the looks and functions are the same.
While improvements have been made in terms of size, battery power, test strips, sharpener devices, blood sample size and test time, in the last thirty years the advancement of the glers has been more of an evolution than a revolution.
The equipment is getting smaller, lighter and faster, but the equipment on the market today usually runs under the same principle and mechanism as the equipment launched in early 1980s, only more bells and whistles.
But considering the relative lack of difference between software and users --
Experience, the hand-held adhesive meter shown in the above figure, is mainly to compete in price.
When consumer goods begin to be finished in price, profit margins begin to decline.
Innovation has stopped, and products have become common.
They look and function the same.
They are not beautiful, most of them are made of cheap plastic materials, poor ergonomics, and cumbersome software.
Compare the slow development of hand-held glue come in the past two to thirty years, as well as the revolution in the mobile phone industry.
Mobile phones in 1980s and 1990s are large, undifferentiated, bulky, poorly-made electronic devices.
Nokia, Sony, Motorola, Ericsson and Telecom are almost all out of the business as they produce older phones that are equally poorly designed year after year.
New entrants like Apple, Samsung, HTC and Google have revolutionized the industry by combining high-quality, ergonomic-designed devices with excellent software, these software not only greatly improve but also enhance the user experience.
Today\'s phones, now known as smartphones, are ubiquitous devices that compete on technology, aesthetics, and emotional attachment. Enter Dario -
Blood glucose monitoring by mobile AgeLabStyle innovation
A leap forward for the blood sugar and diabetes management system.
The Dario product cleans the United Nations.
The original thinking that plagues the heavy, bulky and tedious adhesive meter in today\'s market.
Dario is a compact, simple, elegant device that combines all the components of the blood glucose meter test kit
Instruments and equipment, test strips and cartridges, blood glucose meterswith play-and-
Integrate with leading smartphones in the market. (1)
Lancing equipment: Dario uses Ultra
The thin bayonet with comfortable blood draw is only 0. 3 ml. (2)
Belt box: Each belt box holds 25 strips.
It\'s easy to pull out one at a time (
Use a built-in roller to allocate one at a time)
, Replace the cartridge with a new cartridge. (3)
Meter: the meter is pulled out of the Dario device and easily connected to the smartphone headphone socket.
Once connected to the smartphone, the meter will automatically sync with the Dario app.
Dario\'s goal is to replace the independent self.
An electric blood glucose meter and kit, usually consisting of three separate components.
We have seen several key advantages of Dario devices in the market relative to traditional adhesive meters :-
Ergonomics: Dario is made of high quality materials with an excellent look and feel.
The whole device is roughly the size of a pack of gum that can be handled in the user\'s pocket or wallet. -
Integration: Dario is made with state-of-the-art electronic equipmentChemistry, blood
Standard glucose display based on measurement technology and provide familiar availability.
Dario is easily integrated with the patient\'s own smartphone (play-and-play)
With the application. -
Convenience: Dario has an integrated knife-pulling device and a disposable cartridge.
This will no longer require a separate glucose monitor, tilt device, and bring bottles, which we believe makes Dario the smallest glucose device on the market. -
Availability: The smartphone app comes with the Dario device (
Available on iOS and Android)
When the meter is plugged into the headphone jack, it starts automatically.
Software applications are key to Dario\'s user experience.
The app contains tools to help people with diabetes manage their disease.
We will discuss this application in more detail below. -
Applicability: 55% of new phone buyers buy smartphones, according to Nielsen.
Almost half of mobile phone users have smartphones, and that number is growing every year.
0. 35 billion people with diabetes worldwide, 10-
Insulin accounted for 20%.
Test their blood with a blood glucose meter every day.
In addition to Dario devices, LabStyle will also provide Dario with integrated applications for smartphones (
Currently available on iOS and Android).
As mentioned above, Dario meters work seamlessly with smartphone apps.
Dario device owners can simply download the app and when the meter is connected through the headphone jack it will automatically sync with the meter.
The application software creates a new ecosystem, similar to Apple\'s (NASDAQ:AAPL)
It has been created around iTunes, which allows users to fully connect to the platform.
Similar to the advantages of the device, the application provides a unique advantage for diabetic patients :-
Results: Dario blood glucose meter and its application made blood glucose monitoring fast and simple.
LabStyle\'s product motto for Dario is \"glucose monitoring in the mobile era \".
\"Smartphone users carry their phones with them.
Small and light Dario supports SMBG-the-go. -
Data Sync: The app records each activity, allowing users to track their blood sugar levels over time.
Logs provide users with valuable information about blood sugar control throughout the day or week or month. -
Tools: in addition to blood glucose monitoring, the app also allows users to input carbohydrates and food consumption and to track drug use and physical activity.
Dario\'s application is intended to become an all-round
Including diabetes management tools. -
Sharing: Cloud included in the app-
Based on the data center, users are allowed access to logs on their desktop, tablet, phone, or sent to their doctor, pharmacist or insurance company by email. Screen-
The photos of the Dario app are as follows :. . . . . . Dario ecosystem . . . . . . Above, we talk about the potential of LabStyle to create an ecosystem around Dario, similar to Apple\'s iPhone and
Dario\'s equipment is so small and compact that we expect users to abide by it will be high compared to independent, self-contained
A separate tilt mechanism and an electric adhesive gauge for the Test strip are required.
Seamless integration with smartphone apps synced through the cloud
Computing based on the data center allows users to store, track and analyze their blood sugar information.
Data can be exported and sent (via email)
For patients, doctors, nutritionists, pharmacists, insurance companies or other carers-giver.
Similar to consumers who accept Apple or Google\'s smartphone platform, we believe that once users enter the Dario ecosystem, LabStyle has the potential to retain users for a long time, far beyond the typical service life of the self.
Electric blood glucose meter.
LabStyle can also earn additional income from patients by selling Dario one-time test strips and patient data.
LabStyle believes that its one-time test strip is one of the best in the market today.
This bar allows blood glucose reading with only 0 in 5 seconds. 3 ml of blood.
Coding is not involved.
The Dario device uses enzyme sensors with extensive analysis (10-600 mg/dl).
Dario cartridges can accommodate 25 test strips.
LabStyle plans to be the only supplier of these proprietary strips and sell them directly to consumers (online)
Cooperate with distributors.
We note that the company has entered into a contract with a Korean supplier to supply test strips, connectors and other related components for Dario equipment.
We believe that management will seek contracts for additional supply in a timely manner.
This razor/razor blade strategy is a proven business model that offers high margin, high customer retention.
Data Display, certain types
1 diabetes test their blood up to 8-10 times a day.
LabStyle will endeavor to obtain full insurance reimbursement for test strips upon approval and will further consolidate the income stream once the patient enters the Dario ecosystem.
We also see the possibility of LabStyle monetizing patient data generated by Dario users.
LabStyle wants to provide information to contract research institutions, pharmaceutical companies and other medical device companies to help with trial recruitment and market analysis, and provide information on food and exercise programmes and their impact on blood sugar levels.
In October 2012, LabStyle completed a clinical trial to test the availability of DarioIn.
The purpose of this trial is to promote regulatory applications in Europe and the United StatesS.
The test is designed to help the first user of the Dario device use it with minimal guidance material (i. e.
Quick User Guide and iPhone app)
To demonstrate how the use of Dario equipment and related software can potentially improve compliance in patient care and in patients with diabetes.
The trial also sought to capture and understand the potential weaknesses of the device and to introduce the user to ways to overcome them and to establish the proposition that, in comparison with other devices on the market, the device can be operated by any user.
The study was carried out in Israel using the prototype of Dario\'s product, and its basic functions are combined with the simulation program of the smartphone.
A total of 61 patients with diabetes participated in the study (ages 8 to 80).
These subjects were recruited from the diabetes clinic at the Wolfson Medical Center in Tel Aviv.
More than 95% of patients completed the study.
. . . . . . Regulatory submissions . . . . . . The data from the above studies were included in the European CE Mark regulatory document held in 2012.
Equipment sold in Europe must display the CE mark prior to import or sale and must comply with the requirements of the European Medical Equipment Directive (MDD)
Or actively implanted medical device instructions/In Vitro Diagnostic instructions (IVDD).
LabStyle believes that both instructions will regulate Dario.
Management must also obtain an international organization for standardizing or ISO-
13485 certification.
ISO is an international recognized quality system and is recognized by the applicable agencies of EU member states.
The first audit of the company was conducted by EU regulators in October 2012 and management is currently completing additional technical documents for review.
The company hopes to obtain eu ce Mark certification around 2013, and plans to launch it for the first time in Germany and the United States. K.
Followed by Belgium and Scandinavia. In the U. S.
LabStyle believes Dario will be eligible to become a class
II medical devices must comply with FDA regulations on product design and development
Clinical and clinical testing, manufacturing, labeling, storage, pre-
Market clearance or approval, advertising promotion, sales and distribution.
We believe that it makes sense considering that all new glue is regulated in a similar way.
Approval of a class
II medical devices are available through 510 (k)
Notify the application before listing or approve the application before listing through section 515th (PMA).
LabStyle believes that they will be able to submit documents for Dario at a shorter, cheaper price below £ 510 (k)pathway. A 510(k)
The submission must provide information in support of its assertion that it is substantially equivalent to the assertion device.
Submissions will also include 61-
The patient study mentioned above.
We think this makes sense because the FDA allows the sale of low-risk medical devices without requiring the manufacturer to submit the PMA.
We expect a review of Dario devices after 510 (k)
Submit to be quick and event-free.
We look forward to submitting this material in the second half of 2013.
However, if the FDA does need to submit a PMA, or regulate Dario as a Category --
III. medical devices (Unlikely)
, LabStyle will require additional U. S. S.
Human clinical trials for compiling necessary data.
This will add a lot of cost and time to the United States. S.
Approval of the product.
Outside of two major markets in the United StatesS.
In the EU, LabStyle may seek regulatory clearance in some attractive markets such as Japan, India, South Africa, Russia and Brazil.
Focus mainly on the huge opportunities in foreign markets such as Japan, India and Brazil.
With respect to Brazil, all imported or distributed medical equipment must first be registered with the National Security Agency of argarcia (also known as ANVISA or the National Health Supervision Agency.
However, only companies in Brazil can apply for visa registration.
Therefore, LabStyle must either create a Brazilian subsidiary or work with Brazil-
Obtain a visa and distribute Dario\'s third party in Brazil.
. . . . . . Marketing and sales . . . . . . LabStyle innovation plans to make Dario the internet --
Direct drive productsto-
Seek to reduce consumer marketing and distribution dependent on traditional retail channels.
Besides cost-
Effective way, it eliminates the battle of shelves
The war of shaping and pricing persists when undivided consumer goods are sold in supermarkets, soups, nuts and classes competing for market share --
Medical devices.
We believe that this strategy makes sense given that Dario was designed for the \"mobile era\" and combined with downloadable smartphone apps and the cloud
Platform based on data hosting and sharing.
We doubt, like in the early days.
Dario users will be the adopters of smartphones --
Face, device and social
Be media savvy and able to adapt to the ecosystem of potential paradigm shifts in managing disease.
Therefore, we believe that Dario is well suited to this online distribution program that is directly aimed at consumers.
LabStyle\'s goal is to create effective brand awareness and significantly reduce the use of our capital resources, rather than the amount needed through traditional offline retail channels.
Having said that, we do want the company to use certain aspects of the dealer network and revenue
Share members.
We suspect this relationship will happen. for-
Including well-known online business sites.
We expect that the initial marketing will focus on the young population of people with diabetes, and then gradually expand the marketing efforts for older people with more general diabetes.
The management plan initially focused on insulin dependence (mainly type-1)
Patients with diabetes
Market research shows that although this population accounts for about 10% of the people with diabetes, it accounts for more than 50% of the income of blood glucose monitoring equipment.
On May 2011, the founder of the company submitted a Patent Cooperation Treaty (PCT)
Application of \"monitor of glucose and other body fluid content based on smartphone (
PCT/IL2011/000369)
Including two of the United States. S.
Provisional patent application filed on 2010.
These applications and all relevant intellectual property rights were transferred to LabStyle Innovations.
October 2011 the company founder
PCT covers specific processes related to blood glucose level measurement, as well as more general methods for rapid testing of body fluids.
PCT has been converted into several national patent applications.
PCT/il201/000369 for two United StatesS.
In the interim patent application, the management requires the patent application number to be the patent priority date of September 5, 2010.
Patent application number: 61/332, 778 and November 1, 201161/431,449.
Management holds advanced patent applications for PCT/il11/000369 outside the United StatesS.
Including Israel, Europe, India, South Africa, Australia, China, Japan and Brazil.
With respect to company technology, management is continuing to pursue patent protection and is preparing to submit regulatory documents in multiple jurisdictions of Dario equipment and related software.
Management is also preparing a large number of additional patent applications related to the core technology of Dario\'s products and expected future generations.
LabStyle is defining the final design of the original Dario product and continuing to develop the software through internal and outsourced resources.
In addition, management is seeking to develop new intellectual property around the next few generations of Dario hardware and software, with the goal of achieving enhanced functionality, user interface and data availability.
However, investors should keep in mind that no patent has been granted by any applicable regulatory authority.
Future product sdario and its associated intellectual property represent a platform for rapid mobile diagnostics.
Many signs are noted in its intellectual property document, each of which represents an important opportunity.
These include blood coagulation tests (PT/INR)
The global $700 market, HIV testing and monitoring, $1 billion opportunities, and other programs such as pregnancy and cholesterol testing, each with more than $1 billion opportunities. Risk -
Competition we think Dario is a big leap forward in diet and diabetes management.
This is an elegant design, thanks to the software applications and ecosystems that management has tried to build around the entire platform, it provides users with a better experience and monitoring capabilities.
Nevertheless, LabStyle is entering a highly stable market, with major market competitors including Roche, Bayer HealthCare, Abbott Labs, all backed by a large amount of marketing funds, production of cheap alternatives
Sales Representative, insurance reimbursement and auxiliary treatment agent.
In addition to these four main participants, there are several small, new entrants to the Glucose Monitoring Market, which will provide competition for LabStyle Innovations Corp.
On the device side.
In terms of application, we found
More than a dozen diabetes apps in the ITunes App Store (or iOS devices).
LabStyle\'s app is designed to work seamlessly with Dario devices.
People with diabetes are free to use other diabetes apps as well as Dario and Dario apps.
However, LabStyle innovation
Not the only company trying to capture a smartphone revolution or take advantage of the cloud
Attract patients and build an ecosystem for patients based on computing and social media/shared applications.
. . . . . . On the device . . . . . . Dario was designed for himself.
Blood glucose monitoring (SMBG).
Despite the elegance of the Dario device, it still requires a balance mechanism and a test strip.
Several companies are conducting continuous blood glucose monitoring (CGM)
Platforms that may make SMBG products less common, or at least both systems have patients who may test their blood less frequently (
Less sales of test strips)
Than those without a CGM system.
Let\'s focus on two of these products.
We don\'t think either of these apps is a \"killer app\" that will make Dario obsolete, but they both represent competition and another potential paradigm shift --
Revolution, not evolution.
For diabetic patients with complete lack of insulin.
That is to say, the two devices below still need to be calibrated regularly and people with diabetes can use SMBG and CGM systems.
Other companies have grown.
Small, stylish gluters using smartphones on iOS or Android operating systems.
However, none of these devices combine all three components of the SMBG test suite, and most require people with diabetes to carry devices other than smartphones and blood glucose meters.
We consider Dario devices to be the leading product in the shift to small, smart SMBG devices.
In addition, the combination of cloud
Computing based on application-driven devices is innovative in this field.
Echo therapy (OTC:ECTE)
It is the prelude to SkinPrep and Symphony iCGM installations in developing countries.
Prelude SkinPrep is a platform technology for painless and significantly enhancing skin penetration.
There are no leverage mechanisms and test strips used for Overture and symphonies.
On the contrary, the skin is prepared with a Prelude device (painlessly)
Remove the top layer of the skin, called the corneal layer.
The Symphony device is worn on the abdomen of the skin area prepared by the prelude.
Symphony measured blood sugar through penetration
Chemical glucose sensor
Symphony contains wireless transmitters compatible with ICU software and paired with remote monitors.
Echo\'s Prelude SkinPrep and Symphony iCGM platforms are mainly aimed at Hospital diabetic patients with severe care, complete insulin deficiency
Or elevated blood sugar.
Echo is preparing to launch its CE mark and the United StatesS. PMA (Key procedures)
This platform.
We don\'t think the Prelude/Symphony platform will pose a direct threat to rabstyle and Dario.
LabStyle has been ahead of Echo for many years, and Echo currently focuses on in-
Hospital intensive care unit.
However, this first
A generation of products offers a glimpse of what glucose monitoring might be heading for the next decade.
8 MediSensors, Inc.
A wearable continuous blood glucose monitor synchronized with a user\'s smartphone is being developed.
Like Symphony iCGM, the optical glucose monitor (OGM)
Blood sugar levels are measured without the need for a lever mechanism or test paper.
The device is worn on the skin and is wirelessly output to a smartphone, providing painless and continuous monitoring of glucose levels.
The c8-medisensors OGM has impressive software and integrates with downloadable applications.
The potential impact on the device is the accuracy of reading glucose levels via skin optics, so the device is being designed by the c8-medisenors with the idea of supplementing conventional glue rather than replacing them.
Another obvious blow to the c8-medisensors OGM is the cumbersome, cumbersome design.
The device is secured in place with a belt/package and Velcro.
It\'s in the middle.
The abdomen, right above the abdomen. button.
The picture above is a relatively healthy individual.
We question the wear resistance of the device in patients with higher BMI.
We can see that the equipment is hot or uncomfortable.
The equipment is currently for research purposes only.
We don\'t expect to see it in the market in a few years.
This is
Generation of products, so the absorption may be very low and retained to the most serious type1 diabetics.
However, like Echo\'s products, the c8-medisensors OGM allows investors to understand the market trends of SMBG.
Telecom Medical Supply Co. , Ltd.
Telcare BGM equipment has been developed.
Telcare BGM offers many of the same features Dario offers, including stylish devices with clouds
Data-based hosting (
Called Telserve Hub)
Syncing with mobile smartphones, data analytics applications, and ecosystems designed to provide test strips and add-ons
Provide services to patients.
It does not require coding, personalized features, rechargeable batteries, small blood samples and quick results.
The problem with Telcare BGM is that it is a device separate from the user\'s smartphone.
It even looks like a smartphone.
We question why users would want to carry two devices the size of their smartphones and a financing mechanism once Dario goes public.
LabStyle\'s Dario product takes the Telcare BGM concept to a new level.
Telcare BGM is currently listed in the United States. S.
The retail price of the product is $149.
95, including equipment, 10 lanc knives and 10 test strips. Sanofi-aventis (NASDAQ:SNY)
Developed a very stylish little device called iBGStar.
The device has dock connector compatible with iPhone or iPod Touch
The USB port of the power adapter or the USB port connected to the PC, with port, and the test result display area.
IBGStar is designed to work with the iBGStar mobile app on the iOS platform.
The mobile app provides only a subset of the Dario app, allowing for the sharing of analysis test results, automatic sync, tracking data, historical data storage, dynamic graphics, home or healthcare.
There are two problems we see on iBGStar. fold. No.
1. the device does not contain lancet.
IBGStar comes with a separate lancing device about the size of a lip balm.
This is an additional device that the patient must carry compared to Dario.
Each time the device is used, a new bayonet and a bayonet cap must be inserted together.
Another shock to iBGStar is that the dock is the old iPhone 30-
Pin dock for IPhone 4 or below.
It has no new Apple lighting connection.
The user must purchase this adapter separately for about $30.
In addition, iBGStar is not compatible with Android devices that account for more than half of the smartphone market.
IBGStar\'s retail price in Walgreens is about $75, and the retail price of proprietary test strips is about $1. 30 each.
Medisana AG has developed GlucoDock, a product very similar to Sanofi\'s iBGStar.
We see that the difference between GlucoDock and iBGStar is very small.
It has the same features and the same features, which will limit use, including Dario\'s lack of advanced software and lifestyle integration such as a food database and insulin dose recommendation.
GlucoDock is currently unavailable in the United States. S.
It is available in parts of Europe and retails for 100 euros.
. . . . . . On the software/application . . . . . . Many of the above products have their own software applications that can be synchronized with the device.
The app is free if you buy the software, and if you don\'t buy the device, the app is of little use.
Our search on the iTunes store found more than 20 separate diabetes apps designed to compete with the Dario app.
None will automatically sync with the device.
However, currently patients with diabetes
A separate glue like a free mini or a one-button Ultra may have downloaded a separate
Apply separately.
Recently published an article on clinical diabetes in the fall of 2012 (Tran et al. , Vol. 30:173-178)
Review several of the leading diabetes apps in the iTunes store.
Most of them spend money.
We have compared these applications to the Dario applications.
It\'s clear that LabStyle \"understands\" what people with diabetes are looking for in the app.
LabStyle\'s management believes that the Dario app contains many other unique add-ons that further differentiate it from existing competitors.
These include the ability to burn calorie trackers, insulin recommendation and dose calculations, generate reports and charts, and other measurement sharing tools, sugar profile plans and alarm systems, and the cloud-
Based on access to patient data.
Market Opportunities and sales forecasts are aimed at huge market opportunities.
The World Health Organization estimates that there are about 0. 35 billion people with diabetes worldwide (~90% type-2 diabetics).
In Europe, there are about 52 people with diabetes.
According to Frost & Sullivan, there were 6 million people in 2011, about 25.
8 million diabetes patients in the United StatesS.
According to data from the American Diabetes Association, 2011.
Another $79 millionS.
Pre for adults-
Diabetes, which makes them at a high risk of developing type 2 diabetes.
There are about 0. 138 billion adult diabetes patients in China and India, and about 10 million in Russia.
The medical journal Lancet reported that the number of diabetes patients worldwide has doubled in the past three decades.
While 70% of the increase is due to population growth and aging, this balance is associated with dietary changes, rising levels of obesity and reduced physical activity.
Diabetes is an increasingly popular disease and there is no cure, but the treatment (
Including frequent blood glucose testing programs)are available.
It is estimated that the cost of diabetes complications accounts for 5% to 10% of the world\'s total health care expenditure.
Early diagnosis of early warning signals and continuous monitoring of diabetes are the key to disease prevention and treatment, blood glucose monitoring is the main method of diagnosis and disease management, blood glucose reading matching food (i. e. , carbohydrate)
And the intake of insulin or other drugs.
Self-blood sugar
Monitoring is a key part of managing diabetes, and there is also a large market for SMBG products needed to provide services to these patients.
According to research firm Visiongain, the global SMBG market is worth $9.
$7 billion in 2011 and $27 in the global diabetes monitoring equipment market.
42 billion to 2022.
The company estimates that the global market for SMBG test products is $1.
1994 7 billion.
By 2000, the market has reached about $3.
Global sales of these products climbed to $8 billion by 2008. 8 billion.
It is estimated that the US economyS.
40% of the SMBG market, about $3.
At 9 billion, Frost & Sullivan estimates that Europe accounts for $3.
In 2011, 97 billion of the market.
According to the available data, the compound growth rate of SMBG market is 12%.
Key factors driving market growth include an increase in the population of diabetes, increased awareness of patients, advances in technology, and more self-control of blood sugar in patients. monitoring.
In addition, the price of blood sugar test paper is reasonable and the daily monitoring is increasing, which is expected to help the market growth.
So we think the SMBG market is a huge and attractive opportunity for a new medical device.
However, with the increase in the number of diabetic patients with smartphones, LabStyle will be limited. In the U. S.
According to Nielsen, 55% of new handset buyers bought smartphones as their new phones.
Total percentage of smartphones
There are nearly 50% old phones.
According to data from international data companies, iOS and Android control 91% of the smartphone market (
As of February 2013).
We also see an increasing number of patients and doctors receiving apps for mobile health or mobile health.
According to a 2010 study by research2 guidance, smartphone applications will bring the mobile healthcare industry to 0. 5 billion.
Global smartphone users reached 4 billion in 2015.
An article published in October 2009 in Diabetes, Obesity and Metabolism (Vol. 11:913-930)
It was concluded that the mHealth app had a positive impact on the use and blood sugar control of many health services (
Polisena et al. , 2009).
We believe that the reasonable assumption is that the percentage of smartphone users with diabetes reflects the percentage of the general population, and Dario was designed to be directly involved in the three trends mentioned above --
More and more people with diabetes, more and more smartphone users, and the rapid adoption of mHealth applications.
We have established a detailed financial model to predict the sales of Dario equipment and related accessories, including test strips and application software add-ons.
Here is our statement on the model of the EU and the United StatesS.
We do not model Dario equipment sales outside the EU or the USS. as of now.
We will add these projections to our model based on regulatory opinions from countries outside these regions.
For sales in Europe, we suspect that the company will sign a distribution agreement with the leading medical supplies company in a countryby-county basis.
For example, on April 25, 2013, the company signed an exclusive distribution agreement with Farah Medical.
Dario\'s distribution in the United StatesK. and Belgium.
For the purpose of modeling the price, we suspect that LabStyle will actually \"give way\" to new users of Dario devices, at least early in the release, to gain market share.
Similar to the \"razor/blade\" model, most of the money is earned on consumables.
Give away a device that could retail for $75 (and costs $25)seems counter-
Intuitive until you realize the test strip, it may be sold for $0. 50-$0.
$75 each, only $0. 10-$0.
When we consider the average type, per is a more profitable business.
1 diabetes patients can use 7 items per day.
We see that LabStyle\'s Dario device has a meaningful absorption.
Only a handful of major companies such as Roche, Johnson & Johnson, Bayer HealthCare, Abbott Labs and Sanofi dominate the sales of glucose measuring instruments and test stripsAventis.
Each of the big players above holds 10-
Market share 15%.
We believe that, given the differentiated features of this device, LabStyle Innovations and Dario can be key players in this area.
In addition, the medical perspective behind the improvement of SMBG is clearly.
A paper published in December 2009 on current medical research and opinions (Vol. 25-No. 12:2903-2913)
Entitled \"self\"
Blood glucose monitoring in non-diabetic patients
Systematic review and meta-analysis of insulin therapy for patients with type 2 diabetes
The conclusion of the analysis \"is that SMBG is compared with non-SMBG
SMBG is associated with significant improvement in non-glucose control
Type of insulin therapy2 diabetes.
We think LabStyle is good.
Be able to take advantage of several emerging trends such as SMBG, more smartphone users and cloud computingbased / app-Based on computing.
For the European market, we assume a distribution model in which companies lose little or break even on equipment and then get about 50-
60% per article. For the U. S.
In the market, we assume that more is the direct sales model, in which the company loses money on the equipment and then gets about 70-
80% per article.
We assume the average Type-
7 Diabetes tests per day, average insulin-dependent Type-
Test 3 times a day.
We note that the company is targeting developed countries with a large population of diabetes such as Japan, China, India and Brazil.
The Middle East and Russia also offer significant opportunities.
Before the United States, it was much harder to predict the market share of these countries. S.
And the start of the EU, so we temporarily postponed modeling sales outside the United States. S. or EU.
We are also delaying modeling sales of data generated by the application software or Dario users until we have a better understanding of the future plans here.
On May 10, 2013, LabStyle announced that it had completed financing of $10 million by selling common shares and warrants to a group of accredited investors.
Company sales 4.
Million units, $2.
Each of the 50 units consists of 1 and 0. 5 warrants.
Warrants can be exercised at $5.
00 per share, due in early April 2016.
The total net process for the issue was approximately $9 million.
We believe the company is good.
For the foreseeable future, finance businesses including the launch of Dario in the EU.
Small boot coverage with the purchase of RatingZacks-
Cap Research is launching a report on LabStyle Innovations.
Buy rating.
We believe that Dario is elegantly designed with excellent usability and accessibility through integrated pockets
Size blood glucose meter with smartphone and mobile app.
Dario combines a funding facility, a disposable belt box, and a glucose monitor with a connection plug inserted into the smartphone\'s audio jack.
This is the first and only product we have seen so far that combines all three components with intuitive and valuable applications.
We believe that Dario\'s blood glucose meter and diabetes management system are revolutionary in design and function.
Dario, along with sales of one-time test strips, mobile apps, community and physician interaction software, represents a $0. 5 billion peak opportunity for LabStyle innovation in the USS. and EU.
We have established a positive sales model for Dario equipment, based on our belief that the company can occupy 5 to 10% of the market share in the United StatesS. and EU.
Based on the significant difference between the product and the product, this seems achievable
It\'s easy to buy today and the price is similar.
Only a few major companies such as Roche and Johnson & Johnson dominate the sales of glue come and test strips (NYSE:JNJ)
Abbott laboratory, Bayer Healthcare (NYSE:ABT), and Sanofi-Aventis.
Each of the big players above holds 10-
Market share 15%.
We believe that LabStyle Innovations and Dario can be major players in this area, taking into account the different features of the above-mentioned devices.
Based on this model, we think these stocks are obviously insufficient.
$12 per share.
Disclosure: I do not have a position in any of the stocks mentioned, nor do I have a plan to start any position in the next 72 hours.
This article was written by myself and expressed my views.
I was not compensated.
I have no business relationship with any stock company mentioned in this article.
Comments
Post a Comment