RAMAT GAN, Israel--(BUSINESS WIRE)--LabStyle Innovations Corp. (OTCQB: DRIO), developer of the Dario™ smartphone-based diabetes management system, announces that its common stock is now trading on the OTC Market’s OTCQB marketplace and the OTC Bulletin Board under the ticker symbol DRIO.
LabStyle’s Chairman and Chief Executive Officer, Dr. Oren Fuerst, is also providing an update on the company’s business strategy and plans via the following Letter to Stockholders:
Dear Current and Prospective Stockholders,
The commencement of trading of our common stock marks an important accomplishment in the development of LabStyle Innovations and our Dario™ diabetes management system. We are very proud of this important milestone and are pleased that public equity investors can now participate in the growth of our company as we prepare for the anticipated 2013 commercial launch of our first product Dario, which will address the multibillion-dollar global market for self-monitoring of blood glucose (SMBG) for diabetic patients.
I would like to highlight the considerable progress we have made in developing Dario, and give you a sense of what we are looking to achieve throughout the balance of 2013.
Since our founding in 2011, our focus has been on developing a product that vastly improves the user experience for the millions of people with diabetes who self-test their blood glucose levels. Dario’s motto, “Nothing holds you back,” was chosen to capture that new experience. We believe Dario will be the perfect glucose management solution for people who lead a modern, active lifestyle and crave the freedom to control and improve their condition. We are so excited about the prospects for Dario that we have chosen the stock symbol DRIO to capture the essence of our company and its product offering.
Roughly the size of a pack of gum and significantly smaller than traditional blood glucose meters, Dario is a stylish, all-in-one patent-pending device and software system that integrates with the audio jack of a patient’s smartphone to create a novel SMBG system designed to encourage usage. Dario boasts technology and features far beyond what competing devices offer, and Dario does not require a battery or charging due to its smartphone integration. We believe that the ease of use of Dario will support more frequent testing by patients, which in turn creates the potential for better diabetes management.
Unlike traditional SMBG kits that have several components, Dario is an all-in-one device that consists of a lancet to obtain a blood sample, a cartridge to store proprietary disposable test strips and a glucose reader adaptor to hold the strip and interface with a smartphone, coupled with a smartphone app and internet-based (cloud) data services. Our goal is to offer diabetics, and in particular insulin-dependent diabetics, an innovative and fresh new option to the more cumbersome, standalone SMBG test kits that are the current market standard. Frankly, it is difficult to tell one of those legacy devices from another in terms of design and functionality, and we believe that the SMBG field is ready for a true innovation.
Due to its integration with smartphones, Dario comes with a state-of-the-art mobile app for diabetes management that has an attractive and intuitive user interface that enables the tracking of daily progress wherever users might be. The app’s log is an on-the-go solution to keep track of a patient’s activity and progress where users can easily record blood glucose measurements but also other key variables in diabetes management including carbohydrate and food consumption, medication and physical activity. Dario also features an Event Chart to glance back a week, a month or even a year, providing valuable information to users and their caregivers. The Event Chart allows users to analyze and identify trends and areas for improvement. Simply by clicking an on-screen button, the Event Chart will be able to be transmitted to a patient’s doctor directly via the smartphone, eliminating the need for cumbersome hand-written logs. The system also includes a variety of reminders and alert tools to enhance diabetes care by caregivers such as family members, as well as by clinicians.
Near the end of 2012, we filed for the CE mark for Dario in Europe. We expect it to be granted later this year and plan to begin offering Dario and its proprietary test strips in Germany and the U.K. via distributors soon thereafter. Each of these markets has more than 1 million insulin-dependent diabetics. Later in the year, we plan to roll out Dario on a country-by-country basis in Europe, with initial targets including Belgium and Scandinavia. Our plans also include launching Dario in the U.S., India, Brazil and Japan once we obtain applicable regulatory approvals.
We expect to generate revenue from our razor/razor blade revenue model (meaning only our proprietary strips can be used with the Dario device) as we sell increasing numbers of high-margin test strips. Importantly, third-party reimbursement for test strips is well established in all target global geographies.
The Dario iPhone app has been approved by Apple and will be available for download from the European app store as soon as the CE mark is obtained. We plan to have the Android app available later this year. In preparation for commercial launch, we have engaged a U.S. contract manufacturer for the glucometer with ISO and cGMP (U.S. Food and Drug Administration designated current Good Manufacturing Practices) compliant facilities and deep experience with medical devices. We also have contracted with the supplier of the Dario test strips in Asia.
In short, we are ready to begin bringing the Dario experience to the European market upon receipt of the CE mark.
To acquire and retain customers, we plan to implement highly cost-effective consumer online advertising and engagement with social networks, with a strong emphasis on the use of social media augmented by select print advertising and public relations. We have engaged specialist agencies and consultants in each of these marketing disciplines.
Because social media and our online presence will be important selling tools, we have created a website that mirrors the cutting-edge design of Dario. I invite you to visit www.mydario.com where you will find an engaging site focused on the user experience including instructions for use, and once it is approved, a means of purchasing Dario. The website also contains links to information for diabetics along with influential blog sites and a forum for discussion. The interactivity of the site should engage patients, and provide another means of encouraging more frequent testing.
We have an exciting and eventful year ahead of us. We are looking forward to meeting our challenges and achieving a better experience for the growing number of SMBG diabetics, while creating value for our stockholders. On behalf of our board of directors and employees, we welcome you to LabStyle Innovations and Dario!
Oren Fuerst, Ph.D.
Chairman and Chief Executive Officer
About Diabetes and Blood Glucose Monitoring
Because patient self-monitoring of blood glucose is a key part of managing diabetes, the market for SMBG products is very large, well established and growing. According to research firm Visiongain, the global market for diabetes monitoring devices was $9.7 billion in 2011 and is expected to reach $27.4 billion by 2022. Frost & Sullivan estimates that the U.S. and Europe each represented 40% of this market in 2011.
Key factors driving market growth include the increasing number of people with diabetes, growing patient awareness of the benefits of regular testing, technological advancements and more patients adopting blood glucose self-monitoring. In addition, the affordable cost of blood glucose test strips and the continuing evolution towards more frequent daily blood glucose monitoring also are expected to contribute to market growth.
The World Health Organization estimates that 350 million people have diabetes worldwide, and Frost & Sullivan estimates that the worldwide diabetic population will reach 438 million by 2030, or approximately 7.8% of the world’s adult population. In Europe the diabetic population was approximately 52.6 million in 2011 according to Frost & Sullivan, and in the U.S. there are approximately 25.8 million diabetics, according to the American Diabetes Association. It is estimated that 80 million insulin-dependent diabetics worldwide engage in self-monitoring of blood glucose.
About LabStyle Innovations
LabStyle Innovations Corp. is developing and commercializing a patent-pending technology that is seeking to bring laboratory testing capabilities to consumers in a distinctive, easy to use and affordable way through the use of smartphones such as iPhones. LabStyle’s initial product is Dario™, a stylish, easy-to-use device and software system that will compete in the multibillion-dollar market for patient self-monitoring of blood glucose (SMBG) products. Dario is a comprehensive, patent-pending system that combines an all-in-one SMBG device consisting of a lancet (to obtain a blood sample), a device-specific disposable test strip cartridge and a smartphone-driven glucose reader adaptor, coupled with a smartphone app and internet-based data services. Founded in 2011 as a Delaware corporation with offices in Ramat Gan, Israel, LabStyle has since 2011 undertaken three rounds of private financing, raising more than $5 million from approximately 100 private investors. The company has become a publicly reporting and trading company through a self-managed SEC registration process.
Cautionary Note Regarding Forward-Looking Statements
This news release and the statements of representatives of LabStyle Innovations Corp. (the “Company”) related thereto contains or may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “plan,” “project,” “seek,” "may," "will," "expect," "believe," "anticipate," "intend," "could," "estimate" or "continue" are intended to identify forward-looking statements. Readers are cautioned that certain important factors may affect the Company's actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release. Factors that may affect the Company's results include, but are not limited to, regulatory approvals, product demand, market acceptance, impact of competitive products and prices, product development, commercialization or technological difficulties, the success or failure of negotiations and trade, legal, social and economic risks, the risks associated with the adequacy of existing cash resources. Additional factors that could cause or contribute to differences between the Company's actual results and forward-looking statements include, but are not limited to, those discussed in the Company's filings with the U.S. Securities and Exchange Commission. Readers are cautioned that actual results (including, without limitation, the timing for regulatory approvals for, and the commercial launch of, Dario) may differ significantly from those set forth in the forward-looking statements. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.