RAMAT GAN, Israel--(BUSINESS WIRE)--LabStyle Innovations Corp. (OTCQB:DRIO), developer of the Dario™ smartphone-based glucose monitor and comprehensive diabetes management system for patients and caregivers, announces its receipt of CE mark approval to market Dario. The granting of the CE mark allows Dario to be marketed and sold in 32 countries across Europe as well as in certain other countries worldwide. LabStyle expects to commence an initial soft launch of the product in Europe in the coming months, with the goal of collecting customer feedback to refine its longer-term roll-out strategy.
Further, the company is expecting in the near future to launch the Dario application (app) in Europe to be used in conjunction with other glucose monitors in the marketplace, allowing customers to experience the novel features of the Dario software. With CE mark approval in hand, LabStyle also plans to accelerate its ongoing efforts to prepare and file with the U.S. Food and Drug Administration a 510(k) application for marketing approval of Dario in the United States. This will be followed by regulatory programs in Asia and South America.
“Receipt of the CE mark for Dario is a tremendous milestone for our company and for diabetics across Europe who soon will have a fresh and comprehensive approach to monitoring their blood glucose and managing their disease,” said Dr. Oren Fuerst, LabStyle’s Executive Chairman and co-Founder.
“We are now able to initiate and refine our initial and longer-term launch and marketing strategies for Dario in Europe in just a little over two years since LabStyle was founded, a truly remarkable accomplishment. As previously reported, we have third-party manufacturing for the Dario device and test strips in place and we are preparing to scale-up manufacturing in a manner necessary to support our roll-out. Also as previously reported, we have secured leading distributors for Dario to help us reach customers in the U.K., Italy and Belgium in tandem with our online marketing programs. We are making progress in launching innovative online marketing strategies in other countries, including Germany. We are also actively pursuing third-party reimbursement in our key target geographies in Europe, which we expect to be in place for our soft launch to occur in the coming months.”
“Moreover, the Dario app, which is the key component of our all-in-one system, has been approved by Apple and will be available in the near future as a free download to European iPhone and other iOS devices users,” added Dr. Fuerst. “This means that every diabetic in Europe can soon experience some of the novel functionality of the Dario app even without using the Dario device itself. Over time, we expect to add additional features and functionality in making Dario the new standard of care in diabetes data management. We expect Dario to be the first truly social diabetes management system, with communities of users learning to appreciate and sharing its attributes and benefits. We believe this will only strengthen the value proposition for Dario.”
“We are very pleased to have achieved this important milestone, as we now can formally begin our transition from an R&D-stage company to a commercial enterprise,” stated Erez Raphael, LabStyle’s President and CEO. “The key target populations for Dario are type 1 diabetics as well as insulin-dependent type 2 diabetics, who represent 15% to 30% of the diabetic population and typically test themselves multiple times a day. We will place particular emphasis on these populations as they account for a majority of test strips sold in the market. Our strategy is to commence an initial launch of Dario and gain critical feedback from the market, which we will use in tandem with our partners to further refine our design, marketing and intellectual property programs as we advance to full commercial sales over the next 12 months. Importantly, with CE mark in hand we look forward to accelerating our regulatory approval process in the U.S. and elsewhere during the remainder of 2013.”
Dario is a comprehensive system that combines an all-in-one self-monitoring of blood glucose (SMBG) device consisting of a lancet to obtain a blood sample, a novel disposable test strip vial and a glucose reader adaptor to hold the strip and interface with the smartphone, with a smartphone application and internet-based data services. Among other features, the Dario app includes a data log for blood glucose, food intake, insulin recommendation and analysis, and data sharing tools.
Dario is expected to be particularly useful to insulin-dependent patients who check their blood glucose levels multiple times each day, and represents an innovative alternative to the more cumbersome, standalone SMBG test kits that are the current market standard. Dario’s ease of use is expected to improve testing compliance and increase monitoring. In addition, Dario will provide patients, caregivers and clinicians both real-time and historic data with the goal of better management of blood glucose levels and improved health.
Simple, personal and feature-rich, Dario is poised to revolutionize the self-monitoring of blood glucose. Designed to help type 1 and insulin-dependent type 2 diabetics better manage their lives, Dario is an integrated device and software system that facilitates regular testing and the capture and sharing of critical data, which in turn results in better glycemic control, improved health and lower healthcare expenditures.
Dario’s contemporary design ensures the product complements a user’s lifestyle, with no shame or embarrassment. The compact all-in-one device contains a lancet to obtain a small drop of blood, a strip dispenser and a glucose reader adaptor to hold the strip and interface with a smartphone. The adaptor plugs into the smartphone’s audio jack, and combines with a free app and internet-based data services for unmatched functionality.
With Dario users can enter information about food intake (for comparison with a database on carbohydrates, calories and more), exercise and physical activity, and use a proprietary insulin calculator to determine the correct dose. Self-reported data along with blood glucose results are analyzed and stored, and real-time, historical or tailor-made data can then be shared with physicians, nurses, dieticians, caregivers and others.
Dario provides alerts for abnormally high or low glucose levels, while logs, charts and graphs provide an intuitive and clear display of data, all of which is saved via cloud and syncs automatically with the application and web portal. Frequent testing with Dario is encouraged by multiple reminder systems, virtual rewards and online competitions.
Recognizing that regular SMBG is but one element in managing diabetes, www.mydario.com allows users to participate in a growing online community of fellow diabetics, share stories, exchange tips and support one another. LabStyle is committed to keeping Dario fresh and plans for regular updates and improvements, including new functionality and new web portals.
About LabStyle Innovations
LabStyle Innovations Corp. has developed and is commercializing a patent-pending technology that seeks to bring laboratory-testing capabilities to consumers in a distinctive, easy-to-use and affordable way through the use of smartphones such as iPhones and Androids, and other mobile devices. LabStyle’s initial product is Dario™, an integrated medical device and software system addressing the market for patient SMBG products, which is estimated to exceed $10 billion worldwide. Dario is a comprehensive, patent-pending system that combines an all-in-one medical device consisting of an integrated lancet (to obtain a blood sample), a device-specific disposable test strip cartridge and a smartphone-driven glucose reader adaptor, with a smartphone app and cloud-based data services. Dario is approved for marketing in Europe. LabStyle is pursuing patent applications in multiple jurisdictions covering the specific processes related to blood glucose level measurement as well as more general methods of rapid tests of body fluids using mobile devices and cloud-based services.
Cautionary Note Regarding Forward-Looking Statements
This news release and the statements of representatives and partners 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,” “potential,” “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, and 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, those related to the anticipated commercial launch of Dario in Europe and the Company’s regulatory programs in the U.S. and elsewhere) 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.