LabStyle Innovations Announces Positive Continuation of Dario™ Rollout In New Territories and Provides Update on Recent Milestones
Market reach continues to broaden with positive feedback and interest for the Dario™ Diabetes Management Solution
Oct 15, 2014
CAESAREA, Israel, Oct. 15, 2014 /PRNewswire/ -- LabStyle Innovations Corp. (OTCQB: DRIOD), developer of the Dario™ Diabetes Management Solution, today announced that it is ramping up its market reach over the coming months with the initial product launch in Canada and the Netherlands.
The launch of Dario™ in Canada and the Netherlands represents a positive continuation of LabStyle's worldwide initial rollout of the product, which has been ongoing since late March 2014. LabStyle will launch Dario™ in these new jurisdictions with distribution partnerships already in place and with positive consumer feedback in existing launch locations (including via social media and LabStyle's online marketing campaign) beginning to drive more interest in Dario™ in new locations. This is a trend that LabStyle hopes to continue in the coming months as Dario™ is rolled out in an increasing number of jurisdictions and as the company looks to generate initial revenues from sales with an objective towards potential U.S. approval of Dario™ in early 2015.
Dario™ is a cloud-based, diabetes management solution which includes novel software applications combined with the patented, 'all-in-one', pocket-sized Dario™ Smart Meter that interfaces with a user's mobile device.
"We are very excited about the upcoming product release of the Dario Smart Meter and Management Solution in these new jurisdictions." stated Erez Raphael, President and Chief Executive Officer of LabStyle Innovations. "With Dario, diabetes management is not only about generating accurate blood glucose measurements but also gathering and providing practical information, analysis and suggestions, including via social community channels, to help those with diabetes make better informed decisions and improve their lifestyle. The launch in the new markets and in North America in particular is an important step in bringing Dario to the huge population of people with diabetes. We are now able to take the lessons learned from our soft launch which began earlier this year and put this knowledge to use in our new markets."
The Canadian market is promising for Dario™ as according to the Canadian Diabetes Association, more than 20 people are diagnosed with diabetes every hour of every day and it is estimated that there are approximately two million Canadian diabetics.
LabStyle also provided an update on the following milestones as the company continues to implement its global rollout and user acquisition plans for Dario™:
- As scheduled, the launch of the Android supported Dario™ Smart Meter and app occurred during the month of September 2014. This was a positive addition to the Dario™ community as according to IDC, 80% of the smartphone market is Android device users.
- The product launch has been ramped up in New Zealand and the United Kingdom and positive feedback is being received from users of the Dario™ Smart Meters. The product launch in Italy has been paused in order to reevaluate the Italian marketing strategy and leverage data accumulated regarding the Italian market.
- The Dario app has been downloaded by tens of thousands of users worldwide, and LabStyle is working to convert these app users into Dario Smart Meter device users.
- Reimbursement for the Dario™ Smart Meter has been obtained in the initial Dario™ launch markets. Achieving approval for insurance reimbursement allows LabStyle to reach more users through deeper market penetration. LabStyle believes that this will create a more loyal user base with better customer pick up rates. Reimbursement strategies are being pursued in the additional targeted markets.
- As previously announced, LabStyle's 510(k) for Dario™ has been submitted and is currently under review by the FDA. LabStyle is now in the process of making relevant adjustments in accordance with interactions with the FDA. LabStyle hopes to receive FDA clearance of Dario™ in early 2015 and to launch the product in the U.S. during 2015.
About LabStyle Innovations Corp.
LabStyle Innovations Corp. (OTCQB:DRIOD) develops and commercializes patented technology providing consumers with laboratory-testing capabilities using smart mobile devices. LabStyle's flagship product is the Dario™ Diabetes Management Solution. Dario™ received CE mark certification in September 2013 and began a world rollout in select countries in December 2013. LabStyle filed a Premarket Notification Application, also known as a 510(k), with the US Food and Drug Administration (FDA) for the Dario™ smart meter (Dario™ Blood Glucose Monitoring System) in December 2013. LabStyle is pursuing patent applications in multiple areas 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. For more information: www.mydario.com and http://mydario.investorroom.com.
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 risks discussed in the Company's filings with the U.S. Securities and Exchange Commission. Readers are cautioned that actual results (including, without limitation, the results of the Company's commercial and regulatory strategies and plans for Dario™ as described herein) 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.
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