CAESAREA, Israel, Dec. 18, 2017 /PRNewswire/ — DarioHealth Corp. (Nasdaq: DRIO), a leading global digital health company with mobile health and big data solutions, announced today that it received the Therapeutic Goods Administration (TGA) Mark for its Lightning®-enabled version of the acclaimed Dario™ Blood Glucose Monitoring System in Australia. The regulatory approval ensures that consumers in the Australian market will be able to receive the same quality user experience with DarioHealth on the latest Apple devices, including the brand-new iPhone 8 and iPhone X.
The launch of Apple’s smartphones with only a Lightning® connector posed a unique challenge to the entire mobile ecosystem. With today’s announcement, DarioHealth can now successfully offer its proprietary glucose meter with either a 3.5mm headphone jack or Lightning® connector to users in Australia.
“We are thrilled to announce that DarioHealth secured TGA approval to offer the Lightning®-enabled version and can now accommodate users in Australia who have updated their Apple devices,” said Erez Raphael, Chairman and CEO of DarioHealth. “We hope to help the 1.7 million Australians who have diabetes, specifically the more than 100,000 Australians who have been diagnosed with diabetes in the past year.”
In addition to the TGA approval, users in the U.K. will be able to purchase the Lightning®-enabled Dario device at the end of this month while sales of the device will begin in Australia by January 2018. DarioHealth is still waiting on approval from regulatory agencies in the U.S. and Canada, which is expected in the coming months.
About DarioHealth Corp.
DarioHealth Corp. is a leading global digital health company serving tens of thousands of users with dynamic mobile health solutions. We believe people deserve the best tools to manage their treatment, and harnessing big data, we have developed a unique way for our users to analyze and personalize their diabetes management. With our smart diabetes solution, users have direct access to track and monitor all facets of diabetes, without having the disease slow them down. The acclaimed Dario™ Blood Glucose Monitoring System all-in-one blood glucose meter and native smartphone app give users an unrivaled method for self-diabetes management. DarioHealth is headquartered in Caesarea, Israel with a regional office in Burlington, Massachusetts. For more information, visit http://mydario.investorroom.com/.
Cautionary Note Regarding Forward-Looking Statements
This news release and the statements of representatives and partners of DarioHealth Corp. (the “Company”) related thereto contain 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. For example, when the Company describes that it anticipates offering a Lightning®-enabled version of the acclaimed Dario™ Blood Glucose Monitoring System in Australia by January 2018 and by the end of December 2017 in the U.K., it is using 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 timing for and results of the Company’s commercial and regulatory plans for 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.