RAMAT GAN, Israel -- (BUSINESS WIRE) -- LabStyle Innovations Corp. (OTCQB: DRIO), the developer of the Dario™ smartphone-based glucose monitor and diabetes data-management system, today announced that Shoshana (Shosh) Friedman has joined the company as Vice President Clinical and Regulatory Affairs, with responsibility for all clinical studies and worldwide regulatory affairs for Dario.
“Ms. Friedman is a highly regarded executive who brings to her new position more than 20 years of experience in regulatory affairs, clinical trials and quality assurance for medical devices and biotechnology products. Over the past two decades, Shosh has expertly guided medical companies in the implementation of their clinical and regulatory strategies as an integral and critical part of their preparation for entrance into markets around the world, and we are grateful to have her on our team,” commented Erez Raphael, LabStyle’s President and CEO.
“In addition to all that Shosh brings to LabStyle, we have an added benefit in that she is a co-founder of our company, having offered advice on our regulatory strategy at our inception more than two years ago, so her intimate knowledge of Dario will allow her to rapidly fortify our existing clinical and regulatory affairs team,” said Dr. Oren Fuerst, LabStyle’s Executive Chairman and co-founder. “Shosh brings deep clinical and regulatory affairs experience to LabStyle, and we are delighted to have a professional of her caliber join our executive team as we prepare to go to market with Dario in Europe and ramp up our regulatory programs in the U.S. and elsewhere.”
Since 2006 Ms. Friedman has served as President and CEO of Push-Med LLC, a provider of regulatory, quality assurance and clinical services to the medical device and biotechnology industries. From 2002 to 2006 Ms. Friedman was Senior Vice President, Regulatory and Clinical Affairs and a member of the senior management team of Given Imaging (NASDAQ: GIVN). She has been a member of Given Imaging’s Advisory Board since June 1997, and as a company consultant she led the effort to secure marketing authorizations worldwide. From 1993 to 1996 she served as Regulatory, Clinical and Quality Assurance Director at InStent Ltd., an Israeli medical device company that was acquired by Medtronic Inc. in 1996.
In recognition of her professional achievements, in 2005 the Regulatory Affairs Professionals Society (RAPS) awarded Ms. Friedman the Richard E. Greco Award, the highest honor bestowed by the RAPS to outstanding leaders who have made significant contributions to the field. In 2012 Ms. Friedman received the RAPS Fellowship, which is a RAPS program that recognizes senior regulatory professionals for their continued significant contributions and leadership in the advancement of the profession.
About LabStyle Innovations
LabStyle Innovations Corp. (OTCQB: DRIO) is developing and commercializing a patent-pending technology that seeks to bring rapid diagnostic capabilities to consumers in a distinctive and easy-to-use way through the use of smartphones such as iPhones, Androids and other mobile devices. LabStyle’s initial product is Dario™, an integrated medical device and software system addressing the market for diabetic self-monitoring of blood glucose (SMBG), a market 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, together with a smartphone app and cloud-based data services. 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. For more information, please visit www.mydario.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 performance of the executive described herein or the Company’s clinical and regulatory programs generally) 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.