TIRAT CARMEL, ISRAEL--(Feb. 7, 2011) - D. Medical Industries Ltd. (NASDAQ:DMED)(TASE:DMDC) ("D. Medical" or the "Company"), a medical device company engaged through its subsidiaries in the research, development, manufacture and sale of innovative products for diabetes treatment and drug delivery, announced today that its subsidiary, Spring-Set Health Solutions Ltd. (formerly "Medx- Set Ltd."), has achieved ISO 13485:2003 and ISO 9001:2008 certifications. Spring-Set designs and markets the Company's Universal Detach Detect Infusion Sets.
ISO 13485:2003 is an internationally recognized standard developed to ensure that companies provide medical devices that consistently meet regulatory requirements. In order to obtain the certification, Spring-Set demonstrated the ability to consistently meet strict requirements for Quality Management Systems (QMS) applicable to medical device manufacturing and related services.
ISO 9001:2008 is an internationally recognized quality management standard. The standard focuses on defining customer quality requirements, use of data to analyze the processes, meeting applicable customer and regulatory requirements, enhancing customer satisfaction and continually improving business performance.
"The achievement of both ISO 13485:2003 and ISO 9001:2008 certifications demonstrates our continued commitment to the highest levels of quality management and design controls to ensure the delivery of safe and effective products to our international customer base. In addition, as we prepare to launch our Universal Detach Detect Infusion Sets in the United States, Canada, Europe, Mexico and the BRIC countries of Brazil, Russia, India and China - commencing in 2011 – we believe these certifications will help to simplify and, in some cases, potentially shorten this key product's regulatory pathway in those markets," said Efri Argaman, D. Medical's Chief Executive Officer.
About D. Medical
D. Medical is a medical device company engaged through its subsidiaries in the research, development, manufacture and sale of innovative products for diabetes treatment and drug delivery. D. Medical has developed durable and semi-disposable insulin pumps, which continuously infuse insulin into a patient's body, using its proprietary spring-based delivery technology. D. Medical believes that its spring-based delivery mechanism is cost-effective compared to the motor and gear train mechanisms that drive competitive insulin pumps and also allows it to incorporate certain advantageous functions and design features in its insulin pumps. D. Medical has also developed an infusion set for insulin pumps and is focusing its research and development efforts on the development of next generation insulin pumps and a device that will combine a continuous glucose monitoring system and an insulin pump on the same patch. For more information, please visit http:www.dmedicalindustries.com (corporate) and http://www.springnow.com (healthcare professionals, patients and care givers).
Forward-Looking Statements
This press release contains forward-looking statements (as defined by the Israeli Securities Law, 1968, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended) that involve risks and uncertainties. These statements include, forecasts, goals, uncertainties and assumptions and relate, inter alia, to D. Medical's future expectations in connection with its level of sales and cost of sales, manufacturing volumes, the cost-effectiveness of its spring-based design, target markets, regulatory approvals and timing of markets penetration. The forward-looking statements are based on D. Medical's current expectations and beliefs which are based on, among other things, its analysis of publicly available information and market research reports. All forward-looking statements are subject to certain risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include, but are not limited to, the impact of general economic conditions, competitive products, product demand, product performance, the performance of D. Medical's contract manufacturer and distributors, regulatory trends and approvals and healthcare reform legislation. If one or more of these risks and/or uncertainties materialize, or if the underlying assumptions prove to be incorrect, D. Medical's actual results, performance or achievements could differ materially from those expressed in, or implied by, any such forward-looking statements or results which are based upon such assumptions. No assurances can be given that any of the events anticipated by the forward-looking statements will transpire or occur, or of any of them will transpire or occur, what impact it will have on D. Medical's results of operations or financial condition. D. Medicals does not undertake to update any forward-looking statements.