TIRAT CARMEL, ISRAEL--(April 27, 2011) - D. Medical Industries Ltd. (NASDAQ:DMED)(TASE:DMED) ("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 subsidiaries, Spring Health Solutions Ltd. and Spring-Set Health Solutions Ltd. ("Spring-Set"), have received Canadian Medical Devices Conformity Assessment System (CMDCAS) certification for its ISO 13485:2003 Quality System. As a result, Spring-Set is now in the process of filing an application for Health Canada approval for the Company's Universal Detach Detect Infusion Sets which Spring-Set designs and markets.
On February 7, 2011, the Company announced that Company's Subsidiaries had achieved ISO 13485:2003 and ISO 9001:2008 certifications. Manufacturers of medical devices that wish to sell their products in Canada must submit their devices for licensing by Health Canada. Health Canada reviews the product for safety, effectiveness, and quality, relying on CMDCAS recognized registrars to ensure that manufacturers have an adequate quality system. CMDCAS recognized registrars audit a medical device manufacturer's quality system to ISO 13485:2003 with the implementation of requirements from the Canadian medical device regulations, then provide a certificate of registration. Manufacturers then use this certificate as part of the submission for a device license with Health Canada.
"Achieving CMDCAS accreditation is a further endorsement of our approach to quality management. It will also allow us to move forward with the registration and commercialization of products – starting with our Universal Detach Detect Infusion Sets - in Canada, a country that has the sixth highest incidence rate of Type 1 diabetes in children 14 years or younger in the world," 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.