Company also announces ISO certifications
Quebec City, Quebec, July 29th, 2009 – FISO Technologies Inc. (“FISO” or “the Company”), a subsidiary of Roctest Ltd (TSX: RTT), announces that a new strategic customer has just received U.S. Food and Drug Administration (FDA) approval for a new trauma device in which the Company’s fiber optic sensor is a key element. FISO co-developed this new product with the customer and the Company expects it to be released to the markets within the next few months. Initial revenues from the product are expected to be generated towards the end of 2009.
“With yet another medical device incorporating FISO technology now having received FDA approval, we believe the regulators are gaining increasing comfort with our technology platform,” said Frederic Borne, General Manager, FISO. “Our fiber optic pressure sensors are smaller, more accurate and easier to use than alternative technologies, while our fiber optic temperature probes are insensitive to radio frequency and microwave radiation and can therefore be used in MRI machines without affecting the image clarity. Over 20,000 units integrating our sensors have been deployed by doctors in the past two years, and our strategy is to apply our technology to the development of further applications.”
ISO Certifications
Earlier this year, FISO Technologies obtained ISO Certifications ISO 13485:2003 and ISO 9001:2008 through the independent certification body BSI Group. Complementing the longstanding ISO 9001 system, ISO 13485 is specifically geared towards the design and manufacture of medical devices, and sets out additional requirements related to design controls, process controls, traceability, recall, and other.
“I believe the achievement of ISO 13485 certification enables FISO to provide our customers with even stronger assurance of the quality of our products,” said Frederic Borne. “This certification is not only the result of specific efforts from key members of our quality and continuous improvement team but also the contribution of all employees from every department and reflects our Company’s philosophy and commitment to quality.”
FISO’s recent investment in quality improvement has been highlighted by the completion of a world-class manufacturing facility that offers OEM suppliers automated, low cost, high volume production capacity suitable for disposable medical applications. FISO’s level of innovation, quality and manufacturing capability in the medical fiber optic sensors market are second to none. Continued investment in the manufacturing of catheter and medical devices that integrate its fiber optic sensors is an important element of the Company’s growth strategy.
About FISO Technologies Inc.
FISO Technologies Inc. designs, manufactures and markets fiber optic sensors and high precision measuring instruments for challenging and demanding applications in the process control, energy, healthcare and defense markets. Its products are mainly sold internationally. The Company headquarters are located in Quebec City, Quebec (Canada). FISO Technologies Inc. news releases and product information are available on the Internet at: http://www.fiso.com.
Caution concerning forward-looking statements
Except for historical information provided herein, this press release may contain information and statements of a forward-looking nature concerning the future performance of the Company. These statements are based on suppositions and uncertainties as well as on management’s best possible evaluation of future events, and as such involve a number of risk factors. Such factors may include, without excluding other considerations, risks related to foreign exchange fluctuations, evolution in customer demand for the Company’s products and services, the impact of price pressure from competitors and general market trends, economic and geopolitical changes. As a result, readers are advised that actual results may differ from expected results. The Company is not required to update or revise publicly its forward-looking statements, except as may be required under applicable law.