FRANKLIN, Mass., Jan. 4 /PRNewswire-FirstCall/ -- Sontra Medical Corporation announced today that it received ISO 13485 certification for its Quality Management System (QMS) from the Certification Body of TUV America Inc. Management Service Division, a quality management systems registrar. The scope of Sontra’s Quality Management System includes “Ultrasonic Skin Permeation for Transdermal Drug Delivery, Skin Treatments and Diagnosis.”
The ISO 13485:2003 standard is an internationally recognized quality management system standard developed by the International Organization for Standardization (ISO). To be certified to the standard, companies must implement a QMS that encompasses all company functions including the design and development of products, the purchasing of materials and services and the delivery of the products and services, with all aspects of medical device, regulatory and industry requirements being addressed. ISO 13485 status is required before products can be marketed in Canada, the European Union, and several other countries.
“Sontra’s employees wholeheartedly assisted in the development of our QMS. The management team oversaw each stage of development and ensured that the scheduled progress was timely, efficient and effective. We are very proud to have gained certification,” stated Doug Kornbluth, Director of Quality Systems at Sontra.
“Our ISO 13485 certification is the result of the conscientious work performed by every Sontra employee. Our employees embrace our Quality Policy that is supported by their contributions in everything from innovation to customer satisfaction,” added Tom Davison, President and CEO.
The International Organization for Standardization (ISO) is the world’s largest developer of standards that contribute to making the development, manufacturing and supply of products and services more efficient, safer and cleaner. ISO standards also serve to safeguard consumers and users in general, of products and services.
About Sontra Medical Corporation (http://www.sontra.com)
Sontra Medical Corporation is a technology leader in transdermal science. Sontra’s SonoPrep ultrasound-mediated skin permeation technology combined with technical competencies in transdermal drug formulation, delivery systems and biosensors is creating a new paradigm in transdermal drug delivery and diagnosis. The SonoPrep technology is being developed for several billion dollar market opportunities, including continuous glucose monitoring and the transdermal delivery of large molecule drugs and vaccines. Sontra is currently marketing the SonoPrep device and procedure tray for use with topical lidocaine to achieve rapid (within five minutes) skin anesthesia.
Investor Relations Contacts: Sontra Medical Corporation Sean Moran, Chief Financial Officer 508-530-0334
SonoPrep is a registered trademark of Sontra Medical Corporation. All other company, product or service names mentioned herein are the trademarks or registered trademarks of their respective owners.
This press release contains forward-looking statements, which address a variety of subjects including, for example, the expected benefits and efficacy of the SonoPrep device in connection with diagnostics, vaccine delivery, glucose monitoring and transdermal drug delivery, Sontra’s expected ability to develop, market and sell products based on its technology; Sontra’s expected technological advances; the expected market opportunities, distribution and market acceptance of the SonoPrep device and technology, the expected size of the markets for the SonoPrep device and technology, and Sontra’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. Statements that are not historical facts, including statements about our beliefs and expectations, are forward-looking statements. Such statements are based on our current expectations and are subject to a number of factors and uncertainties, which could cause actual results to differ materially from those described in the forward-looking statements. The following important factors and uncertainties, among others, could cause actual results to differ materially from those described in these forward- looking statements: our technology is new and we may experience adverse results in research collaborations, product development, clinical trials, product evaluations, commercialization efforts, product distribution and market acceptance; markets for our products may develop slower than expected, or not at all; our sales cycle is lengthy and we are still developing sales and marketing strategies which may or may not prove effective; the SonoPrep device may not prove effective in connection with diagnostics, vaccine delivery, glucose monitoring and/or transdermal drug delivery; we may experience difficulties or delays in obtaining regulatory approvals to market products resulting from development efforts or difficulties or delays associated with sources of regulatory-approved transdermal drugs and vaccines; failure to obtain and maintain patent protection for discoveries or commercial limitations imposed by patents owned or controlled by third parties would have an adverse effect on us; we depend upon strategic partners and third-party distributors to develop, commercialize, market and sell products based on our work; and we require substantial additional funding to conduct research and development and to expand commercialization, distribution and marketing activities. For detailed information about factors that could cause actual results to differ materially from those described in the forward-looking statements, please refer to Sontra’s filings with the Securities and Exchange Commission, including Sontra’s most recent Quarterly Report on Form 10-QSB. Forward-looking statements represent management’s current expectations and are inherently uncertain. We do not undertake any obligation to update forward- looking statements made by us.
Sontra Medical Corporation
CONTACT: Sean Moran, Chief Financial Officer of Sontra MedicalCorporation, +1-508-530-0334
Web site: http://www.sontra.com//
