FRANKLIN, Mass., Jan. 4 /PRNewswire-FirstCall/ -- Sontra Medical
Corporation (Nasdaq: SONT) 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.
SOURCE Sontra Medical Corporation
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Related links:
http://www.sontra.com
CONTACT:
Sean Moran, Chief Financial Officer of Sontra
Medical Corporation, +1-508-530-0334
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