FRANKLIN, Mass., June 22 /PRNewswire-FirstCall/ -- Sontra Medical
Corporation (Nasdaq SC: SONT) announced today an update on the status of its
510(k) submission filed with the FDA in March 2004, requesting marketing
clearance for Sontra's ultrasonic skin permeation device and topical lidocaine
kit for rapid skin anesthesia. Pursuant to a request from the FDA, Sontra has
submitted additional information in support of the application. The Company
anticipates that the FDA will respond to the additional information within
ninety days or sooner. The Company expects to launch its topical lidocaine
procedure tray following FDA 510(k) marketing clearance.
"We have focused our attention and resources on quickly responding to the
FDA. We do not view this request as unusual and will continue to vigilantly
pursue market clearance," stated Thomas W. Davison, PhD, Sontra's President
and Chief Executive Officer.
In February 2004, the FDA granted Sontra its first 510(k) marketing
clearance for SonoPrep for use in electrophysiology applications and in March
2004 the Company submitted a 510(k) application seeking marketing clearance
for the use of SonoPrep and a topical lidocaine procedure tray to achieve
rapid skin anesthesia. This 510(k) application was supported by clinical data
from three studies covering 500 patients that demonstrated rapid skin
anesthesia with 4% lidocaine was achieved within five minutes following a skin
pre-treatment with SonoPrep. Existing topical lidocaine products addressing
this $100 million market require a thirty to sixty minute waiting period
before skin anesthesia is achieved.
About Sontra Medical Corporation (http://www.sontra.com)
Sontra Medical Corporation is a leading developer of transdermal drug
delivery and diagnostic products that combine Sontra's SonoPrep ultrasound-
mediated skin permeation technology with synergistic biosensor and transdermal
drug delivery technologies. Sontra's products under development include:
SonoPrep and a topical anesthetic kit for rapid (within five minutes) skin
anesthesia; a continuous non-invasive glucose monitor developed in
collaboration with Bayer Diagnostics and the use of SonoPrep for the
transdermal delivery of vaccines and large molecule drugs.
This press release contains forward-looking statements, which address a
variety of subjects including, for example, the expected timing of the
marketing approval and commercial availability of the SonoPrep device and
lidocaine procedure tray. 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: adverse results in product development, clinical trials
and commercialization efforts; difficulties or delays in obtaining regulatory
approvals to market products resulting from development efforts; failure to
obtain and maintain patent protection for discoveries; commercial limitations
imposed by patents owned or controlled by third parties; dependence upon
strategic partners to develop and commercialize products based on our work;
the commercial success of products; and the requirement for substantial
funding to conduct research and development and to expand commercialization
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.
Contact:
Sean Moran, CFO
Sontra Medical Corporation
Tel: 508-553-8850
Evan Smith, CFA / Erica Pettit
KCSA Worldwide
Tel: 212-896-1248 / 212-896-1289
SOURCE Sontra Medical Corporation
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Related links:
http://www.sontra.com
CONTACT:
Sean Moran, CFO of Sontra Medical
Corporation, +1-508-553-8850; or Evan Smith, CFA,
+1-212-896-1248, or Erica Pettit, +1-212-896-1289, both of KCSA
Worldwide
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