September Market Launch Planned for Rapid Skin Anesthesia Product
Sontra to Host Conference Call on Thursday August 19th at 11 a.m. ET
FRANKLIN, Mass., Aug. 18 /PRNewswire-FirstCall/ -- Sontra Medical
Corporation (Nasdaq SC: SONT) announced today that it has received 510(k)
marketing clearance from the U.S. Food and Drug Administration (FDA) to market
the SonoPrep ultrasonic skin permeation device and procedure tray for use with
topical lidocaine. Sontra received its first 510(k) marketing clearance for
SonoPrep for use in electrophysiology applications in February 2004.
The FDA 510(k) submission 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. SonoPrep skin permeation technology improves the clinical utility of
topical lidocaine compared to existing products that require up to a 60-minute
wait before effective skin anesthesia is achieved. The SonoPrep device applies
low frequency ultrasound to a patient's skin for approximately 15 seconds to
create imperceptible, reversible micro-channels through the stratum corneum
(outermost layer of the skin) making the skin permeable so that the onset of
action for transdermal drugs is accelerated. The SonoPrep device and the
procedure tray for use with topical lidocaine address the $100 million topical
lidocaine market.
"We are very pleased to receive FDA clearance to market our SonoPrep
device and procedure tray for use with topical lidocaine to achieve rapid skin
anesthesia," stated Thomas W. Davison, PhD, Sontra's President and Chief
Executive Officer. "Because of the lengthy waiting time associated with
existing products, topical lidocaine is not frequently administered to provide
pain relief prior to insertion of needles and intravenous catheters. Based on
our market research, we expect physicians and nurses will be interested in
using our product to help patients avoid painful interventions, particularly
chronically ill children and adults who must endure repeated needle sticks and
IV therapy. We expect to commence the product launch through independent
distributors in September 2004."
Mr. Davison concluded, "This marks a significant milestone for Sontra that
will enable the company to initiate product sales in 2004. In addition, we
believe FDA clearance to market the SonoPrep for rapid skin anesthesia will
enhance our ability to increase visibility for the SonoPrep device as we begin
to penetrate our core markets, transdermal drug delivery and non-invasive
diagnostic products, over the long term. A major component of our business
strategy is to commercialize our SonoPrep skin permeation technology across a
broad spectrum of applications in the transdermal delivery of pain drugs,
vaccines, and protein biopharmaceuticals, in addition to continuous non
invasive glucose monitoring."
Conference Call Information
Sontra will host a live conference call and listen-only Webcast on
Thursday, August 19, 2004 at 11 a.m. ET to discuss the pending SonoPrep market
launch, a product pipeline update and its second quarter 2004 financial
results.
To participate in the conference call, please dial: 1-973-409-9259.
A listen-only Webcast of the conference call will be available at
http://www.viavid.net/detailpage.aspx?sid=00001E03
In addition, a replay of the live Webcast will be available at
http://www.sontra.com
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 is marketing the SonoPrep device and
procedure tray for use with topical lidocaine to achieve rapid (within five
minutes) skin anesthesia. Products under development include: a continuous
non-invasive glucose monitor developed in collaboration with Bayer Diagnostics
and the use of SonoPrep for the transdermal delivery of vaccines, pain drugs
and large protein biopharmaceuticals.
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 timing of the
commercial availability of the SonoPrep device and procedure tray, the
expected benefits and market opportunities of the SonoPrep device and
technology, the expected size of the markets for the SonoPrep device and
procedure tray, and Sontra's business and marketing 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: adverse results in
product development, clinical trials and commercialization efforts;
difficulties or delays in obtaining regulatory approvals to market products
resulting from development efforts; difficulties or delays associated with
sources of topical lidocaine; 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.
Sean Moran, CFO
Sontra Medical Corporation
Tel: 508-553-8850
or
Evan Smith, CFA / Erica Pettit
KCSA Worldwide
Tel: 212-896-1251 / 212-896-1248
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,
+1-212-896-1251, or Erica Pettit, +1-212-896-1248, both of KCSA
Worldwide
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