Contact Information: For further information contact: David Carey Lazar Partners Ltd. 646-239-6231 Email Contact
Electro-Optical Sciences Announces Initiation of MelaFind(R) Pivotal Clinical Trial
| Source: Electro-Optical Sciences
IRVINGTON, NY -- (MARKET WIRE) -- January 31, 2007 -- Electro-Optical Sciences, Inc. ("EOS")
(NASDAQ : MELA ) today announced the initiation of the pivotal clinical trial
for MelaFind®, the company's non-invasive, point-of-care instrument to
assist in the early diagnosis of melanoma.
"Initiation of the MelaFind pivotal clinical trial is a significant
milestone for EOS, and we are excited that the first patients have been
enrolled in the study," said Joseph V. Gulfo, MD, MBA, president and chief
executive officer. "We anticipate submitting the Premarket Approval
Application (PMA) to the FDA for review in the second half of 2007."
EOS has a binding Protocol Agreement with the U.S. Food and Drug
Administration (FDA). The Protocol Agreement stipulates the endpoints that
will be used as the basis for determining the safety and effectiveness of
MelaFind. The MelaFind pivotal study will include up to 1,200 pigmented
skin lesions, and at least 93 eligible melanomas for analysis. In October
2006, EOS received notification of Expedited Review designation from the
FDA for the MelaFind PMA application upon its submission.
Concomitant with the initiation of the pivotal clinical development
program, Dr. Gerald D. Wagner, a director of the company, is transitioning
from his role as acting chief operating officer. Dr. Wagner will continue
to serve as a consultant and director of EOS.
"We appreciate Gerry's tireless efforts and his commitment over the past 18
months serving as acting chief operating officer and helping us to achieve
this milestone. We look forward to his continued contributions," Dr. Gulfo
said.
About Electro-Optical Sciences
EOS is a medical device company focused on designing and developing a
non-invasive, point-of-care instrument to assist in the early diagnosis of
melanoma. MelaFind®, EOS's flagship product, features a hand-held
imaging device that emits light of multiple wavelengths to capture images
of suspicious pigmented skin lesions and extract data. Using sophisticated
algorithms, the data are then analyzed against a proprietary database of
melanomas and benign lesions in order to provide information to the
physician and produce a recommendation of whether the lesion should be
biopsied.
Melanoma is the deadliest of skin cancers, responsible for approximately
80% of all skin cancer deaths. Unless melanoma is detected early and
excised with proper margins, the patient survival rate is poor, as there is
currently no cure for advanced stage melanoma.
For more information on EOS, visit www.eosciences.com.
Safe Harbor
This press release includes "forward-looking statements" within the meaning
of the Securities Litigation Reform Act of 1995. These statements include
but are not limited to our plans, objectives, expectations and intentions
and other statements that contain words such as "expects," "contemplates,"
"anticipates," "plans," "intends," "believes" and variations of such words
or similar expressions that predict or indicate future events or trends, or
that do not relate to historical matters. These statements are based on our
current beliefs or expectations and are inherently subject to significant
uncertainties and changes in circumstances, many of which are beyond our
control. There can be no assurance that our beliefs or expectations will be
achieved. Actual results may differ materially from our beliefs or
expectations due to economic, business, competitive, market and regulatory
factors.