MELA Sciences Initiates First Study to Investigate Real-World Clinical Impact of the MelaFind System on Melanoma Biopsy Decis...
June 03 2014 - 8:00AM
MELA Sciences, Inc. (Nasdaq:MELA), developer of the MelaFind®
system, an optical diagnostic device approved for use in the United
States and the European Union to assist dermatologists in melanoma
diagnosis, today announced that it has initiated a study to examine
the real-world clinical impact of MelaFind on dermatologists'
decision to biopsy pigmented skin lesions that are suspicious for
melanoma. Darrell Rigel, MD, MS, Clinical Professor of Dermatology
at New York University Langone Medical Center, will be the
Principle Investigator for the study.
Rose Crane, MELA Sciences President and CEO, commented, "This
trial is significant as the data will be based on patient
assessments by dermatologists using the MelaFind system. It will
provide us with a measure of the real-world clinical impact of
MelaFind on melanoma diagnosis, and we believe it will support our
case for insurance reimbursement. We welcome Dr. Rigel's oversight
as the principal investigator of this important study."
Study Overview
This real world study, preliminary results of which are expected
by year end 2014, will evaluate the impact of the MelaFind system
information on dermatologists' biopsy decisions. It will compare
their clinical assessment and biopsy decision of suspicious
pigmented skin lesions both before and after the use of MelaFind.
Participating dermatologists will be current users of the MelaFind
system. The study will determine the impact of the MelaFind system
information on their diagnostic accuracy as well as the impact of
the MelaFind information on the total number of biopsies
performed.
This study will be the first of its kind to generate information
on the real-world impact of the MelaFind system on a
dermatologist's decision to biopsy a suspicious pigmented skin
lesion. Approximately 15 dermatology practices across the United
States will participate in the data collection, with the goal of
accruing information on over 150 lesions. The Company is also
conducting a similar though larger scale Post Approval Study of
MelaFind, the preliminary results of which are expected in
2017.
About MelaFind www.melafind.com
MelaFind® is the first and only medical device with FDA
Pre-Market Approval (PMA) for the U.S. and CE Marking certification
for the European Union designed to assist dermatologists in the
evaluation and diagnosis of melanoma at its most curable stage. The
MelaFind® system utilizes innovative software driven technology and
state-of-the-art 3-D optical imaging to non-invasively extract data
2.5 mm below the skin surface from patient's pigmented ambiguous
moles and objectively analyzes them with proprietary algorithms.
MelaFind provides important additional perspective to physicians
via 3-D spectral images and 100% objective data analysis to help
them better understand the structural disorganization of a
patient's pigmented ambiguous moles (before cutting the skin)
during the evaluation and diagnosis process for melanoma - a
powerful modern tool to assist their traditional methods
(ABCDEPRU).
About MELA Sciences, Inc.
www.melasciences.com
MELA Sciences is a medical technology company dedicated to
designing and developing innovative software-driven technology for
the clinical early detection and prevention of skin cancer. MELA
Sciences conducted the largest, positive prospective study ever
done on the melanoma disease, and is the first and only medical
technology company to receive both FDA Pre-Market Approval (PMA)
for the U.S. and CE Marking certification for the European Union
for a device of this nature.
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 may contain words such as "seeks,"
"look forward," and "there seems" that suggest future events or
trends. These statements are based on our current expectations and
are inherently subject to significant uncertainties and changes in
circumstances. Actual results may differ materially from our
expectations due to financial, economic, business, competitive,
market, regulatory and political factors or conditions affecting
the company and the medical device industry in general, as well as
more specific risks and uncertainties set forth in the company's
SEC reports on Forms 10-Q and 10-K. Given such uncertainties, any
or all of these forward-looking statements may prove to be
incorrect or unreliable. MELA Sciences assumes no duty to update
its forward-looking statements and urges investors to carefully
review its SEC disclosures available at www.sec.gov and
www.melasciences.com.
CONTACT: Media
Diana Garcia Redruello
MELA Sciences, Inc.
212-518-4226
dgarcia@melasciences.com
Investors
Andrew McDonald
LifeSci Advisors, LLC
646-597-6987
Andrew@LifeSciAdvisors.com
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