MELA Sciences Secures Final Investigative Site & Enrolls 100+ Patients for Post-Approval Study for MelaFind® System Optical ...
April 30 2014 - 8:37AM
Business Wire
MELA Sciences, Inc. (NASDAQ:MELA), developer of the MelaFind®
system, an FDA approved optical diagnostic device that assists
dermatologists in the diagnosis of melanoma, today announced that
it has concluded an agreement with the sixth and final
investigative site participating in the Company’s post-approval
study (PAS) of the MelaFind® system for the diagnosis of melanoma.
More than 100 patients have been enrolled in the study to date.
MELA has established six investigative sites, the maximum
requirement of the study protocol, at leading healthcare
institutions and private practices in Colorado, Florida, Maryland,
Massachusetts, New Jersey and Ohio to enroll patients and conduct
the study. Those sites and their principal investigators are
Joel Cohen, MD
AboutSkin Dermatology and Derm Surgery, PC
Englewood, CO
Armand Cognetta, MD
Dermatology Associates of Tallahassee Tallahassee, FL
Timothy Wang, MD
The Johns Hopkins University Baltimore, MD
Arthur Sober, MD
Massachusetts General Hospital Boston, MA
Robert Nossa, MD
The Dermatology Group, PC Verona, NJ
Meg Gerstenblith, MD
University Hospitals Case Medical Center Cleveland, OH
Rose Crane, MELA Sciences’ President and CEO, commented, “We are
off to a solid start in our post-approval study, having secured
very strong investigative sites led by leading medical
dermatologists. I am thankful for the MELA team’s dedication and
hard work in initiating and monitoring this study, which I believe
will provide us the opportunity to further enhance our technology
and the frequency of its use.”
The three-year PAS is required in connection with the MelaFind
system’s Premarket Approval (PMA) in November 2011 by the U.S. Food
and Drug Administration (FDA). The study will report on the safety
and effectiveness of the system’s non-invasive, optical imaging and
data analysis capabilities in a real-world setting. In April 2014
the FDA approved a revised study timeline to address the slower
than anticipated pace of patient recruitment. The study is now
identified as “Progress Adequate” according to the current FDA
status report.
The PAS protocol anticipates the enrollment of at least 720
patients to accrue the requirement of 78 patients diagnosed with a
melanoma or a high-grade lesion. The study involves a two-year
follow-up period for each lesion enrolled but not undergoing
biopsy. The study is designed to observe dermatologists’ clinical
decision-making behavior in a real world setting under conditions
where the MelaFind system is and is not available to them. This
design will test the primary endpoint hypothesis that the
incorporation of the additional MelaFind system information into
dermatologists’ clinical assessment results in the identification
of more than 110% of the melanomas or high-grade lesions than are
identified without data from the MelaFind system. Central histology
is the reference standard for disease state.
MELA currently targets submission of the PAS report to the FDA
by year-end 2017.
About MELA Sciences, Inc. www.melasciences.com
MELA Sciences is a medical device company developing dermatology
diagnostics utilizing state-of-the-art optical imaging and
innovative software. The flagship product is MelaFind®, an FDA, PMA
and CE Mark approved, non-invasive diagnostic tool to assist
dermatologists in melanoma evaluation and diagnosis. MelaFind® uses
a variety of visible to near-infrared light waves to analyze
atypical pigmented skin lesions 2.5 mm below the skin surface. It
provides images and objective data on the relative disorganization
of a lesion’s structure that provides substantial additional
perspective to assist melanoma diagnosis. MELA is also exploring
new potential uses for its core imaging technology and
algorithms.
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.
MediaMELA Sciences, Inc.Diana Garcia Redruello,
212-518-4226dgarcia@melasciences.comorInvestorsCatalyst
GlobalDavid Collins, Eric
Lentini212-924-9800mela@catalyst-ir.com
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