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Electro-Optical Sciences Announces Additional Data From MelaFind(R) Pivotal Study Presented at American Academy of Dermatology Meeting
Experts Also Presented Data at Concurrent Dermoscopy Meetings
| Source: Electro-Optical Sciences, Inc.
IRVINGTON, NY--(Marketwire - March 12, 2009) - Electro-Optical Sciences, Inc. (EOS) (NASDAQ : MELA ) today announced that additional data on MelaFind®, the company's
non-invasive, point-of-care instrument to assist in the early detection of
melanoma, were presented at a symposium at the American Academy of
Dermatology's (AAD) 67th Annual Meeting held in San Francisco March 6 to
10, 2009. Experts also presented new data at the International Dermoscopy
Society (IDS) Meeting and the International Society for Digital Imaging of
the Skin (ISDIS), which were held concurrent with the AAD Annual Meeting.
The presentations included additional data from EOS' MelaFind Phase III
pivotal study, the topline results of which were announced on February 13,
2009.
"The lesions in the study were exceedingly difficult to differentiate as
'benign' or 'melanoma,'" said Robert J. Friedman, M.D., Clinical Associate
Professor of Dermatology at the New York University Medical Center and
member of the EOS Scientific Advisory Board. "In fact, study
dermatologists had deemed 30 percent of the melanomas found in the study
'unlikely' to actually be melanoma and 45 percent of the melanomas found in
the study were melanoma in situ, the most curable, yet most difficult form
of melanoma to detect."
Currently, clinicians use a set of criteria known as the ABCDEs (Asymmetry,
Border irregularity, Color, Diameter and Evolution) to differentiate
melanomas from many benign pigmented lesions. Atypical pigmented lesions
with diameters of 6 millimeters or greater more often raise concern for
melanoma, although smaller lesions, usually with better prognoses can be
identified with somewhat greater difficulty. Of interest, 57 percent of the
lesions in this study were under 6 millimeters in diameter, Dr. Friedman
said.
"Ultimately, our goal is to find as many melanomas as possible as early as
possible, however, we aim to biopsy efficiently because the process is
invasive and leaves a scar," said Harold S. Rabinovitz, M.D., Clinical
Professor of Dermatology University of Miami School of Medicine, who
discussed the MelaFind pivotal data during a Saturday Cutaneous Oncology
symposium directed by Dr. Friedman. "Importantly, only 13 of the 20 lesions
that the study physicians deemed 'definite melanomas' were confirmed as
melanomas, reinforcing the challenging nature of the lesions in the study."
"In the pilot reader study that used clinical and dermoscopic images of 23
melanomas and 24 benign pigmented skin lesions randomly selected from the
pivotal trial database, 40 percent of the 39 readers failed to detect seven
or more melanomas and 46 percent of the readers missed the same melanoma as
MelaFind," Dr. Rabinovitz added. Dr. Rabinovitz, pivotal study chairman,
investigator and EOS Scientific Advisory Committee member, also presented
the data at the ISDIS meeting on Sunday.
"MelaFind, with its very high sensitivity to early melanomas, compares
positively to expert dermoscopists who biopsy around seven to eight benign
lesions for every melanoma they find," said Dina Gutkowicz-Krusin, Ph.D.,
EOS co-founder and principal scientist, who presented the MelaFind pivotal
data at the IDS meeting on Sunday. "Given the results of the MelaFind
study, we believe the system has the potential to provide clinicians with a
useful and efficient tool to aid in detecting melanomas early."
The biopsy ratio (false positive to true positive) for MelaFind and the
skin cancer experts in the pivotal study was 7.4 and 7.8, respectively.
EOS remains focused on completing its Pre-Market Approval (PMA)
application, which it expects to file with the U.S. Food and Drug
Administration (FDA) shortly.
MelaFind uses 10 different wavelengths of light to see where a clinician
cannot -- up to 2.5 millimeters below the skin's surface. Using advanced
algorithms, trained and developed on a database of over 9,000 pigmented
skin lesions and over 600 melanomas, including those from the pivotal
study, the system is designed to provide information to assist in the
management of the patient, including information useful in the decision of
whether to biopsy the lesion.
The pivotal study, the largest prospective study ever conducted in melanoma
detection, included 1,831 pigmented skin lesions from 1,383 patients. As
previously announced, MelaFind detected 112 of 114 (98% sensitivity; lower
confidence bound of 95%) melanomas that were eligible and evaluable for
primary sensitivity endpoint analysis, and 125 of 127 (98% sensitivity;
lower confidence bound greater than 95%) melanomas overall. MelaFind's
specificity, the ability to accurately rule out disease, was significantly
superior (9.5%) to that of the study dermatologists (3.7%), who are skin
cancer experts (p-value less than 0.02). In order to generate a comparison
with dermatologists' ability to accurately detect melanoma, EOS conducted a
parallel pilot readers' study with a different group of 39 dermatologists.
Using images and clinical histories of 23
randomly-selected melanomas from the pivotal study, this group of
dermatologists, on average, would have decided to biopsy only approximately
18 (80%) of the melanomas, whereas the MelaFind result would have led to a
biopsy of 22 of the melanomas (biopsy sensitivity of 96%).
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 detection of
melanoma. MelaFind features a hand-held imaging device that emits light of
multiple wavelengths to capture images of suspicious pigmented skin lesions
and extract data. The data are then analyzed utilizing imaging processing
classification algorithms, trained on our proprietary database of melanomas
and benign lesions, to provide information to assist in the management of
the patient, including information useful in the decision of whether to
biopsy the lesion.
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 visit www.eosciences.com.
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