Healthcare Industry News:  skin cancer 

Devices Diagnostics Dermatology

 News Release - March 12, 2009

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

IRVINGTON, NY--(Healthcare Sales & Marketing Network)--Mar 12, 2009 -- Electro-Optical Sciences, Inc. (EOS) (NasdaqCM: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.

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.


Source: Electro-Optical Sciences

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