Key Developments For Electro-Optical Sciences, Inc.
Electro-Optical Sciences, Inc. (MELA.O) (Consolidated Issue listed on NASDAQ Capital Market)
FDA Accepts Electro-Optical Sciences, Inc.'s MelaFind Pre-Market Approval Application For Review
Electro-Optical Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) formally accepted for filing the Company's Pre-Market Approval (PMA) application for MelaFind, a non invasive and objective computer vision system intended to aid in the early detection of melanoma. The filing date for regulatory purposes is June 9, 2009, the date the FDA received the Company' PMA submission. The FDA also confirmed that the PMA application will receive expedited review and processing.
Electro-Optical Sciences, Inc. Announces $15 Million Registered Direct Offering
Electro-Optical Sciences, Inc. announced that it has entered into definitive agreements with a select group of institutional investors to sell 2,400,000 shares of common stock at a negotiated purchase price of $6.25 per share in a registered direct offering. The transaction is expected to close on or about July 22, 2009. The offering will result in gross proceeds of $15 million to the Company, before deducting placement agents' fees and estimated offering expenses. The Company intends to use the net proceeds from the sale of the shares to fund pursuit of its pre-market approval application (PMA) for MelaFind, the continued development and, if and when approved by the U.S. Food and Drug Administration (FDA), the commercialization of MelaFind, and for general corporate purposes, including working capital. Needham & Company, LLC served as the lead placement agent.
Electro-Optical Sciences, Inc. Submits MelaFind Pre Market Approval Application to FDA
Electro-Optical Sciences, Inc. announced the submission to the United States Food and Drug Administration (FDA) of its Premarket Approval (PMA) application for MelaFind, a non-invasive, point-of-care instrument to assist in the early diagnosis of melanoma, the cause of death from skin cancer.
Electro-Optical Sciences, Inc. Secures Committed Equity Financing Facility of $45 Million
Electro-Optical Sciences, Inc. announced that it has entered into a Committed Equity Financing Facility (CEFF) with Kingsbridge Capital Limited, a private investment group, in which Kingsbridge has committed to provide, at the Company's sole discretion, up to $45 million in cash during the next three years, through the purchase of newly-issued shares of Electro-Optical Science's common stock. EOS is not obligated to utilize any of the $45 million available under the CEFF and there are no minimum commitments or minimum use penalties. EOS has access, at its discretion, to the funds through the sale of newly-issued shares of EOS' common stock. The funds that can be raised under the CEFF over the three-year term will depend on the then-current price for EOS' stock, for the number of shares actually sold may not exceed 19.99% of the Company's shares outstanding. In connection with the CEFF, the Company issued a warrant to Kingsbridge to purchase 200,000 shares of common stock at $11.35 per share, representing a 50% premium to the average closing price of the Company's common stock for the five days preceding the signing of the CEFF agreement.
Electro-Optical Sciences, Inc. Announces Additional Data From MelaFind Pivotal Study
Electro-Optical Sciences, Inc. announced additional data on MelaFind, the Company's non-invasive, point-of-care instrument to assist in the early detection of melanoma.The presentations included additional data from the Company's MelaFind Phase III pivotal study, the topline results of which were announced on February 13, 2009. 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%).
