SOURCE: MELA Sciences

MELA Sciences

April 30, 2010 10:43 ET

MELA Sciences Announces Results of 2010 Annual Stockholder Meeting

Company Provides MelaFind® PMA Update -- Company to Ring Closing Bell at NASDAQ Stock Market to Commemorate Melanoma Monday® on May 3rd

IRVINGTON, NY--(Marketwire - April 30, 2010) -  MELA Sciences (NASDAQ: MELA), announced that its stockholders have approved all five proposals voted on at the Company's 2010 Annual Stockholder Meeting held earlier today. The Company also provided an update on the status of its MelaFind Pre-Market Approval Application (PMA), as well as other recent activities. The proposals approved at the meeting include:

  1. Re-election of Joseph V. Gulfo, M.D., Breaux Castleman, Sidney Braginsky, George C. Chryssis, Martin D. Cleary, Anne Egger, Charles Stiefel and Gerald Wagner, Ph.D. to the Company's Board of Directors. Board Members will serve until the 2011 Annual Stockholders Meeting and until their respective successors are elected and qualified, or until such director's earlier death, resignation or removal. It was also announced was that Dan Lufkin will serve as Director Emeritus;
  2. An amendment to the Company's Fourth Amended and Restated Certificate of Incorporation (the "Charter") increasing the number of authorized shares of common stock to 45 million shares, from 30 million shares;
  3. An amendment to the Charter changing the Company's name to MELA Sciences, Inc. from Electro-Optical Sciences, Inc.;
  4. An amendment to the 2005 Stock Incentive Plan (the "Plan") increasing the aggregate number of shares of common stock available under the Plan to 3,724,028 shares, from 3,224,028 shares; and
  5. Ratification of the selection by the audit committee of the Company's Board of Directors of Eisner LLP as the Company's independent registered public accounting firm for the fiscal year ending December 31, 2010.

Other Events

  • The Company also reported that it submitted a draft response in mid-April 2010 to the action letter it received from the U.S. Food and Drug Administration (FDA) in March 2010 regarding the Company's PMA application for MelaFind. The Company has had a series of interactions with FDA reviewers, including an in person meeting with the FDA to review its draft response and to clarify several questions. The final formal response to all questions provided by the FDA will be submitted imminently. 

  • MELA Sciences also reported that the large reader study, which was designed to assess physician sensitivity to early melanoma and was performed on images and patient data derived from the pivotal trial, has been completed and is undergoing formal statistical analysis. Top-line data demonstrate consistency with the results of previously reported reader studies. Results will be made available publicly, and the authors are planning to submit a paper for publication in a peer-review medical journal.

  • Two new patents were issued to the Company in 2010 covering certain aspects of the MelaFind commercial cart.

  • The Company discussed its ongoing efforts to obtain a CE Mark in order to allow for commercialization of MelaFind in Europe and other countries, as well as its commercial planning activities outside the U.S. The Company is aiming to obtain approval to commercialize in certain European markets in the first quarter of 2011.

  • MELA Sciences will ring the NASDAQ Stock Market Closing Bell on Monday, May 3, 2010 at 4:00 p.m. EDT, to commemorate Melanoma Monday® and the start of Melanoma/Skin Cancer Detection and Prevention Month®.

To view the Closing Bell Ceremony online, visit:

http://www.nasdaq.com/about/marketsitetowervideo.asx

The live feed will begin at approximately 3:50 p.m. EDT.

Melanoma/Skin Cancer Detection and Prevention Month® and Melanoma Monday® are registered trademarks of the American Academy of Dermatology. The American Academy of Dermatology does not endorse or recommend any commercial products or services.

About MELA Sciences

MELA Sciences is a medical technology company focused on developing MelaFind®, a non-invasive and objective computer vision system intended to aid in the early detection of melanoma. MELA Sciences designed MelaFind to assist in the evaluation of pigmented skin lesions, including atypical moles, which have one or more clinical or historical characteristics of melanoma, before a final decision to biopsy has been rendered. MelaFind acquires and displays multi-spectral (from blue to near infrared) digital images of pigmented skin lesions and uses automatic image analysis and statistical pattern recognition to help identify lesions to be considered for biopsy to rule out melanoma.

The MelaFind Pre-Market Approval (PMA) application was filed with the U.S. Food and Drug Administration (FDA) in June 2009 and is currently under review at the FDA. MELA Sciences cannot predict either the timing of the FDA's decision on the PMA application or the outcome. FDA approval is required prior to marketing MelaFind in the United States.

For more information on MELA Sciences, visit www.melasciences.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.

Contact Information

  • For further information contact:
    For Investors:
    David Carey
    Lazar Partners, Ltd.
    646-871-8485

    For Media:
    Hollister Hovey
    Lazar Partners, Ltd.
    646-871-8485