<SEC-DOCUMENT>0000950123-11-086493.txt : 20110926
<SEC-HEADER>0000950123-11-086493.hdr.sgml : 20110926
<ACCEPTANCE-DATETIME>20110926083622
ACCESSION NUMBER:		0000950123-11-086493
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20110926
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20110926
DATE AS OF CHANGE:		20110926

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			MELA SCIENCES, INC. /NY
		CENTRAL INDEX KEY:			0001051514
		STANDARD INDUSTRIAL CLASSIFICATION:	SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
		IRS NUMBER:				133986004

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	000-51481
		FILM NUMBER:		111106332

	BUSINESS ADDRESS:	
		STREET 1:		50 SOUTH BUCKHOUT STREET
		STREET 2:		SUITE 1
		CITY:			IRVINGTON
		STATE:			NY
		ZIP:			10533
		BUSINESS PHONE:		914-591-3783

	MAIL ADDRESS:	
		STREET 1:		50 SOUTH BUCKHOUT STREET
		STREET 2:		SUITE 1
		CITY:			IRVINGTON
		STATE:			NY
		ZIP:			10533

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	ELECTRO OPTICAL SCIENCES INC /NY
		DATE OF NAME CHANGE:	19971216
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
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<DESCRIPTION>FORM 8-K
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<DIV align="center" style="font-size: 14pt; margin-top: 12pt"><B>UNITED STATES<BR>
SECURITIES AND EXCHANGE COMMISSION</B>
</DIV>

<DIV align="center" style="font-size: 12pt"><B>Washington, D.C. 20549</B>
</DIV>

<DIV align="center" style="font-size: 18pt; margin-top: 12pt"><B>FORM 8-K</B>
</DIV>


<DIV align="center" style="font-size: 12pt; margin-top: 12pt"><B>CURRENT REPORT<BR>
Pursuant to Section&nbsp;13 or 15(d) of The Securities Exchange Act of 1934</B>
</DIV>

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<DIV align="Center" style="font-size: 10pt; margin-top: 6pt">
<B>Date of Report (Date of earliest event reported): September&nbsp;26, 2011</B>
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</DIV>
<DIV align="center" style="font-size: 24pt; margin-top: 12pt"><B>MELA Sciences, Inc.</B>
</DIV>

<DIV align="center" style="font-size: 10pt">(Exact name of registrant as specified in its charter)</DIV>


<DIV align="center">
<TABLE style="font-size: 10pt" cellspacing="0" border="0" cellpadding="0" width="100%">
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    <TD width="30%">&nbsp;</TD>
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<TR valign="bottom">
    <TD align="center" valign="top"><B>Delaware</B>
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top"><B>000-51481</B>
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top"><B>13-3986004</B></TD>
</TR>
<TR valign="bottom">
    <TD align="center" valign="top">(State or other jurisdiction
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top">(Commission
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top">(IRS Employer</TD>
</TR>
<TR valign="bottom">
    <TD align="center" valign="top">of incorporation)
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top">File Number)
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top">Identification No.)</TD>
</TR>
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</TABLE>
</DIV>

<DIV align="center">
<TABLE style="font-size: 10pt" cellspacing="0" border="0" cellpadding="0" width="100%">
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<TR></TR>
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<TR valign="bottom">
    <TD align="center" valign="top"><B>50 South Buckhout Street, Suite&nbsp;1</B></TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top">&nbsp;</TD>
</TR>
<TR valign="bottom">
    <TD align="center" valign="top"><B>Irvington, New York</B>
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top"><B>10533</B></TD>
</TR>
<TR valign="bottom">
    <TD align="center" valign="top">(Address of principal executive offices)
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top">(Zip Code)</TD>
</TR>
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</TABLE>
</DIV>


<DIV align="Center" style="font-size: 10pt; margin-top: 6pt">Registrant&#146;s telephone number, including area code <B>(914)&nbsp;591-3783</B>
</DIV>

<DIV align="Center" style="font-size: 10pt; margin-top: 6pt">(Former name or former address, if changed since last report.)
</DIV>
<DIV align="left" style="font-size: 10pt; margin-top: 6pt">Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions (see General Instructions
A.2. below):
</DIV>


<DIV style="margin-top: 6pt">
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 10pt; color: #000000; background: transparent">
    <TD width="3%" nowrap align="left"><FONT style="font-family: Wingdings">&#111;</FONT></TD>
    <TD width="1%">&nbsp;</TD>
    <TD>Written communications pursuant to Rule&nbsp;425 under the Securities Act (17 CFR 230.425)</TD>
</TR>

<TR>
    <TD style="font-size: 6pt">&nbsp;</TD>
</TR><TR valign="top" style="font-size: 10pt; color: #000000; background: transparent">
    <TD width="3%" nowrap align="left"><FONT style="font-family: Wingdings">&#111;</FONT></TD>
    <TD width="1%">&nbsp;</TD>
    <TD>Soliciting material pursuant to Rule&nbsp;14a-12 under the Exchange Act (17 CFR 240.14a-12)</TD>
</TR>

<TR>
    <TD style="font-size: 6pt">&nbsp;</TD>
</TR><TR valign="top" style="font-size: 10pt; color: #000000; background: transparent">
    <TD width="3%" nowrap align="left"><FONT style="font-family: Wingdings">&#111;</FONT></TD>
    <TD width="1%">&nbsp;</TD>
    <TD>Pre-commencement communications pursuant to Rule&nbsp;14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))</TD>
</TR>

<TR>
    <TD style="font-size: 6pt">&nbsp;</TD>
</TR><TR valign="top" style="font-size: 10pt; color: #000000; background: transparent">
    <TD width="3%" nowrap align="left"><FONT style="font-family: Wingdings">&#111;</FONT></TD>
    <TD width="1%">&nbsp;</TD>
    <TD>Pre-commencement communications pursuant to Rule&nbsp;13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))</TD>
</TR>

</TABLE>
</DIV>

<DIV style="width: 100%; border-bottom: 1pt solid black; margin-top: 10pt; font-size: 1pt">&nbsp;</DIV>
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<DIV align="left" style="font-size: 10pt; margin-top: 12pt"><B>Item&nbsp;8.01 &#151; Other Events</B>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">On September&nbsp;26, 2011, MELA Sciences, Inc. (the &#147;Company&#148;) issued a press release announcing that
the U.S. Food and Drug Administration (the &#147;FDA&#148;) has issued an Approvable Letter for the
MelaFind<SUP style="FONT-size: 85%; vertical-align: text-top">&#174;</SUP> Pre-Market Approval (PMA)&nbsp;application. The Company intends to work with the
FDA to finalize the physician and patient labeling, package insert, user&#146;s guide, training program
and clinical protocol for a post-approval study in order to obtain final approval. A copy of the
press release is attached as Exhibit&nbsp;99.1 to this current report.
</DIV>

<!-- link1 "Item&nbsp;9.01 &#151; Financial Statements and Exhibits" -->

<DIV align="left" style="font-size: 10pt; margin-top: 12pt"><B>Item&nbsp;9.01 &#151; Financial Statements and Exhibits</B>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">(d)&nbsp;Exhibits
</DIV>

<DIV align="center">
<TABLE style="font-size: 10pt" cellspacing="0" border="0" cellpadding="0" width="100%">
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    <TD nowrap align="center" colspan="3" style="border-bottom: 1px solid #000000">Exhibit No.</TD>
    <TD>&nbsp;</TD>
    <TD nowrap align="left" style="border-bottom: 1px solid #000000">Description</TD>
</TR>

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    <TD nowrap align="right" valign="top">&nbsp;</TD>
    <TD align="right" valign="top">99.1</TD>
    <TD nowrap valign="top">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD valign="top"><DIV style="margin-left:0px; text-indent:-0px">MELA Sciences, Inc. Press Release, dated September&nbsp;26, 2011</DIV></TD>
</TR>
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<DIV align="center" style="font-size: 10pt; margin-top: 18pt"><B>SIGNATURES</B>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">Pursuant to the requirements of the Securities Exchange Act of 1934, the Company has duly caused
this report to be signed on its behalf by the undersigned hereunto duly authorized.
</DIV>


<TABLE width="100%" border="0" cellspacing="0" cellpadding="0" style="font-size: 10pt">
<TR>
    <TD width="48%">&nbsp;</TD>
    <TD width="1%">&nbsp;</TD>
    <TD width="1%">&nbsp;</TD>
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    <TD width="15%">&nbsp;</TD>
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<TR>
    <TD valign="top" align="left">&nbsp;</TD>
    <TD colspan="3" align="left">MELA Sciences, Inc.<BR>
&nbsp;</TD>
    <TD>&nbsp;</TD>
</TR><TR>
    <TD align="left">Date: September 26, 2011&nbsp;</TD>
    <TD valign="top">By:&nbsp;&nbsp;</TD>
    <TD colspan="2" style="border-bottom: 1px solid #000000" align="left">/s/ Richard I. Steinhart
&nbsp;</TD>
    <TD>&nbsp;</TD>
</TR><TR>
    <TD align="left">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD colspan="2" align="left">Richard I. Steinhart,&nbsp;</TD>
    <TD>&nbsp;</TD>
</TR><TR>
    <TD align="left">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD colspan="2" align="left">Chief Financial Officer<BR>

(Principal Financial Officer)&nbsp;</TD>
    <TD>&nbsp;</TD>
</TR>
<TR>
    <TD colspan="5">&nbsp;</TD>
</TR>
</TABLE>


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<DIV align="right" style="font-size: 10pt; margin-top: 12pt"><B>Exhibit&nbsp;99.1</B>
</DIV>


<DIV align="center" style="font-size: 10pt; margin-top: 18pt"><IMG src="y92835y9283501.gif" alt="(MELA LOGO)">
</DIV>


<DIV align="center" style="font-size: 10pt; margin-top: 18pt"><B>MELA Sciences Receives Approvable Letter from FDA for MelaFind</B><SUP style="FONT-size: 85%; vertical-align: text-top"><B><SUP style="FONT-size: 85%; vertical-align: text-top">&#174;</SUP></B></SUP>
</DIV>


<DIV align="Center" style="font-size: 10pt; margin-top: 6pt"><B><I>- Company to finalize labeling, training program and clinical protocol for post-<BR>
approval study -</I></B>
</DIV>

<DIV align="Center" style="font-size: 10pt; margin-top: 6pt"><B><I>- Conference call scheduled for 8:30 a.m. -</I></B>
</DIV>
<DIV align="left" style="font-size: 10pt; margin-top: 6pt">IRVINGTON, NY (September&nbsp;26, 2011) &#151; MELA Sciences (NASDAQ: MELA) today announced that the U.S.
Food and Drug Administration (FDA)&nbsp;has issued an Approvable Letter for the
MelaFind<SUP style="FONT-size: 85%; vertical-align: text-top"><B><SUP style="FONT-size: 85%; vertical-align: text-top">&#174;</SUP></B></SUP> Pre-Market Approval (PMA)&nbsp;application. The company intends to work
with the agency to finalize the physician and patient labeling, package insert, user&#146;s guide,
training program and clinical protocol for a post-approval study in order to obtain final approval.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">&#147;The FDA&#146;s Approvable Letter for MelaFind represents a monumental milestone for MELA Sciences and
the millions of Americans who are at risk of developing melanoma, the deadliest form of skin
cancer,&#148; said Joseph V. Gulfo, MD, President and CEO, MELA Sciences. &#147;The company has worked
tirelessly to develop an objective tool to help dermatologists detect melanoma at its earliest,
most curable stages. Although melanoma is virtually 100% curable if detected at its earliest stage,
one American dies from the disease every hour. We firmly believe that MelaFind has the potential
to lower those tragic numbers. We are extremely pleased with the FDA&#146;s decision and will work
diligently to answer all open questions and finalize the post-market study protocol in the coming
weeks.&#148;
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">The Approvable Letter from the FDA comes on the heels of the CE Mark for MelaFind issued earlier
this month. CE Mark approval allows MelaFind to be sold across the 27 nations of the European
Union.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">&#147;MelaFind has the potential to provide dermatologists with significantly more information about
indeterminate pigmented skin lesions to help us when deciding on which lesions to biopsy to detect
melanoma as early as possible,&#148; said Darrell S. Rigel, MD, Clinical Professor of Dermatology at New
York University Medical School. &#147;While there have been incremental improvements in imaging tools
for melanoma detection, we still primarily rely on our judgment based on a visual examination to
select the lesions to biopsy; data show that this is often not enough.&#148;
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">&#147;Taken together, the multiple clinical trials demonstrate that MelaFind represents a significant
advance and should have a positive impact on patient outcomes once it&#146;s approved and available to
dermatologists,&#148; said Laura K. Ferris, MD, PhD, Assistant
</DIV>




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<DIV align="left" style="font-size: 10pt; margin-top: 6pt">Professor of Dermatology and Director of
the University of Pittsburgh Department of Dermatology Clinical Trials Unit.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">The studies used to support the PMA application for MelaFind were the 1,383 patient U.S. pivotal
trial and the companion reader study of 110 dermatologists: the device demonstrated a 98%
sensitivity in the pivotal trial, whereas dermatologists had a 72% sensitivity in the adjunctive
reader study.
</DIV>


<DIV align="left" style="font-size: 10pt; margin-top: 12pt"><B>MelaFind</B><B><SUP style="FONT-size: 85%; vertical-align: text-top">&#174;</SUP></B>
<B>
 Indications for Use</B>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">The FDA and MELA Sciences have agreed to the following labeled indications for use of MelaFind in
the U.S.:
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">MelaFind is intended for use on clinically atypical cutaneous pigmented lesions with one or more
clinical or historical characteristics of melanoma, excluding those with a clinical diagnosis of
melanoma or likely melanoma. MelaFind is designed to be used when a dermatologist chooses to
obtain additional information for a decision to biopsy. MelaFind should NOT be used to confirm a
clinical diagnosis of melanoma.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">MelaFind is only for use by physicians trained in the clinical diagnosis and management of skin
cancer (i.e., dermatologists) who have also successfully completed a training program in the
appropriate use of MelaFind.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">The MelaFind result is one element of the overall clinical assessment. MelaFind positive lesions
(which may include malignant melanoma, melanoma <I>in situ</I>, high grade dysplastic nevi and atypical
melanocytic proliferation/hyperplasia) should be considered for biopsy; the biopsy decision of a
MelaFind negative lesion should be based on the remainder of the entire clinical context. Lesions
that are &#147;non-evaluable&#148; by MelaFind should be carefully re-evaluated for biopsy.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">MelaFind is indicated only for use on lesions with a diameter between 2 mm and 22 mm, lesions that
are accessible by the MelaFind imager, lesions that are sufficiently pigmented (i.e. not for use on
non-pigmented or skin-colored lesions), lesions that do not contain a scar or fibrosis consistent
with previous trauma, lesions where the skin is intact (i.e., non-ulcerated or non-bleeding
lesions), lesions greater than 1 cm away from the eye, lesions which do not contain foreign matter,
and lesions not on special anatomic sites (i.e., not for use on acral, palmar, plantar, mucosal, or
subungual areas). MelaFind is not designed to detect pigmented non-melanoma skin cancers, so the
dermatologist should rely on clinical experience to diagnose such lesions.
</DIV>


<DIV align="left" style="font-size: 10pt; margin-top: 12pt"><B>Conference Call Information</B>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">MELA Sciences will host a conference call on Monday, September&nbsp;26 at 8:30 am ET. To participate,
please dial 888-204-4317 fifteen minutes before the conference is scheduled to begin. Callers
outside of the U.S. should dial &#043;816-581-1703. The conference call passcode is &#147;MELA Sciences.&#148; A
live webcast of this call will be available in the investor
</DIV>



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<DIV align="left" style="font-size: 10pt; margin-top: 6pt">relations section of
www.melasciences.com. A webcast replay of the call will be available for two weeks on the company&#146;s
website by dialing 888-203-1112. Callers outside of the U.S. should dial &#043;719-457-0820. The replay
participant code is 8744426.
</DIV>


<DIV align="left" style="font-size: 10pt; margin-top: 12pt"><B>About Melanoma</B>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">Melanoma is the deadliest form of skin cancer, responsible for approximately 75% of skin cancer
fatalities. The American Cancer Society estimates that there will be 70,230 new cases of invasive
melanoma and about 8,790 related melanoma deaths in 2011 alone. The incidence of melanoma is on the
rise. A 2008 National Cancer Institute report indicates that the annual incidence of melanoma
among young adult Caucasian women rose 50% between 1980 and 2004.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">The five year survival rate for patients with stage IV melanoma is less than 15%, with most
patients dying within 6 to 10&nbsp;months. Detecting early melanoma and conducting prompt treatment is
essential to improving the prognosis. With early detection, surgical removal alone is usually the
only required treatment because the melanoma is limited to the epidermis, the outer layer of skin.
In this early stage, the cure rate with surgical removal is virtually 100%.
</DIV>


<DIV align="left" style="font-size: 10pt; margin-top: 12pt"><B>About MELA Sciences, Inc.</B>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">MELA Sciences is a medical device company focused on the design, development and commercialization
of non-invasive tools to provide additional information to dermatologists during melanoma skin
examinations. The company&#146;s flagship product, MelaFind<SUP style="FONT-size: 85%; vertical-align: text-top">&#174;</SUP>, is intended to be used when a
trained dermatologist chooses to obtain additional information to help decide whether to biopsy
certain indeterminate pigmented skin lesions. MelaFind has received the CE Mark and is approved
for use in the European Union. The company has received an Approvable Letter from the U.S. Food
and Drug Administration (FDA)&nbsp;and is working to submit finalized labeling and other items to the
agency to obtain marketing approval in the U.S.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">For more information on MELA Sciences, visit www.melasciences.com.
</DIV>


<DIV align="left" style="font-size: 10pt; margin-top: 12pt"><B>Safe Harbor</B>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">This press release includes &#147;forward-looking statements&#148; 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 &#147;expects,&#148;
&#147;contemplates,&#148; &#147;anticipates,&#148; &#147;plans,&#148; &#147;intends,&#148; &#147;believes,&#148; &#147;assumes,&#148; &#147;predicts&#148; 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 known and unknown 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
</DIV>




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<DIV align="left" style="font-size: 10pt; margin-top: 6pt">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 facing the company such as those set forth in its
reports on Forms 10-Q and 10-K filed with the U.S. Securities and Exchange Commission (the &#147;SEC&#148;).
Factors that might cause such a difference include whether the company is able to sufficiently
satisfy the requirements set forth in the FDA&#146;s Approvable Letter or even if the company is able to
sufficiently satisfy the requirements set forth in the FDA&#146;s Approvable Letter whether
MelaFind<SUP style="FONT-size: 85%; vertical-align: text-top">&#174;</SUP> ever achieves market acceptance or becomes commercially viable. Given the
uncertainties affecting companies in the medical device industry such as the company, any or all of
these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any
such factors or forward-looking statements. The company urges you to carefully review and consider
the disclosures found in its filings with the SEC which are available at www.sec.gov and
www.melasciences.com.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">For further information contact:
</DIV>


<DIV align="left" style="font-size: 10pt; margin-top: 6pt">For Investors:<BR>
David Carey<BR>
Lazar Partners, Ltd.<BR>
646-871-8485

</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">For Media<BR>
Melissa Hurley<BR>
Ricochet Public Relations<BR>
212-679-3300 x128

</DIV>


<P align="center" style="font-size: 10pt"><!-- Folio -->&nbsp;<!-- /Folio -->
</DIV>



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`
end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
