<SEC-DOCUMENT>0000950123-11-094175.txt : 20111102
<SEC-HEADER>0000950123-11-094175.hdr.sgml : 20111102
<ACCEPTANCE-DATETIME>20111102082440
ACCESSION NUMBER:		0000950123-11-094175
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20111102
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20111102
DATE AS OF CHANGE:		20111102

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:		111173095

	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>

<DIV align="center" style="font-size: 10pt; margin-top: 12pt"><B>Date of Report (Date of earliest event reported): November&nbsp;2, 2011</B></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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<TR valign="bottom">
    <TD width="30%">&nbsp;</TD>
    <TD width="5%">&nbsp;</TD>
    <TD width="30%">&nbsp;</TD>
    <TD width="5%">&nbsp;</TD>
    <TD width="30%">&nbsp;</TD>
</TR>
<TR></TR>
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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%">
<!-- Begin Table Head -->
<TR valign="bottom">
    <TD width="30%">&nbsp;</TD>
    <TD width="5%">&nbsp;</TD>
    <TD width="30%">&nbsp;</TD>
    <TD width="5%">&nbsp;</TD>
    <TD width="30%">&nbsp;</TD>
</TR>
<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>
    <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">&nbsp;</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">&nbsp;</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: 18pt">Registrant&#146;s telephone number, including area code <B>(914)&nbsp;591-3783</B>
</DIV>


<DIV align="center" style="font-size: 10pt; margin-top: 18pt">(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 align="left" style="font-size: 10pt; margin-top: 6pt"><FONT style="font-family: Wingdings">&#111;</FONT> Written communications pursuant to Rule&nbsp;425 under the Securities Act (17 CFR 230.425)
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt"><FONT style="font-family: Wingdings">&#111;</FONT> Soliciting material pursuant to Rule&nbsp;14a-12 under the Exchange Act (17 CFR 240.14a-12)
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt"><FONT style="font-family: Wingdings">&#111;</FONT> Pre-commencement communications pursuant to Rule&nbsp;14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt"><FONT style="font-family: Wingdings">&#111;</FONT> Pre-commencement communications pursuant to Rule&nbsp;13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
</DIV>


<DIV style="width: 100%; border-bottom: 1pt solid black; margin-top: 10pt; font-size: 1pt">&nbsp;</DIV>
<DIV style="width: 100%; border-bottom: 2pt solid black; 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 November&nbsp;2, 2011, MELA Sciences, Inc. (the &#147;Company&#148;) issued a press release announcing that the
U.S. Food and Drug Administration has approved the Company&#146;s pre-market approval application for
MelaFind<SUP style="FONT-size: 85%; vertical-align: text-top">&#174;</SUP>. A copy of the press release is attached as Exhibit&nbsp;99.1 to this current
report.
</DIV>


<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 width="90%">&nbsp;</TD>
</TR>
<TR style="font-size: 8pt" valign="bottom">
    <TD nowrap align="left" 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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<TR valign="bottom">
    <TD valign="top"><DIV style="margin-left:0px; text-indent:-0px">99.1
</DIV></TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top">MELA Sciences, Inc. Press Release, dated November&nbsp;2, 2011</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>
    <TD width="35%">&nbsp;</TD>
    <TD width="15%">&nbsp;</TD>
</TR>
<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: November 2, 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="y93286y9328600.gif" alt="(MELA SCIENCES LOGO)">
</DIV>


<DIV align="center" style="font-size: 10pt; margin-top: 18pt"><B>MELA Sciences Announces FDA Approval 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>MelaFind represents one of the most significant advances in melanoma detection since<BR>
the advent of the ABCD criteria established 25&nbsp;years ago</I></B>
</DIV>

<DIV align="Center" style="font-size: 10pt; margin-top: 6pt"><B><I>Melanoma is the deadliest form of skin cancer, responsible for approximately 75% of<BR>
skin cancer fatalities</I></B>
</DIV>

<DIV align="Center" style="font-size: 10pt; margin-top: 6pt"><B><I>Conference call scheduled for 10:00&nbsp;a.m. ET</I></B>
</DIV>
<DIV align="left" style="font-size: 10pt; margin-top: 6pt">IRVINGTON, NY (November&nbsp;2, 2011) &#151; MELA Sciences (NASDAQ: MELA) today announced that the U.S. Food
and Drug Administration (FDA)&nbsp;has approved the pre-market approval (PMA)&nbsp;application for
MelaFind<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="left" style="font-size: 10pt; margin-top: 6pt">&#147;MelaFind is a groundbreaking technology and represents one of the most significant advances in
early melanoma detection since the advent of the ABCD criteria that our group developed over a
quarter century ago,&#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 eyes, experience and judgment. MelaFind provides
objective information about indeterminate pigmented skin lesions to help us when deciding which
lesions to biopsy to detect melanoma as early as possible when it can still be cured.&#148;
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">&#147;Melanoma is the deadliest form of skin cancer and rates of the disease are on the rise, especially
in younger women,&#148; said Susan Weinkle, MD, Assistant Clinical Professor of Dermatology, University
of South Florida, President-elect of the American Society of Dermatologic Surgery, and Past
President of the Women&#146;s Dermatologic Society. &#147;Early detection is our only chance for survival,
and MelaFind has the potential to have a deep impact on this disease.&#148;
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">Melanoma accounts for approximately 75% of skin cancer fatalities. Although melanoma is virtually
100% curable if detected at its earliest stage, one American dies from the disease every hour.
Detection of early melanoma and conducting prompt treatment is essential to improving patient
prognoses.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">&#147;The FDA approval of MelaFind marks the most important achievement in the company&#146;s history and
represents a significant advance for the millions of Americans who are at risk of developing this
terrible disease,&#148; said Joseph V. Gulfo, MD, President
</DIV>
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<DIV align="left" style="font-size: 10pt; margin-top: 6pt">and CEO, MELA Sciences. &#147;We are actively
working to prepare to launch MelaFind in the Northeast U.S. and Germany during the first quarter.
We&#146;re planning a steadfast, deliberate and measured approach to the commercial launch to ensure
that dermatologists in practices of all shapes and sizes are trained and set up to use MelaFind
effectively on
the patients who can benefit most from the objective information that the system provides during
skin examinations.&#148;
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">In September, the company received CE Mark approval in the European Union, as well. Concurrent with
its 2012 Northeastern U.S. rollout, the company plans to undertake a similar rollout strategy in
Germany.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">&#147;We are thrilled that our years of persistence through the development and regulatory process have
paid off,&#148; Dr.&nbsp;Gulfo continued. &#147;We are ready to start this new phase in the company&#146;s history with
the same energy, passion and tireless dedication that was responsible for this tremendous and
rewarding accomplishment.&#148;
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">The company submitted its PMA application to the FDA in June&nbsp;2009. The studies used to support the
PMA application for MelaFind were the 1,383-patient U.S. pivotal trial and the pivotal trial&#146;s
companion reader study of 110 dermatologists. The device demonstrated a 98% sensitivity in the
pivotal trial, and a similar sensitivity in the reader study compared to a 72% sensitivity for
participating dermatologists.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">MelaFind systems will be placed initially in select, &#147;high&#148; volume, integrated dermatology and skin
cancer specialists&#146; practices.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">Based upon receipt of its FDA approval, the company withdrew its Citizen Petition filed with the
FDA in May&nbsp;2011 that focused on numerous irregularities in the PMA process, and requested that the
FDA Commissioner enforce the binding protocol agreement between MELA Sciences and the FDA.
</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> 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>


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<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 Wednesday, November&nbsp;2, 2011 at 10:00&nbsp;a.m. ET. To
participate, please dial 888-806-6231 15 minutes before the conference is scheduled to begin.
Callers outside of the U.S. should dial &#043;913-312-0698. The conference call passcode is &#147;MELA
Sciences.&#148; A live webcast of this call will be available in the investor relations section of
www.melasciences.com. A webcast replay of the call will be available for two weeks on the company&#146;s
website or by dialing 888-203-1112. Callers outside of the U.S. should dial &#043;719-457-0820. The
replay participant code is 4163857.
</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 six to 10&nbsp;months. Detecting early melanoma and conducting prompt treatment is
essential to improving the prognosis. With detection of early melanoma, 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>


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<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. The FDA has approved MelaFind for use in the U.S. It has received the CE Mark for use in
the European Union.
</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 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
Melafind<SUP style="font-size: 85%; vertical-align: text-top">&#174;</SUP>
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>


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