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Created: 09/27/2009 02:49:51 PM - Followers: 36 - Board type: Free - Posts Today: 0

Mela Sciences, Inc. (NASDAQ: MELA)

www.melasciences.com

Contact Information

MELA Sciences, Inc.
50 South Buckhout St.
Suite 1
Irvington, New York 10533

Tel: 914-591-3783
Toll Free: 800-729-8849
Fax: 914-591-3785

January 16, 2013 Management Presentation

MelaFind® Regulatory Update

The FDA has approved MELA Sciences' MelaFind® Pre-Market Approval application for use in the United States. Following completion of a successful conformity assessment procedure MELA Sciences has also been granted CE Mark approval for sale of MelaFind® in the European Union.

The FDA and MELA Sciences have agreed to the following labeled indications for use of MelaFind®in the U.S.:

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.

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®.

The MelaFind® result is one element of the overall clinical assessment of clinically atypical lesions. A "High Disorganization" MelaFind® output indicates lesions (which may include malignant melanoma, melanoma in situ, high grade dysplastic nevi and atypical melanocytic proliferation/hyperplasia) that should be considered for biopsy; the biopsy decision of a "Low Disorganization" MelaFind® output should be based on the remainder of the entire clinical context. Lesions that are "non-evaluable" by MelaFind® should be carefully re-evaluated for biopsy.

MelaFind® is indicated only for use on lesions with a diameter between 2 mm and 22 mm, lesions that are accessible by the Hand-Held component of MelaFind®, 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.

The Hand-Held component of MelaFind®, used to capture multi-spectral data from beneath the surface of lesions, is made up of:

  • An illuminator that shines light of 10 different specific wavelengths, including near infrared bands
  • A lens system composed of 9 elements that creates multi-spectral data of the light scattered back from the lesions
  • A photon (light) sensor

MelaFind's automatic data analysis algorithms include:

  • Calibration to reduce noise and artifacts in the data
  • Quality control to automatically detect problems such as overexposure, underexposure, inappropriate lesion size or too much hair and when appropriate, direct the MelaFind® operator to re-evaluate the lesion
  • Lesion segmentation to identify portions of the data that belong to the lesion
  • Feature extraction to compute parameters characterizing lesions
  • Lesion classification to classify clinically atypical pigmented skin lesions based upon degree of 3D morphological disorganization providing an output of "High Disorganization" or "Low Disorganization"

Development and training of the lesion classification algorithm is an iterative process involving: (1) creation and enrichment of the lesion database and complementary gold-standard (pathology) information; (2) development of the lesion features that provide discrimination; (3) development of algorithms that enable computers to effectively "learn" based on examples; (4) training of the computer using these algorithms to arrive at the best-performing classifier; and (5) repeating the process. The performance of the lesion classification algorithm is directly related to the size of the database used in training, as well as the degree to which the training database is representative of the lesions that will be evaluated by MelaFind® in a practice setting.

Proprietary Database of Pigmented Skin Lesions. The database includes in vivo multi-spectral data and corresponding histological results of over 10,000 biopsied lesions from over 7,000 patients at 40 clinical study sites. MELA Sciences believes this is the largest such database in the US and a substantial barrier to competition.

MelaFind® Pivotal Trial Results. The Company conducted numerous studies of the MelaFind®system, including the landmark MelaFind® pivotal trial, the largest prospective clinical study ever conducted in melanoma detection. For all subgroups analyzed in the pivotal study, the sensitivity of MelaFind® was greater than 95% (95% lower confidence bound) and its specificity was statistically significantly higher than that of study clinicians. For more information about MelaFind® clinical studies, visit www.melafind.com.

The FDA has approved MELA Sciences' MelaFind® Pre-Market Approval application for use in the United States. Following completion of a successful conformity assessment procedure MELA Sciences has also been granted CE Mark approval for sale of MelaFind® in the European Union.

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#719 Pivotal day for MELA. Green skies ahead. glta ThesT 11/12/2015 01:11:15 PM
#718 Im waiting for BK to buy in yaboy520 08/17/2015 02:51:32 AM
#717 cdp i'm loading up a bit. hoping i've ThesT 08/12/2015 01:12:02 PM
#716 Bonjour Cbd.. Just bought in. This one is ThesT 07/18/2015 12:09:52 AM
#715 Interesting I'm watching this one! Cbdpotential 07/17/2015 05:53:22 PM
#714 Nice accumulation today! Looking good. ThesT 07/15/2015 11:08:33 AM
#713 agreed. this more a sales and marketing play. ThesT 06/30/2015 02:11:51 PM
#712 I'm waiting for .75.... I like what they TheWatcher51 06/30/2015 02:01:08 PM
#711 make that 15-20M in the next year. ThesT 06/30/2015 12:48:44 PM
#710 Just added MELA. The basics financials show an ThesT 06/30/2015 09:52:49 AM
#709 Markets saying sell worthy news... 42 million shares TheWatcher51 06/23/2015 11:09:04 AM
#708 8:00 am ET June 23, 2015 (Dow Jones) Print clydesur 06/23/2015 08:43:24 AM
#707 Got my eye on mela... GLA TheWatcher51 05/21/2015 07:07:00 PM
#706 MELA going to breakout soon. Oversold and near zabigul 04/15/2015 02:55:32 PM
#705 I missed the real move on 3/10. RichDude 03/18/2015 09:15:02 AM
#704 I missed the real move @ $1.70. RichDude 03/18/2015 09:12:08 AM
#703 MELA is good for 10% IMO MONEYMADE 03/17/2015 03:58:43 PM
#702 MELA just popped up on my screener. RichDude 03/17/2015 03:56:18 PM
#701 debt of 5 million* PennyStockpick 03/16/2015 08:00:39 PM
#700 Well it's flaring up now for some reason uptowndw 03/16/2015 03:59:27 PM
#699 $MELA also has legal issues facing them " PennyStockpick 03/16/2015 12:59:54 PM
#698 My reasons to short $MELA** PennyStockpick 03/16/2015 12:36:20 PM
#697 reasons to short $MELA "November 17, 2014, PennyStockpick 03/16/2015 12:34:57 PM
#696 Looks like it... uptowndw 03/13/2015 08:49:17 PM
#695 This POS is done Goldmind 03/13/2015 08:48:34 PM
#693 3/12/2015 HC Wainright Reiterated Rating Buy http://www.analystr BottomBounce 03/12/2015 06:49:21 PM
#692 oversold and way undervalued. BottomBounce 03/12/2015 11:26:58 AM
#691 $MELA shorts getting hurt here nates room is the_little_farmer 03/12/2015 11:20:10 AM
#690 Moving north!!!! uptowndw 03/12/2015 11:12:24 AM
#689 Less than 6M float gonna squeeze soon !! the_little_farmer 03/12/2015 10:38:50 AM
#688 new support level 3.21 up from here imo BottomBounce 03/12/2015 10:29:27 AM
#687 very nice vol. lots of buying from bottom BottomBounce 03/12/2015 10:28:21 AM
#686 Who won in the end??? diannedawn 03/12/2015 10:22:22 AM
#685 http://melasciences.com/melanoma the_little_farmer 03/12/2015 09:21:22 AM
#684 $MELA its MelaFind device can save lives because the_little_farmer 03/12/2015 09:20:03 AM
#683 $MELA shorts confused what a Lesion is? Clue the_little_farmer 03/12/2015 09:19:21 AM
#682 and with GENE it burned just because it the_little_farmer 03/12/2015 09:13:51 AM
#681 yes but if you did a DD and the_little_farmer 03/12/2015 08:52:04 AM
#680 with this low float i wish a nice the_little_farmer 03/12/2015 08:49:47 AM
#679 Warrants convert to free trade and can be Warrior23 03/12/2015 08:49:03 AM
#678 i can understand but float is float and the_little_farmer 03/12/2015 08:47:51 AM
#677 continuation or pullback i would advise buying some Fedex11 © 03/12/2015 08:47:32 AM
#676 Except Gene had an Aussie fund and this Warrior23 03/12/2015 08:44:13 AM
#675 Less than 6 Millions float, full of shorts the_little_farmer 03/12/2015 08:40:59 AM
#674 $MELA Anti-Cancer Biotech 6M float Stock Skyrockets http://www.wallstreetsectors the_little_farmer 03/12/2015 08:38:22 AM
#673 ,,,,,,,THANKS! MONEYMADE 03/12/2015 06:31:35 AM
#672 $MELA https://www.google.com/search?q=MELAFIND&source=lnms&tbm=isch&sa=X& BottomBounce 03/12/2015 04:45:58 AM
#671 $MELA MACD Bullish CrossOver Chart http://stockcharts.com/c- BottomBounce 03/12/2015 01:13:20 AM
#670 Melanoma skin cancers BottomBounce 03/12/2015 12:31:20 AM
#669 Insiders loaded the boat from .50 to 1.35 aapples1992 03/11/2015 11:57:36 PM
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