MELA Sciences Issues Statement on FDA's New Draft Guidance on Pivotal Clinical Trials


IRVINGTON, NY--(Marketwire -08/17/11)- MELA Sciences, Inc.   (NASDAQ: MELA - News) issued the following statement regarding the U.S.   Food and Drug Administration's (FDA) draft guidance on Design Considerations for Pivotal Clinical Investigations for Medical Devices, including those conducted to support Premarket Approval (PMA) applications.   The draft guidance, which was issued August 15, discusses various recommended study designs, including randomized and blinded clinical studies.

"We hold ourselves to the highest, most rigorous clinical standards, and consequently when we designed the pivotal study of MelaFind® with the FDA, we insisted on conducting a blinded study in which patients underwent both tests, investigators' eyes and MelaFind, which is more rigorous and scientifically preferred to randomization," said Joseph V.   Gulfo, MD, President and CEO of MELA Sciences.   "We also set effectiveness thresholds for melanoma detection beyond any standards ever reported in the clinical literature.   We met those thresholds -- and ultimately enrolled more patients than had any other study previously conducted in melanoma detection.   From what I understand about the new FDA draft guidance, the protocol we agreed to with FDA years ago meets or exceeds what the agency is now proposing.   Additionally, we believe our approach is in harmony with the draft recommendations, for example, with respect to meeting with FDA and designing a pivotal trial to achieve a desired claim before starting the study.   We are pleased that the latest draft guidance is consistent with the commitment MELA and FDA made seven years ago."

MELA Sciences developed MelaFind® to serve as a tool to help dermatologists detect melanoma at its earliest, most curable stages.   Clinical literature shows that approximately 25% or more of these early lesions are being missed with current detection techniques.   In the largest clinical trial ever conducted in melanoma detection, MelaFind detected 98.3% of the melanomas, missing fewer than 2% of the early melanomas.

Based on these positive data, the company submitted a PMA application for MelaFind to the FDA over two years ago, yet no final decision has been made.

In its earliest stage, melanoma is limited to the epidermis, the outer layer of skin and the cure rate with surgical removal is virtually 100%.(1) With early detection, surgical removal alone is usually the only required treatment.   However, the five year survival rate for patients with stage IV melanoma is less than 15%, with most patients dying within six to ten months.(2)

Detecting early melanoma not only translates to better results for patients, it also reduces overall healthcare costs.   If diagnosed early, dermatologists excise melanoma at a cost of approximately $1,800 per patient.   Treatment costs increase dramatically as the melanoma progresses, costing close to $170,000 per patient for late stage melanoma.(3)

About MELA Sciences, Inc:
MELA Sciences is a medical technology company focused on developing MelaFind®, a non-invasive and objective multi-spectral computer vision system intended to aid in the detection of early melanoma.   MELA Sciences designed MelaFind® to assist in the evaluation of clinically atypical pigmented skin lesions, when a dermatologist chooses to obtain additional information before making a final decision to biopsy to rule out melanoma.   MelaFind® acquires and displays multi-spectral (from blue to near infrared) and reconstructed RGB 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 deadliest form of skin cancer.   Although no cure is currently available for advanced-stage melanoma, melanoma is virtually 100% curable if caught early.

MelaFind® Proposed Indications for Use
MELA Sciences proposes that MelaFind® is indicated for the evaluation of clinically atypical cutaneous pigmented lesions (those having one or more clinical or historical characteristics of melanoma, such as asymmetry, border irregularity, color variegation, diameter greater than 6 mm, evolving, patient concern, regression, and "ugly duckling"), when a dermatologist chooses to obtain additional information before making a final decision to biopsy to rule out melanoma.   MelaFind® is a non-invasive and objective multi-spectral computer vision system designed as a tool to aid dermatologists in the detection of early (e.g., non-ulcerated, not bleeding, or less than 2.2 cm in diameter) melanoma.

MelaFind® is not a screening device and is not indicated for non-pigmented lesions, banal pigmented lesions, lesions that are clinically identified as definite melanomas, or lesions on special anatomical sites (i.e., acral, mucosal, subungual).

Regulatory Status
The MelaFind® PMA application was filed with the FDA in June 2009, received positive FDA Advisory Panel recommendations in November 2010 and is currently under review at the FDA.   In February 2011, the Company filed an amendment to the MelaFind® PMA application with the FDA, limiting the indication for use to dermatologists and in May 2011 the Company filed another amendment to the MelaFind® PMA that incorporated a training program for users.   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

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," "assumes," "predicts" 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 "SEC").   Factors that might cause such a difference include whether the data from our pre-clinical studies and clinical trials is sufficient to support regulatory approval of MelaFind®, whether we are required to provide the FDA with additional data or perform additional testing on MelaFind® or, even if we do receive regulatory approval, whether any such approval is for the indications we seek.   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 and

(1) American Academy of Dermatology (

(2) Tsao H, Atkins MB, Sober AJ.   Management of Cutaneous Melanoma.   N Engl J Medicine.   2004;251(10):998-1012

(3) Alexandrescu D, Dermatology On-Line Journal.   Melanoma Costs: A dynamic model for comparing estimated overall costs of various clinical stages.   15(11): 1, 2009


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