MELA vor dem Durchbruch?

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neuester Beitrag: 25.04.21 02:56
eröffnet am: 22.08.09 14:19 von: Magnetfeldfr. Anzahl Beiträge: 12
neuester Beitrag: 25.04.21 02:56 von: Kerstinmdqh. Leser gesamt: 9601
davon Heute: 4
bewertet mit 2 Sternen

22.08.09 14:19
2

2170 Postings, 5505 Tage MagnetfeldfredyMELA vor dem Durchbruch?

Electro Optical Sciences hat ein revolutionäres optisches Verfahren entwickelt um Hautkrebs früh und sicher festzustellen und erwartet Ende 2009 die FDA Zulassung!
Vervielfachungspotential!  

26.10.09 20:51
2

2170 Postings, 5505 Tage MagnetfeldfredyMELA vor dem Durchbruch?

Mal wieder ein "uniteressanter" Beitrag von mir, Melanom Dedektor mit 98 % Erkennungsrate, kurz vor der Zulassung und Vervielfachungspotential:

A Big Upgrade for Electro-Optical Sciences
By Dave Mock
October 26, 2009 | Comments (0)

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Electro-Optical

Rate MELA CAPS Rating 5/5 Stars
$11.00 $0.80 (7.84%)


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2 Stocks Hitting High Notes
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Every day, the sun rises on Wall Street, and a plethora of professional analysts wake to issue new opinions on stocks. Here at the Fool, we use our "This Just In" column to examine some of these picks-- and the track records of the companies behind them -- so individuals can make better investing decisions.

In addition to following professional banks, anyone can use Motley Fool CAPS to monitor the collective opinions of more than 140,000 members, many of whom demonstrate better investing insight than published analysts do.

After Electro-Optical Sciences (Nasdaq: MELA) spent the past several months at no better than a four-star ranking, enough top-performing CAPS members have become  bullish on it recently to upgrade it to the highest possible five stars. A total of 139 members have given their opinion on the medical-devices company, with many of them offering analysis and commentary explaining the recent optimism.

Melanoma is the deadliest form of skin cancer and is often described as a graveyard for drugs because there are few treatments available. While Schering-Plough (NYSE: SGP) seeks approval for one of its drugs and Bristol-Myers Squibb (NYSE: BMY) has one in clinical trials, many others like Pfizer (NYSE: PFE) have failed in trying to market a treatment in the past. The Food and Drug Administration has put Electro-Optical Sciences' melanoma detection device, called MelaFind, on the fast track, with a decision coming as soon as the end of the year. Test results in February showed that MelaFind found 98% of the detectable melanomas in nearly 1,400 patients, while causing no adverse side effects. General Electric (NYSE: GE) and Siemens manufacture PET/CT scanners for early detection, but Electro-Optical's MelaFind is expected to play a big role in early detection if it is approved.

While other medical-devices companies such as Intuitive Surgical (Nasdaq: ISRG) and Boston Scientific (NYSE: BSX) have established histories and generate healthy revenue, Electro-Optical has no revenue or earnings yet and has relied on equity financing to get by. Some CAPS members write that the company is a speculative play, while some are drawn to MelaFind's potentially huge market and like the device's chances of winning approval  

10.12.10 16:53

2074 Postings, 6132 Tage Joschi307wie wird die fda entscheiden?

vor-voting knapp 8-7 dafür...

aber wirds es auch bei der hauptentscheidung durchgewunken?  

07.09.11 17:36

2170 Postings, 5505 Tage MagnetfeldfredyMela

....was lange währt wird endlich gut, der beste Hautkrebsscanner wurde für die EU zugelassen und die USA ist unmittelbar vor der Entscheidung:

Needham & Company Maintains a 'Buy' on MELA Sciences (MELA); Receives CE Mark to Sell in Europe

More News related to MELA
Morning Movers 09/07: (MELA) (WLT) (FCEL) (CONN) (MTG) Higher; (MCOX) Lower
Pre-Open Movers 9/07: (MELA) (WLT) (YHOO) Higher; (URBN) (ALTR) (GLD) Lower (more...)
Needham & Company Maintains a 'Buy' on MELA Sciences (MELA); Receives CE Mark to Sell in Europe
After-Hours Movers 09/06: (MELA) (NVDA) (FST) Higher; (DRI) (PBY) (ALTR) (NNN) Lower
Mela Sciences (MELA) Confirms CE Mark Approval for MelaFind(R)
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September 7, 2011 7:59 AM EDT

Needham & Company maintains a 'Buy' on MELA Sciences (NASDAQ: MELA) price target of $14.00.

Needham analyst says, "Receipt of the CE mark is a major milestone for MELA and we think the company could easily reach profitability in its first European market, Germany. This may also add to the pressure on the FDA. The head of the CDRH, the division reviewing the MELA application, is on record in congressional testimony saying that the original “non-approvable” letter was a mistake and should not have been sent, and that if the data supports MelaFind approval (and we already know it does via protocol agreement) that the device would be approved." (Needham lowers FY11 EPS estimate from (0.95) to (1.08), but raises FY12 from (1.13) to (0.87))

For more ratings news on MELA Sciences click here and for the rating history of MELA Sciences click here.

Shares of MELA Sciences closed at $2.24 yesterday, with a 52 week range of $1.75-$8.32.  

26.09.11 13:24

2170 Postings, 5505 Tage MagnetfeldfredyMela approvable letter from FDA

Jetzt gehts up:


MELA Sciences Receives Approvable Letter From FDA for MelaFind(R)

Company to Finalize Labeling, Training Program and Clinical Protocol for Post-Approval Study; Conference Call Scheduled for 8:30 a.m.



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Press Release Source: MELA Sciences On Monday September 26, 2011, 12:01 am EDT


IRVINGTON, NY--(Marketwire -09/26/11)- MELA Sciences (NASDAQ: MELA - News) today announced that the U.S. Food and Drug Administration (FDA) has issued an Approvable Letter for the MelaFind® Pre-Market Approval (PMA) application. The company intends to work with the agency to finalize the physician and patient labeling, package insert, user's guide, training program and clinical protocol for a post-approval study in order to obtain final approval.

"The FDA'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," said Joseph V. Gulfo, MD, President and CEO, MELA Sciences. "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's decision and will work diligently to answer all open questions and finalize the post-market study protocol in the coming weeks."

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.

"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," said Darrell S. Rigel, MD, Clinical Professor of Dermatology at New York University Medical School. "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."

"Taken together, the multiple clinical trials demonstrate that MelaFind represents a significant advance and should have a positive impact on patient outcomes once it's approved and available to dermatologists," said Laura K. Ferris, MD, PhD, Assistant Professor of Dermatology and Director of the University of Pittsburgh Department of Dermatology Clinical Trials Unit.

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.

MelaFind® Indications for Use

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. MelaFind positive lesions (which may include malignant melanoma, melanoma in situ, 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 "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 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.,  

27.09.11 06:14

2170 Postings, 5505 Tage MagnetfeldfredyMela approvable letter from FDA

New upgrades & targets after the bell $13-$15    26-Sep-11 08:08 pm    





16:48 EDT MELA Sciences target range raised to $13-$15 from $11 at Leerink
Leerink raised its target range for MELA Sciences and believes MelaFind should receive final approval in three months after the company announced an FDA approvable letter this morning. The firm keeps an Outperform rating on the stock.

15:36 EDT MELA Sciences mentioned positively at Needham
Needham said MELA's final approval is imminent for its MelaaFind hand held melanoma detector following the "Approvalable" letter from the FDA. The firm expects the product to be on the market in 1Q12 and reiterates its Buy rating and $14 price target.  

02.11.11 16:55

2170 Postings, 5505 Tage MagnetfeldfredyMela approved!

Eine neue effektive Waffe für die Früherkennung von Hautkrebs und für Investoren ein Schnäppchen:


MELA Sciences Announces FDA Approval for MelaFind(R)


MelaFind Represents One of the Most Significant Advances in Melanoma Detection Since the Advent of the ABCD Criteria Established 25 Years Ago; Melanoma Is the Deadliest Form of Skin Cancer, Responsible for Approximately 75% of Skin Cancer Fatalities; Conference Call Scheduled for 10:00 a.m. ET



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MelaFind(R) is a non-invasive tool to provide additional information to dermatologists during melanoma skin examinations. It is intended to be used when a trained dermatologist chooses to obtain additional information to help decide whether to biops



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Press Release Source: MELA Sciences On Wednesday November 2, 2011, 7:00 am EDT


IRVINGTON, NY--(Marketwire -11/02/11)- MELA Sciences (NASDAQ: MELA - News) today announced that the U.S. Food and Drug Administration (FDA) has approved the pre-market approval (PMA) application for MelaFind®.

"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," said Darrell S. Rigel, MD, Clinical Professor of Dermatology at New York University Medical School. "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."

"Melanoma is the deadliest form of skin cancer and rates of the disease are on the rise, especially in younger women," 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's Dermatologic Society. "Early detection is our only chance for survival, and MelaFind has the potential to have a deep impact on this disease."

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.

"The FDA approval of MelaFind marks the most important achievement in the company's history and represents a significant advance for the millions of Americans who are at risk of developing this terrible disease," said Joseph V. Gulfo, MD, President and CEO, MELA Sciences. "We are actively working to prepare to launch MelaFind in the Northeast U.S. and Germany during the first quarter. We'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."

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.

"We are thrilled that our years of persistence through the development and regulatory process have paid off," Dr. Gulfo continued. "We are ready to start this new phase in the company's history with the same energy, passion and tireless dedication that was responsible for this tremendous and rewarding accomplishment."

The company submitted its PMA application to the FDA in June 2009. The studies used to support the PMA application for MelaFind were the 1,383-patient U.S. pivotal trial and the pivotal trial'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.

MelaFind systems will be placed initially in select, "high" volume, integrated dermatology and skin cancer specialists' practices.

Based upon receipt of its FDA approval, the company withdrew its Citizen Petition filed with the FDA in May 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.

MelaFind® Indications for Use

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. MelaFind positive lesions (which may include malignant melanoma, melanoma in situ, 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 "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 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.

Conference Call Information

MELA Sciences will host a conference call on Wednesday, November 2, 2011 at 10:00 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 +913-312-0698. The conference call passcode is "MELA Sciences." 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's website or by dialing 888-203-1112. Callers outside of the U.S. should dial +719-457-0820. The replay participant code is 4163857.

About Melanoma

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.

The five year survival rate for patients with stage IV melanoma is less than 15%, with most patients dying within six to 10 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%.

About MELA Sciences, Inc.

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's flagship product, MelaFind®, 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.

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

16.01.13 10:28

21075 Postings, 4965 Tage wes_kleiner rebound?

16.01.13 10:31
1

21075 Postings, 4965 Tage wes_Volumen

~10x fach über "normal" (dem Durchschnitt) hmm... schaunmamal... Gruß  
Angehängte Grafik:
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11.03.15 13:18

1217 Postings, 3510 Tage GlückstrefferDoch, geht was.

Jedes im Januar geht es los, dieses Mal heftig.



 
Angehängte Grafik:
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20.04.15 11:47

138 Postings, 3699 Tage AntonpBin neu eingestiegen

Mal sehen wie die weit die mit ihrem Produkt kommen. Cash ist ja noch da..., also können sie los legen mit dem Verkauf.  

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