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MELA - neue Rakete??? - 500 Beiträge pro Seite


ISIN: US86272A2069 | WKN: A2DQVU | Symbol: SSKN
2,000
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19.10.19
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+4,99 %
+0,095 USD

Neuigkeiten zur Strata Skin Sciences Aktie


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MfG MaatMOD
Da steht alles drinn was passiert ist.

http://www.finanznachrichten.de/nachrichten-2010-11/18596806…

Hoffer der link funzt.

Der Satzt ist wichtig: "Approval (des Krebserkennungssystems, das was die Jungs vertreiben wollen) is critical for Mela Sciences, which has no other products."

Naja, irgendwie gab es von der FDA Auflagen, dass das Gerät zu Hautkrebserkennung Proleme verursachen könnte, wenn es von Jedermann benutzt werden darf. Da ist die Aktie 60% im November gefallen. Dann haben die MELA Leute jetzt gesagt, dass das Gerät nur an Dermathologen vverkauft werden wird (eine Auflage der FDA) und der Aktienkurs geht hoch.
Aber nichts neues ob das alles wirklich so sensationell gut (also die Krebserkennung) geht.
Und dann noch der Satz: "On Wednesday, the company said it was working towards getting the device approved by European regulatory authorities, and hopes to get the nod in the second half of this year."

Dauert wohl noch die Rakete. Aber man kann ja schoneinmal Platz nehmen. :-)
SmarTrend identified a Downtrend for MELA Sciences (NASDAQ:MELA) on November 30, 2010 at $3.59. In approximately 3 months, MELA Sciences has returned 18.9% as of today's recent price of $2.91.
In the past 52 weeks, shares of MELA Sciences have traded between a low of $2.44 and a high of $9.62 and are now at $2.91, which is 19% above that low price.
MELA Sciences is currently below its 50-day moving average of $2.97 and below its 200-day moving average of $5.56. Look for these moving averages to decline to confirm the company's downward momentum.
In the last five trading sessions, the 50-day MA has fallen 0.86% while the 200-day MA has slid 1.51%.
SmarTrend will continue to scan these moving averages and a number of other proprietary indicators for any changes in momentum for shares of MELA Sciences.
So, noch jemand hier, jetzt geht die Rakete ab.

http://finance.yahoo.com/news/MELA-Sciences-Receives-iw-1517…


IRVINGTON, NY--(Marketwire -09/06/11)- MELA Sciences (NASDAQ: MELA - News) today announced that it received CE Mark approval for MelaFind®, allowing the company to market its MelaFind device to dermatologists across the European Union (EU). The company intends to initially market MelaFind in Germany, which has the highest incidence of melanoma in Europe.
So, mal schauen wenn die NASDQ eröffnet.

Hopp oder topp. Wenn die EU die Verwendung des Hautkrebs Detektor erlaubt sollte die FDA auch mal nachziehen.

http://www.streetinsider.com/Corporate+News/Mela+Sciences+%2…

Na dann ziehhhhhhh.............
ist zwar nur beschränkt einsatzfähig, zumindest noch, aber trotzdem
http://barchart.com/quotes/stocks/MELA

So nun schönen Feierabend
http://www.foxbusiness.com/industries/2011/09/07/mela-scienc…

However, a positive vote from the General and Plastic Surgery Devices Panel in 2010, which the U.S. agency has been known to follow closely, coupled with the rapid approval in Europe, has risen hopes the device will achieve approval in the U.S.
Ein älterer Artikel über die Wirksamkeit des Gerätes.

MelaFind Device Surpassed Dermatologists in Identifying Melanoma
http://www.globalacademycme.com/news/skin-allergy-news/singl…

Kurs ist zwar nicht so rasant abgehoben wie gehofft, aber das Positive ist, es findet definitiv kein Abverkauf statt, wenn es einmal nach unten geht.
Da wird unterstützend weiter gesammelt.
Trotzdem. OBACHT.

Cheers,

alten
Wie wird das heute ein Rebound oder doch wieder ein Verrecker.
Seit drei Tagen geht es mit kleinen Stücken etwas hoch und oben werden die größeren Brocken geschmissen.

Na viel Glück.
Was ist heute los.
bis jetzt 11% plus und reger Handel.
Hat jemand eine Idee. Ich finde keine News.

alten
Alter Falter da muß was im Busch sein.
Wer kauft hier über 9000 Stück bei den heutigen Höchstkursen, wo sonst nur geschmissen wurde.

gleich 15% Plus.

Hossa.
Nicht schlecht 2.3 Millionen Shares gehandelt (mehr als die letyten 4 Tage zusammen) und der letzte kauft 25829 fuer 3,40 macht knapp 90000 Euro.
Wenn das fuer montag kein gutes Zeichen ist.
zureuk lehnen und warten.

Schoenes We,

alten
Guten morgen,

was lange währt wird endlich gut.

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.

Jetzt zurücklehnen und festhalten. :-)

alten
Haha,

3.60 realtime. Man muß ja nur einmal schauen wo wir vor der "Ablehnung" der FDA standen. Da war das CE Lable noch nicht einmal aktuell.

Hoffentlich zieht die NASDAQ heute einmal nach.

alten
So ich bekomme schon 3.90 das Stück.

Die Händler von Übersee werden wohl langsam wach. Da steht die Nachricht ja noch nicht einmal in den einschlägigen Newsblättern.
Antwort auf Beitrag Nr.: 42.134.909 von altenman am 26.09.11 13:09:26Geiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiil!:cool:
Jawohl, ein Mitleser/schreiber/freuer.

Alter Schwede, bei den Amis sind wir im Pre-Market bei schwankenden 7$. Macht Pari 5.20. hehe
Antwort auf Beitrag Nr.: 42.135.270 von altenman am 26.09.11 14:25:55Ok, ich habe gerade den CC gehört, Kommerzialisierung in Q1 2012!:D:eek:
Kann zweistellig werden bis dahin!:cool:
ich bin auch mal dabei; Hautkrebs ist nicht zu unterschätzen und die Zahl der Erkrankten nimmt ständig zu. Schlimm, dass daran noch Menschen heutzustage sterben (müssen).
Ich hoffe, vielen Menschenn kann jetzt geholfen werden.
Na dann herzlich willkommen an alle.
Zur Zeit hängen wir hier aber bei +60% fest.
Mal sehen wie es nach der Frühstückspause weitergeht. :-)
Hmm,
immer das selbe bei MELA, am Anfang stark beginnen dann nachlassen und am Ende fängt es sich meistens wieder naja.

Für alle die neu sind, hier ein schöner link:
http://online.wsj.com/article/SB1000142405297020401060457659…

Schönen Feierabend,

alten
September 26, 2011 4:30 PM EDT

Leerink Swann maintains an 'Outperform' on MELA Sciences (NASDAQ: MELA) price target range raised from $11 to $13-$15.

http://www.streetinsider.com/Analyst+Comments/Leerink+Swann+…
Antwort auf Beitrag Nr.: 42.138.066 von franzisca am 27.09.11 00:01:22New 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.:cool:
Morgen,
hier wieder etwas vom Motley Fool, welche immer recht negativ zu MELA Science waren.

http://www.fool.com/investing/high-growth/2011/09/26/closer-…

Das darf man nicht vergessen: "Until then, MELA remains a risky investment even though an approval seems more likely than it did earlier this year."

Risky risky, aber eben auch mit den möglichen Gewinnen.

Allen viel Glück,

alten
Antwort auf Beitrag Nr.: 42.140.877 von franzisca am 27.09.11 16:08:08Der Tag ist noch nicht rum!;)
Ahh,
heute mal etwas Balsam auf die Aktionärsseele, man muß nur ALLE anderen Werte ausblenden.:cry:

Erstmal eine Woche Urlaub und dann mal sehen ob es die Börse noch gibt. :p

Viel Glück,

alten
Antwort auf Beitrag Nr.: 42.168.353 von altenman am 04.10.11 17:46:27Vielleicht kommt nach dem approvable letter bald der richteg approval!:lick:
Jetzt das richtige A P P R O V E, aber fast keine Reaktion, gut Ding braucht Weil!
Antwort auf Beitrag Nr.: 42.291.561 von Magnetfeldfredy am 02.11.11 16:14:42Sorry der Text:


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.
Antwort auf Beitrag Nr.: 42.291.806 von Magnetfeldfredy am 02.11.11 16:49:43Da war die Börse wohl mal wieder schneller und hat das schon eingepreist. Naja. Ich bin leider an der Außenlinie da im Urlaub mit SL gegriffen hat. War ich wohl zu gierig. :-)
Aber wenn es hier nochmal was günstig gibt (ja ja, jetzt wohl eher nicht mehr).

Allen viel Erfolg.

alten
Antwort auf Beitrag Nr.: 42.292.082 von altenman am 02.11.11 17:39:37...schönen Urlaub und Mela läuft so schnell keinem davon!
Oh man,
da ging es gestern aber weit nach unten, und Schuld war wohl der quarterly report.
http://quote.morningstar.com/stock-filing/Quarterly-Report/2…" target="_blank" rel="nofollow">http://quote.morningstar.com/stock-filing/Quarterly-Report/2…

Da ist wohl der Besitz etwas geschrumpft. Naja, war wohl zu erwarten, wenn man NOCH nicht wirklich etwas verkaufen konnte.

Nun gut, mal schauen was die Analysten am Montag dazu sagen.

alten
Antwort auf Beitrag Nr.: 42.306.587 von altenman am 05.11.11 12:38:48Mela on market:

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MELA Sciences Announces Commercial Launch of MelaFind(R)
Press Release: MELA Sciences, Inc. – 1 hour 14 minutes ago.. .
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IRVINGTON, NY--(Marketwire -03/07/12)- MELA Sciences, Inc. (NASDAQ: MELA - News), the medical device company that has developed MelaFind®, today announced that the company has commenced commercialization of MelaFind as part of a controlled and deliberate launch in the U.S. and in Germany.

"We are enthusiastic about the success of our final beta user experience which took place during the first quarter in both the U.S. and Germany," said Dr. Joseph V. Gulfo, President and CEO of MELA Sciences. "We are pleased to be transitioning from beta to a controlled and deliberate commercial launch of MelaFind, which will be focused predominantly in the Northeastern United States and in several key cities throughout Germany."

"We will work with our customers to train and assist them in using MelaFind appropriately and to incorporate its use successfully into their practices. We believe that this approach is best suited for a first-of-its-kind breakthrough product in order to provide a strong platform for a more widespread dissemination of MelaFind in the future."

About MELA Sciences, Inc.
MELA Sciences is a medical device company focused on the commercialization of its flagship product, MelaFind®, and its further design and development. MelaFind is a non-invasive tool to provide additional information to dermatologists during melanoma skin examinations. The device uses light from visible to near-infrared wavelengths to evaluate skin lesions up to 2.5 mm beneath the skin. The device provides information on a lesion's level of morphologic disorganization to provide additional objective information that may be used by dermatologists in the biopsy decision-making process. MelaFind has been approved by the US Food and Drug Administration for use in the US. In addition, MelaFind has received CE Mark approval and is approved for use in the European Union.

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

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 MelaFind® achieves market acceptance. 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.
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For further information contact:
For Investors
Lynn Pieper
Westwicke Partners
415-202-5678
For Media
Melissa Hurley
Ricochet Public Relations
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