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MELA will do more of these private placements if 2016 remains the insurance reimbursement target year.
They will survive because of all the believers in MELAFIND.
I am waiting to buy back in but watching MELA with a lot of continued interest.
And here it is...Today's news "MELA Sciences Announces $27.3 Million At The Market Private Placement of Preferred Stock, Debentures and Warrant"
"Subject to certain ownership limitations, the debentures are convertible into approximately 5.8 million shares of common stock at an initial conversion price of $2.565 per share, will bear interest at 4% per year, and will mature on the five year anniversary of the date of issuance. The Series B convertible preferred stock is convertible at any time into an aggregate of approximately 4.8 million shares of common stock at an initial conversion price of $2.565 per share. The Series B convertible preferred stock is only entitled to dividends in the event dividends are paid on the Company's common stock and will not have any preferences over the Company's common stock, including liquidation rights. Of the warrants issued, 5.0 million will expire eighteen months from the date of issuance, and 6.1 million will expire five years from the date of issuance. "
I am giving new mgmt more credit than I think most people are willing to.
We on this board don't know the ground work that must go into getting all of your ducks in a row in order to put in an application that will get approved.
They spoke of this after the mgmt change in the very next 10Q.
I guaranty, it's not as simple as filing your paperwork for a drivers license.
There is an additional "management effectiveness" issue as well! Those of us following MELA for well over a year have been "pounding" on the need for the company to aggressively seek mechanisms to accelerate the pursuit of reimbursement. I wrote an SA blog on exactly this subject over a year ago. The company ultimately acknowledged the importance and accomplished a management change. Unfortunately, here it is July 2014 and it appears MELA has just now started the Medicare diagnostic code application. It seems, with experienced people in charge, this would have been started over a year ago. Had this been done, maybe the investors would be looking at the potential for reimbursement in early 2015. Brilliant science does not always equate to "business savvy."
That is not what I am saying. MELA has highlighted January 2016.
I will live with that, and they have to last until then via private placements or secondaries.
I think they will survive until then.
I also think the share price is going to sink under a dollar even after the R/S.
I don't know what they can do about it.
I also don't know why a big pharma/medical equipment company hasn't scoped up MELA. They have a $12.6 MM market cap. That's chump change.
MELA's is a one product company. Their long term liabilities are over $10 MM. They are close to being worth less than they owe. That's going to be a tough position to sustain. They are going to need Angel Investors.
MELAFIND is a revolutionary diagnostic machine. Derms in large numbers will not use it without insurance company reimbursement. It's a Catch-22.
I took my money out at 40¢.
I started watching MELA when it was almost $10 and bought in about 18 months ago when it was near one dollar and then bought more at 60¢.
I thought they were very close to making MELAFIND a "must-have" piece of equipment in derms' offices. So did some docs I know. We all bought into MELA.
It's too bad. America could use MELAFIND.
I remain very interested and will look to buy back in. I'm going to wait and let the price slip and then buy back when it gets closer to the time when they might get insurance company reimbursement, and or when some of the thought leaders at teaching hospitals start to have papers published about MELAFIND.
If they aren't publishing, that is a bad signal.
So are you saying insurance won't come to fruition?
It's too bad. I hate losing money, but it's better to lose it trying to be smart in the market than at a casino.
I sold out at 40¢ and will look for an appropriate time to buy back in. I am watching closely.
I wonder about their cash position, and insider investments coordinated with the loan agreements.
They have plenty of cash, but they will need more money from private offerings to last until 2016.
It would be very encouraging for them to announce news/research papers if any have been published from the teaching institutions where the MELAFINDS are operational.
The void of anything like that is disturbing and probably indicative that none have been published.
It's very disappointing.
MELA Sciences Begins Insurance Reimbursement Process With Application for New CPT Code for the MelaFind System
IRVINGTON, N.Y., July 10, 2014 (GLOBE NEWSWIRE) -- MELA Sciences, Inc. (MELA), announced today that it has taken the first step in the process of seeking insurance reimbursement for its Multi-Spectral Digital Skin Lesion Analysis (MSDSLA) procedure that is performed by dermatologists utilizing the MelaFind(R) system as an aid in the detection of melanoma. The company has submitted an application for a Current Procedural Terminology (CPT(R)) code, which is necessary for Medicare Part B reimbursement by the Centers for Medicare and Medicaid Services (CMS). MSDSLA could be eligible for payment under Part B as early as January 1, 2016. The company will also commence efforts to obtain reimbursement from private insurance companies as the CMS review process proceeds
MELA had do the split to get back in compliance with the NASDAQ dollar stipulation. Doing the R/S basically says the company is probably not close to anything major, which might make the pps spike to over $1.00. I hate to say it, but JMHO, there is a about 5% chance of any significant near-term good news, i.e. reimbursement. It is really too bad, but "F'ed" might well turn into an apt description. Again IMO, right now and for the remainder of this year and well into next, the cash burn is going to be ugly! After riding MELA and losing money for over a year, while waiting for positive news regarding progress on the reimbursement front, I will continue to sit on the sidelines until there is an indication that Medicare and/or the insurance providers might be ready to get on board.
I hope they have news or a plan to support the new split price or we are f'ed!
MELA Sciences Announces Pending One-for-Ten Reverse Stock Split
Thursday 3 July 2014
Well my investment is not that large so I will let it roll. Sadly with the state of Healthcare in our Nation due to LIBERAL policies it might not turn out well. R & R and Hospitals are taking a beating I know several people that have been laid off at Hospital's in last 6 months shameful . So now that we have a open border policy it will just burden the system even more.
Seems to be faltering at the moment Hoping for a uptick here soon .
Here's the best info that is quickly available (SEC.gov-view the Q1 10-Q):
AS 95,000,000
OS 52,107,465
(These numbers are as of March 31, 2014)
The outstanding increased by a little less than 5mm shares during Q1.
Revenue "goals" are in a state of flux! Basically, most people believe, barring a shift to new areas outside scanning lesions to identify potential melanoma, the success of MELA will be driven by the procedure's reimbursement status! Getting this from the insurers or Social Security appears to be a long fused process. Until then, MELA will continue to "burn" cash!
Looking to get in with small position doing more DD before.Any thought on LONG TERM revenue goals here ?
This puppy must run.
One insider purchase:
SEC Filing
Trade Date
Ticker
Insider
Title
Shares
Transaction
Value
Owned
Held
May 27 15:20:28
MMay 22 2014
MELA Dimun Anthony J Director 87,500 Purchase at $0.38 $33,381 101,013 indire
20¢ That's my buy target. MELA is unloved by the insurance industry and Derms won't buy it in big enough numbers without insurance coverage.
It's a Catch-22.
OSprey broke the lower band of a down trend to close at .38. Then also it just did an 8k dramatically increasing authorized to 150k and additionally requesting an R/S - these are not positives imo
http://biz.yahoo.com/e/140516/mela8-k.html
MELA Chart: Breakout radar........0.39 is the KEY level to close above today........a close above 0.39 should = Showtime!.........MA(7) @ 0.38 is ready to bullish cross MA(10) @ 0.39........key early reversal signal........MACD set up for a bullish crossover.......Fast Sto @ 17.36......Oversold w/ a ton of juice to run.........a close above MA's(7 & 10) today would be extremely bullish.........MELA setting up nicely.........MA(20) / Middle Bollinger Band @ 0.45 is the next SMA resistance level..............$$$
Always nice to see...
I guess he's averaging down too...
his first purchase was @ .74
:)
There was an insider purchase Yesterdsy. 87.500 shares at 38 cents.
I want more certainty before investing more into MELA. In the blind it's a crap shoot.
Until they reveal more about the process to get insurance company reimbursement and a timeline, I am on the sidelines, holding on and hoping it's not 3 more years.
Thanks for the insight...
you brought up some good points!
I generally scale into things...so I don't have a big position.
I prefer to average UP :)
but I am willing to average down when needed.
I think I'll hold off for awhile...
maybe buy another chunk after we get through the summer selloff
that seems to be hitting.
MELA is taking a long time to get the job done, but I cut management a lot of slack.
Until the new CEO came along, they had an entirely different marketing model, heading in the wrong direction.
She's only had her hand in the process for 8 months. Getting insurance company reimbursement is a "years-process".
I feel your pain. I thought it would have happened faster. I thought it was easier. I thought derms would see the benefits and demand insurance companies investigate the cost Vs benefits.
I was wrong.
The product is revolutionary, but they are struggling to get teaching hospitals to adopt the technology. That's troubling.
All is not lost because they have made some progress on that front. Some very significant universities are using MelaFind.
I placed a lot of buy orders during the past two weeks ... USAT, PGTI, BLDR, TIS, WR and VZ.
I spread my money around. My unrealized MELA investment has been cut in half. I won't be buying more at this level. I believe they will need more dilutive capital raises, and succeed in getting them. They will have no trouble finding plenty of people who believe in MelaFind.
MELA will live to fight another day and survive for years because the people who know what MelaFind is are like a cult. Money will be available.
I just don't know how much dilution is in store, if insurance company reimbursement is 3 years away, and how low the price will go.
I thought when MELA hit this level I would buy a lot more.
Everything seems too uncertain now. I am on MELA's "investing sidelines" for a while. I am watching it closely though.
MELA Sciences' (MELA) CEO Rose Crane on Q1 2014 Results - Earnings Call Transcript
May. 13, 2014 6:52 PM ET | 1 comment | About: MELA Sciences, Inc. (MELA)
Executives
David Collins – IR
Rose Crane – President and CEO
Bob Cook – CFO
Analysts
Jared Cohen – JM Cohen & Company
MELA Sciences Inc. (MELA) Q1 2014 Earnings Conference Call May 13, 2014 4:30 PM ET
Operator
Good day, ladies and gentlemen, thank you for standing by. And welcome to the MELA Sciences First Quarter Results Conference Call. At this time, all participants are in a listen-only mode. Later, there will be a presentation followed by question-and-answer session. (Operator Instructions).
I would now like to hand the conference over to your first speaker today, Mr. David Collins. Thank you. And please go ahead.
David Collins
Before we begin, we must remind you that management’s comments today may include 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, plan, intend, 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 matter.
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.
Factors that might cause such a difference include whether MelaFind achieves market acceptance or becomes commercially viable. Given the uncertainties affecting companies in the medical device industry, any or all of the company’s forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements.
In addition, more specific risks and uncertainties facing the company, are set forth in the company’s reports on Forms 10-Q and 10-K filed with the SEC. MELA Sciences urges you to carefully review and consider the disclosures found in its SEC filings, which are available at www.sec.gov and www.mealsciences.com.
I will now turn the call over to Rose Crane, MELA Sciences’ President and Chief Executive Officer.
Rose Crane
Thanks, David. Well, good afternoon and thank you for joining today’s call. I am here today with Bob Cook, who joined MELA Sciences in April as our CFO.
It’s been really great to have Bob on the team. He’s hit the ground running and he brings with him a wealth of experience from his 20 plus years of Senior Finance and management leadership in the healthcare industry, including a substantial experience in publicly traded companies. Bob will be reviewing the financials later on in our call.
So, as previously discussed MELA Sciences is focused on key strategies in 2014. The strategies are designed to drive MelaFind toward becoming a standard of care in the detection of melanoma by providing physicians with the unique and proprietary imaging and data analytics, ultimately helping them to make better decisions.
Today, I would like to report our progress with these key strategies. In the fourth quarter call, I had said that we were focused on introducing the MelaFind system in some of the key institutions, where our leading dermatologists treat high risk patients.
I’m happy to report that we have now placed MelaFind Systems at several institutions including most recently Baylor, Stanford University and Ohio State University. The idea is to provide their specialist in dermatology with hands-on access to the system so that they can then become comfortable with this operation, the data it provides and most importantly learn to incorporate it into their diagnostic regimen.
We’re also continuing to focus our efforts on clinical trials, in order to build our base of research and data to further illustrate the value of MelaFind.
During quarter one, Dr. Darrell Rigel, one of the top dermatology specialist in melanoma, facilitated a predicted probability study with 191 dermatologists to assess their ability to diagnose melanoma with and without the use of MelaFind. The study reported a statistically significant outcome, concluding that physicians are truly more accurate when they use MelaFind.
Three performance measures showed improvement. One, the ability to detect melanoma, two, the ability to rule-out melanoma and three overall diagnostic accuracy. The important takeaway is the use of MelaFind, significantly improve these performance measures but improve without having to do more biopsies. Put simply, the doctor’s batting average improved. This is the first of three such studies that Dr. Rigel will conduct over the next few months.
Additionally, our Post Approval Study or PAS for MelaFind is now on track. As we’ve signed up our sixth and final site with Dr. Joel Cohen in Colorado. He joins out other sites, including Dr. Armand Cognetta in Tallahassee, Dr. Timothy Wang at Johns Hopkins, Dr. Arthur Sober in Mass General, Dr. Robert Nossa in Verona, New Jersey and Dr. Meg Gerstenblith at Case Western University Hospital.
As many of you are aware, this study was required by the FDA to report on the safety and effectiveness of the MelaFind system in a real world setting. The study will continue to enroll until 78 patients with melanoma or high grade lesion are approved.
We expect that about 720 patients will be required to meet this target. We have approved approximately 115 patients with 183 lesions to date.
Also importantly, we are now advancing our technology. We recently launched our new user interface or UI for MelaFind in both Germany and in the U.S. The new UI was launched in the U.S. at the 2014 Annual AAD Conference in March. This new interface allows dermatologists to have a more interactive discussion with patients and includes the data shown in the above referenced predictive probability study. The commercial roll-out is currently in process.
Another of our very important strategies is to begin the process needed for insurance, reimbursement for MelaFind, which can be a significant driver for future demand of our system.
We will be submitting our application to the EMEA or the American Medical Association, for a new CPT code in July of this year. Submission of the CPT code will then start the clock for what we hope to be an approval of a new CPT code for MelaFind.
As I have stated in the past, this is the first step in a long process. Once secured, we will then have to work with major insurance companies to obtain reimbursement. The three reader trials that I previously referred to, will be part of the dossier for reimbursement and will help to support the economic story for MelaFind. And I will continue to update you as we move along this timeline.
The final strategy that I would like to discuss today is the focus of our resources to improve our financial position. Our goal is to manage resources tightly and direct them to areas for future growth, including those that I have mentioned, clinical trials, technology enhancement, KOL support and a focus on reimbursement.
We have redirected a very small sales force to the areas of high incidents of melanoma and/or where our key institutions reside.
Additionally, we have most of the sales models discussed previously. We have secured third party medical leasing companies who will help physicians to finance the system. And our reps are now in discussion with physicians regarding the new model.
As you will see, no revenue from sales of the MelaFind system were recorded during the first quarter, but any sales contracts that were signed during that quarter will be recorded in the second quarter.
Again, let me say I will continue to update you on our progress, against some milestones within our key strategies. I believe that at this time, focus is critically important to our success.
Now, at this point, I would like to turn the discussion over to Bob Cook, who will review our first quarter 2014 financials. Bob?
Bob Cook
Thank you very much Rose. Let me say at the outset that I am delighted to be a member of the MELA team. While there is much to do, I’m very impressed with the results Rose has already achieved in only a few months as the company’s CEO, and I am looking forward to working with her and supporting her efforts to achieve the success we believe MELA can be.
Now, for the financial review. For the three months ended March 31, 2014, the company reported a net loss of approximately $8 million or $0.16 per common share, compared with a net loss of approximately $6.5 million or $0.17 per common share for the comparable three-month period ended March 31, 2013.
Included in the net loss for the 2014 three-month period, where liquidated damages of approximately $3.4 million incurred and paid in connection with the filing and effectiveness of the company’s registration statement to register the common stock underlying the preferred stock and common stock purchase warrants that were issued in connection with the company’s financing that was completed in February of this year.
The company’s first quarter 2014 operating expenses declined more than 29% compared with the first quarter of 2013 to $3.9 million from $5.5 million. Significant declines were recorded in selling, general and administrative expenses as a result of the company’s ongoing expense reduction program.
A decline in research and development expense was also recorded in the first quarter of 2014 compared with the first quarter of 2013, as a result of a reduction in management overhead and the reclassification of certain expenses out of R&D.
On a consistent basis, our R&D expense in the first quarter of 2014, exceeded our R&D spending in the fourth quarter of last year, and we anticipate that research and development spending will increase modestly over the balance of the year, as we continue to invest in MelaFind’s future applications and new product development. Further actions are anticipated during the year that may further reduce our quarterly rate of SG&A expense.
Net revenues and cost of sales were adversely affected during the first quarter of this year by the company’s change in business strategy from our rental based revenue model to a sales based revenue model.
No revenue from sales of the MelaFind system were recorded during the first quarter, however sales contracts signed during the first quarter have been completed. We believe that once we obtain the CPT code and reimbursement approval from the centers for Medicare and Medicaid services, and major healthcare insurers that revenues from the MelaFind system could increase significantly.
Net cash used in operations was approximately $7.1 million for the three months ended March 31 of this year. Net cash used in operations includes the $3.4 million in liquidated damages that were paid to investors in the February 2014 financing.
Without the inclusion of this transaction related expense, our net cash used in operations during the first quarter would have been only $3.7 million, about 40% lower than the first quarter of 2013.
On a monthly basis, cash used in operations averaged $1.23 million during the first quarter, which we believe can be further reduced throughout the balance of the year.
In connection with the February 2014 financing, the company granted registration rights with respect to the shares of common stock, underlying the Series A preferred stock and the warrants pursuant to the terms of the registration rights agreement.
The investors in this financing were entitled to receive liquidated damages upon the occurrence of a number of events relating to filing effectiveness and maintaining an effective registration statement, covering the shares, underlying the preferred stock and the warrants.
The company did not meet the very strict filing and effectiveness requirements that were set forth in the contract. And as a result, paid liquidated damages to the investors in the aggregate amount of approximately $3.4 million.
The company’s cash balance at March 31, 2014 was $8.1 million compared with $3.8 million at the end of last year. We believe that our existing cash on hand and the actions that we have taken will support the company’s operations into the fourth quarter of this year.
We continue to assess the effects of our previously announced cost reduction plan and will reduce various costs as necessary. We will need additional capital during the upcoming months which may take the form of equity, equity linked or debt financing.
In addition, we anticipate that funds will be required to support further advances in our technology and to support clinical trials. The timing and amount of any additional funding we may seek will be affected by numerous factors, many of which are not under our control.
Let me now turn it back to Rose for her closing comments.
Rose Crane
So, thanks Bob. And in closing, I continue to be really excited by our technology and what we can achieve in the ongoing effort to help to detect melanoma. What we are doing is truly vital to the health of thousands. A person dies every hour from melanoma, 16 people are diagnosed every hour and 75% of all skin cancer deaths are from melanoma.
If caught early and treated, melanoma is curable. And MELA Sciences is dedicated to that cause. Thanks very much for your attention.
Operator, please open the lines for questions.
Question-and-Answer Session
Operator
(Operator Instructions). Your first question comes from the line of Jared Cohen of JM Cohen & Company. Jared, please ask your question.
Jared Cohen - JM Cohen & Company
Yes, it’s Jared. To start, two questions. One, on your balance sheet, I noticed – I haven’t noticed it before the warranty reserve, was $8 million this past quarter. And the prior quarter, it was about $3 million. What exactly does that represent, does that represent the systems that are out in dermatologist practices or?
Bob Cook
Jared, this is Bob Cook. No, what it actually represents is the liability that the company incurred in issuing the warrants related to that financing. The warrants that were issued in the February financing were – are being treated as a liability because they didn’t meet the particular guidelines that are required, so it really doesn’t have anything to do with the business and just with that.
Jared Cohen - JM Cohen & Company
Okay, okay. And second question, how helpful will the paper you printout or whatever you want to call it last week in terms of the predictability of what the MelaFind does in terms of marketing in the future do you think?
Rose Crane
Yes, Jared. And so, Dr. Rigel did that at the Winter Clinical with 200 physicians and I was there. And the reason that we’re really well with the physicians and the data is very powerful is because, the story as physicians use their eyes to look at lesions.
And when they go through this reader trial study, right there in the audience they have a response pad in front of them. They look at a lesion they then look at lesion with a dermatoscope and then they decide whether to biopsy or not. And then they get the MelaFind data and decide whether to biopsy or not.
And what happens is they miss melanomas and they actually do biopsy benign lesions. And so they themselves see that they miss it, it’s extremely powerful to the people who the physicians are taking the tests.
And the data really points to the fact that in the end it’s a really good strong story because we improve their batting average and they don’t do more biopsies. So, we can talk about it from an actual – this is what happened when physicians do it and we can talk about it from the health economic point of view which says you don’t do more biopsies, but you certainly – you take out less healthy tissue and you miss less melanomas and they’re less costly when caught early.
Jared Cohen - JM Cohen & Company
Right. So, there won’t be anymore, because I noticed some dermatologists have used the argument that it’s been too expensive relative to doing a biopsy or so forth. So they won’t have that argument anymore?
Rose Crane
So that’s why we did these reader trials. We wanted to point out the fact that what really happens to improve their accuracy exactly Jared.
Jared Cohen - JM Cohen & Company
Okay. All right, thank you very much.
Rose Crane
Sure.
Operator
There are no further questions at this time. Please continue.
Rose Crane
So, well with no further questions and I really like to thank everybody for listening. And look forward to reporting our progress as we move through the year. Thank you very much.
Operator
Ladies and gentlemen, that does conclude our conference for today. Thank you all for participating. You may all disconnect.
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Geez! They're killing this!
I would like to buy more too...
and the 40's are here...
just need to find a bottom.
I wonder if any of the insiders will join in and buy?
Did you by chance listen to the CC?
MELA Sciences Predictive Probability Study Supports Increased Diagnostic Accuracy by Dermatologists for Melanoma
IRVINGTON, NY–(Marketwired – May 08, 2014)
MELA Sciences, Inc. (NASDAQ: MELA), developer of the MelaFind® system, an optical diagnostic device approved for use in the U.S. and the European Union to assist dermatologists in melanoma diagnosis, today announced statistically significant preliminary results of a study that measured the impact of predictive probability information (probability of lesion being melanoma and melanoma/high-grade) on dermatologists’ decisions to biopsy ambiguous pigmented skin lesions.
Study Overview
At the January 2014 Winter Clinical Dermatology Conference, 191 dermatologists reviewed images of 12 lesions in a reader study facilitated by Darrell S. Rigel, MD, MS. Dr. Rigel is a Clinical Professor of Dermatology at New York University, Langone Medical Center. The physicians were asked if they would biopsy each lesion before and after seeing the MelaFind system probability information, and then both sets of data were analyzed.
Study Results
The biopsy sensitivity of dermatologists increased from 68% to 89% with the addition of the MelaFind system probability information, and specificity increased from 39% to 54%. Sensitivity measures the percentage of lesions correctly identified as melanoma, and specificity measures the percentage of lesions correctly identified as not being melanoma. The average percentage of benign lesions selected for biopsy decreased from 61% to 46%. The p-value in all three measurements was statistically significant at p < 0.001. There was a non-significant change in the percentage of total lesions selected for biopsy.
Dr. Rigel, who facilitated the reader study, commented, “The preliminary results of this study are very compelling. The ability to improve diagnostic accuracy without increasing the rate of biopsies is very meaningful for physicians.”
This data will be presented at the 2014 American Dermoscopy Meeting, June 17-19 in Bar Harbor, Maine.
About MELA Sciences, Inc. www.melasciences.com
MELA Sciences is a medical device company developing dermatology diagnostics utilizing state-of-the-art optical imaging. The Company’s flagship product is the MelaFind® system, a non-invasive diagnostic tool to aid dermatologists in melanoma evaluation and diagnosis, which has secured FDA Pre-Market Approval (PMA) for the U.S. and CE Marking certification for the European Union. The MelaFind® system uses a variety of visible to near-infrared light waves to evaluate skin lesions from the surface to 2.5 mm beneath the skin. It provides images and data on the relative disorganization of a lesion’s cell structure that provides substantial additional perspective to aid melanoma diagnosis. MELA is also exploring new potential uses for its core imaging technology and algorithms.
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 may contain words such as “seeks,” “look forward,” and “there seems” that suggest future events or trends. These statements are based on our current expectations and are inherently subject to significant uncertainties and changes in circumstances. Actual results may differ materially from our 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 set forth in the company’s SEC reports on Forms 10-Q and 10-K. Given such uncertainties, any or all of these forward-looking statements may prove to be incorrect or unreliable. MELA Sciences assumes no duty to update its forward-looking statements and urges investors to carefully review its SEC disclosures available at www.sec.gov and www.melasciences.com.
Media
Diana Garcia Redruello
MELA Sciences, Inc.
212-518-4226
dgarcia@melasciences.com
Investors
David Collins, Eric Lentini
Catalyst Global
212-924-9800
mela@catalyst-ir.com
I read it that way too, but am hopeful we just don't have enough info and that insurance company don't need these results. Who knows though; it may be 3 more years.
So really, we are dead money until 2017 huh
MELA Sciences : Secures Final Investigative Site and Enrolls 100+ Patients for Post-Approval Study for MelaFind® System Optical Melanoma Diagnostic Device
05/02/2014 | 09:39am US/Eastern
Irvington, NY, April 30, 2014 - MELA Sciences, Inc. (NASDAQ: MELA), developer of the MelaFind®system, an FDA approved optical diagnostic device that assists dermatologists in the diagnosis of melanoma, today announced that it has concluded an agreement with the sixth and final investigative site participating in the Company's post-approval study (PAS) of the MelaFind® system for the diagnosis of melanoma. More than 100 patients have been enrolled in the study to date.
MELA has established six investigative sites, the maximum requirement of the study protocol, at leading healthcare institutions and private practices in Colorado, Florida, Maryland, Massachusetts, New Jersey and Ohio to enroll patients and conduct the study. Those sites and their principal investigators are
Joel Cohen, MD
AboutSkin Dermatology and Derm Surgery, PC
Englewood, CO
Armand Cognetta, MD
Dermatology Associates of Tallahassee
Tallahassee, FL
Timothy Wang, MD
The Johns Hopkins University
Baltimore, MD
Arthur Sober, MD
Massachusetts General Hospital
Boston, MA
Robert Nossa, MD
The Dermatology Group, PC
Verona, NJ
Meg Gerstenblith, MD
University Hospitals Case Medical Center
Cleveland, OH
Rose Crane, MELA Sciences' President and CEO, commented, "We are off to a solid start in our post-approval study, having secured very strong investigative sites led by leading medical dermatologists. I am thankful for the MELA team's dedication and hard work in initiating and monitoring this study, which I believe will provide us the opportunity to further enhance our technology and the frequency of its use."
The three-year PAS is required in connection with the MelaFind system's Premarket Approval (PMA) in November 2011 by the U.S. Food and Drug Administration (FDA). The study will report on the safety and effectiveness of the system's non-invasive, optical imaging and data analysis capabilities in a real-world setting. In April 2014 the FDA approved a revised study timeline to address the slower than anticipated pace of patient recruitment. The study is now identified as "Progress Adequate" according to the current FDA status report.
The PAS protocol anticipates the enrollment of at least 720 patients to accrue the requirement of 78 patients diagnosed with a melanoma or a high-grade lesion. The study involves a two-year follow-up period for each lesion enrolled but not undergoing biopsy. The study is designed to observe dermatologists' clinical decision-making behavior in a real world setting under conditions where the MelaFind system is and is not available to them. This design will test the primary endpoint hypothesis that the incorporation of the additional MelaFind system information into dermatologists' clinical assessment results in the identification of more than 110% of the melanomas or high-grade lesions than are identified without data from the MelaFind system. Central histology is the reference standard for disease state.
MELA currently targets submission of the PAS report to the FDA by year-end 2017.
About MELA Sciences, Inc. www.melasciences.com
MELA Sciences is a medical device company developing dermatology diagnostics utilizing state-of-the-art optical imaging and innovative sofware. The flagship product is MelaFind®, an FDA, PMA and CE Mark approved, non-invasive diagnostic tool to assist dermatologists in melanoma evaluation and diagnosis. MelaFind® uses a variety of visible to near-infrared light waves to analyze atypical pigmented skin lesions 2.5 mm below the skin surface. It provides images and objective data on the relative disorganization of a lesion's structure that provides substantial additional perspective to assist melanoma diagnosis. MELA is also exploring new potential uses for its core imaging technology and algorithms.
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 may contain words such as "seeks," "look forward," and "there seems" that suggest future events or trends. These statements are based on our current expectations and are inherently subject to significant uncertainties and changes in circumstances. Actual results may differ materially from our 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 set forth in the company's SEC reports on Forms 10-Q and 10-K. Given such uncertainties, any or all of these forward-looking statements may prove to be incorrect or unreliable. MELA Sciences assumes no duty to update its forward-looking statements and urges investors to carefully review its SEC disclosures available at www.sec.govand www.melasciences.com.
Media
Diana Garcia Redruello
MELA Sciences, Inc.
212-518-4226
dgarcia@melasciences.com
Investors
David Collins, Eric Lentini
Catalyst Global
212-924-9800
mela@catalyst-ir.com
From $MELA 10-K: The Series A Warrants are exercisable beginning on May 1, 2014 at a price of $0.85 per share and expire on May 1, 2019. Let's see what they do to the share price now.
MELA Sciences : Patent Issued for Assessing Features for Classification
04/17/2014 | 03:17am US/Eastern
By a News Reporter-Staff News Editor at Journal of Engineering -- From Alexandria, Virginia, VerticalNews journalists report that a patent by the inventors Wojton, Maciej (Roslyn Heights, NY); Kabelev, Nikolai (Irvington, NY), filed on August 6, 2010, was published online on April 8, 2014.
The patent's assignee for patent number 8693788 is MELA Sciences, Inc. (Irvington, NY).
News editors obtained the following quote from the background information supplied by the inventors: "This description relates to assessing features for classification.
"Classifications may be useful, for example, in the medical field, to classify an image, a test result, a genetic sequence, or a radiograph as being indicative of either a disease or no disease. In the security field, it may be useful to classify an x-ray as one that indicates either that a threatening object was present in the space imaged or that no threatening object was present. In the communications field, it may be useful to classify a sound as being a human voice or as being other noise.
"Frequently, classification uses values of features, each feature relating to a characteristic of data that represents a case being examined (e.g., a lesion, a potential bomb, or a sound signal). For example, features of a multispectral image (e.g., of a skin lesion or of suitcase contents) may include an area, a contrast, a perimeter length, a color variability, a color intensity, a perimeter-to-area ratio, an asymmetry, a border irregularity, and a diameter of the lesion. Features of a sound file may include an amplitude at a frequency or a variation in volume or frequency amplitude across time. A value for each of the features may be determined for each case (e.g., for each lesion based on an image of the lesion) that belongs to a set of cases. For example, if there are ten images (cases) of skin lesions in a data set, a value for the area may be determined for the lesion of each image.
"Different features may be more or less useful in effectively classifying cases of a data set (e.g., whether a lesion is melanoma, whether a suitcase-content item is a bomb, or whether a sound signal is a human voice)."
As a supplement to the background information on this patent, VerticalNews correspondents also obtained the inventors' summary information for this patent: "In general, in an aspect, a degree is determined to which values, of a feature that characterizes cases, correctly predicts classes to which cases belong, the degree depending on a combination of at least two factors that include: (a) uncertainty about the values that the feature will have depending on knowledge about classes to which cases belong, and (b) comparison of one or more first values of the feature that are associated with cases that belong to a first class with one or more second values of the feature associated with cases belonging to a second class.
"Implementations may include one or more of the following inventive features. The uncertainty is represented by a mutual information measure. The comparison includes a distance measure. The distance measure is normalized. The uncertainty includes an entropy of values of the feature. The uncertainty includes an uncertainty about the values of the feature when the classes to which the cases belong are known, and an uncertainty about the values of the feature when the classes to which the cases belong are not known. The degree is determined as a score. The comparison of one or more first values of the feature with one or more second values of the feature includes determining differences between first values and second values. The comparison of one or more first values of the feature with one or more second values of the feature includes a comparison of a first value of the feature with two or more second values of the feature. The degree is determined with respect to values of more than one such feature, the degree depending on: (a) uncertainty about values that the more than one such feature will have depending on the classes to which cases belong, and (b) comparison of one or more first values of the more than one such feature that are associated with cases that belong to a first class with one or more second values of the more than one such feature associated with cases belonging to a second class. The comparison includes a metric distance between the one or more first values of the feature and the one or more second values of the feature. The cases include cases in a communications field (e.g., sound files), a medical field (e.g., image files), a computer-vision field (e.g., image files of undersea growth), a computer-security field (e.g., strings of text), a voice-recognition field (e.g., sound files), or a genetic field (e.g., strings of text representing genetic sequences). The cases include medical cases. The cases include skin lesions and the classes include melanoma and non-melanoma. A first degree is determined to which a value of a first feature that characterizes cases correctly predicts classes to which a particular cases belongs; a second degree is determined to which a value of a second feature that characterizes cases correctly predicts classes to which a particular cases belongs; and the determined degrees are compared. A feature is selected for use in classification, based at least in part on the determination of the degree. The cases are represented by digital images and the features relate to what is portrayed in the digital images. The values include measures of features that appear in the digital images. The uncertainty is represented by an accuracy measure.
"In general, in an aspect, a degree is determined to which values, of a feature that characterizes cases, correctly predict classes to which cases belong. The degree is determined based on a combination of at least two factors selected so that the degree: substantially corresponds to a fixed number when distributions of values for cases in the two classes completely overlap, and depends, in a non-saturating manner, on a separation between the distributions.
"These and other aspects, features, and implementations, and combinations of them, can be expressed as methods, means or steps for performing functions, business methods, program products, compositions, apparatus, systems, components, and manufactures, and in other ways.
"Other aspects, inventive features, advantages, and implementations will be apparent from the description and from the claims."
For additional information on this patent, see: Wojton, Maciej; Kabelev, Nikolai. Assessing Features for Classification. U.S. Patent Number 8693788, filed August 6, 2010, and published online on April 8, 2014. Patent URL: http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=35&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=1746&f=G&l=50&co1=AND&d=PTXT&s1=20140408.PD.&OS=ISD/20140408&RS=ISD/20140408
Keywords for this news article include: Genetics, MELA Sciences Inc.
Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2014, NewsRx LLC
(c) 2014 Journal of Engineering via VerticalNews.com
Not a bad decision.
You can always get back in.
We're never married to a stock, and even then, we can still get out
I am out. With the biotechs getting hammered over the last few days, there are other good opportunities. Hope reimbursement comes soon! I will continue to watch. GLTY!
Insurance reimbursement can happen at any time or never.
The day they announce it, the stock will soar. They finally have the management team who can get MELAFIND across the finish line, or they'll sell the business. I feel pretty comfortable holding knowing these are the two most likely outcomes.
If it drops into the 40's, I will start accumulating more, otherwise I am letting it ride. Time will tell.
You are right. Until they get reimbursement they'll continue to make losses and the share price will continue to decline.
I interpret this to read that Broadfin no longer qualifies under the terms of their agreement. I interpret that to mean they sold 70% or more of their investment. If correct, that's not an encouraging development.
MELA SCIENCES, INC. /NY FILES (8-K) Disclosing Termination of a Material Definitive Agreement
(Edgar Glimpses Via Acquire Media NewsEdge) Item 1.02 -
Termination of a Material Definitive Agreement On January 31, 2014, MELA Sciences, Inc. (the "Company") entered into an agreement (the "Agreement") granting to Broadfin Capital, LLC ("Broadfin"), in connection with its purchase of the Company's Series A Convertible Preferred Stock (the "Preferred Stock") and warrants to purchase common stock, the right to designate one director to the Company's Board of Directors, so as long as it retains 30% of its investment in the Preferred Stock (or the shares of common stock underlying the Preferred Stock) or holds any warrants. On March 31, 2014, the Company and Broadfin terminated this Agreement.
Lease or purchase, MELA offers both now. They added the purchase option because it was requested by most of the people they've met with. My friends didn't want to lease the equipment either.
Regarding depreciating the remaining inventory, I cannot hazard a guess.
It was nice to see that after yesterday's S3 filing, and the market beat down after Janet Yellon upset the markets when she fumbled her first news conference, MELA only dropped -0.0088 today.
Just an aside...I too am not worried about the $10,000 purchase price, but why not offer a lease/purchase or straight lease as well? Most hardware vendors have various procurement options. Having options is a better marketing approach. And you have to believe some number of prospective buyers, knowing MELA isn't exactly on solid financial ground, are delaying the $10K outlay to avoid making a purchase, then having the supplier go "kaput." Possibly the "sales only" decision was driven by needing quicker revenue recognition. The lease plans spread revenue out over the life of the lease. IMO...the "sales only" plan is going delay unit sales and reek havoc as the result of having to constantly depreciate and restate inventory valuations. Some of this has been done, but do you have any idea how much more is likely to come?
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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
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:
MelaFind's automatic data analysis algorithms include:
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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