MACI featured on CBS2 News in New York today:

http://newyork.cbslocal.com/2017/03/08/knee-cartilage-replacement/

Ditto on realfast95 numbers.
Was not able to listen to call and have no idea what those numbers are supposed to mean.

Curious as to what you base that statement on.

Personally I do not believe the 4th quarter report for Vericel has much long term meaning. So any gain or loss based strictly on 4th quarter numbers will probably be short lived.

You would think that because they were expecting MACI approval around the beginning of January 2017, that some Carticel surgeries might have been put off until then. But I don't know if that is so. Anyway, I read the conference call from the 3rd quarter and was pleased to see that Colangelo was pretty confident that 2016 Revenues would beat 2015 by at least 10%.

In 2015 they did $51M so adding 10% would bring 2016 to $56M.
For the first 3 quarters the total revenues were around $38M. So to hit their expectation, 4th Quarter Revenues would have to be about $18M.

That would be a great number as far as I am concerned. Especially since the analysts estimates are for $16M.

But, it is also expected that expenses for the 4th quarter would probably be high as they were ramping up for the MACI launch. So they might fall below the analysts EPS of .18.

So, it is very difficult to predict what the actual numbers might be and also what the reaction to the numbers might be. Personally, I have decided to just hold all my shares through earnings because it doesn't make sense to take any action. It is the long term prospects that make VCEL a compelling investment.

Thanks realfast.

Since this one was done on February 15th and the announcement of the first one was on Feb. 1st, we know of at least those 2 plus the one done by the DoD. So that's at least 3. My guess is there have been many more.

Love how they talk about the simplicity compared to previous procedures, and the excellent results it has already had in Europe.

Fasten your seat belt.

Well, the battle continues. Pretty much of a stalemate right now. The good news is that normally when there is no news, small caps like VCEL go down. Right now it's holding its own.

When good news does come we could be looking a a very fast, very big gain.

Biotech Stocks Under Scanner -- Immunomedics, Peregrine Pharma, Vericel, and Biogen

Last update: 01/03/2017 4:15:14 am


NEW YORK, March 1, 2017 /PRNewswire/ --

Four Biotech equities have been lined up by Stock-Callers.com today, and they are Immunomedics Inc. (NASDAQ: IMMU), Peregrine Pharmaceuticals Inc. (NASDAQ: PPHM), Vericel Corp. (NASDAQ: VCEL), and Biogen Inc. (NASDAQ: BIIB). These firms are part of the Healthcare sector, which extended its declines in afternoon trade on Tuesday, February 28(th) , 2017, with the NYSE Health Care Index falling about 0.5%, while shares of health care companies in the S&P 500 were down more than 0.4% as a group.

Vericel

Cambridge, Massachusetts headquartered Vericel Corp.'s stock finished the day 1.69% higher at $3.00 with a total trading volume of 219,711 shares. The Company's shares have gained 15.38% in the last one month and 17.65% in the previous three months. The stock is trading above its 50-day and 200-day moving averages by 3.66% and 18.35%, respectively. Additionally, shares of Vericel, which researches, develops, manufactures, markets, and sells patient-specific expanded cellular therapies for use in the treatment of patients with severe diseases and conditions, have an RSI of 57.20.

On February 21(st) , 2017, Vericel announced that the US Food and Drug Administration has designated the investigation of ixmyelocel-T for reduction in the risk of death and cardiovascular hospitalization in patients with chronic advanced heart failure due to ischemic dilated cardiomyopathy as a Fast Track Development Program. Register for free on Stock-Callers.com and download the PDF research report on VCEL at:

http://stock-callers.com/registration/?symbol=VCEL

687,725 Shares in Vericel Corp (VCEL) Acquired by Alyeska Investment Group L.P.
Posted by Andrew Walz on Feb 28th, 2017

Alyeska Investment Group L.P. purchased a new stake in shares of Vericel Corp (NASDAQ:VCEL) during the fourth quarter, according to its most recent 13F filing with the Securities and Exchange Commission (SEC). The fund purchased 687,725 shares of the company’s stock, valued at approximately $2,063,000. Alyeska Investment Group L.P. owned about 3.20% of Vericel Corp as of its most recent filing with the SEC.

To me those short numbers are TERRIFIC.

Price on January 31st was $2.60.

Price on February 15th was $3.00.

So try as hard as they may, the VCEL shorts could not stop a 15% increase in share price during that period.

Of course without all this manipulation the share price would be much higher right now, but soon they will realize that when you are in a hole it is best to stop digging. And when they all try to climb out, it is going to be fun to watch.

Speculated dates for earnings reports are meaningless. Only thing that counts is when the company announces an actual date.

Anyway, with all the events upcoming that Vericel is attending, it appears that they think that they have something really exciting to tell people about.

Sounds good to me.

Matrix-induced autologous chondrocyte implantation versus microfracture in the treatment of cartilage defects of the knee: a 2-year randomised study.

"MACI is superior to MF in the treatment of articular defects over 2 years. MACI and MF are complementary procedures, depending on the size of the defect and symptom recurrence. The MACI technique represents a significant advance over both first and second generation chondrocyte-based cartilage repair techniques for surgeons, patients, health care institutions and payers in terms of reproducibility, safety, intraoperative time, surgical simplicity and reduced invasiveness."

Word getting out in the Orthopedic community:

From Spine & Orthopedic News:

http://www.spinalorthopedicnews.com/

MACI reaches Alaska:

http://orcaak.com/maci-matrix-applied-characterized-autologous-cultured-chondrocytes/

Watch IxCell on You Tube

Had hit my goal number of long term shares at $3. Thought I would be finished buying for a while. But events today made it impossible not to buy more. Picked up another 5000 at $3.07 that I will use for trading around core.

Very exciting times for VCEL.

The same attempts to hold VCEL's share price down were tried at $2.60, $2.65, $2.70, $2.75 and every .05 cent rise thereafter.

Yet we are now over $3.

It is obvious that they can hold it down a bit, but they can't stop it.

Any shares bought today will probably be worth double in a few months.

Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions.

Determining whether a condition is serious is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the condition, if left untreated, will progress from a less severe condition to a more serious one. AIDS, Alzheimer’s, heart failure and cancer are obvious examples of serious conditions. However, diseases such as epilepsy, depression and diabetes are also considered to be serious conditions.

Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy.

Any drug being developed to treat or prevent a condition with no current therapy obviously is directed at an unmet need. If there are available therapies, a fast track drug must show some advantage over available therapy, such as:

Showing superior effectiveness, effect on serious outcomes or improved effect on serious outcomes

Avoiding serious side effects of an available therapy

Improving the diagnosis of a serious condition where early diagnosis results in an improved outcome

Decreasing a clinical significant toxicity of an available therapy that is common and causes discontinuation of treatment

Ability to address emerging or anticipated public health need
A drug that receives Fast Track designation is eligible for some or all of the following:

More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval

More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met

Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA
Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious condition.

Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.

Completely agree. Articles like that pop up all the time regarding stocks that are considered "hot" at the time. As a shareholder I like that, but also realize that they generally have no lasting value regarding ultimate worth of an equity.

On the other hand, the DOD news is very important. I agree with whoever said the company should do a PR about it. So far it is probably only known by a tiny percentage of investors. But even if they don't announce it, it is a fact and those who do know about it can feel good about holding their shares and adding if they can.

Well, this guy seems to like VCEL:

$VCEL – Vericel Corp. Analysis

BY SALMAN AZIZ / SUNDAY, 19 FEBRUARY 2017 / PUBLISHED IN DAY TRADING
Vericel Corp. (VCEL: NASDAQ) formerly Aastrom Biosciences, Inc., is a commercial-stage biopharmaceutical company dedicated to the identification, development and commercialization of therapies that enable the body to repair and regenerate damaged tissues and organs to restore normal structure and function.

As of February 17, 2017, VCEL closed very strongly at $3.05 not only above the 50 day moving average, but also above major resistance of $3.00. The MACD is bullish crossover and remains above the 0 trend line. VCEL shares traded below the average volume, over 877k shares exchanging hands. In addition, VCEL had experienced a gradual rise in the RSI closing above to the 60 trend line, suggesting VCEL should continue to experience ongoing buyer’s interest and momentum.

A purchase price below $3.10 is an ideal entry position and could bring you returns of 15% to 20% in the next 30 days. If the stocks begins to experience some retracement, I would not recommend purchasing the stock if if drops below the $2.85 range.
If VCEL breaks out above $3.10, we could see it reaching the $3.40 plus levels within the next two weeks thereafter.

Be sure you place a stop loss at 10% below you buy price, and don’t be greedy, a consistent 10% to 15% per month can help dealing with losses and sometimes help bring in more profits.

Also, please keep in mind we are not offer trading advice, we are just sharing an idea.

Week 8 Breakout Forecast: Short-Term Picks To Give You An Edge. Top selections for Week 8 are as follows:

Positive Acceleration Momentum Stocks

These stocks have strong characteristics of positive momentum into acceleration for short-term gains. The typical momentum duration horizon from this analysis is one to three weeks. Based on past analysis it is not uncommon for stocks to sustain the momentum criteria for longer periods. The selections of momentum stocks for this week include, AGEN, ARCO, BCOV, CCCL, IDRA, JRJC, PQ, VCEL:

http://seekingalpha.com/article/4047352-week-8-breakout-forecast-short-term-picks-give-edge

Great article.

Probably why share price jumped up later in the day on Friday and continued into after hours. Suspect if knowledge of it becomes more wide spread that we will see another nice move in coming week.

Thanks for the info.

"Cardiovascular disease costs will exceed $1 Trillion by 2035
Nearly half of Americans will develop pre-existing cardiovascular disease conditions, analysis by RTI International shows"

https://www.rti.org/news/cardiovascular-disease-costs-will-exceed-1-trillion-2035

Not such good news for human beings, but maybe so for Ixmyelocel-T, and Vericel shareholders:

“The results of the ixCELL-DCM study, which we believe is the largest randomized cell therapy trial to treat congestive heart failure completed to date, demonstrated a statistically significant and clinically meaningful reduction in cardiac events in patients who received treatment with ixmyelocel-T compared to placebo,” said Dr. David Recker, Vericel’s chief medical officer. “We are very excited about these study results given the lack of treatment options for end-stage heart failure patients.”

http://www.streetinsider.com/Corporate+News/Vericel+(VCEL)+Announces+Ixmyelocel-T+Phase+2b+ixCELL-DCM+Met+Primary+Endpoint/11408148.html

WOW! In 2 minutes between about 1:14 & 1:16 it looks like about 50,000 shares were bought at the ask taking it from $2.90 to $3.00.

Was that you lazer & Hurley?

Here's what a MACI cerftification looks like:

http://www.azisks.com/dr-bailie-has-performed-carticel-autogenous-chondrocyte-implantation-aci-cartilage-transplant-for-cartilage-defects-in-the-knee-and-other-joints/

Thanks hurley.

I had found that training video earlier this morning, watched it, and came here to post it, when I saw that you had already done so. I think it is a must watch for anyone planning to be a long term Vericel shareholder. It was directed at surgeons interested in MACI and does a good job of explaining the procedure, the advantages over Microfracture, the differences from Carticel, and the expectations of insurance coverage.

Most striking to me was that they have on-line training that only takes a surgeon about 15 minutes to complete. Must be a very simple procedure. They also expect to completely phase out Carticel within the first half of 2017. Any biopsies taken for Carticel surgery can just be used for MACI.

Like most new things in the Medical field it takes a while for it to catch on, but my guess is that MACI will be in full stride within a few months and be a gangbusters revenue producer going forward.

http://www.maci.com/webcast/index.html

Ah yes, you are correct.

Do hope they convert and sell for at least 3 times current price.

Appears COO, CFO, & CEO all exercised options and bought shares @ $2.75.

I am with them and added again today @ 2.75.

"The short interest increased largely on us. What is any ones thought on it."

My thoughts are that looking at the share price activity during the period that short interest covers, it is not surprising that the short interest was up so much. The period covered was January 13th to January 31st.

On January 13th the share price was $2.95.
On January 31st the share price was $2.60.

So it took almost a 50% increase in shares short to create a .35 reduction in share price. I would say that is a very bullish sign. It confirms what I have been posting all along, that there has been a concerted effort to hold the share price down and it has not been very effective. It is also a good sign that in just the last 9 days we have gained back half of the lost share price.

FNY Managed Accounts LLC just filed a portfolio update (also known as a 13-F), dated February 08, 2017. The portfolio holdings are as of December 31, 2016.

FNY Managed Accounts LLC reported adding to its positions of:

Aralez Pharmaceuticals Inc.
Arrhythmia Research Technology Inc.
United States Steel Corporation
Ultralife Corporation
Tesla Exploratin Services Inc.
St. Jude Medical
S&P Quality Rankings Glbl Equ Mngd Tr
World Gaming plc
Quotient Ltd
Mallinckrodt Plc
Elbit Imaging Ltd.
BHP Billiton Limited

It appears that it is getting harder and harder to keep VCEL's share price down. Any good news about MACI or Episel sales or IXt partnership could result in a very quick double.

Loading up at anything under $3 would be very wise.

77,500 shares BOUGHT at 2.75 in the last minute of trading.

I actually came across Conformis shortly before Vericel. For knee replacement it sounds like a good concept. My wife had a replacement about 15 years ago and it never was quite right. After about 7 years she had a revision done and the doctor explained that the first replacement was not the right size. Conformis seems to solve that problem.

That said, at the moment my VCEL investment is about 20 times that of CFMS.

"This is excellent news for $VCEL. However it is not good news for Knee replacement companies."

Completely agree with you. But the funny thing is that I own shares in Conformis (CFMS) too and that stock was up 2.41% today while VCEL was up only 1.92%.

Go figure.

MM's still playing their game with 100 share sells at the Bid. When that ends the share price will fly. I can wait.

Still have never before seen such strange trading in a stock. Almost every day the total shares on the bid greatly outnumber those on the ask. And almost every sale is above the bid price. This shows that there is far more interest in buying the shares then selling them. Yet, the price struggles to move up .05 and most days is either flat or goes down.

Not saying anything illegal is going on, but definitely seems to be manipulation to keep the share price down. So the questions would be who is doing this, why is it being done, and what will the end result be?

If anyone has the answers I sure would like to know. The one thing I do know is that stock share prices are like gravity. You can fight the pull of gravity for a while, but eventually it always wins.

Ladenburg Thallman seem to agree with me. They say:

MACI Approval Unlocks Next Leg for Growth. Maintain BUY and $11.60 Price Target.

The following is an analysis by Piper Jaffray of the market potential of MACI as compared to Carticel.

"MACI's label includes two improvements over Carticel that expand the applicable patient population. First, MACI was approved to treat any part of the knee, whereas Carticel was limited to repair of the medial, lateral or trochrea femoral condyle. Both tibia and patella sections of the knee are included in MACI's label. Secondly Carticel was only approved for second-line therapy or patients who had inadequate response to prior arthroscopic or cartilage repair procedure. MACI is indicated to repair first-line patients who have not undergone prior surgery, significantly expanding existing patient pool."

In 2016 Vericel will do approximately $36M in Carticel revenue. Between the expanded useages for MACI over Carticel, the more simplistic surgery, the faster patient recovery and the potential for better results, it seems like a doubling or tripling of revenues should be almost a sure thing.

Yet share price right now is almost identical to what it was before MACI became FDA approved. That makes no sense. And when there exists an imbalance between actuality and reality there is usually big money to be made. I think this may be one of those situations and I have continued to accumulate as the share price has declined. For those who have TIME & PATIENCE, this could be one of those rare great stock opportunities.

Worth reviewing:

Recent Business Highlights
During and since the third quarter of 2016, the company:

Increased total Carticel and Epicel net revenues approximately 8% compared to the first nine months of 2015, with Carticel revenue increasing 9% and Epicel revenues increasing 5%, respectively, compared to the same period in 2015;

Implemented the new agreement with Dohmen Life Science Services, LLC for patient support services, as well as payer contracting and product reimbursement services, for Carticel and MACI, if approved;

Increased preparations for the potential launch of MACI in anticipation of the January 3, 2017 PDUFA goal date;

Received FDA approval for in-house production of 3T3 cells used in the Epicel manufacturing process, which is expected to yield more than $1 million in annual savings in cost of product sales once the current inventory of purchased 3T3 cells is exhausted;

Entered into an expanded $20 million credit facility and term loan with Silicon Valley Bank and MidCap Financial Services and a $25 million common stock at the market offering program with Cowen and Company, LLC;

Announced the acceptance of an abstract for presentation on November 14, 2016 at the American Heart Association’s Scientific Sections 2016 entitled: “Reduction in Ventricular Arrhythmias with Ixmyelocel-T: Results from the ixCELL-DCM Trial”;
and
Initiated the open-label crossover portion of the ixCELL-DCM study with the first patient treated in October 2016.

“This is an exciting time for Vericel as we head into our historically strongest quarter of the year, prepare for the potential launch of MACI and expand our promotional efforts for Epicel,” said Nick Colangelo, president and CEO of Vericel. "We believe that the investments we are making to expand our commercial organization and implement new programs to support our patients and other key stakeholders will drive a period of significant growth for the company in 2017 and beyond.”


Seems like a lot going on for a company with a Market Cap of only $79M, 3 FDA approved products and another on the way.

Many times when a stock a person owns has a down period it is easy to get angry or frustrated. Those who make buy & sell decisions based more on emotion than logic can often make incorrect decisions during these periods. Right now there are people claiming MACI is a fraud, the company is a scam, and the management of VCEL doesn't know what they are doing. All this because the share price has been going down.

I suppose it is possible that all those things are true, but there doesn't seem to be any evidence for those claims. Better to look at more likely reasons for the drop.

A good starting point would be to take a look at the Biotechnology index. If you do you would find that on January 10th it was at 2997 and today it is at 2804. That's a drop of 193 points or 6.4% in just 2 weeks. During the same period VCEL has gone from 2.85 down to now at 2.50. A drop of .35 or 12%. Generally microcaps like Vericel can go up or down 3 to 5 times what their index does. So a 2 times drop is actually not bad.

So a rational conclusion might be that the drop has more to do with market sentiment towards the industry as a whole rather than something horrible specifically about this company. Just something to think about.

Interesting article regarding MACI recovery time:

http://www.workerscompensation.com/compnewsnetwork/news/25181-new-maci-knee-cartilage-surgery-shortens-rtw-time.html