Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
hold on, Epicel is from your own body and does not have rejection
common, in your talk to me, is it Autologous Cell Therapy? , not all skin replacement is from your own body and grown, so there is no rejection
Thoughts?
VCEL Regarding FDA approval of MACI stem cells, If this doesn't tickle your fancy, I don't know what would
Epicel, watch the video in full screen with sound cranked up! And with your wife.
https://player.vimeo.com/video/174392248?autoplay=1
lasers, has the fda ever approved a drug without going to ph 3 ?
Like lasers says, this is a AMGN in the making, no competition in the stem cell arena for 3 to 5 years per the 12-14-2016 CC
Not to mention Epical sales going potentially 50x with the new FDA HDE
And the Ixmyelocel-T Heart stem cell surfacing to phase 3 maybe in Japan for FAST TRACK
30 to 100 PT in 3 to 5 years, imho
Question is, can you hold that long
VCEL IMHO, I think we will hit our analyst targets by mid half of 2017
No brainer, all we need now is some insider buying over and above the employee stock purchase plan in effect.
13 minute mark of that video ceo says VCEL will be the first profitable stem cell company
17 minute mark of 12-14-16 CC discusses MACI pricing
http://edge.media-server.com/m/p/c6n8umpi
noun: parity
1.
the state or condition of being equal, especially regarding status or pay.
"parity of incomes between rural workers and those in industrial occupations"
synonyms: equality, equivalence, uniformity, consistency, correspondence, congruity, levelness, unity, coequality
"we strive for a parity of wages"
So approximately $44k per MACI potential market 20,000 procedures = $900M aprox, starting Mid January 2017
Yes that is correct per the 5 minute mark of this VCEL slide presentation video, Oct 2016
VCEL Japanese Partnership mid to 2nd half 2017 per the 24 minute mark of this:Ladenburg Thalmann 2nd Annual Healthcare Conference
September 27, 2016
New York, NY
http://wsw.com/webcast/ladenburg2/vcel/index.aspx
Note you can fast forward to the time on the video to the 24 minute of this webcast, and listen to the next few minutes to end
VCEL So we may have some word on Ixmyelocel-T by June 2017
http://vcel.com/about-vericel/
http://vcel.com/about-vericel/
How did they pull that off?
http://www.nasdaq.com/symbol/vcel/short-interest
12/15/2016 277,977 5,838,814 1.000000
11/30/2016 289,423 256,504 1.128337
11/15/2016 463,674 357,618 1.296562
after the bell
Lasers, we get our 12-15 short numbers after the bell today.
But what is going on with the Cowen ATM, is it still open or closed? I wish VCEL mgmt would press release to us if it is closed.
Are we going to see a short covering of any sort today?
Piper's offering is closed, is the Cowen ATM still open, are they the ones shorting this, manipulating the share price?
Next Tuesday after the bell we get the 12-15-2016 short numbers.
VCEL, cheap shares after hours, ceo said at PIPER JAFFARY conference on 11-30-2016 MACI will start in January 2017 and sales can be 20x of that of CARTICEL, 800 MILLION and EPICEL can be 50x of current revenues of like 10 million now, or 500 MILLION
http://edge.media-server.com/m/p/etsr9s8y
13 minute mark and 19 minute mark
Must be why PIPER JAFFARY scooped up the over allotment of the offering, no brainer for them., jmho
VCEL Excellent news
The shares include 930,000 shares of common stock sold pursuant to the over-allotment option granted by the Company to the underwriters
VCEL, I ALREADY LOVE 2017, going to be our best year advancing, and Ixmyeloce-T is going to be our wild card
I just pray there are no more atm's or equity raises.
lasers, do you know how powerful of a press release that would be
IMO
in 2017 $VCEL expands MACI with FDA approval for other other key mobility joints required for Athletic performances such as shoulder rotary cuffs, hips, elbows etc.
lasers, in your guess, if there was no more dilution ever again, what would be the minimum amount of revenues to put the pps at 10, what about min revenues to put pps at 20 under the current post December 21 share structure
When does anyone think any updrades will come about here, when MACI gets going in January 2017 or sooner ?
I wouldn't expect any upgrades until after the December 21 one is closed.
VCEL, Partnership with a Japan pharmaceutical company for FAST TRACK of the Ixmyelocel-T should boost the pps Hugely.
lasers, did they
do both the 25mil atm and this 17 mil equity raise
or did one get cancelled, or modified
I don't think they need more cash, they are seeking the Japenese Partnership for Ixmyelocel-T for FDA Fastrack
Any chance of a new Analyst PT ? After the conference call today ?
Next stop $8 - $12 so the $7.40 guy makes his juice. imho
lasers, that atm should be complete, wouldn't ya think?
C'mon, CarticeL is 1 hour with STICHES TO HOLD DOWN FLAP , MACI is 15 minutes stem cell with glue, less invasive
GOLD MINE
COWEN should be done, ATM sold in full, any thoughts
Conference Call Information
Today's conference call will be available live at 9:00am (EST) in the Investors section of the Vericel website at http://investors.vcel.com/events.cfm. Please access the site at least 15 minutes prior to the scheduled start time in order to download the required audio software if necessary. To participate in the live call by telephone, please call (877) 312-5881 and reference Vericel Corporation investor call. If calling from outside the U.S., please use the international phone number (253) 237-1173. If you are unable to participate in the live call, the webcast will be available until December 13, 2017. A replay of the call will also be available until 12:00pm (EDT) on December 18, 2016 by calling (855) 859-2056, or from outside the U.S. (404) 537-3406. The conference ID is 39558058.
MACI is the first FDA-approved cellularized scaffold product that applies tissue engineering processes to grow cells on scaffolds using healthy cartilage tissue from the patient’s own knee.
“Bringing an important new therapy to orthopedic surgeons and patients is a significant milestone for Vericel, and I would like to thank the FDA for working closely with us to make MACI available for these patients,” said Nick Colangelo, president and CEO of Vericel. "We believe that the introduction of MACI, along with investments to expand our commercial organization and implement new patient support programs, positions Vericel to generate significant growth in 2017 and beyond."
Conference Call Information
Today's conference call will be available live at 9:00am (EST) in the Investors section of the Vericel website at http://investors.vcel.com/events.cfm. Please access the site at least 15 minutes prior to the scheduled start
Conference call 9am, calling in sick to work today
4.70
First Tissue-Engineered Autologous Cellularized Scaffold Product Approved by the FDA
Conference Call Today at 9:00am Eastern Standard Time
CAMBRIDGE, Mass., Dec. 14, 2016 (GLOBE NEWSWIRE) -- Vericel Corporation (VCEL), a leading developer of expanded autologous cell therapies for the treatment of patients with serious diseases and conditions, today announced that the U.S. Food and Drug Administration (FDA) has approved MACI® (autologous cultured chondrocytes on porcine collagen membrane) for the repair of symptomatic single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults.
“The treatment of articular cartilage defects in the knee is challenging because articular cartilage in adults has minimal capacity to repair itself,” said David Recker, MD, chief medical officer of Vericel. “While orthopedic surgeons have long understood that autologous chondrocyte implantation can regenerate cartilage tissue, the previous surgical procedure was technically complex and time consuming, and the indicated patient population was limited. MACI is the first product to show a statistically significantly greater improvement in KOOS pain and function scores compared to microfracture, a commonly performed alternative surgical treatment for cartilage repair, in a well-controlled Phase 3 clinical study. With the introduction of MACI, orthopedic surgeons will have a simplified treatment option available for a broader patient population supported by solid clinical evidence.”
The approval of MACI is based on the SUMMIT study (Superiority of MACI implant versus Microfracture Treatment in patients with symptomatic articular cartilage defects in the knee), a two-year prospective, multicenter, randomized, open-label, parallel-group study which demonstrated a statistically significantly (p=0.001) greater improvement in KOOS pain and function (SRA) scores in the MACI group compared to the microfracture group at two years. Patients from the two-year SUMMIT study had the option to enroll in a three-year follow-up study (extension study). A majority of the patients who completed the SUMMIT study also participated in the extension study. Overall efficacy data support a long-term clinical benefit from the use of MACI in patients with cartilage defects of the knee.
MACI is the first FDA-approved cellularized scaffold product that applies tissue engineering processes to grow cells on scaffolds using healthy cartilage tissue from the patient’s own knee.
“Bringing an important new therapy to orthopedic surgeons and patients is a significant milestone for Vericel, and I would like to thank the FDA for working closely with us to make MACI available for these patients,” said Nick Colangelo, president and CEO of Vericel. "We believe that the introduction of MACI, along with investments to expand our commercial organization and implement new patient support programs, positions Vericel to generate significant growth in 2017 and beyond."
Conference Call Information
Today's conference call will be available live at 9:00am (EST) in the Investors section of the Vericel website at http://investors.vcel.com/events.cfm. Please access the site at least 15 minutes prior to the scheduled start time in order to download the required audio software if necessary. To participate in the live call by telephone, please call (877) 312-5881 and reference Vericel Corporation investor call. If calling from outside the U.S., please use the international phone number (253) 237-1173. If you are unable to participate in the live call, the webcast will be available until December 13, 2017. A replay of the call will also be available until 12:00pm (EDT) on December 18, 2016 by calling (855) 859-2056, or from outside the U.S. (404) 537-3406. The conference ID is 39558058.
About MACI
MACI (autologous cultured chondrocytes on porcine collagen membrane) is an
If any Upgrades and PT put out, please post link
4.55 and 300k vol
4.40 now, take us to the teens
VCEL, now this is amazing
http://www.bizjournals.com/boston/news/2016/12/13/fda-approves-cambridge-based-vericels-knee.html?ana=yahoo&yptr=yahoo
It has been a down year for FDA approvals, with just 20 new drugs approved thus far. That's compared to more than 40 in each of the past two years. Maci is only the fourth biotech treatment to get FDA approval this year developed by a Massachusetts-based company.