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Vericel Corp. (VCEL)

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Vericel Corporation. (VCEL)




Acquisition of Sanofi’s CTRM Business
On May 30, 2014, we completed the acquisition of the Cell Therapy and Regenerative Medicine (CTRM) business of Sanofi, a French  société anonyme  (Sanofi), certain assets, including all of the outstanding equity interests of Genzyme Biosurgery ApS (now known as Vericel Denmark ApS), a wholly-owned subsidiary of Sanofi, and over 250 patents and patent applications of Sanofi and certain of its subsidiaries, and assumed certain liabilities for purposes of acquiring the portion of the CTRM business, which researches, develops, manufactures, markets and sells Carticel, MACI and Epicel.
We believe that our acquired CTRM business has been a pioneer in the development and commercialization of autologous cell therapies. The CTRM portfolio includes three autologous cell therapy products: Carticel (autologous cultured chondrocytes), a first-generation product for autologous chondrocyte implantation (ACI) currently marketed in the U.S., Epicel (cultured epidermal autografts), a permanent skin replacement for full thickness burns in adults and pediatrics with greater than or equal to 30% of TBSA, also currently marketed in the U.S, and MACI (matrix-applied characterized autologous cultured chondrocytes), a third-generation ACI product approved in Europe and for which a Biologics License Application (BLA) is under review by the FDA. Our product candidate portfolio also includes ixmyelocel-T, a patient-specific multicellular therapy currently in development for the treatment of advanced heart failure due to ischemic DCM.




                                                                      Click on Yellow to REVIEW FDA WEBSITE APPROVING MACI


Interesting FDA Transcript discussions on MACI going forward for widened age bracket and other body joints. 
                                                                                                                                      CLICK ON THE ABOVE LINK



 Our preapproval stage portfolio includes ixmyelocel-T, a unique patient-specific multicellular therapy derived from an adult patient’s own bone marrow which utilizes our proprietary, highly automated and scalable manufacturing system. Our proprietary cell manufacturing process significantly expands the mesenchymal stromal cells (MSCs) and M2-like anti-inflammatory macrophages in the patient’s bone marrow mononuclear cells while retaining many of the hematopoietic cells. These cell types are known to regulate the immune response and play a key role in tissue repair and regeneration by resolving pathologic inflammation, promoting angiogenesis, and remodeling ischemic tissue. The novelty and advantage of using ixmyelocel-T is the expansion of a unique combination of cell populations, including MSCs and M2-like macrophages, which secrete a distinct combination of angiogenic and regenerative factors, and possess the ability to remain anti-inflammatory in the face of inflammatory challenge.

Our lead clinical development program for ixmyelocel-T is focused on severe, chronic ischemic cardiovascular diseases. We have completed the double-blind portion of the Phase 2b ixCELL-DCM study, which is a randomized, double-blind, placebo-controlled clinical trial for patients with advanced heart failure due to ischemic DCM. Ixmyelocel-T has been granted a U.S. Orphan Drug designation by the FDA for the treatment of DCM. We also have conducted clinical studies for the treatment of critical limb ischemia and the treatment of craniofacial defects.
The Phase 2b ixCELL-DCM clinical study treated 114 patients at 28 sites in the U.S. and Canada. We completed enrolling and treating patients in February, 2015. Patients were followed for 12 months for the primary efficacy endpoint of major adverse cardiovascular events, defined as all-cause deaths, all-cause hospitalizations, and unplanned outpatient or emergency department visits for IV treatment of acute worsening heart failure. Secondary endpoints include clinical, functional, structural, symptomatic, quality of life, and biomarker measures at 3, 6 and 9 months. On March 10, 2016, we announced the trial had met its primary endpoint of reduction in clinical cardiac events, and that the full data results from the ixCELL-DCM trial were presented at the Late-Breaking Clinical Trial Sessions of the American College of Cardiology 65 th Annual Scientific Session & Expo on April 4, 2016. On April 4, 2016, we announced that incidence of adverse events, including serious adverse events, in patients treated with ixmyelocel-T was comparable to or lower than patients in the placebo group.  With respect to the secondary endpoints of the trial, the components of the primary endpoint were also analyzed using the Win ratio in a hierarchical manner to incorporate both the incidence and timing of the endpoint components.  The Win ratio result of 1.56 showed that more often ixmyelocel-T was the "winner" in that the time to death, left ventricular assist device placement, heart transplantation or time to cardiovascular hospitalization was shorter for placebo-treated patients, but this difference did not reach statistical significance.  The time to first

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event was longer in the ixmyelocel-T group compared to placebo, but was not statistically significant.  There were no significant structural changes in left ventricle cavity size or left ventricular ejection fraction as measured by echocardiogram in either the ixmyelocel-T or placebo groups.  Both treatment groups had an improvement in the New York Heart Association class and six-minute walk test, with no statistical difference between the groups after 12 months using the last observation carried forward. Because the trial met the primary endpoint, patients who had been assigned to the placebo group or randomized to ixmyelocel-T in the double blind portion of the trial but did not receive ixmyelocel-T will be offered the option to receive treatment.
Future development plans for ixmyelocel-T are dependent upon input from our regulatory interactions and the availability of financing. We are focused on determining the most appropriate manner to fund future development of ixmyelocel-T, balancing risk to the overall business, dilution to current shareholders, and retaining a significant portion of the upside potential of the program for the company and our shareholders.

Ixmyelocel-T for Craniofacial Tissue Engineering

                           Click on above picture to enter another talk/idea zone


About Vericel Corporation:

Vericel develops, manufactures, and markets autologous cell-based therapies for patients with serious diseases and conditions. The company markets two cell therapy products in the United States. Carticel® (autologous cultured chondrocytes) is an autologous chondrocyte implant intended to treat cartilage defects in the knee in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure. Epicel® (cultured epidermal autografts) is a permanent skin replacement for the treatment of patients with deep dermal or full thickness burns greater than or equal to 30% of total body surface area.  Vericel is also developing 2 additional cell products. MACI is a third generation autologous chondrocyte implant intended to treat cartilage defects in the knee. Ixmyelocel-T is a multicellular therapy intended to treat advanced heart failure due to ischemic dilated cardiomyopathy (DCM).

Developing autologous (patient’s own) cell therapies—with integrity
Vericel uses rigorous scientific methods to develop novel therapies for the treatment of patients with autologous (patient’s own) cells.  In addition, personal integrity, team work, collaboration, and innovative technology are the foundations of our work.  We seek to practice transparency in our clinical trials and research, and in our relationships with each other, our patients, and the investors who support us.

                                                                                               CLICK ON ABOVE PICTURE TO SEE NASDAQ.COM SHORT INTEREST

Clinical Research:
Recent News:

Events and Presentations:

Analyst Coverage:


Share Structure:
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YOU TUBE VIDEOS, and the fourth video down, you will NOW appreciate the meaning of less invasive on the new FDA approved MACI procedure and why MACI is anticipated to be 20x the procedures of Carticel  MUST WATCH

Conference Calls
September 27, 2016 Ladenburg Thalmann
October 24, 2016 Meeting on the Mesa
November 30th, 2016 The 28th Annual Piper Jaffray Healthcare Conference
December 14th, 2016 Vericel Corporation Investor Call

Investor Relations:




 Yummy Land, click on Above Picture


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#4674  Sticky Note The ixCELL-DCM Trial: Transendocardial Injection of ixmyelocel-T in lasers 04/05/16 05:33:01 PM
#7452   Not a word on ixCELL in the Needham MaineMan5 01/19/18 03:18:22 PM
#7451   It's really hard to get more Bullish than Lunacy aka John Galt 01/19/18 03:03:49 PM
#7450   Thanks for the connection CW. Yes, when I MaineMan5 01/19/18 02:47:47 PM
#7449   Here’s an interesting conduit to the RTW knowledge Cat Whisperer 01/19/18 10:35:20 AM
#7448   I do not feel alone any longer now manisero66 01/18/18 07:20:09 PM
#7447   From the RTW website: MaineMan5 01/18/18 03:08:12 PM
#7446   New 13G Lunacy aka John Galt 01/18/18 01:01:54 PM
#7445   We'll see if buzz becomes fact.. Eblair84 01/16/18 06:40:37 PM
#7444   MACI alone warrants a 300MM-500MM+ market cap. Epicel meistermell 01/16/18 05:56:59 PM
#7443   3 products for vericel? Epicel, Maci... What else? Eblair84 01/15/18 02:35:52 PM
#7442   Anaptysbio goes over $110 Wall per share since manisero66 01/15/18 08:13:54 AM
#7441   We won't see q anything before March.. You Eblair84 01/13/18 11:10:43 AM
#7440   No that’s q1 2018. At least my E*TRADE silvergun 01/13/18 11:07:58 AM
#7439   Early enough that one relatively small tranch has north40000 01/12/18 08:39:05 PM
#7438   North, Glad to see your a VCEL contributor Chris2125 01/12/18 08:05:39 PM
#7437   Haven't seen you in a month, lasers, on north40000 01/12/18 06:47:19 PM
#7436   Fair enough, my mistake! Eblair84 01/12/18 11:43:08 AM
#7435   Pretty sure q4 for vcel will be reported Eblair84 01/12/18 11:41:42 AM
#7434   Not at all. I say what I think manisero66 01/12/18 10:23:50 AM
#7433   Q4 2017 coming out January silvergun 01/12/18 08:42:11 AM
#7432   Would think earnings in March? Eblair84 01/11/18 08:58:24 PM
#7431   Thought you were short? Eblair84 01/11/18 08:54:36 PM
#7430   Vericel in sky-rocket like behaviour: Light-headed and heated manisero66 01/11/18 09:48:04 AM
#7429   One piece of good news and shorts get fried...... Gremlin3a 01/10/18 11:34:55 PM
#7428   Awesome 6.55 :) earnings 1/30 should be good. silvergun 01/10/18 02:58:09 PM
#7427   New 52 week high!! Only good news JDBJMB 01/10/18 01:59:33 PM
#7426   Finally back to $6! Waiting months for this. Lol NagStocks 01/08/18 11:41:19 AM
#7425   Were in a good spot now. Very strong silvergun 01/08/18 09:42:16 AM
#7424   Vericel Corporation (the “Company”) will be conducting meetings realfast95 01/08/18 08:40:46 AM
#7423   Thanks. Setting a particular dollar amount to exit a commoncentsinvestor 01/07/18 05:45:52 PM
#7422   I share your sentiment, and thanks for sharing Lunacy aka John Galt 01/07/18 02:18:08 PM
#7421   Back in June I made a comment on commoncentsinvestor 01/06/18 03:07:26 PM
#7420   It seems that now is downturn time, nothing manisero66 01/05/18 09:58:37 AM
#7419   Agreed. ICT wants IXCELL. They’ve mentioned it before CoastalTrader83 01/04/18 10:41:31 AM
#7418   Excellent stuff. Nice DD. Thx you . CoastalTrader83 01/04/18 10:36:59 AM
#7417   5.95 close on 1/3/18 realfast95 01/04/18 07:13:30 AM
#7416   new video 1/3/18 NewYorkOrtho realfast95 01/04/18 06:49:03 AM
#7415   1/2/2018 BTIG Research Set Price Target Buy $8.00 realfast95 01/04/18 06:46:05 AM
#7414   Thanks, CW - I think we are all MaineMan5 01/02/18 02:44:25 PM
#7413   the wording of the May 10, 2017 PR Cat Whisperer 01/02/18 02:21:34 PM
#7412   and another saying which says " Better sung manisero66 01/02/18 01:06:27 PM
#7411 $9. CoastalTrader83 01/02/18 12:49:48 PM
#7410   Summary: Piper Jaffray raised its price target on realfast95 01/02/18 12:23:31 PM
#7409   manisero, There's an old saying that goes something like commoncentsinvestor 01/02/18 12:19:02 PM
#7408   Big milestone + Big volumen - Down PS manisero66 01/02/18 10:30:36 AM
#7407   Yes . Agreed ! ICT wants to begin CoastalTrader83 01/02/18 10:21:19 AM
#7406   It will depend of the details of contract manisero66 01/02/18 10:16:19 AM
#7405   I liked that they specifically mention ixcell in MaineMan5 01/02/18 09:19:25 AM
#7404 Lunacy aka John Galt 01/02/18 08:21:10 AM
#7403   Let's hope 2018 starts out strong, Gremlin3a 01/01/18 07:31:30 PM