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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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#7592   As far as I know the date for manisero66 04/18/18 08:47:28 AM
#7591   Thx Chris Whalatane 04/13/18 03:57:41 PM
#7590   At the conference was talked that VERICEL only manisero66 04/12/18 12:40:41 PM
#7589   Kiwi, This is what they spoke about on analyst Chris2125 04/12/18 10:59:44 AM
#7588   M. Can you provide any links, video's of Whalatane 04/12/18 10:54:47 AM
#7587   Chris ( plus anyone else on this board Whalatane 04/12/18 10:39:29 AM
#7586   Anyone have a target marketcap for VCEL? $1 iOSecure 04/12/18 10:13:09 AM
#7585   New 52 week high. Looking great for 20+ silvergun 04/12/18 09:48:49 AM
#7584   Everlasting conference done by surgeons, Ceo, management and manisero66 04/12/18 09:42:15 AM
#7583   New YouTube Vericel´s video "Maci implant from Vericel manisero66 04/09/18 09:48:49 AM
#7582   Is it possible or not possible for stem Murph1953 04/08/18 12:59:01 AM
#7581   They shut down the idea of expansion into Lunacy aka John Galt 04/06/18 01:09:16 PM
#7580   Thanks Luna. I suppose that MACI is not manisero66 04/06/18 01:07:15 PM
#7579   Lun. thx for the Whalatane 04/06/18 11:56:29 AM
#7578   Very limited right now. I would love Lunacy aka John Galt 04/06/18 11:01:38 AM
#7577   Just a question for you gentlemen....We all know manisero66 04/06/18 09:48:35 AM
#7576 Lunacy aka John Galt 04/05/18 03:17:50 PM
#7575   Kiwi, Yes that was published April 4. Chris2125 04/05/18 10:11:35 AM
#7574   Question, for those of you more knowledgeable than too simple 04/05/18 09:56:15 AM
#7573   Thx Chris Was that today / recently Kiwi Whalatane 04/04/18 10:00:54 PM
#7572   Kiwi, Chris2125 04/04/18 09:50:09 PM
#7571   Great DD thanks . Whalatane 04/04/18 07:29:29 PM
#7570   04/04,just over an hour´s trade. 14% UP , manisero66 04/04/18 10:50:55 AM
#7569   This is great news for VCEL... Lunacy aka John Galt 04/04/18 10:50:49 AM
#7568   Shorts camping in VERICEL at ease in just manisero66 04/02/18 01:13:51 PM
#7567   Now going for new first support level at manisero66 03/28/18 11:14:09 AM
#7566   Yes I agree. Seeing a lot of sell silvergun 03/28/18 09:53:29 AM
#7565   We’ve been here before and will be here Lunacy aka John Galt 03/27/18 02:04:24 PM
#7564   Right now I think that VERICEL has done manisero66 03/27/18 01:34:25 PM
#7563   What do U guys think of this price silvergun 03/27/18 10:32:33 AM
#7562   Yea long term chart and company prospects both silvergun 03/23/18 10:17:24 AM
#7561   I expect a strong surge from now on manisero66 03/23/18 09:10:23 AM
#7560   Amazing praise coming from the CEO of Histogenics commoncentsinvestor 03/15/18 08:13:16 PM
#7559   It seems going down towards $10.40 support.At this manisero66 03/12/18 11:51:14 AM
#7558   There was also a $2mm write off for Tomog 03/09/18 10:48:12 PM
#7557   Luna, Thanks again. manisero66 03/09/18 04:09:59 PM
#7556   The $1m was an upfront payment to VCEL. Lunacy aka John Galt 03/09/18 12:22:40 PM
#7555   Thanks Luna. I don´t understand that only $1m manisero66 03/09/18 12:15:23 PM
#7554   Also, only $1m of the ICT $ was Lunacy aka John Galt 03/09/18 07:49:15 AM
#7553   Q1 17 revenue was only $9m. Q1 Lunacy aka John Galt 03/09/18 07:47:51 AM
#7552   -0,13,EPS is the estimate for 1q 2018 I manisero66 03/09/18 07:39:25 AM
#7551   Yes and very few shares available for trading silvergun 03/07/18 06:48:10 PM
#7550   This quickly went from a drastically undervalued ticker Lunacy aka John Galt 03/07/18 01:03:42 PM
#7549   Actually now with a high of 12.80 maybe silvergun 03/07/18 10:48:03 AM
#7548   well it all cant happen in 1 day silvergun 03/06/18 11:48:26 AM
#7547   Some stops got triggered. Oh well, that was MrWizWard 03/06/18 09:59:41 AM
#7546   He hinted some history about IXMYCELL but nothing manisero66 03/06/18 09:58:57 AM
#7545   looks like profit taking this morning. TVDirector 03/06/18 09:38:08 AM
#7544   All boilerplate language. Lunacy aka John Galt 03/06/18 09:29:40 AM
#7543   Today's 10-K > 100's of cautionary possibilities! Plus crudeoil24 03/06/18 09:23:46 AM