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Vericel Corp. (VCEL)

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Last Post: 1/17/2019 8:43:19 AM - Followers: 154 - Board type: Free - Posts Today: 0

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:
See Filings

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
https://www.youtube.com/watch?v=3MFL10O-avE  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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#7738   Thanks Real! And no foreseeable competition! too simple 01/17/19 08:43:18 AM
#7737   2 billion dollar addressable market for MACI realfast95 01/17/19 06:02:20 AM
#7736   corrected link, kinda late realfast95 01/16/19 05:40:11 PM
#7735   Was a joke ihub is so comical runningsloth 01/05/19 06:25:44 PM
#7734   WHAT A POS!! runningsloth 01/05/19 06:25:11 PM
#7733   The other product realfast95 01/04/19 10:12:59 AM
#7732   what a year +300% realfast95 12/31/18 04:30:51 PM
#7731   The last remaining competition in the game is NOVOCART realfast95 12/24/18 02:30:32 PM
#7730   $HSGX toast. $VCEL monopoly realfast95 12/21/18 04:15:50 PM
#7729   On December 14, 2018, Vericel Corporation (the “Company”) realfast95 12/20/18 04:22:51 PM
#7728   sure did read... TVDirector 12/20/18 02:34:54 PM
#7727   Did you read the filings? Did you Lunacy aka John Galt 12/20/18 01:58:18 PM
#7726   and it never ceases to amaze me how TVDirector 12/20/18 11:57:24 AM
#7725   not sure if it's a christmas gift for TVDirector 12/20/18 11:53:57 AM
#7724   So far so good for VERICEL but I manisero66 12/20/18 07:46:56 AM
#7723   perhaps- but the increase has been expected and TVDirector 12/19/18 03:08:57 PM
#7722   This is market-wide with fed news... Lunacy aka John Galt 12/19/18 03:05:09 PM
#7721   a monster, yes... TVDirector 12/19/18 03:01:54 PM
#7720   She’s a monster GreenBastard 12/03/18 02:19:28 AM
#7719   This video explains in stark detail the trading north40000 11/28/18 06:13:58 AM
#7718   “Blow-out” revenues & earnings released, good YOY results. north40000 11/22/18 09:17:27 PM
#7717   I bought some back in 2016 at $2.00, phil anthropist 11/09/18 09:04:26 AM
#7716   I hardly ever post here but read a too simple 11/08/18 02:35:20 PM
#7715   Likewise, but not $millions; retained some 1000s of north40000 11/07/18 09:47:19 PM
#7714   There will be dips. I am holding a silvergun 11/07/18 04:54:49 PM
#7713   I sold too at 14.20 because I needed realfast95 11/06/18 04:59:07 PM
#7712   That’s why I sold. Buy back lower after BigBankStory 11/06/18 03:51:33 PM
#7711   52 week high 16.24 realfast95 11/06/18 11:10:27 AM
#7710   perhaps news was leaked yesterday, not shown on realfast95 11/06/18 08:20:21 AM
#7709   Vericel Reports Record Third Quarter Revenues of $22.5 realfast95 11/06/18 08:12:49 AM
#7708   10.7 was a steal. Should head back up silvergun 11/01/18 07:50:27 AM
#7707   Q4 is the strongest quarter because of a realfast95 10/31/18 12:58:14 AM
#7706   Once we know the cost of a procedure, manisero66 10/31/18 12:54:04 AM
#7705   $VCEL revenue estimates were based on submissions of realfast95 10/30/18 09:32:28 AM
#7704   scam advertisement on my ihub vcel page realfast95 10/29/18 04:36:27 PM
#7703   then the underlying issue is more complex and disconcerting. TVDirector 10/29/18 03:12:31 PM
#7702   weekly chart of the S&P with predictions. The realfast95 10/27/18 06:08:53 PM
#7701   article on seeking alpha today realfast95 10/25/18 08:48:05 AM
#7700   market chart and prediction realfast95 10/24/18 06:39:47 PM
#7699   chart realfast95 10/23/18 06:04:01 PM
#7698   not affected by, China, oil, steel, labor, Saudis, realfast95 10/23/18 12:08:11 PM
#7697   Deerfield Mgmt, L.P. 13G realfast95 10/22/18 06:38:42 AM
#7696   thanks for the, ahem, advice... TVDirector 10/18/18 02:45:29 PM
#7695   The options cashed in were rule 10b5-1. Lunacy aka John Galt 10/18/18 02:15:43 PM
#7694   Take a look at entire market; down since north40000 10/18/18 12:08:59 PM
#7693   and in the meantime,...... TVDirector 10/18/18 12:04:15 PM
#7692   VCEL has not traded at $20 as soon north40000 10/16/18 07:34:26 PM
#7691   Its not just VCEL the whole market looks silvergun 10/16/18 03:35:10 PM
#7690   down a buck today and like 3 since- TVDirector 10/15/18 03:54:36 PM
#7689   funny how magically the PPS rises when an TVDirector 10/10/18 09:47:34 AM