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Vericel Corp. (VCEL)

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Last Post: 9/19/2017 11:43:09 PM - Followers: 150 - Board type: Free - Posts Today: 19

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

Table of Contents
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

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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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News News Alert: Current Report Filing (8-k) 09/19/2017 04:07:20 PM
#4674  Sticky Note The ixCELL-DCM Trial: Transendocardial Injection of ixmyelocel-T in lasers 04/05/16 05:33:01 PM
#6498   VCEL is a much safer and with greater me33 09/19/17 11:43:08 PM
#6497   All SHs of VCEL should take a look north40000 09/19/17 09:17:09 PM
#6496   Tell me that when VCEL gets accelerated approval hurley cruppers 09/19/17 08:37:06 PM
#6495   I think the space they are playing in MaineMan5 09/19/17 08:31:39 PM
#6494   You are correct. Because of their dissimilarity in north40000 09/19/17 05:48:00 PM
#6493   We are fortunate in holding many 1000s of north40000 09/19/17 05:42:47 PM
#6492   Am not an expert but I think VCEL's MaineMan5 09/19/17 05:33:24 PM
#6491   This is exacting what I'm referring to ... pbor 09/19/17 05:27:38 PM
#6490   Speaking of Amgen, were we aware of this north40000 09/19/17 03:20:36 PM
#6489   Now, I can see this in 2 digits, pbor 09/19/17 02:20:32 PM
#6488   Now, let's raise the bar to 5.55 by pbor 09/19/17 09:37:39 AM
#6487   Yes, 20K procedures is the potential market for hurley cruppers 09/19/17 08:57:09 AM
#6486   $VCEL 300 MACI procedures for the QTR. 20,000 lasers 09/19/17 08:45:07 AM
#6485   300 MACI procedures covers the nut possibly hurley cruppers 09/19/17 08:16:35 AM
#6484   Congress cannot ask the Pharmaceutical Co, or the lasers 09/19/17 08:10:34 AM
#6483   pbor The "$1000 net profit on MACI per lasers 09/19/17 07:52:57 AM
#6482   lasers, can you clearify to pbor in post hurley cruppers 09/19/17 07:38:11 AM
#6481   I do not envision any benefits at this lasers 09/19/17 05:50:10 AM
#6480   north40000 I do not envision BMY/Halozyme technology to lasers 09/19/17 05:40:01 AM
#6479   From Roche/HALO PR: north40000 09/18/17 11:33:41 PM
#6478   I have not read the bill itself, but north40000 09/18/17 11:08:27 PM
#6477   This is NOT the case for $VCEL Ixmyelocel-T lasers 09/18/17 10:59:21 PM
#6476   I do not see a problem because IMO lasers 09/18/17 10:51:19 PM
#6475   Ixmyelocel-t is a procedure using the patient's own Gremlin3a 09/18/17 10:49:04 PM
#6474   Who would cover the costs of hospital and lasers 09/18/17 10:47:40 PM
#6473   But nothing done apparently....August 4th was date sent north40000 09/18/17 10:42:12 PM
#6472   Reps. Andy Biggs of Arizona and Brian Fitzpatrick lasers 09/18/17 10:40:14 PM
#6471   But note----> to be supplied at company cost north40000 09/18/17 10:36:29 PM
#6470   north40000 Thxs for that timely post on the lasers 09/18/17 10:33:50 PM
#6469 The Senate approved north40000 09/18/17 10:19:13 PM
#6468   Thanks Hurley. I have little doubt, this will pbor 09/18/17 10:12:39 PM
#6467   pbor, I don't have all the answers, but hurley cruppers 09/18/17 09:16:13 PM
#6466   Most welcome. lasers 09/18/17 09:06:19 PM
#6465   Thanks Laser for clarification. pbor 09/18/17 09:04:52 PM
#6464   There comes a time in Symptomatic heart lasers 09/18/17 09:04:34 PM
#6463   I am saying that $VCEL can get Commercial lasers 09/18/17 08:54:25 PM
#6462   Very informational, so you are saying accelerated approval hurley cruppers 09/18/17 08:22:46 PM
#6461   hurley cruppers that is correct. There is no lasers 09/18/17 08:06:02 PM
#6460   There is no time restriction for the BLA lasers 09/18/17 08:03:09 PM
#6459   It is the real deal with FDA approval lasers 09/18/17 07:57:49 PM
#6458   pbor, quick question, how can you make a hurley cruppers 09/18/17 07:03:47 PM
#6457   This gets more and more interesting. pbor 09/18/17 06:36:06 PM
#6456   Is the BLA still 12 months under RMAT hurley cruppers 09/18/17 06:34:26 PM
#6455   IMO also. IMO the FDA will approve Commercial lasers 09/18/17 06:23:21 PM
#6454   That is exactly why I think we will hurley cruppers 09/18/17 06:20:21 PM
#6453   The $VCEL Ixmyelocel-T three heart disease Clinical lasers 09/18/17 06:15:09 PM
#6452   We don't know the date of the FDA hurley cruppers 09/18/17 05:45:58 PM
#6451   Hurley, agree with your comment on accelerated approval. MaineMan5 09/18/17 05:33:23 PM
#6450   Just waiting to see if VCEL becomes profitable hurley cruppers 09/18/17 04:45:37 PM
#6449   Listing my dog and buying more $VCEL. :) pbor 09/18/17 02:32:20 PM