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Vericel Corp. (VCEL)

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Last Post: 5/25/2019 8:04:00 PM - Followers: 151 - 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:
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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
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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#7827   Pioneer’s Mitchell overcomes long odds to get to realfast95 05/25/19 08:04:00 PM
#7826   They were also on this TDA broadcast today. realfast95 05/23/19 04:17:38 PM
#7825   right now they're looking for the bottom TVDirector 05/23/19 04:08:02 PM
#7824   the UBS presentation (and May) had 3 panels. realfast95 05/23/19 03:57:41 PM
#7823   cant' see GERN either TVDirector 05/23/19 03:54:07 PM
#7822   You never know what $BMY would buy. realfast95 05/23/19 03:49:44 PM
#7821   designed to get you to their site TVDirector 05/23/19 03:44:34 PM
#7820   2 twitter accounts that is obviously BS said today realfast95 05/23/19 03:34:04 PM
#7819   must be a hell of conference! TVDirector 05/22/19 11:14:12 AM
#7818   low today 15.56 TVDirector 05/21/19 02:20:12 PM
#7817   while it appears there's no real reason for TVDirector 05/20/19 11:26:33 AM
#7816   If it goes below today's low 15.87. Then realfast95 05/20/19 10:20:37 AM
#7815   or opening a week premarket down significantly again- TVDirector 05/20/19 09:55:36 AM
#7814   same story, but covered by CBS with video realfast95 05/18/19 06:53:19 AM
#7813   and I always hate... TVDirector 05/17/19 04:00:50 PM
#7812   hope you are correct TVDirector 05/17/19 12:09:56 PM
#7811   NexoBrid DD - part 3 $MDWD realfast95 05/16/19 06:17:11 AM
#7810   Report: Vericel to supply Epicel-based grafts for baby realfast95 05/16/19 05:55:13 AM
#7809   Institutional ownership up to 96% with numerous new Lunacy_John Galt 05/15/19 02:05:10 PM
#7808   NexoBrid DD - part 2 - short term realfast95 05/15/19 01:11:25 PM
#7807   NexoBrid DD - part 1 - short term realfast95 05/15/19 12:46:21 PM
#7806   Oppenheimer gets it. realfast95 05/15/19 11:15:28 AM
#7805   gotta wonder TVDirector 05/15/19 10:26:48 AM
#7804   Tue - 13:34 Vericel analyst commentary at realfast95 05/08/19 05:25:46 PM
#7803   Vericel looks to market a gel for burns realfast95 05/08/19 07:14:01 AM
#7802   Earnings call transcript available realfast95 05/08/19 07:03:23 AM
#7801   Premarket is being done by junior trading. Excellent manisero66 05/07/19 08:40:09 AM
#7800   Still taking quite the beating premarket TVDirector 05/07/19 08:19:13 AM
#7799   The miss was because of Epicel. Excluding Epicel, realfast95 05/07/19 07:17:24 AM
#7798   Vericel EPS in-line, misses on revenue realfast95 05/07/19 07:07:20 AM
#7797   MediWound Enters into Exclusive License Agreement with Vericel realfast95 05/07/19 06:23:55 AM
#7796   Anticipation before earnings in the morning realfast95 05/06/19 04:30:25 PM
#7795   crossroads https://finviz.com/publish/050119/VCELc1dl1918.png realfast95 05/01/19 07:19:22 PM
#7794   shall I remove the rock to mention today's debacle? TVDirector 04/30/19 01:43:33 PM
#7793   very nice to see an up day! TVDirector 04/23/19 04:51:21 PM
#7792   Welcome @Briefingcom Followers! realfast95 04/18/19 09:42:01 AM
#7791   You certainly have a pattern of crawling out Lunacy_John Galt 04/18/19 12:23:14 AM
#7790   16.26!is quite the walking down! TVDirector 04/17/19 09:23:37 PM
#7789   Looks cheap here close to $16 VCEL should silvergun 04/17/19 06:23:08 PM
#7788   no news. they walked it down with weak realfast95 04/17/19 11:49:29 AM
#7787   What’s with the steep plunge this am? TVDirector 04/17/19 10:10:03 AM
#7786   Competitor HSGX officially dead. realfast95 04/08/19 07:48:13 AM
#7785   intra day 17.12 down .72 realfast95 03/27/19 11:46:11 AM
#7784   ouch- down over another buck since I wrote that! TVDirector 03/26/19 01:56:24 PM
#7783   18.83- low vol/interest + higher short holdings TVDirector 03/19/19 10:25:30 AM
#7782   The vast majority of the time the company Lunacy_John Galt 03/15/19 09:07:11 AM
#7781   Las Vegas AAOS convention realfast95 03/15/19 07:25:59 AM
#7780   Your suggestion that "surgeons study for the sake manisero66 03/15/19 12:28:48 AM
#7779   Of the 900 trained surgeons, many of them Lunacy_John Galt 03/14/19 05:37:51 PM
#7778   And 3.000 patients divided by 900 surgeons makes manisero66 03/14/19 05:08:42 PM