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Vericel Corp. (VCEL)

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Last Post: 9/17/2020 2:39:40 PM - Followers: 146 - Board type: Free - Posts Today: 0

Vericel Corporation. (VCEL) 

 

 

http://www.vericel.com/

 

 

http://epicel.com/healthcare-professionals/what-is-epicel/epicel-is-fda-approved/
https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/ucm543860.htm

vericel-map

COMPANY PRESENTATION, CLICK ON above picture AND HIT THE LEFT/RIGHT ARROWS FOR SLIDE SHOW





CLICK ON PICTURE ABOVE for GENZYME MACI Patient Information Sheet



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.
http://secfilings.nasdaq.com/filingFrameset.asp?FilingID=10025872&RcvdDate=6/2/2014&CoName=VERICEL%20CORP&FormType=8-K&View=html




 















 



 


                                                                      Click on Yellow to REVIEW FDA WEBSITE APPROVING MACI

                                                                                                                                                http://www.maci.com/

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




                   CLICK ON THE ABOVE PICTURE TO GO INTO VCEL'S CAREER'S SITE



IXMYELOCEL-T

 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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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
http://stemcellstm.alphamedpress.org/content/3/12/1495.full
https://www.findmecure.com/ClinicalTrials/Show/NCT00755911


                           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
 
 

Management:
http://vcel.com/about-vericel/#Management
 
Clinical Research: 

http://vcel.com/research-and-development/#cardioMyopathy
 
Recent News: 

http://investors.aastrom.com/releases.cfm
http://www.4-traders.com/VERICEL-CORP-18635051/
http://finance.yahoo.com/q/h?s=VCEL+Headlines

Events and Presentations:
http://investors.aastrom.com/events.cfm

Analyst Coverage:
http://investors.aastrom.com/analysts.cfm
http://www.streetinsider.com/Analyst+Comments/Vericel+(VCEL)+MACI+Approval+Puts+Profitability+Within+Reach+-+Needham+%26+Company/12343070.html
https://www.thecerbatgem.com/2016/12/19/needham-company-llc-analysts-give-vericel-corp-vcel-a-9-00-price-target.html
https://sportsperspectives.com/2016/12/22/piper-jaffray-cos-begins-coverage-on-vericel-corp-vcel.html
http://www.4-traders.com/VERICEL-CORP-18635051/consensus/
http://seekingalpha.com/symbol/VCEL
http://seekingalpha.com/article/1228921-is-takeda-interested-in-aastrom-bio

Filings:
http://www.sec.gov/cgi-bin/browse-edgar?company=&match=&CIK=0000887359&filenum=&State=&Country=&SIC=&owner=exclude&Find=Find+Companies&action=getcompany

Share Structure:
See Filings
http://data.cnbc.com/quotes/vcel
http://finance.yahoo.com/quote/VCEL/?p=VCEL

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=y3S1kFfT0Qk
https://www.youtube.com/watch?v=dP5TgnS3Vr4
https://www.youtube.com/watch?v=gCbpFoY6ZUM
https://www.youtube.com/watch?v=3MFL10O-avE  MUST WATCH
http://wnyt.com/health/maci-new-procedure-to-repair-damaged-knee-cartilage/4369510/
https://www.dvidshub.net/news/223965/wbamc-employs-state-art-knee-implant-first-time-dod

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:
http://investors.aastrom.com/index.cfm


 

 


 

 Yummy Land, click on Above Picture

 

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PostSubject
#7993   Don´t trust the Trust. julius66 09/17/20 02:39:40 PM
#7992   Trust Co > Sun Trust > Truist realfast95 09/17/20 11:13:49 AM
#7991   Truist tops VERICEL at $24. julius66 09/17/20 10:34:13 AM
#7990   Realfast thanks. Everything should be ready to commence julius66 09/16/20 10:45:49 PM
#7989   June 29th is when the FDA will reply realfast95 09/16/20 10:43:36 AM
#7988   Realfast does it mean that from 29th June julius66 09/16/20 10:38:22 AM
#7987   Vericel Corporation (NASDAQ: VCEL) today announced that the realfast95 09/16/20 07:38:08 AM
#7986   Thanks Realfast. Do you think Californian fires has julius66 09/13/20 04:54:29 AM
#7985   currently in a breakout range realfast95 09/11/20 10:41:48 AM
#7984   Hi Realfast. I find Vericel a very positve julius66 09/11/20 10:34:13 AM
#7983   On September 1, 2020, Gerard Michel notified Vericel realfast95 09/08/20 04:51:49 PM
#7982   MediWound and Vericel Announce Acceptance of the First realfast95 08/25/20 07:34:18 AM
#7981   unfortunately there isn't any catalyst until November, after realfast95 08/06/20 02:34:05 PM
#7980   I did not get a chance to listen too simple 08/06/20 01:56:50 PM
#7979   Vericel Q2 EPS $(0.18) Beats $(0.21) Estimate, Sales realfast95 08/05/20 08:09:10 AM
#7978   Vericel Announces Preliminary Second Quarter 2020 Financial Results realfast95 07/09/20 08:41:56 AM
#7977   We should see a response back on acceptance realfast95 07/02/20 01:31:34 PM
#7976   How long does it take the FDA to A2Z 07/02/20 01:04:33 PM
#7975   When the FDA "accepts" the Nexobrid filing, it realfast95 07/02/20 03:44:34 AM
#7974   Commercial launch of Nexobrid was expected for Q1 julius66 07/01/20 10:17:59 PM
#7973   MDWD is running, get on board realfast95 06/30/20 10:51:01 AM
#7972   And look at it run!!! TVDirector 06/30/20 10:32:19 AM
#7971   Vericel Announces Submission of Biologics License Application to realfast95 06/30/20 07:17:11 AM
#7970   insider seller COO exercised realfast95 06/18/20 04:10:42 PM
#7969   13G - 3,751,168 BROWN CAPITAL MANAGEMEN realfast95 06/10/20 12:47:52 PM
#7968   Needham analyst Chad Messer assigned a Hold rating realfast95 05/06/20 09:27:38 AM
#7967   transcript is available realfast95 05/05/20 04:50:26 PM
#7966   Ryan Zimmerman from BTIG reiterated a Buy rating realfast95 05/05/20 01:57:35 PM
#7965   Vericel Reports First Quarter 2020 Financial Results realfast95 05/05/20 09:35:20 AM
#7964   Any comments on earnings call? XenaLives 05/05/20 08:13:35 AM
#7963   Institutional ownership 86% XenaLives 05/01/20 08:22:55 AM
#7962   Blocks >=10K XenaLives 05/01/20 08:17:44 AM
#7961   interview on TDA realfast95 04/20/20 10:22:52 AM
#7960   Phase2 realfast95 04/17/20 02:02:13 PM
#7959   Phase 1 realfast95 04/17/20 12:32:58 PM
#7958   Press Release: Vericel Provides Business and Financial Updates realfast95 04/02/20 09:52:31 AM
#7957   Vericel continuity of business statement regarding COVID-19 realfast95 03/25/20 08:40:32 AM
#7956   Lmao Docstemcell2020 03/12/20 10:41:37 AM
#7955   I would sell any rally. realfast95 03/03/20 07:07:41 AM
#7954   Yup- another blood letting TVDirector 02/27/20 08:31:26 AM
#7953   And now even more blood.... MrWizWard 02/26/20 04:53:20 PM
#7952   and boom--- just like that TVDirector 02/26/20 01:04:29 PM
#7951   It´s raining hail. Something we don´t know, A julius66 02/26/20 10:25:35 AM
#7950   Edit PART TWO: TVDirector 02/26/20 10:15:36 AM
#7949   and another 6+% down already- TVDirector 02/26/20 09:51:51 AM
#7948   It is maddening. A good friend of who too simple 02/25/20 06:46:31 PM
#7947   the same thing happened in 2019 - Feb 26th realfast95 02/25/20 06:44:34 PM
#7946   fact stock is down nearly 3bucks and nearly 16% TVDirector 02/25/20 02:41:40 PM
#7945   You trying to tel me this is a Lunacy_John Galt 02/25/20 02:36:17 PM
#7944   bullish sign? TVDirector 02/25/20 02:33:55 PM
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