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Vericel Corp. (VCEL)

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Last Post: 10/16/2017 3:41:14 PM - Followers: 156 - 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
 
16

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
#4674  Sticky Note The ixCELL-DCM Trial: Transendocardial Injection of ixmyelocel-T in lasers 04/05/16 05:33:01 PM
#6852   4.65 is the technical 50% retrace from the realfast95 10/16/17 03:41:14 PM
#6851   4.65 is the technical 50% retrace from the realfast95 10/16/17 03:41:13 PM
#6850   IMO FDA just wanted to play it safe. me33 10/16/17 03:30:17 PM
#6849   If it does go lower I will be too simple 10/16/17 03:24:17 PM
#6848   That's fine. I'm just saying VCEL isn't going me33 10/16/17 11:30:50 AM
#6847   I am a 2 or 3 year long manisero66 10/16/17 11:28:43 AM
#6846   We will have an answer in about 3 hurley cruppers 10/16/17 11:16:24 AM
#6845   VCEL isn't going to $3.90. I think we me33 10/16/17 11:16:12 AM
#6844   I did not sell a single share I manisero66 10/16/17 11:10:46 AM
#6843   So you sold and you want it to hurley cruppers 10/16/17 10:39:14 AM
#6842   Vcel trying 4,50 once again sooner than manisero66 10/16/17 10:24:44 AM
#6841   $VCEL Job Openings lasers 10/14/17 07:00:02 AM
#6840   2017-10-13 13F-HR ACADIAN ASSET MANAGEMENT LLC Prev Shares pbor 10/13/17 01:12:50 PM
#6839   New job hire, so they do work weekends, hurley cruppers 10/13/17 07:15:58 AM
#6838   Can you be more specific? pbor 10/12/17 07:28:50 PM
#6837   IF VCEL STAY OVER 1,000,000 Wow1234 10/12/17 04:34:02 PM
#6836   And we will pass $6 into $7ish area pbor 10/12/17 11:21:05 AM
#6835   Good to see $VCEL in the $5s again. lasers 10/12/17 11:00:55 AM
#6834   Let's see how far this last half an pbor 10/11/17 03:30:25 PM
#6833   It looks a 7 feeter head and a manisero66 10/11/17 02:15:41 PM
#6832   looks like head and shoulders to me realfast95 10/11/17 01:24:44 PM
#6831   Drop from $6 to $4.60 COMPLETELY UNWARRANTED. commoncentsinvestor 10/11/17 01:20:05 PM
#6830   $VCEL HOD $5.00. Welcome back to the $VCEL $5s! lasers 10/11/17 01:07:57 PM
#6829   $VCEL trending back into the high $4s looking lasers 10/11/17 11:17:43 AM
#6828   north40000 $VCEL has super state of the art lasers 10/11/17 08:04:58 AM
#6827   Lasers, note my post #313532 on PPHM board north40000 10/11/17 07:51:19 AM
#6826   Exactly 4,50 is playing now as a big manisero66 10/11/17 05:08:57 AM
#6825   People most likely going to play it safe NagStocks 10/10/17 09:54:34 PM
#6824   Once we pass the $5 brick, in no pbor 10/10/17 06:04:57 PM
#6823   I don't remember if I posted this or pbor 10/10/17 01:31:53 PM
#6822   So what happened? commoncentsinvestor 10/10/17 12:38:27 PM
#6821   north40000 It is important to note that $VCEL lasers 10/09/17 06:58:14 PM
#6820   ICT and the Chinese hgov't ad already made lasers 10/09/17 02:22:00 PM
#6819   Look at your yellow sticky above ... Fwiw, all north40000 10/09/17 02:12:03 PM
#6818   When the Chinese gov't approves $VCEL Ixcell BLA lasers 10/09/17 02:04:32 PM
#6817   ICT China and $VCEL have already signed licensed lasers 10/09/17 01:33:38 PM
#6816   Were any patients in the trial you mention north40000 10/09/17 01:28:38 PM
#6815   $VCEL and ICT should then immediately submit to lasers 10/09/17 01:15:30 PM
#6814   I filled some around 4.8 this AM; will pbor 10/09/17 11:52:25 AM
#6813   Chinese stories apart and coming back to reality. manisero66 10/09/17 11:33:35 AM
#6812   Thxs for the China Pharmaceutical and Gov't update. lasers 10/09/17 10:43:55 AM
#6811   Anyone here good with charts ? Is this silvergun 10/09/17 10:40:30 AM
#6810   And China regulatory arm now accepting clinical trial north40000 10/09/17 10:13:30 AM
#6809   Yes there would be. However what is important lasers 10/09/17 10:08:49 AM
#6808   There maybe a difference between a wholly owned north40000 10/09/17 09:41:27 AM
#6807   I do not know. ICT may be a lasers 10/09/17 09:29:29 AM
#6806   Welcome back. I was just filling in for pbor 10/09/17 09:28:12 AM
#6805   Does it have an ADR traded in U.S.? north40000 10/09/17 09:24:32 AM
#6804   ICT is directly linked to the Chinese gov't lasers 10/09/17 08:59:09 AM
#6803   lasers http://in.reuters.com/article/us-china-pharmaceuticals/china-to-accept hurley cruppers 10/09/17 08:23:50 AM
PostSubject